United States of America
Health ond Human Services
Importation Task Force
Stakeholder Meeting

Friday, May 14, 2004

The Task Force met in Conference Rooms D and E in the Parklawn Building, 5600 Fishers Lane, Rockville, Maryland, at 1:00 p.m., VADM Richard Carmona, Chairman, presiding.

TASK FORCE MEMBERS PRESENT:

VADM RICHARD CARMONA, Chairman

MR. JAYSON AHERN

MR. ALEX AZAR

DR. LESTER CRAWFORD

MS. TRACEY HARDIN

DR. WILLIAM RAUB

MR. AMIT SACHDEV

MS. ELIZABETH WILLIS

PRESENTERS:

Panel 1:

DR. RANDALL MAXEY, President, National Medical Association

DR. REBECCA PATCHIN, Trustee, American Medical Association

MS. KAREN COLLISHAW, Associate Executive Vice President of the American College of Cardiology (representing the Alliance of Specialty Medicine)

MS. SUSAN HILDEBRANDT, Assistant Director of Government Relations, American Academy of Family Physicians

DR. CAROLE JENNINGS, Legislative Liaison, American Academy of Nurse Practitioners

Panel 2:

MR. CARMEN CATIZONE, Executive Director/Secretary, National Association of Boards of Pharmacy

MS. SUSAN WINCKLER, Vice President, Policy and Communications, Staff Counsel, American Pharmacists Association

MR. DOUGLAS SCHECKELHOFF, Director, Section of Pharmacy Practice Managers and Director, Pharmacy Practice Sections, American Society of Health-System Pharmacists

DR. MARV SHEPHERD, Director, Center for Pharmacoeconomic Studies, College of Pharmacy, The University of Texas at Austin (representing the Academy of Managed Care Pharmacy)

MR. ROBERT McNELLIS, Director, Clinical Affairs and Education, American Academy of Physician Assistants

Panel 3:

MS. DEANNA WILLIAMS, Registrar, Ontario College of Pharmacists

MR. DONALD MacARTHUR, Secretary General, The European Association of Euro-Pharmaceutical Companies

MR. DAVID McKAY, Executive Director, Canadian International Pharmacy Association

MR. NATHAN JACOBSON, President & CEO, MagenDavidMeds.com

INDEX

I.  Opening Statement - Task Force Chair, VADM Carmona

II.  Panel I

Opening Remarks

Dr. Rebecca Patchin, Trustee, American Medical Association

Ms. Karen Collishaw, Associate Executive Vice President of the American College of Cardiology (representing The Alliance of Specialty Medicine)

Ms. Susan Hildebrandt, Assistant Director of Government Relations, American Academy of Family Physicians

Dr. Carole Jennings, Legislative Liaison, American Academy of Nurse Practitioners

Dr. Randall Maxey, President, National Medical Association

Questions & Answers

III.  Panel II

Opening Remarks

Mr. Carmen Catizone, Executive Director/ Secretary, National Association of Boards of Pharmacy

Ms. Susan Winckler, Vice President, Policy and Communications, Staff Counsel, American Pharmacists Association

Mr. Douglas Scheckelhoff, Director, Section of Pharmacy Practice Managers and Director, Pharmacy Practice Sections, American Society of Health-System Pharmacists

Dr. Marv Shepherd, Director, Center for Pharmacoeconomic Studies, College of Pharmacy, The University of Texas at Austin (representing the Academy of Managed Care Pharmacy)

Mr. Robert McNellis, Director, Clinical Affairs and Education, American Academy of Physician Assistants

Questions and Answers

IV.  Panel III

Opening Remarks

Ms. Deanna Williams, Registrar, Ontario College of Pharmacists

Mr. Donald MacArthur, Secretary General, The European Association of Euro-Pharmaceutical Companies      

Mr. David Mackay, Executive Director, Canadian International Pharmacy Association

Mr. Nathan Jacobson, President & CEO MagenDavidMeds.com

Questions and Answers

V.  Closing Statement - VADM Carmona

Adjournment

PROCEEDINGS

1:11 p.m.

SURGEON GENERAL CARMONA:  Good afternoon, ladies and gentlemen.  Thank you for being with us again for this Task Force Meeting on Drug Importation.  We were stalling a couple of minutes to see if the other Panel Members would come, so we'd have a full Panel when we begin, but we don't want to inconvenience anybody that's here already, so we'll get started and work in the other Panel Members as they arrive.

I'd ask the speakers to please be cognizant of the clock.  Again, we've requested that you keep your remarks to five minutes or less and we'll just go in succession across the table to all of the speakers and then the Task Force Members will be able to ask you questions at that point.

Otherwise, we'll conduct the meeting as we have the previous meetings, so there will be no changes.

Once again, thank you all for being with us, so Dr. Maxey is not here, so why don't we go ahead with Dr. Rebecca Patchin from the American Medical Association.

DR. PATCHIN:  Thank you, Dr. Carmona.  My name is Rebecca Patchin.  I am an anesthesiologist, a practicing pain management specialist and a member of the American Medical Association's Board of Trustees.

I'm in solo practice in Riverside, California where I've had a number of patients cross the border into Mexico to attempt to buy more cheaply the prescription medication that I have prescribed for them. 

Am I concerned about this?  Absolutely.  In fact, this is a concern shared by the AMA and practicing physicians across the U.S.  We are concerned because when patients go outside of this country to purchase their drugs, there is no way for physicians to be certain that the drugs they prescribe for them are the drugs they are going to receive.  Whenever patients get their prescription drugs from Mexico, Canada or the European Union, the concerns remain the same, that our patients are getting the right drug, the right dose, and in the right way.

What the right way means is that the drugs come from manufacturers, wholesalers, retailers, whether internet or brick and mortar pharmacies; that it can assure quality while at the same time balancing against the needs for patients to get their prescriptions at the lowest possible price.  But when it comes to drug importation, patient safety is the AMA's number one priority.

At its 2003 Annual House of Delegates Meeting, the AMA chose not to adopt a resolution supporting prescription drug importation.  Concerns over patient safety were at the center of AMA's debate.  On the legislative front, the AMA also opposed H.R. 2427, the Pharmaceutical Market Access Act of 2003, primarily because the bill lacked a provision that required the Secretary of HHS to certify the safety of imported drugs.

The only way to assure the safety of imported drugs is to make certain that all drugs for sale for patients in the U.S. are FDA approved.  That means, among other requirements, that the drug has been approved by the FDA for safety and efficacy, that the drug manufacturer has met all U.S. laws and regulations for good manufacturing practices, that the FDA has the authority to inspect all manufacturing facilities, that the drug has met all FDA labeling and packaging requirements, and finally, that the drug's chain of custody can be assured and traced.

Admittedly, these requirements would demand significant federal resources, but if we are to allow drug importation, these measures are necessary to protect the American people and to preserve our stringent and very effective approval process.

      Another AMA concern is drug counterfeiting.  In a recent FDA report, drug counterfeiting outside the U.S. was described as widespread and affecting the drug supply of both developing and developed countries.  In some instances, counterfeit drugs accounted for more than half of a country's drug supply.

The AMA has concerns that if prescription drugs are allowed to be imported from foreign countries, counterfeit drugs will more likely enter our system, a system that is now well protected for its drug distribution.  If we allow importation, the distribution system must be closed and all drugs must be subject to reliable, electronic track and trace methodology to secure the integrity of our drug supply chain and to prevent the importation of counterfeit drugs.

The AMA is also concerned with whether or not individual patients will be allowed to import drugs directly via the internet.  This is largely an unregulated area with an increasing number of rogue websites already selling prescription drugs of unknown quality and often without a valid prescription.  The problem is likely to increase, if direct importation by patients is legalized.

Without the safeguards I have described, the American people cannot be certain that the imported drugs they are taking are safe, effective and of high quality.  These may seem like high standards to demand, especially when many patients struggle to pay the high cost of their prescription drugs.  However, if we permit unsafe, ineffective, adulterated, misbranded, expired or counterfeit drugs to reach our patients, it may result in patient harm, even death.

To use an example from my field of pain management, if a subpotent or counterfeit drug means the difference between a scale of 6 on a 1 to 10 scale, and a scale of 9, I'm sure you can appreciate the difference that would be to you, if you were in that severe pain.

These and other patient safety issues must be weighed carefully before any decision should be made on drug importation.

Thank you for the opportunity to address you.  I'll be happy to answer your questions.

SURGEON GENERAL CARMONA:  Thanks very much.  Our next speaker, Ms. Karen Collishaw.

MS. COLLISHAW:  Thank you, Dr. Carmona.  Thank you for offering health care providers the opportunity to comment on the important public policy issue of prescription drug importation.

My name is Karen Collishaw and I am the Division Vice President for Science and Advocacy at the American College of Cardiology.  I am here today representing the Alliance of Specialty Medicine. Founded in 2001, the Alliance brings together 14 medical specialty societies representing over 200,000 physicians throughout the U.S.  The Alliance is dedicated to being a strong voice for specialty medicine and the patients who need access to specialty care.

The escalating cost of many prescription drugs affects the most vulnerable patients, the elderly, the uninsured, and those with chronic health conditions.  As is widely known, these patients often present with advanced and co-morbid conditions leading to complex decision making for physicians.  Unfortunately, this decision making process must include consideration of whether the patient can afford the most appropriate drug or in many cases multiple drugs for treatment.  The effectiveness of any disease management regimen will be seriously reduced if a patient skips doses to stretch medication or is forced to make the difficult decision not to fill a prescription because of a lack of financial resources.

The Alliance is most concerned that our nation's prescription drug importation policy be designed to provide a safe and reliable source of these medications for patients.  There are undoubtedly many safety and procedural issues associated with prescription drug importation that must be addressed by the FDA and other relevant agencies.

The Alliance supports the necessary authority and funding for these agencies to design and implement a monitoring system with controls to ensure the safety of imported drugs consistent with the provisions of current law.  Specifically, the safeguards in any and all importation policies must ensure that prescription drugs brought into our country are safe and effective for their intended use.

As you know, there are always opportunities for prescription errors, whether in the United States or any other country.  No system can be guaranteed 100 percent effective and sanitized against human error.  However, the protections specified under current law on this subject, in addition to innovation such as bar coding and tamper resistant packaging should help reduce the risks to patients for drug importation.

The Alliance recognizes that prescription drug importation is not the solution to address all problems that patients have with access to care.  However, the Alliance believes that importation of prescription drugs, done safely, may be in the step in the direction of reducing cost barriers and providing much needed financial relief for patients.

On behalf of the Alliance, thank you for the opportunity to share our views.

SURGEON GENERAL CARMONA:  Thanks very much.  Ms. Susan Hildebrandt.

MS. HILDEBRANDT:  Thank you.  Good afternoon.  I apologize for being late.

I'm Susan Hildebrandt and I'm Assistant Director of the Division of Government Relations with the American Academy of Family Physicians.  I've an extremely brief statement because perhaps like many of the groups, we are just beginning to look at this issue more thoroughly and we have really decided to look at the issue of drug importation really through the prism of drug coverage.

Frankly, we looked at this for the first time only about a year ago in May of 2003 and came up with a recommendation.  The key points in this recommendation were as follows:  first, the Academy believes that the re-importation or importation of pharmaceutical drugs from Canada and other countries is really symptomatic of a larger problem, namely, the lack of affordable prescription drugs.  Secondly, prescription drug costs and the lack of coverage really limits their availability in the United States.  And thirdly, the Academy really believes that Congress should address this issue and make sure that these drugs are available to patients at affordable prices.

Parenthetically, the Academy also believes that other issues such as internet drug -- the people getting drugs through the internet is also part of this larger high cost problem. 

Next week, our Academy's Commission on Legislation is going to be looking at this issue again and I don't know if our policy will be revised, but we are certainly looking at the two most recent pieces of legislation in Congress, namely, the bipartisan bill that was recently introduced and then the bill that was introduced by the Senate Finance Committee Chairman Grassley and at that point we may revise these comments.  But at this point, I appreciate the Academy's, you allow the Academy to present this statement.  Thanks.

SURGEON GENERAL CARMONA:  Thank you.  Next speaker, Dr. Carole Jennings.

DR. JENNINGS:  Dr.  Carmona, it's good to see you again.  I think you started your professional life in health care as a nurse.

SURGEON GENERAL CARMONA:  Yes ma'am.

DR. JENNINGS:  So it is nice to be here.  I am representing the American Academy of Nurse Practitioners.  We represent over 97,000 advanced practice nurse practitioners throughout the U.S. and we're very acutely aware of the high cost of prescription drugs.

As primary care clinicians who prescribe medications for their patients on a regular basis, nurse practitioners are reminded daily of the negative impact those costs have on the health of their patients.  Patients often do not fill their prescriptions or partially fill prescriptions because their cost of prohibited or they may take a medication that is prescribed daily two or three times a week.  They often make the medication last longer or they take medication temporarily until the next paycheck or pension check is available.  The result is poor management of illnesses, poor quality of life and increased need for hospitalizations and emergency room care.

The inability of patients to pay for prescription drugs actually increases the cost of medical care and the cost of chronic disease management which we know is now a very big priority with the Medicare Program.

When medications cannot be taken as directed, the risk for increased hospitalization and ER visits multiplies.  It is in the best interests of the American public that affordable ways to obtain medication be developed. 

And we have three principles or areas that we are particularly concerned about.  The first is safety, as my colleagues have also mentioned.  If drugs are to be imported, it's important to know that they are safe, that they don't have variable doses from tablet to tablet or capsule to capsule and that their composition consist of the correct therapeutic ingredients.

Consumer friendly.  If drugs are to be imported, it should be done so that patients can have access in a timely and uncomplicated manner.  If too many restrictions are placed on patients so that it becomes impossible to obtain drugs more cost effectively through this mechanism, then the purpose for drug importation is lost.

The last one, limiting access to provider groups.  If the implementation consists of identifying providers who can prescribe these drugs that have been brought over from Canada, we just ask that you include nurse practitioners because like our primary physician counterparts, it is a huge problem for us and for our patients.

So in conclusion, nurse practitioners remain acutely aware of the burden high cost prescription drugs places on patients and providers.  The Academy believes that steps do need to be taken to reduce the financial burden of these high cost prescription drugs.  We are so delighted that you asked us to participate.  We look forward to working with you as you implement the Medicare prescription drug legislation.

Thank you.

SURGEON GENERAL CARMONA:  Thank you very much.  I think what we'll do now is Dr. Maxey has not arrived yet, oh, there he is.  I'm sorry.  Perfect timing.  Dr. Maxey, right on cue.  Right there, sir.  Thank you for joining us.

DR. MAXEY:  Thank you.  How are you, sir?

SURGEON GENERAL CARMONA:  Dr. Maxey is from the National Medical Association and the floor is yours, sir.

DR. MAXEY:  Thank you, sir.  Just one second.

Good afternoon, Surgeon General Carmona and Members of the Secretary's Task Force on Drug, Food and Drug Importation.  The National Medical Association, the conscience of American medicine is America's premiere membership association of physicians of African descent.  As such, the NMA represents over 25,000 medical practitioners and the patients they serve.  Many of our patients are from underrepresented and underserved minority groups and are therefore representative of the most vulnerable populations seeking services from our nation's health care system.  These populations are also the victims of disparities in health care based upon race and ethnicity in their every day lives and communities across our nation.

Consequently, the outcomes of this inquiry process relating to drug re-importation is directly relevant to the practice of medicine for African Americans, in particular, and for the U.S. population as a whole.  We are appreciative, therefore, for this forum and we thank the Health and Human Services Task Force on Drug Importation for inviting us to participate.  We're hopeful that our input, in addition to the input of all the other stakeholders will bring us to a viable commonsense strategy for dealing with this thorny issue.

Fundamentally, the NMA, the National Medical Association, is of the opinion that the quality and safety of the drugs to be imported must be our paramount concern.  If any doctor or physician in America writes a prescription for a patient and cannot be confident that the prescription will be correctly filled, then the patient may as well have written the prescription.  It stands to reason then that the Food and Drug Administration's role in this process will be critical.

To this end, the following recommendations are been proffered by the NMA in response to the specific solicitation from the Task Force.  We have listed our responses in sequential order.

The first question, to assess the scope, volume and safety of unapproved drugs including controlled substances entering the United States via mail shipment.  The FDA should concern itself with determining which countries of the world have equivalent regulatory and approval processes for bringing pharmaceuticals to market.  There is also a need for determining the safety of said pharmaceuticals if they are to be imported into the U.S.  If the drugs are safely produced, we need to be certain that they are safely shipped as well.  The FDA could develop standard protocols that can be enforced at our nation's ports of entry.  These protocols could be signed affidavits from the issuing pharmacist that demonstrates that the products being inspected meet U.S. quality and safety standards and therefore merit allowance into the U.S.  The burden of proof could then be placed on the individual or individuals seeking to do the importing, thus minimizing the administrative/regulatory burden placed upon the resources of the FDA. 

Volume requirements should be reasonable.  If an individual U.S. citizen or resident attempts to bring drugs into the U.S., it should be up to them to demonstrate that the products are only for a specified period to treat a specific condition.  This information may be included as a line item on the aforementioned affidavit which should also be signed by the intended user or designee. 

If the affidavit is bar coded, it could be tracked for data collection and for enforcement purposes if any questions of legality later arise.  Any attempt to mislead the U.S. government in this process should be treated as a felony with the appropriate penalties.  Commercial shippers and mail carriers should be required to ask if packages contain prescription drugs and if so, require that customers present the aforementioned affidavits.

The second question:  to assess pharmaceutical distribution chain and the need for and feasibility of modifications in order to assure the safety of imported products.  If a prescription drug shipment goes through an intermediary before it gets to the intended consumer, then the intermediary should also be required to certify that the shipment is delivered to the intended recipient in the safest and timeliest possible fashion.  This would include relevant information such as meeting refrigeration and packaging requirements, for example.  This certification should be numerically linked to the aforementioned affidavit, probably as an addendum or Part B of the document.  Intermediaries of the supply chain should be restricted to certain categories of persons.  It is possibly safest if each category of intermediaries has a pharmacist designated for this purpose in order to improve the probability, the integrity of the product is maintained pending delivery to the customer.

The third question.  To determine the extent to which foreign health agencies are willing and able to ensure the safety of drugs being imported from their countries to the U.S.  This determination requires a collaboration of other U.S. government entities such as the Department of Commerce.  To the extent that international trade agreements affect these arrangements, the FDA should be given the prerogative in setting the pharmaceutical requirements necessary to protect the interest of the American consumer.  The protocols of foreign health agencies with regarding to exploiting their pharmaceuticals to the U.S. should be considered in light of what works best for our nation's taxpayers.

Fourth, to identify the limitations including limitations on resources and current legal authorities that may inhibit the Secretary's ability to certify the safety of imported drugs.  The NMA has no specific input on this question at this time.  But the current relationship between the FDA and the U.S. Customs is worth investigating.  It is probably worth the time and resources necessary to develop compatible documentation mechanisms for these two entities for the purpose of regulating drug importation.

Fifth, to estimate Agency resources including additional field personnel needed to adequately inspect the current amount of pharmaceuticals entering the country.  The NMA has no specific comments on this question at this time.

Sixth, to identify ways in which importation could violate U.S. and international intellectual property and describe the additional legal protections and agency resources that would be needed to protect those rights.  Foreign pharmacies should be prohibited from exploiting pharmaceuticals that do not pass U.S. safety and quality standards to the extent that the FDA can ensure compliance.

All American manufacturers should be held to the same standard, whether or not they manufacture generics.  The NMA is strongly committed to the principle that the best therapy should be sought for each patient irrespective of whether the drug is generic or brand name or for that matter whether the patent was issued in the U.S. or elsewhere.

Seventh, to estimate the cost borne by entities within the distribution chain to utilize anti-counterfeiting technologies that may be required to provide import security.  The NMA has no comments on this question.

Eighth, to assess the potential of short and long-term impacts on drug prices and prices for consumers associated with importing drugs from other countries.  An HHS entity such as the Agency for Health Care Research and Quality or the National Center for Health Statistics should be definitively involved in answering this vital question.  The findings would particularly be useful to the Centers for Medicare and Medicaid Services which, as we know, is America's most significant purchaser of pharmaceutical services.  The population served by CMS happened to significantly overlap with NMA's key constituencies, so we would be very interested to answer this question if as a nation we decide we can successfully import safe, top quality drugs, then it means viable competition for America's drug manufacturers, and therefore greater bargaining powers for purchasers such as CMS.  This should translate into lower out of pocket costs for the most vulnerable consumers who are currently forced to choose between medications and other essential goods and services.  HHS should commission a study on this question as soon as possible.

SURGEON GENERAL CARMONA:  Dr. Maxey, could you sum it up, please?

DR. MAXEY:  Yes sir.

GENERAL CARMONA:  Thank you.

DR. MAXEY:  The pharmaceutical industry should -- we do need to collect data to find out the best ways to approach this and NMA would support any efforts to do the research that are required to make sure that our patient's receive the best quality medications regardless of their conditions, whether they're imported or not.  Safety is the most important thing for the NMA.

Thank you.

SURGEON GENERAL CARMONA:  Thank you, sir.  At this time, I'd like to open the floor to questions from the Task Force Members.

Dr. Crawford?

DR. CRAWFORD:  Yes.  Thank you, Dr. Maxey, for your excellent testimony.  We appreciate it very much.

You had talked about some safe harbors for importation of drugs.  I have basically a two-part question.  One is if, in fact, we go forward with legislation which I believe you mentioned indirectly, I assume you would hope that they would require, that is, if there's a new law, to make this legal, country of origin labeling and if so, how prominent would you like that to be? 

You talk about FDA should determine what countries should be eligible to import or export to the United States under some new sort of scheme.  Normally, where the product is manufactured, if it's a U.S. product which is all we have to deal with now is sort of list it in very small print.

We've had these debates in the food area and in other areas that FDA regulates and it becomes a very big sticking point as to whether or not you want to clearly identify, some color coding scheme or something like that.

Do you have any thoughts on that?

DR. MAXEY:  Yes.  We do know that some countries are very sophisticated in terms of how they judge the quality of their drugs and we know that many of these drugs are manufactured by the same companies that manufacture here. 

Where we do lose control, even in the United States, is when we get to our wholesalers and get to the people who distribute and we know even here we don't have total control over the quality there.  So we do think that FDA standards, our high quality standards should be applied to some of the more sophisticated foreign countries and those should be probably the countries that we would limit where drugs would be imported from, if that's possible.

Clearly, there's some countries that are not up to snuff, where you couldn't certify anything and I think those would have to be a long time in coming.  So we're concerned with the safety of drugs we have now because we know once they leave the manufacturer, get to the wholesaler and distributer, we lose all control.  But to the extent that we can put controls in there, as well as in the more sophisticated foreign countries, then we are for bringing in things that can approach the treatment of our patients at a price they can afford.

DR. CRAWFORD:  And a follow-up, if I may?

SURGEON GENERAL CARMONA:  Please.

DR. CRAWFORD:  The next thing generally this takes us to is if, in fact, FDA or some other entity certifies that another country has the same kinds of standards, equivalent standards, would you countenance or what would be your opinion about some sort of labeling system which would say not FDA approved, let's say approved in Canada, for example.  Or would you want some sort of formal declaration of FDA approval?  See, we could do it a couple of ways and I'm not sure how to do it at this point.  But these are some of the kinds of questions that your testimony engender in my mind.

DR. MAXEY:  I don't claim to be an expert, but we do want to know that our FDA can have some sort of oversight of that process to the extent possible.  Somewhat of what you asked is a legal question and there's a liability question so if you certify something that you don't have total control of, you don't want to take that liability either.  But to the extent that we have control of our own system, we should try to have those countries that wish to cooperate with re-importation to have some standards that we can approve of.  That's as far as I could really say and be safe.

DR. CRAWFORD:  Thank you.

SURGEON GENERAL CARMONA:  Other questions?

Amit?

MR. SACHDEV:  This question is for Mr. Maxey and actually others, if they have comments, are free also to provide their input.

In all the discussions that we've had, your testimony was certainly the most complete and I appreciate the fact that you actually went through each of the questions that we are grappling with and try to provide us with information about those because in some cases, we've gotten testimony on certain questions, but not all of them.  And I think that's very appreciated.

One thing that you mentioned right up front that I want to ask you about is the comment that you made about equivalence and the need for the FDA, if Congress considers legalization of importation, to assure that any imported drugs are equivalent to U.S. drugs. 

Can you help us with how you would define equivalence?  And in particular, some legislation that's pending has looked at that issue and said that some products can be like FDA products, but not necessarily the same as FDA products, differing in things like labeling, differing in terms of bioavailability and as we have thought about that issue and are trying to respond to the questions that Congress has given us, we struggled with trying to understand how much product exists outside of the United States that is truly the same as U.S. approved products or is, in fact, equivalent, but not quite the same as U.S. approved product.

DR. MAXEY:  Boy, I almost feel like I'm back in medical school.

Most of our major pharmaceutical firms are multi-national anyway and most scientists tend to be multi-national in terms of their training and their travels.  So it shouldn't really be a hard reach to find bioequivalence and speaking the same language and find that.

We also, there's some differences even in generics and brand names in terms of bioequivalence whether it's Digoxin or other drugs that we know and bioequivalence is something that you determine in a laboratory of what meets what standard.  And that should not be a hard scientific question to answer.  It will require some real time testing of products.  Just because something bears the same name and label, does not mean it has the same bioequiavlency.  That's something that we would have to devise standards for that the scientists of each company would have to meet approval of their country, and of course, our FDA. 

So that's not a hard question.  Bioequivalence is something you determine by actual testing.

MR. SACHDEV:  And what you're suggesting then is that you would be interested in seeing an importation scheme, if Congress put one in place, that had basically drugs that were meeting the same standards that are in the United States?

DR. MAXEY:  Absolutely.  Are labeled appropriately, just so you know what you're getting if you're going to take an aspirin from here and one comes from England, you should know that one is half the equivalent of the other or something.  That doesn't seem like a very hard technical challenge.  Most of our companies work every place in the world.  They produce drugs here.  They produce drugs in Africa.  They produce them in Europe and so there shouldn't be really a problem if the same companies are dealing with these drugs.

SURGEON GENERAL CARMONA:  Others on the Panel who want to comment on that?

MR. SACHDEV:  I have one follow-up question as well.

SURGEON GENERAL CARMONA:  Please.

MR. SACHDEV:  Another one of the questions that we're grappling with has to do with the extent to which there are certain categories of products, either by virtue of their -- the way they're manufactured, the way they have to be handled and stored, the types of doctor-patient or medical professional-patient interaction that's required when they're prescribed.  And in fact, in some cases, the type of labeling that's on them, there are a lot of these products out there that vary tremendously.

And the question for us is in thinking about importation, how do we address the fact that you have these various types of products, which have differing risk profiles?  And in the context of importation, are there certain categories of products that the witnesses today believe simply aren't appropriate for importation because of particular characteristics?  Or would pose more risk if, in fact, Congress were to legalize importation because of the characteristics?

And again, it's open to anyone on the Panel.

DR. MAXEY:  Just to -- one answer is there are certain drugs and I don't know the cost of them, but the Coumadin or warfarin type drugs can be somewhat lethal if you didn't have some standardization of these drugs, they could cause bleeding.  But simply by testing such things as LD-50 and having the appropriate protocols should again avoid that.  So we would want to know the appropriate testing for equivalence has gone on.

The one concern I do have is that many of our drugs, even here in the United States, have not been appropriately clinically tested on a broad range of ethnic people.  Many African Americans, for example, have not undergone clinical trials for some of the ace inhibitors.  That leads to some problems.  So if we're going to bring in drugs from other countries, again, we would want to know that appropriate testing among ethnic groups and cultural groups has been done so that we really know the appropriateness of these drugs.  So that is something we have as a problem right here, right now, with our own medication.  So that's going to be compounded when you're bringing in drugs from outside.  So that should also be considered that the appropriate database has been obtained so that they apply to all people that they're intended for.

SURGEON GENERAL CARMONA:  Others?

DR. PATCHIN:  I think speaking for the AMA, we would view the FDA process as the gold standard and one that we would want to have our patients and our physicians have confidence in wherever the drugs came from.

MR. SACHDEV:  Are there particular products like controlled substances or biologics or injectables that you know, that folks think are probably of greater concern than other products, maybe fixed dose type products?

MS. COLLISHAW:  We haven't talked about that, but it strikes me individually as reasonable that there would be probably be certain things that people would be uncomfortable with coming from outside the country.

Sounds reasonable that you would have to make some choices.

SURGEON GENERAL CARMONA:  Dr. Raub.

DR. RAUB:  I had a question for all of the members of the Panel that builds on the last several, but it begins with my stating the obvious, that is, the dilemma for this Task Force is that our citizens can look across the border to Canada or across the ocean to the U.K. and see people able to acquire safe and effective medications, and at least for some of the non-generic varieties at a substantial reduction in price.

If we were able to create a mechanism whereby drugs approved by those national authorities for distribution within their own countries could, in fact, be brought here through a certified distribution mechanism, and made available in our distribution system and then to our pharmacies, what would be wrong with that?

DR. PATCHIN:  I'll start with that.  Again, if they meet our FDA standard and they meet all of the items I said in my prior testimony, I think that we have a trial under way of that very subject of the cost to pharmaceuticals in this country and it was released about a week and a half ago when the Medicare website went up that compared the cost of pharmaceuticals.  I think we've done a service to our elderly and as someone not eligible for Medicare, I too, have benefited by the cost comparison that has been obtained by looking at that website.  When we get the drug cards and we get the ability to negotiate prices in this country, we may see that market forces affect the cost of pharmaceuticals in this country, but whatever we bring in, we need to make sure it meets our existing standards so that patients can understand that it is safe and that the physicians can know that it is safe when they write that prescription.

DR. MAXEY:  From the National Medical Association, one, we're going to pretty much ditto what the American Medical Association says with the proviso that even though we have very safe drugs, many of my patients can't buy them, can't afford them and that's a major problem.  If you have the safest, best thing in the world, but you can't get it, it's of no consequence.  So it's very important to us that we solve this dilemma by having both safety, but also availability.

DR. RAUB:  But the mechanism I was describing would bring drugs, safe and effective, for Canadians --

DR. MAXEY:  That we support.

DR. RAUB:  Or Brits, but at a lower cost.

DR. MAXEY:  We support that.

MS. COLLISHAW:  If you have a system for certifying that they're safe and effective, it's hard to argue with that, right.

SURGEON GENERAL CARMONA:  Other questions from the Task Force Members?

I have one for all of you.  You have spoken all eloquently about safety, about cost, about quality.  We've heard testimony earlier, if we're looking at importation as an option that those who have expertise in the safety aspects, all of the technology that's available today and we posed a question to them in hypothetical, assuming that cost is not an issue, do we have the technology available today to be able to ensure the safety of importation of all drugs and the testimony we heard was that the technology wasn't there.

So what do we do in that case if we're looking at importation as an option and the experts who deal in this field tell us probably can't do it, at least for a few years.  We don't have the technology, not only to look at the bulk packaging which is similar, but when we get down to the repackaging as you said, Dr. Maxey and the distribution and warehouses and the breakdown and repackaging and getting down to every single pill or every single ounce of medication, how do we ensure that that's safe?  Then what do we do?  What are our options then?

DR. MAXEY:  Well, I understand that we have a very safe situation, but we know that it's not safe down to the pill, as I've said before.  So we can get as close to what we have now with the effort to make it as perfect as possible.  I think that's the best we can do.  We have to err somewhere between a perfect system that nobody can afford and an imperfect system where you have death and destruction.  So we do have to get these drugs to people.  So I think we have to make best efforts to develop that technology.

We do have the knowledge and we know how to certify those, but we have to have the will to do it, which does mean putting some of the finance and development into getting that system up and running.

DR. JENNINGS:  I haven't heard anybody talk about the process that the Canadians go through to assure the safety of their medications, but I think it would be important that we just don't reinvent the wheel, that they may have a very good process.  I've heard patients and colleagues in Canada feel that they have a very successful prescription drug system and I would somebody suggested that maybe the FDA should be involved with doing research on what the regulations and the mechanisms for patient safety and medications are, I guess at this point, you know, to start with, Canada.  But I just don't think -- we're not the only ones who can assure that patients receive safe medications and I think other countries have done a good job in that area.

SURGEON GENERAL CARMONA:  Other comments?

MR. SACHDEV:  I'd like to follow up on that line of questioning.  I think -- I'd like to get opinions from you all or thoughts.  Concerns have been raised in the past in these listening sessions that follows on Dr. Carmona's question and it relates to the extent to which there is an effort to legalize importation.  And we are able to address some of the safety concerns.  We've had raised questions about -- and I know most of you are medical professionals, doctors, and so you have a special relationship with lawyers, but in particular, there's been questions about the extent to which there would be adequate legal recourse for patients who might be harmed by products that are imported into this country from overseas or from Canada or from anywhere where the U.S. regulatory entities including the federal Food and Drug Administration, but also the state pharmacy regulators do not currently have the ability to reach.

Do you have comments, any of you, on how that issue would need to be addressed or how it could be addressed or if you think it's a significant concern?

DR. PATCHIN:  Well, we have 19 states in this country in crisis with medical liability.  We have only five or six that are not on the tipping point to become one of the 19 that have been identified by the AMA.  And anything that potentially would harm patients has potential to impact on the medical liability system.

I'd like to just share with you a personal story.  Dr. Carmona practiced in what I call one of the other border states which I do, living in southern California, and I won't say which patient it was, but it is a patient that I see in a county hospital who pays for his own medications.  And he had told me about his friend.  And I don't know whether it was him or his friend who had gone to Mexico and purchased the prescription medication that I had written for him to fill in this country at a much lower cost.  And he asked me if it was okay to take.  And I went into I have no idea, you know.  I don't know what the FDA does in that country.  He says but it looks exactly the same.  The bottle looks exactly the same.  And I said well, I still don't know what is actually inside that pill.

The next month he came back in and told me that his friend had opened one of those pills and that his friend had found common dirt inside of the tablets, not any medication.  And I said how did you know it was dirt?  And he said my friend analyzed it.  It was just dirt.  And that is what we're dealing with, whether it be counterfeit meds from wherever they come, is whether that patient took that medication.  Dirt probably wouldn't harm him, but if it was something else, he could have come to harm with either a drug to drug interaction or a lack of effectiveness.  And it is the patient is why we're here, so thank you.

SURGEON GENERAL CARMONA:  Thank you.  Another issue, you know, the issue -- we spend a lot of time, of course, speaking about Canada as maybe being representative when certainly a northern border it is, but we have the southern border with Mexico as well as many other countries that will potentially import drugs in.

Dr. Jennings, you had mentioned looking at the Canadian system.  We have and certainly Dr. Crawford and others are expert in that.  And I think that we all agree that pharmacy by pharmacy and their pharmacies are like ours and they have a very adequate system, maybe as good as ours.  But even in the Canadian government has told us that they don't sanction, nor can they certify the drugs that come through their country not for use by their citizens.  So basically there are those we have found in our investigation that take advantage of that and just use the country of Canada as a through put to send the drugs out.  And so with that in mind, I take to heart your comments, but when the Canadian government has told us, we can't guarantee the safety because these drugs aren't being used for our people and others take advantage of that, how do we handle that?  Because as we've seen through various investigations here from Customs from DEA from others when they do their investigations, a great many internet sites as well as proprietors put up information of Canadian drugs giving the false impression that these are secure when really the Canadian government or their FDA equipment, their health ministry have had nothing to do with that.

DR. JENNINGS:  Well, I think for years many patients have gone to Canada and purchased their drugs and brought them back and I guess it would be interesting to look at that history and see if, in fact, they had adverse reactions or they found that the medication was ineffective, the medication that came somewhere else other than the U.S.

MR. SACHDEV:  I have a follow-up.

SURGEON GENERAL CARMONA:  Please.

MR. SACHDEV:  I thought the distinction that Dr. Carmona was trying to draw was between the licensed Canadian pharmacist that the person who drives across the border goes to and what we're seeing now which is operations in Canada that are being created solely or primarily for the purpose of export to the United States.  And in that situation, I think that's the situation you were describing, was it not?

SURGEON GENERAL CARMONA:  Yes.

MR. SACHDEV:  Where the Canadian regulators really in their laws don't focus on those products getting exported, similar to how the U.S. treats our products when we have products that flow through our country for exportation.  In that context, I guess that was the question.  How do we handle that or what is the -- are the recommendations from this Panel as to what to do about that trans-shipment problem.

SURGEON GENERAL CARMONA:  Exactly.  I think that we've seen enough information that for the average person who goes across the border to fill a prescription in a licensed pharmacy in Canada is not an issue.  But the issue is much broader, much bigger than that because of the importation into Canada, the redistribution and repackaging of medications and really nobody really having oversight of that and then how do we protect the consumer and what recourse does the consumer have when and if there's an adverse reaction to the medication?

So those are the complex issues that have surfaced during this investigation.  Do any of you have any comments on any of that?

Any other questions or comments from our Panel?

Yes, Dr. Crawford.

DR. CRAWFORD:  Just to follow up a little bit with that.  We are aware and all of you are I'm sure aware through pressure ports and others that companies and others around the world have taken note of the fact that we have a porous border with Canada, that we have this issue that has gained a lot of national and international attention and in effect, Canada is reaffirming this week that they have no control over these products that are so-called trans-shipped.  And essentially, these are products that are brought in as, Mr. Sachdev and the Surgeon General have said, they're called import for export products.  So they're brought in either in bulk to be repackaged or they're brought in already packaged for export and then if you will, smuggled into the United States.

Our problem with declaring countries of origin would be very, very great indeed.  It would be far larger than just say if we certified Canada, for example, we would have to also figure out a way for them to join us or us to get some independent international body to make sure that the products that have come in from other countries that might even be labeled Canadian, we have some supervision over because with every product we regulate, whether it's food products or whatever, we can't stand at the northern border and stop them.  We've got to have some system, as all of you have correctly pointed out in your testimony, to deal with it.

But the utilization of the current non-system by people in countries and companies bent on getting the product here at all costs is something I have to tell you is a major concern of ours, as is the possibility of terrorism.

DR. JENNINGS:  I just have one question.  Is the Panel considering perhaps only approving a very limited number of drugs for importation to begin with, rather than open it to the whole area of prescription drugs?

SURGEON GENERAL CARMONA:  Dr. Jennings, at this point we are considering everything.  The door is open.  In fact, we've had some who have contributed to the docket and haven't spoken and others who have spoken who have made recommendations similar to what you're suggesting, a limited group of drugs and a limited amount of pharmacies and so on and certainly, that will be considered.  We haven't reached an opinion yet, and obviously, we still have a great deal of deliberations to consider.  But that is one of the options that has been presented to us.

DR. MAXEY:  I'm wondering if anyone has dealt with the basic question is with the pharmaceutical companies why don't we charge them like the Canadians or other countries charge them so that from the beginning they come to us at a reasonable price and find some other way to support the research that they need.

We're basically bearing the research dollar that it takes to care for the rest of the world.  And you wouldn't have to re-import if they brought it here at the right price in the first place which is a whole different consideration, which may be political.

SURGEON GENERAL CARMONA:  We've actually had panel discussions just on that issue.  We've had economists from here and abroad who have spoken to us on the global implications of importation on the issues of the United States shouldering the burden of all of the research and development and the rest of the world, in effect, being free riders, what are the possibilities to deal with those issues?  We've had discussions about presenting this as a trade issue in negotiations for our government.

So we've heard all of that information and we've still got to synthesize it among our deliberations and come up with a recommendation for the Secretary.

Any other comments or questions, Task Force Members?

Thank you very much, ladies and gentlemen.  We appreciate you being here.  We'll switch over to the next Panel right now and just take a quick stretch break and we should back in session in the next couple of minutes.  Thank you.

(Off the record.)

SURGEON GENERAL CARMONA:  All right, ladies and gentlemen, we'll go ahead and begin.  Our first speaker for Panel 2 is Mr. Carmen Catizone, National Association of Boards of Pharmacy.  Thank you, sir.

MR. CATIZONE:  Thank you, Dr. Carmona and Members of the Task Force.  I serve as the Executive Director of the National Association of Boards of Pharmacy whose members are the state agencies and provincial authorities that regulate the practice of pharmacy in the United States, Canada, Australia, New Zealand and South Africa.

The illegal importation of drugs is one of the most complex and frustrating issues for pharmacy regulators.  It's an issue that has the potential of altering how medications are dispensed in the United States and how the practice of pharmacy is regulated.  In fact, if illegal importation is allowed to continue, the impact on patient safety, pharmacy practice and the regulation of pharmacy practice will be devastating.

Patients illegally importing drugs are bypassing the drug approval system of the FDA and the safety of U.S. licensed pharmacies and placing their health and well-being in the hands of the country, territory or back room with the seemingly lowest priced pharmaceuticals.

NABP does not oppose importation within the safe and secure regulatory framework of the FDA and the State Boards of Pharmacy.  NABP does oppose the illegal importation of medications which is presently occurring.

At our recently concluded annual meeting, the states and provinces passed a resolution which resolved that NABP continue to oppose illegal importation of medications and expressed to the FDA the concerns of member states and strongly urged the FDA or appropriate legal authority to pursue actions against state and local governments for endorsing, promoting or engaging in the illegal importation of medication.

At its worse, the illegal importation of drugs creates the opportunity for unknowing and unsuspecting patients to suffer harm.  Counterfeit and dangerous drugs contaminate the U.S. medication distribution system and a thalidomide-like disaster to reoccur.

NABP cannot accept the premise that people must die from the illegal importation of drugs before the existing laws ensuring the safety of patients are complied with and enforced.  The "show us the body strategy" proposed by some legislators, governors, mayors and other public officials is irresponsible.

NABP acknowledges that appropriate safeguards exist within Canada's federal and provincial regulatory systems to ensure that the dispensing of medications in Canada to Canadian patients is safe.  Unfortunately, the same safeguards do not exist for U.S. patients purchasing and importing drugs from Canada and other countries.  The regulatory void and breach of the safety net for U.S. patients is significant and unknown to the overwhelming majority of patients ordering drugs from other countries.

NABP has learned that medications shipped from locations purportedly to be in Canada have originated in Slovenia, Pakistan and Vietnam.  Each progression to extend the distribution source to unknown borders further away from the FDA drug approval process and the state regulation of pharmacy practice makes the situation more dangerous.  The extension of importation to countries lacking effective drug approval processes, regulatory systems or practice standards further the erosion and destruction of the entire regulatory system for the practice of pharmacy.

The U.S. system, based with the states and the FDA, has been exemplary in protecting the citizens of the various states and providing patients and health care practitioners with the assurances and confidence that the medications prescribed and dispensed are safe and effective products.  NABP recognizes that a solution resolving the conflict of affordable access to medications versus safety must be developed to address the needs of U.S. patients and prevent irreparable damage to, if not the elimination of, the regulatory systems in the U.S.

NABP is in discussions with a variety of regulatory agencies and affected stakeholders to develop the necessary framework to regulate the Inter-Board of Practice of Pharmacy in the dispensing of medications to patients in the U.S. and Canada.  The framework would provide similar protections as those afforded U.S. patients to utilize pharmacies engaged in the interstate practice of pharmacy and would focus on identifying and monitoring the source of medications.

The framework will coordinate the regulatory efforts and resources of the Canadian provinces and the U.S. State Boards of Pharmacy.

In closing, NABP respectfully requests the Task Force recognize that allowing and encouraging the purchase and importation of medications from other countries without the appropriate regulatory safeguards is a serious threat to our regulatory foundation and patient safety.  NABP requests further the Task Force assistance in preserving the sanctity of current regulations so as to prevent any patient from being seriously injured by the illegal importation of medications from other countries where U.S. laws and regulations are being ignored or the laws of that country or territory do not equate to U.S. laws and regulations.

NABP does not believe that even one patient should suffer or be harmed as a consequence of disregarding federal and state laws that ensure the dispensing of safe and effective medications to U.S. patients.  Thank you.

SURGEON GENERAL CARMONA:  Thank you very much, sir.  Our next speaker, Ms. Susan Winckler.  Nice to see you again.

MS. WINCKLER:  Good to see you, Dr. Carmona and Members of the Task Force, thank you for inviting the American Pharmacists Association to present today.

I'm Susan Winckler.  I'm a pharmacist and an attorney and serve as APhA's Vice President for Policy and Communications.

It's important to note that APhA was founded in 1852 because of problems with the medications supply and recognizing that if drugs don't contain what they should or contain things that they should not, we have a problem.

It's interesting that in 2004, APhA's mission is to help improve medication use and advance patient care.  I think the problems facing the Task Force today get at both why APhA was founded and what we do today.  And that's trying to assure that patients have access to medications that are what they say they are as well as trying to assure that if we provide broader access to medications, that that doesn't pose a problem with coordination of care here in the United States.  Those are the two things I'll talk about this afternoon.

The first, talking about product integrity.  We are concerned that opening the door to importation, although we try to put in limits, will open the door to those who want to corrupt our system and to introduce counterfeits and we're very concerned about that.  We're particularly concerned about that reality in the context of personal importation.  And in that idea that if we open the door and allow anyone to import medications, how could we set up a system to try and make sure that it is only the limited, legitimate medications that we want to see.

The second challenge in the product integrity area is that differences in products do matter and this is the difference between the U.S. approved products and what we would see in foreign versions of approved products.  It's important as the AMA representative noted that consumers get what their doctor or their physician assistant ordered.  And differences matter.  It matters if it's a tablet versus a capsule.  Differences in names matter when we're trying to make sure that we don't have medication errors.  Differences in strengths matter.  Differences in salts and esters matter when we're trying to adjust doses and make sure that consumers indeed get what they're looking for.

To address this issue, we frankly would recommend that any importation be limited to FDA-approved products.  We recognize that's a very, very narrow range of what's on the international market, at least from our understanding, but you, at least know what it is your pharmacist and your physicians will know what it is that they're dealing with and consumers will know what it is that they're dealing with.

This is where most discussions stop.  We stop and we forget that medication use and good pharmacy practice goes beyond getting patients the right drug at the right time.  We forget that good medication use requires doctors, pharmacists and patients knowing how to make the best use of that medication.  Getting the right drug doesn't mean that the tablets leap out of the bottle and into our bodies and we use them correctly, or that we know how to use inhalers correctly.  There's something beyond that. 

And importation poorly constructed, can create significant problems there and that's in our coordination of care. 

What we're concerned about here is because of the stigma involved in importing medications and what happens today, many patients don't tell their doctors or their pharmacists that they're importing medications, that they're securing those products from outside the U.S.  It's understandable and dangerous, because unless the patient provides that information to the pharmacist, they really cannot watch for drug to drug interactions.  They cannot help the patient make the best use of that medication if they don't know what it is they're taking.

Limiting a system to a commercial importation helps with some of this challenge because you at least use the distribution systems that are present here in the United States, but we just have to understand that it's more than making sure we have an okay product.  We also have to make sure that the doctors and the pharmacists and the consumers who use that product understand how to use it and know to make the best use of it.

The bottom line of what APhA is very concerned about is the recognition and we know the task force has considered this, but I must underscore it, that medications are different.  And that it matters what's in the tablet, but it also matters that the consumer knows how to use that.

If we are going to move to a system to legalize importation, as Mr. Catizone mentioned, we have to make sure that it has appropriate protections, not only in statute and regulation, but in enforcement.

I do also have to note that it's unfortunate that Congress failed to establish a task force to address the broader issue that's driving these discussions and that's improving access to necessary medications.  The current international pricing structure is flawed and U.S. consumers bear the brunt of that flaw.  We want new technology to help us, but we have to bear the disproportionate price for the world.

I regret that we're not here today to talk about how to improve consumer access to medications and to pharmacist services to help them make the best use of their medications.  That discussion has promise.

Thank you.

SURGEON GENERAL CARMONA:  Thanks very much.  Our next speaker, Mr. Douglas Scheckelhoff.

MR. SCHECKELHOFF:  Thank you and good afternoon.  

I'm Douglas Scheckelhoff and I'm the Director of Pharmacy Practice Sections at the American Society of Health-System Pharmacists.  ASHP is a 30,000 member national professional association that represents pharmacists that practice in health systems including hospitals, ambulatory clinics, HMOs, long term care and home care.  I'm pleased to provide you with ASHP's views on the importation of prescription drugs into the United States.

For more than 50 years, the U.S. could boast the safest, most tightly regulated system for approving and distributing prescription drugs.  Today, however, there are challenges facing our system.  The growing illegal drug trade, including counterfeit medications, rogue internet sites and efforts to open U.S. markets to medications imported from abroad have all raised questions regarding the FDA's ability to respond to those challenges.

First, regarding the impact of unapproved drugs.  Pharmacists who work in hospitals are confronted with the issue of purchasing quality pharmaceuticals at the lowest cost on a daily basis.  ASHP has received numerous phone calls from pharmacy directors whose hospital administrators have asked them to purchase drugs from Canada at lower prices rather than from U.S. sources.  We have referred them to FDA regulations that prohibit that kind of importation, but the pressure to find lower cost, alternate sources remains.

The scope and volume of unapproved drugs entering the United States has raised the concern of ASHP members.  That's why our House of Delegates will vote next month to reaffirm the following policy:  to oppose importation of pharmaceuticals except in cases in which the Food and Drug Administration determines it would be necessary for the health and welfare of United States citizens.

The issue of safety in our nation's drug supply has been obscured by the issue of allowing individual citizens to purchase prescription drugs at lower prices from non-U.S. locations.  While there are no hard data to indicate serious patient harm caused by these imported drugs, and it make take years to identify clusters of problems caused by imported medications, the safety perspective must be the highest priority.

There's another factor of the importation issue that has not been addressed adequately and it relates to foreign terrorism in our nation's counter-terrorism activities.  The integrity of the drug supply and the health of consumers is at significant risk if terrorists utilize more lenient importation rules to introduce harmful agents into the United States.

Regarding FDA's ability to assure safety.  The FDA's regulatory system has been the world's gold standard of drug approval.  To assure the safety of imported products, the FDA will need significantly greater resources to examine those products for quality, purity, safety and effectiveness, since a significant amount of imported drugs are ordered via the internet, the Agency should consider ensuring the adequate regulation of internet pharmacy sites.

Regarding regulatory and legislative issues, the FDA must have the authority to assure the same level of safety for imported drugs as consumers expect from drugs purchased from a state-licensed pharmacy.  Consumers are ill-equipped to make these types of risk-benefit decision and there is no added level of risk beyond today's safety standards that ASHP members would consider acceptable.

Regarding technology.  The FDA's efforts to encourage manufacturers to include electronic track and trace technology into their product packaging for anti-counterfeiting measures should work well to also prevent the importation of unapproved drugs and to prevent the reintroduction of diverted drug products.  Other anti-counterfeiting technologies will improve safety, but will have less impact than that of an effective track and trace system.

Regarding the financial impact.  The FDA must thoroughly study the financial impact of importation and determine whether it would actually lower the cost of drugs for American consumers.  Regulations put in place to implement Section 1121 of the Medicare Prescription Drug Improvement and Modernization Act of 2003 must not be burdensome to pharmacists or wholesalers.  If pharmacists or wholesalers are required to conduct testing or authentication of imported drugs, the additional cost of doing so would largely eliminate the anticipated cost savings for consumers.

In conclusion, ASHP appreciates the opportunity to comment to the FDA on this significant issue.  We are ready to assist the Department of Health and Human Services in any way that we can in implementing policies related to the importation of prescription drugs.

Thank you.

SURGEON GENERAL CARMONA:  Thank you, sir.  Our next speaker is Dr. Marv Shepherd.

DR. SHEPHERD:  How are you all doing?

SURGEON GENERAL CARMONA:  Doing fine.

DR. SHEPHERD:  Mr. Chairman Carmona and Members of the Task Force, the Academy of Managed Care Pharmacy appreciates the opportunity to participate as you receive testimony on the issues related to the importation of prescription drugs.

My name is Marv Shepherd and probably as you can tell from my greeting, I'm from Texas and I'm the Director of the Center for Pharmacoeconomic Studies at the University of Texas.  I have been studying the issue of drug importation for over 10 years, especially Mexican drugs coming across the border and now the last three years, Canadian drugs.

The Academy of Managed Care Pharmacy, who I speak for this afternoon, is an association of pharmacists and professionals who serve the patients and the public through managed care principles.  The Academy has over 4800 pharmacist members who provide comprehensive coverage in pharmacy service to over 200 million Americans.

The Academy is opposed to proposals that would allow personal importation of prescription drugs.  There is no system for double checks on accuracy.  There is no counseling on the pharmaceuticals.  There's no one to call if you've got a question as a consumer.  The potential for problems is particularly serious when individuals are ordering their prescriptions on-line.  The prescription order via the internet, from what seems to be a Canadian pharmacy, may in fact, may not be a Canadian pharmacy.  In addition, when patients received their medications through individual importation, there's no pharmacist involved who can verify that the patient even understands how to take the pharmaceutical correctly.

Personal importation of pharmaceuticals is growing enormously.  In my opinion, it is way out of control as FDA has documented in many documents, approximately 200 million packages coming in last year.

There's no guarantee that legislators, regulators and pharmacists can provide the information necessary to consumers, letting them know whether the imported prescription drugs they are receiving are adulterated, counterfeit or approved for use in the United States and there's also no way for local pharmacists to determine whether the medication is safe and effective.

The Academy also has concerns of proposals that would allow the importation of prescription drugs by U.S. pharmacists and wholesalers.  The Academy understands the plight of individuals unable to afford much needed prescription drugs and supports the goal of lowering drug costs for American consumers.  However, the anticipated savings, as mentioned already, developed by importation may generate uncertainty between the factors involved in importation and basically the differential in price for specific drugs isn't that great.

The availability of the product for importation is it going to be a consistent availability?  You don't want to move from one source to another source.

What are the additional overhead charges for the importation problems?

One negative consequences of the program and I don't believe anybody has ever mentioned this in front of your group, is that I'm a hypothesis believer that it may permit pharmacies and wholesalers to import prescription drugs and the development of a two-tiered drug system in the United States, two-tiered based on cost.  If states base reimbursement to pharmacists on the importation base acquisition cost, pharmacies would have to establish a dual inventory system, one system for U.S.-made drugs and one system for imported drugs.  That brings all kinds of ramification of control and cost control and patient controls.

I'll be glad to entertain any questions you have on that.

Mostly importantly, prudent importation legislation must ensure maintenance of quality assurance as others have stated throughout the international drug distribution system.  In order to guarantee patient safety, agencies such as FDA and U.S. Customs Service must have technological and financial resources to address these safety concerns.

I'm telling you, after being at the border of Mexico and monitoring the drugs from across the border, they are in dire need of technology to monitor the pharmaceuticals, dire need.  Pen and paper and pencil just doesn't make it.

All of us are aware of the potential for drug counterfeiting and drug counterfeiting is a world-wide problem.  No country is immune to drug counterfeiting.  However, drug importation, especially personal importation, only opens the door wider for counterfeits in the United States.  Counterfeits go where the money is and the United States has the market and an excellent target where the money is.

You will find pharmaceutical fraud, deception and counterfeiting, if we continue with importation.  The recent FDA report on combating counterfeit drugs puts forth an excellent strategy for combating drug fraud and ensuring drug integrity for Americans, but at the same time, we have governmental agencies allowing U.S. residents to import substandard, inferior and sometimes counterfeit drug products.  We have been fortunate, as already has been mentioned, that we have been fortunate that people haven't been hurt or killed by these products.  And I have said and I will continue to say it's only a matter of time before a horrific tragedy involving imported pharmaceuticals will occur.

The Academy believes that until more conclusive data are available as to likely impact the importation on the cost of drugs and the risk imposed to American citizens, we will oppose proposals that allow importation of prescription drugs for sale to U.S. citizens.

Thank you again, for this opportunity and I look forward to answering any questions you may have.

SURGEON GENERAL CARMONA:  Thank you, sir.  Our next speaker, Mr. Robert McNellis, American Academy of Physician Assistants, thank you for being with us.

MR. McNELLIS:  Thank you, Dr. Carmona.  Good afternoon, Dr. Carmona, and the rest of the Task Force.  I thank you on behalf of the American Academy of Physician Assistants and the 51,000 clinically practicing PAs to provide some testimony today about the perspective, in particular, of PAs and how they're looking at this particular problem.

What PAs have in common, even though they work in every specialty and every state dealing with patients of all ages is a commitment to providing quality, cost effective, accessible healthcare.  That is, in fact, our mission statement.  And that's really the guidance that I have from our Academy's policies as to what I say today.  We don't have a policy on drug importation per se, but we use that to guide it.

For PAs, the focus is really on the patient and it's not to imply that other organizations don't have that perspective as well, and certainly I know that that's in your interest as the patient, but that's all we do is do patient care.  And we understand the concerns of consumers, as well as states, that they need to bring in affordable drugs.  We understand that the pharmaceutical industry and distributors want to maintain safety as well as incentives for future drug development.  But in the world of our members, kind of outside of the beltway, they see this as a balancing act between safety and affordability.  Those are the two things that resonate with our members.  And that ensuring a safe and genuine drug supply is critical, but so is ensuring an accessible one.

As Dr. Maxey said, safe drugs that are unaffordable aren't really of any benefit to those who need them the most.  And I know it's cliché and it's anecdotal as well, but I still get stories from our members about their patients who have to choose between their groceries and their drugs, so it still is a problem.

I'm spoken a lot recently with PAs who are in Maine, Seattle, Detroit and other many of the border states and they tell stories about their older patients getting on buses, the things you've heard probably over and over again during the last five or six listening sessions.  But it certainly is happening.  And one of our members though described it this way, you know, who is going to Canada to buy their drugs?  Is it the insured person who has got a pharmacy card for $20 they can go and pick up their Lipitor?  No, probably not.  It's the person on low fixed income or the uninsured who are going to essentially pay cash, out of pocket to get less expensive drugs so they can afford them.  And then I'm sure the PAs in Texas and California, they certainly have similar stories about Mexico.

But for the most part, our patients seem to be buying brand name drugs, the brand ones are the ones that are the most expensive.  They're not going across the border to buy the more affordable generic drugs.  And these brand name drugs are essentially manufactured to the same standards, same packaging as drugs sold in the U.S. and there's a sense that the Canadians aren't really suffering any increased consequences due to the unsafe drugs in their system.

Now clearly safety is an issue to consider.  Unsafe counterfeit drugs seem to enter the system when the traditional distribution system breaks down, when retailers or distributors buy drugs through other channels or consumers purchase their drugs through internet pharmacies, that's when the supply is most at risk. 

PAs, I know, as a profession, don't generally recommend that their patients buy drugs over the internet, unless of course, that particular site might have a reputation for providing quality products.  But again, it begs the question, who's going to be buying drugs over the internet?  And once again, it seems like it's the most vulnerable who are likely to be scammed or given counterfeit drugs, the patients who are looking for alternative sources to try to afford their drugs, and that demand for less expensive sources of medication seems to have paralleled in some ways as well as other things, the growth of the number of uninsured which the IOM, of course, estimates now at 43 million.

And we appreciate the efforts of pharmaceutical companies to make available discounted drugs to the patients who need them.  I note that the process is still a little burdensome, I think.  We're also optimistic that the new Medicare discount card will provide our seniors some of the drugs that they can -- more affordable.

We appreciate the viewpoints of Governors that Canada or even Europe might offer solutions to immediate crisis, but unfortunately, unaffordable drugs seems to be just one system of the broader health care problems.  And I know it's out of the scope of the Task Force, in particular, but I think this problem is within the context of kind of broader problems with an ailing health care system.

Really, our view of best is that Canada, allowing importation of Canada or other countries is really a limited solution to some of these broader problems.  There need to be more permanent solutions to the inequities of drug pricing, especially since from the perspective of PAs, the people who are paying most for their medications are the ones who can least afford it.

Certainly, there are some potential fixes out there.  You've heard from lots of experts whether consumers be billed directly from wholesalers or states could negotiate more Canada-like prices, but that's not what we know.  What we know is patient care and PAs feel strongly about their role as patient advocates and they know that really affordable drugs is just kind of one part of the whole health care system.  They don't have to be either safety or affordable.  They need to be both safe and affordable and we need to find ways to diminish that.

So thank you very much for allowing me to express the viewpoints of physician assistants in this very complex debate before you.

SURGEON GENERAL CARMONA:  Thanks very much, appreciate it.  Now we'll open the floor for my fellow Task Force Members, questions. 

Dr. Crawford?

DR. CRAWFORD:  Dr. Winckler, thank you very much for your testimony, and thank you also for your candor in establishing that re-importation is only a symptom of the larger problem that we're dealing with.  Those may not be your words, but they would be good words.

The thing I wanted to focus on in terms of what you said though is the international pricing structure is flawed and although that's a bit beyond the scope of our task, I would appreciate any commentary you would have about how to fix that or how to address it or something like that?

MS. WINCKLER:  Sure.  I guess it's the one thing that doesn't fit in either my degree in pharmacy nor my degree in law, so --

DR. CRAWFORD:  My experience with lawyers in the government is you can stake out any turf you like.

(Laughter.)

MS. WINCKLER:  All right.  I guess it comes back to what other people have likely said before you and the economists have pointed out, but we just do have to look at the broader issue and I guess what frustrates APhA and what frustrates our pharmacist members is that we're talking about importing the drugs when it appears what some people want to do is import the price controls.  And if that's what you want to do, please talk about that and have that discussion.  And I'm not saying that we support price controls, but that would at least seem to be an intellectually honest conversation, rather than this proxy of let's import the drugs. 

So I guess broadly what we're looking at is the need to make sure that American consumers have access to the medications that they need, whether that's through making sure we protect the uninsured or the under insured and doing more through that.  If it's through direct negotiation for price controls, I don't know those answers, but do know that we have to tackle that broader issue.  And is it seeing if this new Medicare drug benefit works for that population.  Is it doing something else for the uninsured?  Is it doing -- taking other issues and part of the broader issue here too is again remembering it's not only the price of the medication when you get it, it's the value of that medication to the patient, so in the whole cost structure, if they got the right medication, but they don't know how to use it, you've wasted all of the money.  And it doesn't matter how expensive or how cheap it was. 

So I guess I would just implore the Task Force to recognize and I know you recognize this, that it's a much broader issue and whatever we can do to underscore those challenges, will be important in your report.

SURGEON GENERAL CARMONA:  Other questions?

Amit?

MR. SACHDEV:  I have some for each and all of you, but particularly for Mr. Catizone.  We've heard testimony from the Minnesota Governor about the program that Minnesota has set up.  We've heard testimony from other Governors about state programs that have been set up that facilitate importation by creating websites that link to particular Canadian pharmacies for their state citizens to use in purchasing prescription drugs. 

In Minnesota, in particular, the Minnesota Board of Pharmacy issued a report when they evaluated Canadian pharmacies that they wanted to link to where they found seven of the nine pharmacies they looked at, Canadian pharmacies they looked at were deficient in some way or another and so in the end that state ended up linking to two particular pharmacies as opposed to more than that.

Can you comment on why you think there were deficiencies in those Canadian mail order type pharmacies and whether you think that is indicative of a distinction between maybe the practice of pharmacy in the U.S. and what we're seeing in terms of the practice of pharmacies that are exporting products to the U.S.?

MR. CATIZONE:  What concerned us about that whole process is that it operated outside of the traditional regulatory framework and process, so that even though members of the Minnesota Board of Pharmacy were involved in that inspection, we would categorize that inspection as a visit and not an inspection that would normally be conducted on a traditional brick and mortar pharmacy or a pharmacy based in the U.S.

The pharmacy was given notice of the inspection or visit.  The inspectors were restricted to certain areas of the pharmacy.  They were not allowed to talk to any of the pharmacists involved in that operation and instead, only spoke to the business agents and the lawyers representing those pharmacies.  They were also restricted from asking questions about certain information or requesting certain information that would be part of a normal inspection.

So our concern with the inspections, in general, and with the approaches that many of the Governors have taken is that they are bypassing and operating outside of the standard regulatory framework.  So it's not a question of the Canadian system not being equivalent to, it's the system being employed by these Governors in states to bypass traditional regulatory safeguards.  Those seven of nine pharmacies that did not meet those standards had serious problems with recording the source of the medications, recording the patient interactions, recording very important critical patient data and dispensing information about those medications and therefore those seven pharmacies were rejected.

MR. SACHDEV:  My question was, and it's open to anyone here, but why do you think that is?  Why was there an 80 percent deficiency rate for these pharmacies that were looking at to participate, even despite the fact that they knew people were coming and looking at their facilities?

MS. WINCKLER:  I think part of the challenge comes from the challenge of trying to at some level meet a different federal and different state laws.  Those pharmacies, I'm sure, are very good at meeting the provincial law and the law that they have to meet for Canada, but as I understand it, the Minnesota folks were looking at how it compared with the Minnesota law and rules and very challenging for those individuals and entities to navigate that complex system.

The pharmacies in the U.S. that serve patients in all 50 states have extensive processes set up so that they can try to meet all the different requirements that we have from state to state and comply with the federal system and I can't imagine them trying to learn and comply with an international set as well.

DR. SHEPHERD:  One possible reason why there was neglect of some of the regulations is the fact that the growth of the industry.  In 1999, there were 10 Canadian internet pharmacies.  Right now, you've got 120, most of which are located in one province and when you look at the news articles on this one province, it's pretty lax and there's a big rift between the community pharmacists and the internet pharmacy operations in that province.  There's actually a big rift between those two.

The internet pharmacies are stealing them out of the community pharmacies by offering higher wages.  There's a shortage.  Internet pharmacies are having troubles getting access to drugs.  They're buying off the independents from the communications I'm getting.  They can't get the drug out of the wholesaler.  There's a shortage, so they're buying it from independents and independents have the opportunity to make the money or the community pharmacy, so they end up selling them under the table to the internet pharmacies in order to dispense.  So it's kind of like a fast growth industry that the Manitoba pharmacists have just started to jump on in the internet section and develop it.  So it could be part of the growth.  It may smooth out.  I'm not saying it won't, but I think that's probably the reason.

SURGEON GENERAL CARMONA:  Mr. Ahern -- oh, do you have another one, a follow up?

MR. SACHDEV:  I do have a follow up.  And this is open to all of you, we've heard a lot of discussion here in listening sessions about the types of drugs that are, in fact, being imported today in this country from not just Canada, but elsewhere.  And varying points of view about the quality of those drugs and in particular, their equivalency to federal standards, but also the equivalency between how they're dispensed in terms of foreign pharmacies versus U.S.

Generally, do members of this panel have evidence or reason to believe that the products that are coming in are, in fact, more likely to be the same as, equivalent or more likely to not be similar or the same as U.S.-approved product based on what you know?

And again, it's open to the panel.

DR. SHEPHERD:  When I visited a couple, three mail operations that received the drugs back and we've opened up packages, I can unequivocally say that I don't think they're equivalent, the vast majority of the products.  They are not equivalent. 

When you get products coming in in baggies, boxes of them, and they're talking about a 90-day limit, quantity, I've seen boxes half the size of this table addressed to personal people in Southwest United States, filled with baggies filled with tablets and capsules.

I've seen bags, envelopes, three by four cartons of nothing but Viagra and sexual dysfunction drugs coming in one day.  Thirty thousand drug packages are coming in daily right now in Miami, a day.  You multiply that by the 13 other sites out there, you can imagine.  But I cannot say that the products are equivalent.  They're coming from all over the world, Brazil, Argentina, Chile, South Africa, Nigeria, Vietnam, Cambodia.  They're coming from everywhere.

Canadian -- well, I think Mr. McNellis talked about this, I think Canadians only represented 18 percent of the packages out of 1400 that were opened coming out of Canada.  But they're coming world wide.

And I want to dispel a myth here.  Everybody is talking about price and use of the internet.  I agree with you that price is important, why people do it.  But I also believe access, you don't need a prescription with these people, is a big issue.  You don't need a prescription.  So you get your oxycodone or any other narcotic or drug you want without going to the doctor and that's the number one reason why they go to Mexico, is access.  I don't need a prescription.  The drugs are all over the counter.  You can walk in any pharmacy in Mexico and buy anything you want, except for the controlled substances, without a prescription. 

It's hard to get that data and I've tried to get that data to figure out what's the demographics of people using the internet and because of the patient confidentiality, you cannot get that data to even survey them.  But I'm -- I really believe that there are a lot of elderly or a lot of seniors and a lot of people who can't afford drugs using them.  There's no other about it.  But I also believe there are a lot of young people doing it because of the easy access.  They don't have to go see a doctor, they can just fill out a form and get it wherever you want to get it.

MR. CATIZONE:  I think your question is actually two questions.  Are the drugs approved through Health Canada's drug approval process equivalent to the U.S. FDA approved drug products and I think from NABP's perspective which is not as scientific as the FDA, the answer would appear to be yes. 

The second part of the question is though are patients in the U.S. receiving those Health Canada approved products and the answer is no.  In the cases that we've studied where consumers have complained to us, they are coming from outside that Canadian drug approval process.  Our colleagues in Canada effectively regulate the practice of pharmacy and those internet pharmacies that would allow an FDA and state board inspection, would be able to provide safe, effective medications to U.S. citizens. 

Those pharmacies that you asked about in your first question that have stepped forward and jumped on this bandwagon, they would probably not allow an FDA state board inspection and therefore they probably shouldn't be operating in Canada or the U.S.

MR. SACHDEV:  One follow up question that flows from testimony that we heard from the listening session two weeks ago from a woman from a key Canadian equivalent, NAPRA, and the question was asked about the trans shipment issue that was discussed by Dr. Carmona and Dr. Crawford and whether or not under the provincial authorities and they obviously vary in Canada, but under the provincial authorities, generally, would the trans shipment of a product from Europe to Canada and then from Canada to the United States or the facilitation by Canadian pharmacy of shipment of a product from Europe, say the U.K. to a U.S. consumer, where it didn't actually flow through Canada, but still is facilitated by a Canadian pharmacy through a mail order operation, they testified that it was their belief in both those instances under provincial pharmacy regulatory authority in most of the provinces, in all of the ones that testified, which I believe included Ontario, Manitoba and Quebec, that it was, in fact, unapproved.

We've heard differences of opinion and I wanted to get your opinion on that, on that practice and also to have you elaborate a little bit more about what your inter border regulatory proposal would do in terms of assessing sort of the pharmacies. And these are two questions, but the pharmacies' practices in Canada versus the ones in the United States.

MR. CATIZONE:  We would concur with the testimony from Barbara Wells of NAPRA in that those products are unapproved and that the provincial authorities and Health Canada and I know there's a representative from Ontario that will speak on the third panel.  As Dr. Carmona and Dr. Crawford mentioned though, they are not regulated or monitored by Health Canada or the provincial authorities.

MR. SACHDEV:  Okay, so because we haven't had Health Canada, they were not able to attend, all we have is their public statements from the past.  And so what we're trying to ascertain is we want to get a clear answer.  I think it's very important for this group, as we go and try to respond to the questions, a clear answer about what folks' understanding is of the trans shipment issue, but in particular, how the Canadian laws at both the federal level and also at the provincial level address products that are not necessarily Canadian licensed, but are intended for export and the intersection with U.S. law in that regard.

Others have a comment?

DR. SHEPHERD:  I have a comment and an issue.  I don't know if you're aware or not, but the Canadian ‑‑ Health Canada does not visit facilities outside their country for approval of drugs.  I'll repeat that:  they do not visit that facility outside of Canada for approval. 

When you're a manufacturer in Canada ‑‑ and I downloaded their forms and I'm in Ecuador and I want to export to Canada ‑‑ I fill out a one- or two-page form that says I comply with the Canadian good manufacturing processes and sign my name and I can ship the drug in.

So they don't ‑‑ like FDA visits facilities for FDA-approved drugs, Canada doesn't do that.  So I don't think that we're going to have the equivalent approval process when you look at it for the processes and the inspections of the plants involved with it.  And it could be the same plant where you got an FDA-approved drug going through Canada.  That very well could be, but they don't ‑‑ they don't leave the country.

SURGEON GENERAL CARMONA:  Thank you.

Let's see, I had Mr. Ahern first, and then Dr. Raub.  Thank you.

MR. AHERN:  Dr. Shepherd, very quickly, you said you've done a lot of study with importation of pharmaceuticals from Mexico, and recently have now started to do some studies in Canada as well.

DR. SHEPHERD:  Right.

MR. AHERN:  Have you seen any significant ‑‑ and you also made a statement that the Canadian supply is starting to be depleted or diminished.  Are you starting to see any shift from the Mexican supply into the Canadian supply?

DR. SHEPHERD:  Yes, I have.

MR. AHERN:  And do you have any figures of what that might be?

DR. SHEPHERD:  I don't ‑‑ I know the types of drugs ‑‑ that VancouverCanadianPharmacyTrust.com site is shipping Mexican-made sexual dysfunction drugs to U.S. people, and neither drug ‑‑ both drugs have been approved by Health Canada or the United States.  That's been published, and it was published two weeks ago in Scripts Reports World Health News, that U.S. consumers have been reporting the product coming out of Mexico and being shipped through Canada.

MR. AHERN:  And very briefly, also, you made a statement here that FDA and the Customs Service should have the technological resources to address some of the safety concerns.  What would be some of the technological resources you believe would help the situation?

DR. SHEPHERD:  Just monitoring the amount of drug coming across the border, whether you're in Canada or the United States, is a difficult task.  You can ‑‑ I'll give you an example.  You stand on the border of Nuevo Laredo, Mexico, and Laredo, Texas.  You have 25- to 30,000 people walk across that bridge in one Saturday afternoon.

One in two people will bring back pharmaceuticals.  And they won't bring back just a 30-day supply; they'll bring back a shopping bag full of pharmaceuticals.  I've seen people drop $2- or $3,000 going over there.

Now, when they come back through U.S. Customs there, and the U.S. Customs agent has no way of recording all of that information ‑‑ it's a pencil and paper job, declaration form, even document to what extent the drugs are coming across the border, what are the products, what's the quantity, what's the value?

They're required to fill out ‑‑ if they're asked, they're required to fill out a declaration form where they estimate how much they bought.  Most of them don't even estimate it.  Most of them just stick the drugs in the bag, and they just walk across the border. 

But just monitoring the process and knowing exactly what they're buying and the demographics, there's just no data.  And it's ‑‑ to me, there ought to be a way that you can electronically scan the label out of Mexico, electronically get the information in a sheet, and just do it periodically just to keep track of what's coming in and what's going out of the country.  But right now that doesn't exist.

We have tried to develop something like that and tried to work with Customs on it.  It's difficult.  That's the first thing I would do.  We don't ‑‑ if you can just give me the demographic information of who is using the internet, that would provide this task force with immense information.  You don't even have that.

MR. AHERN:  Thank you.

SURGEON GENERAL CARMONA:  Thanks.  Dr. Raub?

DR. RAUB:  Thank you, Mr. Chairman.

I have a question for Mr. Catizone, because it's keyed off the statement in your testimony, but others may want to address it as well.

The statement is, if the illegal importation of drugs into the U.S. is allowed to continue, the impact on patient safety, pharmacy practice, and regulation of pharmacy practice will be devastating. 

Many of our witnesses have talked about the first item ‑‑ of the jeopardy for individuals.  Others have not addressed how the impact would be adverse on either pharmacy practice or the regulation thereof, and I'd appreciate it if you'd elaborate on that.  And others may want to comment as well.

MR. CATIZONE:  Our specific concerns are that the importation is bypassing all of the state regulatory systems.  So inspections or visits are being conducted by personnel other than the boards of pharmacy, even though the state legislatures have decreed that the responsibility of those state agencies. 

State laws are being ignored and bypassed.  In the State of Illinois, it was interesting ‑‑ our Attorney General, in dealing with the last gaming license to be awarded to a land-based casino, voided that license and those proceedings and said that she could not worry about the state balancing its budget in lieu of following state laws, but yet she allows importation to occur, even though it is breaking state laws and does create, in our opinion, serious patient harm.

So from those perspectives, that's where our concerns lie.

DR. RAUB:  There's an erosion of the confidence in the regulatory ‑‑ I mean, it seems like it's going on outside the regulatory mechanism.  I'm trying to understand the link as to why the regulatory infrastructure is harmed.

MR. CATIZONE:  Once a decision is made that you don't need to follow state regulation, and that the governor or other public officials ‑‑ based upon economic reasons ‑‑ can decide which laws to follow or not, there's really no need for a State Board of Pharmacy or state regulation.  The governors or other public officials can simply decide based upon what's best for the economic structure of the state.

DR. RAUB:  Okay.  Thank you.

Others from the panel?

MS. WINCKLER:  I'll start with a challenge to pharmacy practice, and part of that challenge is coming in when the pharmacist ‑‑ you have a patient who is importing something, and then they need an acute prescription.  So they go to the local pharmacy for a pain medication or an antibiotic or something else.  Ask the patient what they are taking.

In some situations, the consumer will not tell the pharmacist and probably didn't tell the physician about what they're importing, because they may know it's illegal or simply may not remember to do that.  If they do tell them, it creates a challenge for the pharmacist, because it's the consumer reporting that they are importing a cholesterol-lowering medication. 

But trying to do a drug-to-drug interaction check when you may not know what the cholesterol-lowering medication is, or know anything about the foreign version of the medication, creates challenges. 

One of the things we've talked about, if importation were to be legalized and you let