HHS Importation Task Force

Public Meeting

Wednesday, April 14, 2004
Natcher Auditorium, National Institutes of Health
Bethesda, Maryland

I.  Opening Remarks

II.  Presentations from Registered Speakers

Rick Roberts, Consumer

Rene Rodriguez, Inter-American College of Physicians & Surgeons

Noel T. (Tom) Curb, SPC Global Technologies

Peter Neupert, drugstore.com

Kurt Hilzinger, Healthcare Distribution and Management Association

The Honorable Jim Doyle, Governor of Wisconsin

Mark Barondess; Christensen, Miller, Fink, Jacobs,

Glaser, Weil & Shapiro, LLP                                                    

Sharon Cohen, Biotechnology Industry Organization                

Pete Sepp, National Taxpayers’ Union              

Bruce Kuhlik, Pharmaceutical Research and Manufacturing Association     

James Green, King Pharmaceuticals                                  

Flora Green, The Seniors’ Coalition

Scott McKibbon, Special Advocate for Prescription Drugs, State of IL.     

Ram Kamath, Special Advocate for Prescription Drugs, State of IL.       

Lothar Dueck, Coalition for Manitoba Pharmacy                                     

Joel Miller, National Alliance for the Mentally Ill                                     

Panos Kanavos, London School of Economics                       

Lunch break

Jeffrey Axelrad, Consultant

Jack Sharry, Group Benefits Strategies                              

Bernard Kerik, Kerik-Kerik, LLC                            

Lew Kontnik, Consultant                            

Durhane Wong-Reiger, Consumer Advocare Network                     

Louise Binder, Canadian Treatment Action Council              

Gary Stein, American Society of Health Systems Pharmacists     

Charles Hardin, RetireSafe.com; Council for Government Reform

Lynda Mitchell, Parents of Food Allergic Kids                                      

Jim Rittenburg, Authentix                                 

James Love, Consumer Project on Technology                  

Raymond Keating, Small Business Survival Committee       

Jamie Martinez, Latinos Unidos Health Access Alliance  

Nancy Martin, Pharm-D                                            

I. Opening Statement – Task Force Chair, Vice Admiral Richard H. Carmona, M.D., M.P.H., FACS

Good morning, ladies and gentlemen. I would like to call meeting to order and start the meting. I am Richard Carmona, the U.S. Surgeon General. I would like to welcome you to this public meeting of the Task Force on Drug Importation. Today we will hear from members of the public who have indicated that they would like to make presentations to this task force.

Secretary of Health and Human Services Tommy Thompson formed this task force to explore whether and how drug importation might be conducted safely and its potential impact on the health of American patients, medical costs, and the development of new medicines.

On behalf of Secretary Thompson, I want to thank the members of the task force for your willingness to work on this important issue. It’s an extraordinarily complex topic that challenges the best minds in the field.

The past two weeks, we have held the first two listening sessions of this task force. We heard presentations, in the first session from consumer and advocacy groups, and at the second session from pharmaceutical development and distribution companies. Those presentations were very useful to this task force. I thank the presenters not only for their thoughtful presentations but also for their responses to our follow-up questions.

The safety and efficacy questions related to importing prescription drugs into our country are very important to the nation’s health.

As a trauma surgeon, the former CEO of a health system, and now doctor the American people, I understand the critical role that prescription drugs have in our public health system. The miracles of modern medicine are often found in a pill. It’s truly wonderful that science has brought us medications that can unclog arteries, lower blood pressure, cure infection, and save or enhance life.

Millions of Americans have come to depend on prescription drugs to keep them healthy. The biomedical research that has led us to the development of these drugs is truly awesome.

The task force is first and foremost about the facts and the science. And we will go as far as the facts and the science will lead us. I thank everyone, in advance, for keeping this in mind.

Together, this task force, the members of the public, and the stakeholders are exploring whether prescription drug importation can be done safely and effectively. And if so, what resources are needed. Our mission, outlined in the Medicare Prescription Drug Improvement and Modernization Act of 2003, is to determine whether there is a safe structure for prescription drug importation.

As I did at our first two sessions, I want to promise all of the presenters today and in the future meetings, the opportunity to be heard. I expect this process to be completely transparent, with frank, open, and honest discussion about the health implications of drug importation. I expect that diverse ideas will be presented, and I ask everyone to be respectful of that diversity.  

These meetings are being conducted in an organized manner, in an effort to produce the best possible information. As with previous sessions, each of today’s presenters will have up to five minutes for prepared remarks. Please note, in the front is a timer; goes from green to yellow to red. I’d ask speakers the speakers to be cognizant of it, when you see the yellow light, you have about a minute left, and I’d ask you to begin summing up at that point. After a presenter has concluded his or her remarks, the task force members may follow up with some questions for that presenter.

I ask each presenter to be mindful of the five-minute limit for presentations so we can ensure that everyone has an equal opportunity to be heard. In addition, the task force will welcome all written and supporting materials that parties would like to submit.  

Those materials, along with the transcript of each listening session, will be available to the public, The Department of Health and Human Services has developed a web site for the task force that can be reached through www.hhs.gov

One last bit of business; is there anyone in the audience that would require signing for any of their presentations this morning? Because we want to make sure that’s available. Nobody is identified; OK, thanks so much.

With that, lets get going with today’s business. I would like again to thank my fellow task force members for their time and we will now welcome the first presenter and that would be Rick Roberts. Mr. Roberts, thank you and Mr. Roberts let me just mention for you and any of the speakers, that you have the option to come to the podium on the stage if you like, or use one of the three microphones -- the one you’re at or either at the two aisles – so, whatever makes any of the presenters the most comfortable to you, please make the selection of where you’d like to be.

Presentations from Registered Speakers

Rick Roberts, Consumer

Great, thank you, and I’m just going to move this, if that’s OK, ‘cause I can’t see the light from here and I want to try to stay to my time.

My name is Rick Roberts and I feel very fortunate to be here today. And I’m glad to have the opportunity and I thank you for the chance to share my experience, what I have learned through those experiences, and my concerns about importation and reimportation.

I started college as an 18-year old in 1981 in San Francisco. I was infected with HIV in the early 80’s. As you know, HIV was later discovered and in 1988, I became ill and was diagnosed with AIDS Related Complex, which progressed to AIDS. I’m going to kind of fast forward 12 years from that time to the year 2000. Those 12 years were an interesting time; had some ups and some downs, but in the year 2000 I was diagnosed with AIDS wasting syndrome, although it doesn’t look like it right now, I was wasting at that time. And I had failed on a couple of therapies and my doctor said our last try was going to be a drug called Serostim recombinant human growth hormone. And that cost four to six thousand dollars a month, and I was fortunate enough to have the insurance company approve a 12-month supply.

I started injecting that and had very good results. More than half way through my time of injecting Serostim, I noticed a stinging at the injection sites that I hadn’t noticed before, and some subtle differences in packaging and in the amount – or the dose – of the power itself. What… I wasn’t alarmed. I’ve had lots of drugs change size, shape, color. I just a note I wanted to ask my pharmacist, so I went into the CVS pharmacy where I got my Serostim every month and I asked the pharmacist. And, I told him what was going on and I asked him if I was doing something wrong or if something had changed? And he nonchalantly commented that “You should go home and check, because you may have received some of the fake stuff.”

So, I did go home, and by the time I got off the bus and got home I had convinced myself I must have misunderstood what he said, because how could that be? I went to the CVS pharmacy in my neighborhood and it was the box just as it was supposed to be. I was wrapped in plastic, it has the label on it. Fake stuff. I went online and, sure enough, found an article in the Boston Globe. Three paragraphs saying that fake Serostim could be found in seven different states. And that the FDA was doing an investigation. Went to the FDA website, found the notice there; went to Serono, the manufacturer’s web site and they said were cooperating with the FDA.

I called my doctor. She hadn’t heard about this. Went in to talk to her and she said, we have to find out if it wasn’t growth hormone what it was you were injecting, because we need to know if there’s something we should be doing if you have done some harm, we want to counter that -- we need to find out. We couldn’t find out. Nobody knew what was in those vials. Which started, for me, a really difficult time of not being able to sleep, I became very preoccupied. Couldn’t focus; I teach at the University of San Francisco, and found it really difficult to do what I was supposed to do. I started having anxiety attacks. For 12 years, we knew who the enemy was, we were fighting HIV. For the first time, I had no idea what we were up against.

In my mind, though, I kept going to the thoughts that they had put Hepatitis-C in those vials, and I had injected myself with Hepatitis-C. And, that’s what I thought. It took three months to find out that it wasn’t Hepatitis-C in those vials. I had been injecting HCG – Human Chorionic Gonadotropin -- which is the hormone women make when they are pregnant and it’s used as a fertility drug. It’s not meant to be injected subcutaneously, and it’s certainly not meant to be injected every day. It does explain why I was an emotional wreck for a while.  So, I, though, discovered that I had received two different batches perpetrated by two different persons or groups. The second batch, I found out three months later, had contained that form of growth hormone but, based on the contaminants, it was probably produced outside of the U.S. and it was 1/6 the dose I was supposed to be receiving.

How does this relate to reimportation or importation? I had gone through an American pharmacy. It turns out that this was distributed through the secondary market, through a licensed wholesaler in Florida. As far back as I know that it’s been traced, who sold it to a licensed wholesaler in Las Vegas, Nevada, who sold it to a secondary licensed distributor in New York. This is much like money laundering to clear the pedigree, because once they put it through an authorized dealer, the pedigree doesn’t have to be included in the next sale. And then it was sold to the major distributors who had contracts with the major pharmacies and that’s how it got to the seven different states.

I have since worked with – talked with the FDI, to the manufacturers, the Nevada Board of Pharmacy the law enforcement agency for the state of Florida (who investigates counterfeit medicine), and even the FBI. I have testified against these bad guys. They are really bad – they don’t care. They found $47 million of bad medicine in Florida in one year: cases of insulin, not refrigerated in the Florida sun. These are bad guys, and they know what they’re doing and they do it really well.

I have learned that the longer the distribution chain, the more likely -- or the more doors are opened for these bad guys to do what they want to do which is to make money at the expense of sick people. So, I need to sum up. I am afraid… these are my concerns: that as we elongate and go outside the jurisdiction of the FDA, and we go with links in this chain of distribution, that we create opportunities for the bad guys.

So, the safely issue, I don’t think, is secondary or a smoke-screen, as people have told me. I think it is a primary concern. My concern is that, people like me, who may receive a counterfeit, what recourse do we have? What do we have – where do we find relief? Who would we find responsible? If we’re having trouble paying for our medicines – and I’ve been there, maxed out my credit cards buying AZT in the 80’s, and borrowed money to get my medicine – I’m not going to going to be able to afford an international tort lawyer to represent me in some other country. Who will be responsible if this happens and why would we open the doors that would allow this to happen? I don’t know of any savings monetarily or discounts that could be offered that would make it worth jeopardizing people’s health, or allowing the bad guys to do to you or anyone in this country what they’ve done to me. Again, thank you. I feel fortunate to be here, and thanks for listening to my story.

Carmona – Thanks very much Mr. Roberts. Would you hang on just a second in case any of our task force members have any questions of you?

Roberts – Yes, sorry.

Carmona – Thanks. We’ll all get used to it as we go through the day. Members, anybody have any questions for Mr. Roberts? Yes, Dr. Crawford.

Lester Crawford, DVM, PhD, FDA deputy commissioner – I’d just like to thank you for that testimony and for your courage in being here. Since the event in the year 2000, obviously you have educated yourself about this problem. Are there special steps you could share with the group that you yourself take in order to ensure against this happening again?

Roberts – Yes. I am now well-known to my pharmacy, I go to another pharmacy. I go -- it’s a 24-hour pharmacy -- I usually go after midnight. They know me by name; they know I won’t leave the counter until I’ve gone through every prescription. I look at every drug before I leave the counter, because once you take it away from the counter they can’t take it back. They’re used to me calling with questions and asking questions. And I question everything that’s different. I have a bottle of Lipitor at home that we can’t track to the Lipitor recall and I’m not going to take it. I don’t know what the odds of getting three counterfeits are, but I’m not going to take a chance. So, that’s what I can do, I just think the responsibility shouldn’t fall on the patient. Cause I don’t know what else we can do except to ask the pharmacist or our doctors. But I do recommend, if anyone feels anything different they hadn’t noticed before, or notices any changes, they should check, and the FDA website is a useful place to look, too.

Crawford – We would invite everyone to do that, on behalf of the FDA. Thank you.

Carmona -- Other questions?

William Raub, HHS deputy assistant secretary for public health emergency preparedness -- Just to follow up on that, when you went back and found the drug with the burning sensation – you said there were subtle packing differences. Can you describe those and the quality of the product in terms of the sophistication and the comparison?

Roberts – Would you like to see them? I have them with me.

I would, I would. Did in fact, the pharmacist that gave it to you, that gave you the product, did they in any way realize that the product was counterfeit? Even when you brought it back and looked at it, could they tell that it was a counterfeit product?

Roberts -- I don’t think so, and I’m glad to share it. I actually have the counterfeit and the real. I understand how the pharmacist passed it one. I don’t think that they are necessarily looking for counterfeit all the time, and you can tell for yourselves if you could be able to identify the difference or not. And I certainly didn’t; only because I was looking at it so closely -- each vial -- because I was injecting it, I noticed some subtle changes. But I don’t think… I mean, it’s such a good counterfeit, I don’t think the pharmacist would be able to pick it up. What was surprising to me was that when I got home, the FDA knew, the manufacturer knew and the pharmacy knew – because they had received a letter saying the product had been recalled and they had sent everything they had on their shelves back. That’s how he knew to tell me to go home. But, nobody ever notified me. And, I’ve said this before, when I’ve had a car part recalled, they have had to track me down, notify me, track that part, remind me that I didn’t get it fixed. But for some reason, there’s no policy like that for pharmaceuticals, so I found out by chance. I have no idea how many people might think they just failed on the Serastim, and got the fake stuff.

Carmona – Any other questions?

Raub – It would be nice if we could see the product, if he’s got it.

Roberts – I’ll just point something out, if I can, and then I’ll have you take it, look at it. It comes in a seven-day supply box, it comes with a diliant bottle and a powdered drug bottle. This, well, top one is real; the bottom one is counterfeit. And you can look at the vials and decide. After it happened, Serono put a hologram on the box to help identify the real stuff, but within a couple of months, the counterfeiters were able to make the boxes with the holograms as well and there were two more counterfeits of this drug a year later with the holograms on it. The one with the hologram, the way I can tell, is because this blue is a little bit darker on the fake one. So, when you get it, look really closely, and this blue that’s a little darker is the fake one

Carmona – So what you’re saying is – I hadn’t seen those before – is that those who made this provided countermeasures in effect to make it look the real thing, and when we got a hologram on it, they also put a hologram on it?

Roberts – And there’s another difference. You can tell that the labels are slightly rounded on the corners on the bottle on the vials, that’s the real drug, and the more square corners are the counterfeit. They weren’t real good at cutting the labels out. But very small, subtle differences, as you’ll see. And, with laser printing and scanning, they were able to – they had the package insert and the instructions to the patients, all that they were able to recreate and pass it off.

Carmona – Yes, Ms. Willis.

Elizabeth Willis, chief of the Drug Operations Section, Office of Diversion Control, US Drug Enforcement Administration  – Yes, Mr. Roberts, you mentioned that the drug had gone through several layers of the secondary distributors industry. Do you know how many layers it had actually passed through?

Roberts – The FDA may have more answers. When I testified in the case in Las Vegas against the company in Las Vegas, their sole supply of the medicine came from a company licensed under the name Rekcus in Florida. R-E-K-C-U-S, which is that’s “suckers”, spelled backwards, that was their license name in Florida. And, they were getting medicines from a number of places; expired medicines that were supposed to be destroyed that doctors were sending them from South Carolina so they could reliable with new expiration dates. Things like that. They were getting them from a lot of different places and some that were, apparently, international. So, we’re don’t know exactly where these started but we can trace it from Florida to Nevada to New York -- the big three. And the FDA is still on-going, so the FDA has a lot of things they say they can’t talk to me about.

Carmona – Other comments, questions? No? Mr. Roberts, to echo what Dr. Crawford said, we appreciate your time and also your willingness to expose these very private parts of your life for the benefit to the American public.

Roberts – Yes, thanks for listening.

Carmona – Before we move on to our next speaker, let me… I was remiss in not introducing a new member of our task force. At the very far end on the right, Tracy Hardin, an attorney with the Department of Justice. Her predecessor left because she was promoted to a judgeship, I believe, and Tracy was good enough to come and join us after being nominated by the Department of Justice, so welcome and thank you for being with us. Our next speaker is Dr. Rene Rodriguez, from the Inter-American College of Physicians and Surgeons. Dr. Rodriguez, welcome and Dr. Rodriguez, if you’d like you can use the podium on the stage or any of the microphones on the floor. Whichever you prefer, sir, your call.

Rene Rodriguez, Inter-American College of Physicians & Surgeons

Thank you very much, sir, and good morning. My name is Rene Rodriguez and I am a medical doctor and president of the Inter-American College of Physicians and Surgeons. Since 1979, we have worked to promote cooperation among U.S. Hispanic physicians. I am here today because this great country, and some of its most vulnerable citizens are in grave danger.

We have the safest and best medicine supply in the world but proposals for prescription drug importation could dismantle this system. Those who favor importation have good intentions: to lower costs and increase access to medicine. But that they propose to do with an irresponsible and unacceptable trade-off between price and safety. With foreign importation, the U.S. FDA would not be able to exercise the same safety control over prescription drugs that it does now. The drugs may be real drugs or they may be counterfeit, they may be effective in treating patients, or they may not. 

Even worse, they may actually be harmful. The truth is, we don’t know which is which until someone has paid the ultimate price with his life. While some think that imported drugs are somehow OK, because Canada has tough domestic standards, nothing could be further from the truth. Imported medicine – you saw what happened already -- are not guaranteed to have been inspected by Canadian authorities who have stated that they do not have safety responsibility for drugs exported to the U.S.

Doctors know that, when they prescribe a drug for a patient, that they will be able to get real medicine that really will cure the patient. Right now, doctors have that confidence. If this misguided proposal becomes law, no doctor will be able to have this confidence and the health and safety of millions of Americans will be compromised.

The Inter-American College of Physicians and Surgeons plays an important role in minority communities. And I ask you to consider this issue from the point of view of minorities. Minority and low-income and other traditionally underserved populations will likely get a disproportionate share of these bad medicines. As state Medicare programs struggle to save money, it is those who have the least ability to pay who will be hurt the most. They will end up with a two-tier system, where people in the suburbs get safe, FDA medicines, and people in the barrios get medicines of unknown quality and origin. For these reasons, we believe that importation drugs really will end up in the low-income areas, in the barrios, and we believe they are a bad prescription for the good medicine that we have in this country. Thank you, sir.

Carmona – Thank you, Dr. Rodriguez, task force members, does anyone have questions for Dr. Rodriguez. No? Dr. Rodriguez, thank you so much, we very much appreciate your being here. Our next speaker will be Steven Gibson, from the ALS Association. Is Steve Gibson present? OK, what we’ll do then, for a matter of administrative course in these proceedings is, if someone is not present, they’ll just move to the end of the list. So if any of you know Mr. Gibson and he comes in, we’ll just take him at the end of the list. We’ll move on to our next speaker, who will be Mr. Noel Curb, SPC Global Technologies. Mr. Curb, are you OK standing there?

Noel T. (Tom) Curb, SPC Global Technologies

Yes, I came up here; this [podium] will help hold me up. I just wondered, did ya’ll start timing me when I started up the stairs? I told the chairman that I’m from Texas, I can’t introduce myself in five minutes. I asked for 30 or 40 minutes for my comments. (Laughter.) I’m going to parse this down, but it will be complete in the hard copy and a CD for you guys.

My name is Tom Curb, I’ve been a resident pharmacist for 41 years with more than 38 dedicated aspects of managed care pharmacy benefits related to hospitals, HMOs, PBMs, retail pharmacy networks, development of prescription claims processing, pharmaceuticals purchasing and as an independent consultant on matters pharmaceutical.

My background and experience qualify me to allow me to make the following comments and observations. The challenge before this commission is to assess the potential for a cost effective and safe system for the importation of Canadian prescription drugs.

I will describe such an importation program with documented cost-effectiveness and patient safety. First, necessary elements must be defined and addressed. Lowered drug cost is a given; informed Americans know they can obtain cheaper drugs from outside the United States. The effectiveness and safety, appropriate therapeutic response and patient safety demand two primary considerations: product efficacy and real-time electronic safeguards; the former being affected by accountability of source, and the latter by applications of proven, technological edits.

Product efficacy. Dire government and industry predictions about unsafe or substandard drugs from licensed Canadian pharmacies have proved invalid. Documentation of more than 38,000 Canadian source prescriptions subjected to the below-described safeguards reveal that there were no reports of counterfeit drugs, substandard drugs, or adverse drug events. These statistics are especially important because the majority of patients had affiliated medical benefit programs and thus were subject to consistent and routine physician oversight.

Real-time electronic safeguards. Although there is no validated evidence of product-related death or injury to Americans importing drugs from licensed Canadian pharmacies, tens of thousands of patients obtaining drugs from within the U.S. system die or are seriously injured from adverse drug events. To help prevent these, U.S. pharmacists are required to maintain patient profiles with their drug utilization histories that interface real-time with technologies that identify potential medication-related problems. Also, prescription benefits managers, or PBMs, require claims processors to maintain a central profile of each member’s drug utilization within the provider network, and for the profile to be linked to similar patient-protective technologies.

The primary purpose for these patient-protective technologies is the prevention of adverse drugs events caused by drug-to-drug interactions. An essential deterrent for which is a comprehensive patient profile. Obviously, even within the internal U.S. system, applications of these patient-protective measures are not universal. Many Americans do not consistently trade at one pharmacy, and an out-of-network situation will occur if a customer obtains a prescription from a non-technologically linked pharmacy, or if a prescription is not submitted to a PBM claims processor.

An out- of-network prescription permanently contaminates the patient’s profile with respect to that medication and all subsequent medications. Without appropriate technological monitoring, imported prescriptions will also meet this out-of-network criteria. Increasing public awareness of cheaper foreign drugs, and ease of acquisition via the Internet, cause perceptive health care providers to recognize an imminent danger to their members’ health from potential out-of-network prescriptions.

To alleviate risks due to omission of data about imported drugs from members’ drug history, and in an effort to fulfill their obligations to protect members’ health (and in many cases the plan’s resources), proactive benefits plans took preemptive actions to incorporate proven protective measures into benefit’s designs. Also, recognizing the danger from data omission in customers’ drug profiles, visionary retail pharmacist retailers have tried to fill that obvious void. Facing the increasing threat of reduced revenues, they offered to supplement their in-house patient profiles with imported drug data, to inform their importing customers or safer mechanisms, to advise them of the relative cost of domestic versus imported medications and to answer customers’ questions about the products that they may choose to import.

I emphasize this technological aspect of a safe mechanism because some regulators seem to misunderstand the process or they underestimate its importance. Despite the irrefutable need for these universally acclaimed and professionally endorsed safeguards -- and ignoring evidence that the lack thereof is a much greater threat to citizens than unsupported, product-related concerns --- the federal government, in concert with state officials and regulatory agencies, is attempting to prevent application of these safety measures to imported prescriptions.

Hopefully, theirs is just not another effort to placate a narrow but influential constituency. For, by discounting the necessity of such measures, regulators will create a preventable and yet grave and imminent danger to American consumers. If regulators do not ensure to these safeguards, they will have abandoned their mission to protect Americans’ health and, instead, create a deadly environment that is diametrically opposed to the safer one of application of universally endorsed and proven health care technologies.

Carmona – Mr. Curb, would you please sum up now?

Curb -- Yeah. Under the safe and cost effective mechanism, licensed Canadian pharmacies would be certified or subject to an acceptable professional criteria. In the absence of this reciprocity and our dual licensure, Canadian prescribers would be credentialed based on accepted, professional criteria that would include review of requirements. U.S. prescription benefits plans, and all other PBMs, would be allowed to coordinate with credentialed Canadian pharmacies to obtain medical and drug data that have been supplied to them by their importing members, and to electronically processed Canadian prescription claims for these members. U.S. retail pharmacy would be allowed and encouraged to establish cooperative relationships with Canadian pharmacies and/or U.S. PBMs that would enable them to become involved in their customers importation processes. The technologies, safeguards and processes that could accomplish these programs have been developed, prototypes can be demonstrated and positive results validated. For those 38,000 prescriptions that were mentioned earlier, the Canadian savings were in excess of $6 million, when compared to already-reduced prices in the U.S. pharmacy network – an average saving of $150 per prescription, more than 50 percent. I have answers to all of your specific questions, but I guess you’ll have to get them off of the CD.

Carmona – We’ll certainly look at your record that you’ve provided to us. I appreciate it. Task force members, anyone have any questions for Mr. Curb? Thank you, sir, for your testimony. Appreciate it. Our next speaker is Peter Neupert of drugstore.com. Mr. Neupert.

Peter Neupert, drugstore.com

Good morning, and thank you for the opportunity to speak today. I’m Peter Neupert, Chairman of Drugstore.Com, a leading online of health, beauty, vision, and pharmacy products. We were one of the first fully licensed online pharmacies, back in 1999. 

The Internet has empowered consumers to comparison shop for their prescriptions. For example, Drugstore.com was the first to make all of our prescription drug prices available online to any consumer. Because we believe that empowerment is a positive thing. However, it is the same medium, the Internet, that has made it so easy for unscrupulous, unregulated and untouchable entrepreneurs to put U.S. consumers at real risk for their health.

Since 1999, our safety and privacy claims have been substantiated by a thorough audit, conducted by a trusted, independent organization – the NABP, the National Association of Boards of Pharmacies. Trusted verification is especially important on the Internet, because the consumer does not have the visual cues available in the physical word; things like which neighborhood it’s in, the cleanliness of the site, the licenses, the orderliness and the like.

As cross-border importation of prescription drugs becomes more popular and widespread, the problems will only get worse, exponentially. This is the nature of the Internet; trends accelerate at a breakneck pace. Consumer demand will create supply, while more marginal players that exist will set up shop to tap into the bigger and more lucrative markets. Many problems that exist with the current laisse faire approach to cross-border importation will increase, from therapeutic failures to life-threatening events; all will be exacerbated. An uncontrolled free-for-all, without mandatory certification and enforcement, can never claim to put patients’ interest first.

By harnessing the Internet, we believe that Drugstore.com is onto something quite important and possibly revolutionary. Today, we have safely dispensed more than 2.5 million prescriptions to consumers in all 50 states. We leverage the power of the Internet volume to offer discounts of 10-25 percent off prices of traditional brick and mortar pharmacies. Moreover, we are providing important health information that can improve health outcomes, and we have an e-med alert service that proactively goes out and alerts consumers when the FDA has recalled a drug, or any other agency has recalled a drug -- which would solve the problem noted by the first consumer this morning. And we do all of this while conforming to applicable federal, state and local regulatory controls. For the safety of consumers and the viability of the Internet as a lower cost drug delivery channel, it is critical that all Internet pharmacies – whether here or outside the United States -- play by the same rules. Without appropriate standards and enforcement mechanisms in place, opening our borders undermines the confidence in the safety and reliability – and affordability – of the Internet distribution channel. Health Canada, for example, does not regulate pharmacies catering to U.S. citizens.

A spot check on the popular search engine, Google, identified over 250 websites that dispense drugs. Over 25% of those are outside the U.S. or Canada, and those are only the ones that we could identify. Over 167 of those 250 provide medications without a prior prescription, and over 40 more without a prescription at all. Many dispense compounds that are illegal, or subject to special controls. The average consumer cannot say, with certainty or any degree of confidence, which sites are safe and which are not. Right now, the situation is “buyer beware.”

(Displays TropicRx site.) Here’s a site that I got in my email two days ago. I venture to say that we’ve all received such things. This one is particularly interesting because of all of the various things going on. I would venture to say this site is not FDA-approved, although it says it is, although the [FDA] logo is there. This site undermines the doctor-patient relationship and patient safety by requiring no prescriptions. It showcases the U.S. flag, but gives a Canadian address. There are thousands more suspicious sites like this.

So, what do we do? I recommend that we adopt the uniform standards, similar to the NABP – VIPS program. Once such a uniform standard has been adopted and introduced, I recommend the following three-tiered approach to help enforce that standard.  

One: make it illegal for on-line pharmacies to advertise on search engines, unless they meet the approved certification standards and prohibit search engines from accepting advertisements from on-line pharmacies that are not properly certified. Two: stop credit card payments to pharmacies that do not meet the certification standards, and stop the funding at the source. And, third, motivate third party shippers to refuse shipments from pharmacies that do not meet the certification standards.

Buying drugs online should be a superior experience: convenient, affordable and private. But in today’s world, purchasing drugs on-line is fraught with peril. I see the red light is on. I would say that all Americans deserve a system they can trust, this means finding a solution that combines safety with affordability. We deserve to be protected from fly-by-night operations and unscrupulous providers that set aside all safety concerns to make a buck.

Carmona – Thank you, sir. Task force members, Dr. Raub?

Raub – You mentioned mechanisms to reach out to customers in the event of, say, a recall of a product or, by extension, the discovery of a containment product. Would you elaborate on what that mechanism is?

Neupert -- We harness the low-cost, two-way communications of the Internet. We keep a database of our customer name and every drug they received, even by lot number. So, if we get a recall, we monitor the FDA website. If we get a recall, within less than 24 hours, we send an email to each customer who has received anything from that lot number or from that drug. We also do it for non-drug products, you know, we sell baby products and things like that. If they get recalled, we also send notices to those customers. We sent over 30,000 when, I can’t ever say it, when phenyl propylene was taken off from market for some reason, we send out over 38,000 emails to customers within 24 hours.

Alex Axar, HHS general counsel – Mr. Neupert, have you all done any kind of comparison of prices available through your website versus the prices that would be available through websites that offer drugs for importation? And, by that, I mean particularly brands and generic drugs, how they compare.

Neupert – Absolutely. Typically, on generic drugs, we’re cheaper than foreign sources, because there’s a much more robust generic drug market here in the U.S. On brand drugs, my favorite example is that we typically sell Lipitor for $73; probably the traditional retail price is in the mid-80s.  Our foreign competition from Canada sells it typically for $32.

Axar – And what would you say are the major safety concerns? Since the way Drugstore.com is, if I understand your testimony, it operates, you work solely with FDA-licensed and approved drugs and distribution channels. What is your perspective of what the major risks would be with imported drugs, where are the points in manufacture, distribution, where in that chain where you would have the greatest safety concerns?

Neupert – Well, I think that the major risk is that consumers don’t know who they are going to be doing business with. That, if you really think of mass scale importation, it’s going to happen largely on the Internet. There’s no physical way to make it happen from a consumer perspective, and when you’re doing business on the Internet, you don’t know -- unless there’s some uniform, certification standard – if that person is in Canada, even if you think they are in Canada, you have no way to credential them. And there’s no remedy, if it’s not what you think it is, there’s no way for any U.S. authority to go out and deal with it. In terms of the drug supply, if you could have some sort of regulated system, certainly drugs manufactured in other parts of the world are as of good a quality (if FDA-approved) as if manufactured here. I think the issue is, how do you have a controlled system once you leave the border? We have a controlled system, because it’s the only way we can ensure the end results. Once you leave the borders, how do you end up with a controlled system? That, I think, is the ultimate challenge.   

Axar -- Thank you.

Carmona – Dr. Crawford.

Crawford – You’ve basically called for a regulatory system geared towards policing the Internet pharmacies; do you see a role for the states in the U.S., as well as the federal government, or by the very nature of Internet pharmacies is it only the federal government that should be involved?

Neupert -- In 1999 and 2000, I testified in front of Congress on this very issue. States of course, currently certify pharmacies. We preferred voluntary regulations at the time, we didn’t see a particular role for federal government at that time. I’d have to say that my experience since 1999 suggests that that was probably the wrong approach. That certainly, there is a role for states, but the issues about enforcement, about location, about how do you solve all that. I think the Internet has changed the rules. Bottom line, and that you need some national, federal, specific certification capability with enforcement behind that. And that… it’s not just a problem outside the U.S., but inside it as well. Of the 250, the over 40 that sell drugs without a prescriptions – hydrocodine, OxyContin, Vicodin, all that stuff – many of those are inside the U.S. And, so I think that the Internet drug distribution issue is a big issue both internal and external.

Jayson Ahern, assistant commissioner in the Office of Field Operations, US Customs and Border Protection, Department of Homeland Security – Actually, Dr. Crawford asked part of the question, but I was going to ask if you could elaborate a little bit more on your three-step process for certification of online pharmacies, particularly on the importation aspect?

Neupert – What we have been focused on is how do you control something that has been, in effect, the Wild Wild West so far. And, try to do it in a way that enables innovation and takes advantage of the low-cost Internet business model while still providing consumers with some confidence? So, we start by sating you have to have some sort of national certification system that can be secure. When we designed VIPPS with the NAPB, we had to make sure the shield – the certification -- couldn’t be stolen by any entrepreneur and put up on their site just like a fake state license could be. So it has to be a secure certification, which means that the link is controlled by a single person and that you get, through this certification process whatever set of standards you want, but then it’s controlled by a central server. So, that’s step one. Once, then, you have a definition of a what a good pharmacy is, what a legitimate pharmacy is, then you can call the “arms dealers to the Internet’s ecommerce companies” and say, “You can only do business with the good guys.” It’s unfair today to tell Fed Ex or UPS that you shouldn’t be accepting all of these packages coming into the U.S. They can’t tell who the good guys are from the bad guys. Visa, MasterCard and the payment systems can’t tell good guys from bad guys. But once you have a certification standard, one that defines here are the good guys, then you can tell the search engines, the payment systems and the delivery systems that they can only do business with good guys. And I think that is a potential way to control 90-95 percent of the problems – the no prescription issues, and the importation issues. And that would work even if you want to make, to enable someone outside the U.S. to do it, if they had the same set of rules. And that’s the only system that I’ve been able to think of, in five years, that would be able to accomplish it.

Raub – Mr. Neupert, on your slide that you put up, it looks like some of the products that you have on that slide are pain control products. And, you mentioned some other pain control medications, some of which are controlled substances. You also talked about a survey that you did in which you characterized, you know, 167 of 250 sites as not requiring a prescription. Can you tell us what you are seeing from your evaluation, from your expert evaluation of the Internet, in terms of the types of products that people are trying to get to order? Is it a lot of controlled substances and other products? 

Neupert – Absolutely. Go do a search of Vicodin at Google. You’ll see over 50 different websites that will sell you Vicodin without a prior prescription. Deliver it overnight, to your door. It used to be, when I started in 1999, it was all about Viagra; then it was about Zenecal, then it was about some other things. It’s very quickly accelerated, in the last year, to OxyContin and Vicodin.

Raub – Can you elaborate about why that is, when a consumer has the alternative to go to a pharmacist or an on-line pharmacy, or a non-VIPPS on-line pharmacy?

Neupert – Well, our number one drug at drugstore.com is Propecia, because we’re low cost and it’s a cash drug; no benefits, in general. Our second big one is Lipitor, which would be traditional with other pharmacies. The reason that you have so many illegitimate pharmacies pushing controlled substances is that people want them. Bottom line is, they don’t want to go to a doctor to get a prescription, and they want to be able to self- medicate and the Internet’s a good way to self-medicate and it’s more convenient than trying to find a street corner.

Willis – In regard to the controlled substances, do you find that the majority of them offered over the Internet are coming from domestic sites or from foreign pharmacy sites?

Neupert – It’s difficult to tell exactly where they are coming from. Many of the sites will hide their contact information. I spent a couple hours trying to figure it out: called the 800-number, wouldn’t identify what site it was. You couldn’t figure it out, you go to the domain registration, couldn’t figure it out because they use some third party registration. I’d say it’s about 50-50 right now. I’d say the problem is probably bigger inside the U.S., because, frankly, there is very little enforcement because it’s hard to find.

Willis – As a follow up, and you’ve answered part of that, how is a consumer to know exactly where the drugs are coming from? While this advertisement has the American flag and has a street address in Canada, is there any assurance that the drugs are actually coming from Canada, for the consumer?

Neupert -- Without some certification system, there’s no assurance. I mean, I’m a professional and I’ve had engineers try to figure it out. There is no assurance. And that’s why I think you have to have some form of certification, both for the benefit of U.S. citizens using U.S. pharmacies, and for anyone who might try to take advantage of lower prices outside the U.S.

Elizabeth Duke, PhD, administrator of HHS’ Health Resources Administration Services – You’ve several times said, “some form of certification”. Do you have a picture in your mind of what that certification system would look like and what it would take – you’ve identified it as a federal responsibility – what it would take for us to produce such a thing?

Neupert – I think that the work that we did with the NAPB, building the VIPPS – the Verified Internet Pharmacy Site -- is a good model. There may be some additional things that people want to layer onto it. It’s basically what, the similar types of things you go through to get licensed as a mail-order pharmacy. And what this goes as an extra step is an on-going, regular audit to make sure you’re up-to-date, and you make certain agreements to follow all the rules from HIPPAA on through whatever the state- of-the-art is with regards to pharmacy practices at the time. We just went through our second audit, in November/December of this prior year. They spent two days at our site, visited our facilities, made sure our pharmacists were properly doing the right thing, looked at our exception reporting, looked at all kinds of stuff. It’s that kind of thing. There are, today, 13 VIPPS-certified pharmacies, largely because it’s voluntary. But, when you think about the work that has to get done to regulate the 50,000 pharmacies in the U.S., I don’t think it’s more work than is already happening. It just has to get transferred from the people who are doing it today to some other agency in a way that has this secure capability that the VIPPS situation does, on-line.

Duke -- Thank you

Carmona -- Dr. McClellan.

Mark McClellan, PhD, incoming Administrator for HHS’ Center for Medicare and Medicaid Services -- Would this require international participation to conduct the inspections abroad, to monitor the drug supplies abroad and that sort of thing? I’m just trying to understand what additional authorities in the U.S., but perhaps also …

Neupert – I understand your questions, and I’m not here proposing that we accept drugs from overseas. I think this would be a good step for the U.S., to improve its U.S. system. Should the Commission, in its wisdom, say we want to do it outside the U.S., and we want to enable Canada, then yes -- those pharmacies should have the same rules that we have here in the U.S. And that would require that whoever the authorities are – whether they’re provincial or federal in Canada -- accept the same sort of standards and the same sort of oversight that a U.S. pharmacy does. The next point, that I didn’t mention is that there needs to be some sort of a consumer awareness campaign; that there is good guys and not good guys. And that is one thing that has never been funded, that the VIPPS program never got off the ground, frankly, because as the Internet bubble burst, we couldn’t afford it.

Carmona – Ms. Hardin.

Tracy Hardin, Department of Justice – If importation was allowed, is this something you would use? Would you use Canadian drugs in your business to pass along greater savings to the consumer, or is this something you would not want to be involved in it?

Neupert – I’ve always, in participating in this debate over the last few months, I’ve thought it was a mistake to have consumers try to figure out how to import products from around the world. That, it would make much more sense, if you wanted to allow importation, that you would have commercial importation fit into all of the controls and safeguards of the U.S. system. As the prior speaker mentioned, the DUR, the  patient profile, all of the sort of linked in networked claims, these issues that happen, could occur if you allowed commercial importation. As opposed to expecting consumers to try to figure out who the good guys are and who the bad guys are throughout the world. And the one issue that I’d like to mention in that regard is, if you empower consumers, and encourage them to go off-shore to go shopping, I don’t think that there’s any way to control it. To think that it’s just going to stop in Canada is just naïve. People are shopping around the world, and there’re going to go to where the lowest prices are, because, hey, if it’s safe to get drugs from Canada, why isn’t it safe from New Zealand? Why isn’t it safe from Thailand? And they’re not going to be able to tell the difference. And if two million people have done it so far, and everyone’s telling their friends, or ten friends, how they saved $100 a month, there’s going to be four million people this year and ten million people next year. This is going to go like this, because it already has from a very small base.

Carmona – Any more questions? Mr. Neupert, thank you so much for providing this information, particularly your comments on informing the consumer, which has been a challenge for us. Because, in our first meeting, I spoke about the aspects of health literacy, that is consumer awareness. And, you know, to the average person, looking at a website like this, you feel very secure. As you said, you see the American flag, you see “FDA”, and yet there’s a whole sinister operation below that, that has nothing to do with safety or efficacy. And we keep seeing more and more of that, yet the American public has this false sense of security by seeing their flag and seeing FDA and so on. And we are struggling with how to breach that gap and instill that body of knowledge into the American public so they will understand and recognize that there is a risk. Thank you very much for bringing it to our attention. Next speaker is Kurt Hilzinger, from HDMA.

Kurt Hilzinger, HDMA

Morning, Mr. Chairman and members of the task force, and thank you for allowing me to participate in today’s important meeting. My name is Kurt Hilzinger, I am President and Chief Operating Officer of AmerisourceBergen Corporation. However, I am here today in my role as a member of the Board and Executive Committee of the Healthcare Distribution and Management Association.

HDMA is a national trade association representing full-service distribution companies responsible for ensuring that billions of units of medication are safely distributed to tens of thousands of retail pharmacies, hospitals, nursing homes, clinics, and other provider sites across the United States.

In our presentation last week to the Industry Roundtable, convened by this task force, HDMA stressed that assuring patient safety is of paramount importance when considering the feasibility of importation. With this in mind, we focused on the top three safety issues we believe must be addressed: product authentication, product liability, and product availability. Each offer significant challenges that cannot be overemphasized.

While these remain at the top of our list, I would like to turn today to two additional safety issues HDMA believes are critical for the task force to consider.  Specifically, these are recalls and repackaging and re-labeling.

I’ll start with recalls. One of the key safety features incorporated into U.S. policies and regulations is the current FDA managed system for “recalls.” Systems are in place today to facilitate domestic recalls that are initiated by the manufacturer and processed by wholesalers and pharmacies. When dealing with foreign imports, it will be critical to ensure that the FDA has the authority and resources to apply the same level of oversight to international product recalls as they have to domestic product recalls. Foreign manufacturers should be held to the same standards for evaluating when a product should be recalled as is currently done in the U.S.

This leads to a number of questions, such as: Who will have responsibility for initiating, regulating, and monitoring international recalls? Will FDA have the jurisdiction and oversight over a foreign firm’s recall plan? How will post-marketing complaints and adverse event reports be gathered and assessed? What will happen if foreign originated product is recalled but its domestic counterpart is not: will this require wholesalers and pharmacies to maintain separate inventories? If so, this implies a whole new set of procedures and costs that should be factored into your study.

Next is the issue of repackaging and relabeling. Imported products may have to be repackaged to met FDA specifications. This, in turn, means they should also have to be assigned a new National Drug Code or NDC. This number is used throughout the U.S. health care system to identify products in support of such wide-ranging activities as product ordering, drug recalls, and reimbursement of pharmacies under public and private sector insurance programs. The imported drugs may also have to be bar-coded to meet the newly promulgated regulations and to enhance distribution efficacies. They also should be marked as to the country of production and be accompanied by patient package inserts that meet FDA-approved language requirements. All of these steps are critical, but they will result in additional time in getting drugs to the patient and have costs associated with them that will need to be factored. In.

If a decision to move forward with importation is made, patient safety must be the paramount consideration. Wholesalers are best positioned to help maintain the safety and security of the national drug supply. However, importing product from foreign sources introduces significant challenges and must be addressed to ensure the broad safety of imported products while maintaining the desired cost benefits for consumers. Before the green light is given to importation, the three safety issues HDMA outlined last week – product authorization, integrity and availability – as well as the ones we raised today – processing recalls and repackaging and re-labeling – should be thoroughly evaluated by this task force. There are still other important issues that remain to be addressed and discussed for your evaluation, but we will cover those in extended remarks that we will submit to this task force by June 1.

Thank you again for allowing me the time to speak today. I would be happy now to take any questions.

Carmona – Thank you. Any questions from the task force? Mr. Azar.

Amit Sachdev, acting FDA deputy commissioner for policy – Mr. Hilzinger, I’m not sure if you were here earlier and got to hear Mr. Roberts’ testimony about the counterfeit drugs that he received from a CVS store in his neighborhood?

Hilzinger -- I did hear it.

Sachdev  – Could you explain, from the distributor’s perspective, what you might know about how – how could something like that happen in the distribution system. How could someone end up going to a CVS that’s here in America and receiving a drug that’s counterfeit, multiple counterfeit drugs? It sounds like different drugs that he had purchased ended up being counterfeit. How can that happen?

Hilzinger – Well, there are a lot of ways that it can happen. As a primary way it can happen, we, today, take returns from our pharmacy customers in part for product recalls – which obviously go back to the manufacturer and their FDA guidelines – but we take returns for good product, for in-date product. We would like to believe that our pharmacy customers today buy all of their pharmaceutical products solely from us, but pharmas today are under tremendous pressure in their own businesses. They do procure product from other sources; sometimes that product is, in fact, counterfeit and when we take a return back from a customer, it is very difficult for us to tell – virtually impossible for us to tell -- if it is counterfeit or authentic. As witnessed by the product packaging today. So, we have… we can… We do a superb job of controlling product from the manufacturer down to our pharmacy, but there is a reverse distribution function that we perform as well. And our pharmacies will buy product from other sources than ourselves. There is also an issue, obviously, with the number of distributors that have been licensed in this country. Florida was an extreme example, with over thousands of wholesalers licensed at the state level. And I think, you know, additional regulations need to be put into place to control the number of licensed wholesalers who are approved at the state level.

Carmona – Other questions, Dr. Raub.

Raub – You had mentioned the prospect of increased costs for the wholesaler with respect to the recalls and the repackaging and the relabeling. Could that be of a magnitude that would virtually wipe out the theoretical savings of importation?

Hilzinger -- Theoretically yes. I think we would need to know, you know, what the model is that would be contemplated by the task force. How broadly importation would be allowed in the U.S. If there are multiple sources around the world from whom product could be welcomed in to the United States, then it could be significant costs to repackage and relabel the product to make sure it’s safe for U.S. consumers. 

Raub – Of course, as one of earlier presenters testified this morning, the longer the chain or, by extension, the more complex the web, the potentially greater costs for you.

Hilzinger – I would agree with that. I think the task force should be assured that there will significant additional costs to reimport product and repackage it to make sure that it’s safe.

Raub – Thank you.

Hilzinger – Yup.

Carmona -- Other questions from task force members? Ms. Hardin.

Hardin– I was just wondering if you could give a brief description of what liability issues distributors face in situations like the one Mr. Roberts described with counterfeit drugs in the distribution chain, and if you’ve given any thought to how that issue might change if importation was allowed?

Hilzinger – Well, we’ve not… in a world where importation was not allowed, we’ve really not thought about our liability until we know what kind of model will be approved by the task force and the government. Clearly, we feel that, you know, we have a moral and ethical responsibility to safeguard the supply chain as best we physically can today. We do have, we have been asked to participate, we’ve been part of the lawsuits, have been named in some of the lawsuits for situations like that. And obviously, we have our own views as to what we can control and what we can’t control and we’ll have to defend ourselves accordingly. Historically, wholesalers and distributors have been indemnified by manufacturers for most of our liability in the marketplace. We provide a logistics and distribution function for our manufacturing partner, that’s our primary role.

Carmona – Other comments? Mr. Azar.

Azar  -- We’ve heard testimony from others that for importation of prescription drugs, that you can import dugs that are FDA-approved drugs that meet FDA specifications. Your testimony appears to support that type of implication if we go in that direction. But, others have suggested that you could import drugs that are FDA-equivalent or like FDA-approved drugs. Do you have a sense of how, of how much more difficult, how that would compare to FDA-approved importation?

Hilzinger – You know, you’re out of my area of expertise. The industry association is very comfortable with a closed system, where if we were to have an importing situation in this country, it would come from an FDA-approved manufacturing site, to an FDA-approved importer and then obviously down to pharmacy. When you’re dealing with FDA-equivalent products, today I would tell you that our systems and our technologies are not set up that we could determine the difference between an FDA-equivalent and an FDA-approved. Now, unless of course there was ID tagging of some sort and we could get very specific identification of the source of that product.

Carmona – Other questions? No. Thank you sir, appreciate it. Our next speaker will be Governor Doyle, the Governor of Wisconsin. Welcome Governor, thank you for taking the time to be with us.

The Honorable Jim Doyle, Governor of Wisconsin

Thank you again Mr. Surgeon General and members of the task force. I appreciate your giving me -- and other members of the public – the opportunity to come and speak about an issue that is so important, and certainly one that – as Governor of the state of Wisconsin – I hear about daily from citizens from our state. Citizens who really are struggling, as you well know, truly struggling to afford the costs of basic medical care.

There is no doubt that medical science has yielded enormous discoveries that have extended and improved the quality of our lives. But, it is equally true that the skyrocketing cost of prescription drugs threatens to deny many of our citizens in Wisconsin and across this country with access to these lifesaving cures.

Like most Americans, like most people in Wisconsin, we are disappointed that the federal government has not done more to address this dramatic inflation, or to provide meaningful prescription drug coverage to those who need it most. And we appreciate the work of this task force in looking into this very important issue, and hope that the result is going to be one that truly provides some relief to the citizens of our state. 

As I have often said, there is one thing the federal government could do tomorrow that would make prescription drugs more affordable for every American, and that’s to allow the safe reimportation of U.S.-made and –approved prescriptions from Canada.

Every day, I meet citizens of Wisconsin who struggle with the high cost of these drug, and are often forced to make the inhumane and unbearable choices between food and medicine, or skipping a dose here or there. I know you are hearing testimony from citizens who are in that predicament and I know that you have all heard those stories about people who are making those difficult decisions.

But just across the border, Canadians can walk into their corner drug store and buy prescriptions for a fraction of what we pay. These are the same medications available here, but may be as much as twice or even more for Wisconsin consumers.

Wisconsin has acted and we have been forced to take a lead. In February, in response to overwhelming demand from the people of Wisconsin, we launched a website which is on the screen – www.drugsavings.wi.gov -- this site empowers our citizens to order these lower-price prescription drugs from pharmacies that our state has visited and has found to be safe, reputable, and reliable. For example, just one of the most common pain relievers, Celebrex, the state of Wisconsin for hundred doses, as the state, with the discounts that we receive, we pays $106.71, but through our website, an individual can purchase the same drugs for $72, a savings of 58 percent.

The response to our website has been remarkable and I hope should provide some measure to you of what the demand is out there among American citizens. Over the last six weeks, we have had 87,000 visitors to the website, an average of 2,000 visitors a day trying to find help with affordable drugs.  And here are some of the stories they have shared with me.

Connie sent an email to tell me that the only way she and her husband can afford the drugs he depends on is to buy them from Canada, since there are no generic substitutes.

Cari is 48 years old, disabled and has no prescription drug coverage. She hopes that the website will help her with the costs of the nine prescription drugs that she takes.

Clare wrote to tell us that her husband is a transplant patient and his anti-rejection medication costs $1,000 to $1,300 per month, depending on the pharmacy used. Her husband is 65 years old and still working, and she wonders how anyone except the wealthy can afford this medication.

Mary from Brookfield says that she has been ordering drugs from Canada for over a year for herself and her husband. They are senior citizens, they take multiple medications and just can’t afford the high prices.

The emails come to me from Wisoncon and around the country make one thing very clear to me, and I’m sure that it’s clear to this panel -- people are going to Canada. Whether we like it or not, people are going to Canada. They are going in bigger and bigger numbers, because the simple dollars demand it and it is the only option that many of them have. We have, we hear from people not only from Wisconsin but from all over the country, writing the same thing, emailing through the website, saying, telling us that in many cases they have been going to Canada for a year and a half. They appreciate the fact that some body has checked the pharmacies out and has negotiated some prices and that they can deal with those pharmacies. 

Now, I can understand that the pharmaceutical companies don’t want us buying safe prescription drugs from Canada, because it cuts into profits. But I really hope that the federal government gets on our side, trying to help the citizens of Wisconsin.

This Administration has the authority – right now – to allow the safe reimportation of U.S.-made and –approved prescription drugs from Canada. And I hope that this task force will recommend that the Administration use its authority to do just that.

The drug companies have waged an expensive, highly coordinated scare campaign to try to convince people that buying from Canada is unsafe. But do any of us really believe that the Canadian health system is more dangerous than our own? If we were in Canada, and got sick, would any of us really think twice about going to a Canadian hospital or a Canadian pharmacy for prescription drugs?

If the FDA has concerns about the safety of these drugs, then I would encourage the FDA to do what our state has done. Put some inspectors on a plane, send them to Canada, and check out these pharmacies for yourself. You will find what we would find, that the ones on our website are reputable, long-standing, highly regulated pharmacies in whom we can have confidence.

It’s time, I believe, for the federal and state governments to stand together on this issue, not do the bidding of the drug lobby, but stand up for the people of our states and implement a safe system of prescription drug reimportation.  I have found it amazing in these recent months that the FDA has time to send out press releases attacking out website, it has had time to send staff to Wisconsin to hold press conferences criticizing our efforts, but not to actually work with us to put this system into place. It is a story of missed opportunities and misplaced priorities, and it is a disservice to the people of this country.

One thing is clear: someone has to stand up to deal with the incredible soaring prices of pharmaceutical drugs. And somebody in this task force is in the position to do it, to say that we are going to look out for the people of the United States, the people of the state of Wisconsin. U.S. drug manufacturers have threatened to blacklist Canadian pharmacies and cause shortages in Canada if they move ahead with reimportation. I have asked Attorney General Ashcroft to investigate these companies for violations of anti-trust laws.

But, unfortunately, no action has been taken. And, unless some action is taken, the 25 largest on-line Canadian pharmacies have said that they may not be able to do business with citizens of Wisconsin or any other state.

Even more recently, we have heard that several merchant credit card payment processors have been scared off from providing their e-commerce credit card services to Canadian mail order pharmacies. Three weeks ago, Visa and MasterCard announced that they will not service Canadian mail order pharmacies because they have been under pressure from the FDA to cease their support of the payment processing. They cited pressure from the FDA and have warned their member financial institutions to avoid so-called “illegal” transactions.

The simple fact is this: people in Wisconsin – and all over America – need relief from the high price of prescriptions drugs. Reimportation holds the promise of significantly lower prices, and expanding access to life-saving medicines. It’s time for the federal government to stand with us against to move past the scare campaigns and heavy handed tactics, and to start being on our side in making prescription drugs affordable for all Americans.

Not only does the federal approval of prescription drug reimportation holds the potential for huge savings for citizens, it has huge savings for Wisconsin taxpayers. Our state spends more than $700 million annually on prescription drugs for Medicaid recipients, employees, inmates and others in our state institutions. If we could just save a fraction of that amount by purchasing drugs from Canada with federal approval, it would mean savings to the taxpayers of our state in the tens of millions of dollars.

Again, I truly thank the task force for your attention to this matter. As I said earlier, this is happening. No matter what I do, as the Governor of a state, no matter what you do, as the task force, people -- particularly in the Northern states and I assume this is happening all over the country, but particularly in the Northern tier states – are going to Canada. And they are going to Canada in increasingly large numbers and nothing is going to stop that, given the price differential. It is going to happen, it is going to happen in greater and greater and greater numbers. And I am proud of the fact that we in Wisconsin have taken some steps to protect our people.

We have checked out the pharmacies that are on our website, and I feel confidant that if the FDA goes to those pharmacies, you will come away fully satisfied with the safety of the prescription drugs that come from those pharmacies. They are exactly the same drugs that people are buying at pharmacies in Wisconsin at prices that are 30, 40, 50 and 60 percent higher than what they can purchase through Canada.

So, again, I thank you very much for your attention to this. I look forward to the findings of this task force. I hope that you are going to help work with us to provide some relief for the taxpayers of the state of Wisconsin. Thank you very much.

Carmona – Thank you, Governor. Governor, would you have a moment to answer some questions from the task force?

Doyle – Yes.

Carmona – Dr. Crawford.

Crawford – Thank you, Governor. Taking into account that the past two Secretaries of Health and Human Services – Secretary Shalala and Secretary Thompson – have been unable to guarantee or assure the safety of products coming in from Canada, and none of us want something like this to be a permanent solution to a permanent problem, what do you see as the long-term solution to this? I mean, what you’re doing, and what other states are contemplating, and some municipalities, may not, with all due respect, get to the root cause. Could you enlighten us as to what you see that as being?

Doyle – Well, I believe pretty much in the marketplace. I believe that what we’re doing in Wisconsin and what I hope that reimportation will do, is actually to bring competition in a way such that the drug companies will have to start moving the prices down in the U.S. I would strongly prefer an internal system in which we are working not through a website but through Wisconsin pharmacies, but one where  there real, competition in place. And world-wide competition. I mean, the fact is, if you believe the drug companies -- and I think that given the amount of money being spent on advertising it’s little hard to believe it, but if you believe the drug companies -- we as American consumers are footing the bill for all of the research going on, essentially, in the world. And, I think what has to happen is that they have to see that there is not a safe haven for just whatever profits they want to make in the U.S. That’s what Canadian reimportation does. It introduces real competition into the marketplace, and it’s going to make the drug companies have to find a better structure of pricing world-wide that will help American consumers. People in Wisconsin shouldn’t have to pay for all the advertising and all the research in the world. And that’s why I believe what we are doing here is trying to introduce a level of competition into the marketplace.

Carmona – Dr. Raub.

Raub – When your inspectors go on a visit with pharmacies in Canada, is there an involvement with your counterpart provincial officials or with Health Canada?

Doyle – The involvement; there was some contact, but primarily this was our inspectors going right to the pharmacies and making same kind of inspections of the pharmacy that they would of a Wisconsin pharmacy.

Sachdev  – Governor, I have a follow-up question. The witness before you testified about concerns with regard to what would happen in the event that there were adverse events that resulted from purchasing drugs from a Canadian pharmacy where U.S. domestic authorities don’t have regulatory authority. What is the state in terms of its responsibility for that possibility?

Doyle – Well, obviously, this is where we’d like to have the FDA involvement and a national agreement between the U.S. and Canada. I mean, Wisconsin can’t do what the federal government can do in the relationship with Canada. Our recourse would be, and I don’t think this will happen, because I feel quite confident with the pharmacies that we have chosen, but we would take the pharmacy off the list. But we do not have… again, this is why it is so important for the FDA to get involved in this – the ability to have the government to government, U.S.--Canadian government kind of arrangements that would help ensure the effectiveness of system. But, I do believe, again, if anyone went to look at the three pharmacies that are on our site, that they would walk away from those pharmacies with any significant concerns that they wouldn’t have with any American pharmacy.

Sachdev  – As a follow-up to Dr. Raub’s question, on the comment you just made. So the, what you’re suggesting is that, if there were a product that was purchased from a Canadian site that was problematic in that there was an adverse event seen, the state would investigate and take down the website. Would it do so with the Wisconsin Board of Pharmacy? And, to what extend was the Board of Pharmacies involved in assessing these Canadian sites?

Doyle – The Board of Pharmacy does not have jurisdiction, obviously, over a Canadian site, would not have jurisdiction over taking it down. They were not involved because they have no jurisdiction in Wisconsin over a Canadian pharmacy.  

Ahern – Governor, a couple of very quick questions about the certification or the inspection on the three pharmacies in Canada. First part is, how did you select those three for inspection by your state officials? And, tow many did you actually consider and why did you discount the others and just focus on the three that were inspected?

Doyle – I can get you the exact numbers of how many we considered. Part of this, I give due credit to the state of Minnesota, which had done some of the preliminary work, and obviously we were able to benefit from the work that they had done. Still have a number of them soliciting us to get on the website, as you can imagine. There are a variety of ways that these came to us and, again, I’d be happy to provide the task force with that information. And we have looked at a number of them, and did not include every one we looked at in making the decision about what we were going to put on the website. We may still add more to website as well, further inspections are made.

Ahern – Were there any pharmacies that were either contemplated for inspection that were dismissed because of concerns, and was that posted, and would they be posted; kind of “buyer beware” outreach?

Doyle – We would not post ones we had concerns about.

Carmona – Mr. Azar.

Azar – Governor, thank you for your testimony. As I understand it, you had found that these pharmacies that you posted on the website, that they are safe, reputable, and reliable. That was your testimony, right? And that the consumer can buy the same safe prescriptions that we have here in the U.S., also, is what you have concluded?

Doyle – Well, in fact, the ones that we list, if anyone uses the pricing on the website, are all named prescription drugs, that are manufactured and approved in the U.S. We don’t have any prescription drug on that list that is not a prescription, named drug in the U.S.

Azar – And again, because we don’t know what your inspectors did with these pharmacies, how do you all know that the particular drugs were, in fact, manufactured in the U.S. as opposed to manufactured elsewhere? The drugs that would be bought on these Canadian pharmacies

Doyle – Our inspectors looked at the drug lots and so on, as they went.  I suppose people could have been hiding bad drugs in back rooms, and so on. I mean, it’s the same thing that we do in Wisconsin, and we rely on the representations that were made. We also looked historically at these companies, these pharmacies, we looked at what their history was, the extent to which the Canadian and provincial governments in the state relied on them for their various prescription drugs programs. I mean, all of those things were looked at – these are good, reputable, long-standing pharmacies in Canada.

Azar – So, the state of Wisconsin is very confident that these drugs are safe for importation into the U.S. for people?  Like you, I’m a lawyer. So, I went to your website, and on your website there is a disclaimer. And the disclaimer says that the state of Wisconsin, as well as its officers and employees makes no representation as to the legality of the importation, or reimportation of pharmaceuticals from Canada. And it expressly disclaims any and all liability for such importation or reimportation or the use of any product so acquired. And then, there’s a separate lengthy list of disclaimers: a disclaimer of liability, a disclaimer of warranties and accuracy of data, a disclaimer of endorsement, a disclaimer of for external lengths and a disclaimer of duty to continue provision of data. I’m just wondering, if the state of Wisconsin is encouraging people to buy these drugs from these pharmacies, why there would be the need for these types of disclaimers? Because it seems like your lawyers must have decided that there is some significant litigation risk to the state here, from people getting unsafe drugs, and that they needed to put these disclaimers on there. I just wanted to get a sense from you, of why there needs to be these types of disclaimers if things are so safe.

Doyle – In the first place, we are not encouraging people to buy drugs from this website or any other. What we have done is to provide them with alternatives that they have been demanding in Wisconsin. If they buy from this website, or using the prices on the website from those pharmacies, they make the purchase themselves. It’s a direct purchase from the consumer to the pharmacy. And, we don’t assume any liability for purchases that are made in Wisconsin pharmacies. The state does its best to regulate that, as the FDA does. But, go to the FDA website and count the number of disclaimers on the FDA website. This is… we do not pretend be at the site of every drug purchase, making every… looking at every single drug and testing every drug, making sure it’s exactly what it is. What we have done on the site is to say, these are three pharmacies we have visited, that are reliable, reputable, long-standing pharmacies, and that these are drugs that are approved in the U.S. That’s what we tell people, and they will make their own decisions if that is what they are going to purchase or not. The FDA certainly doesn’t, the state of Wisconsin does not accept liability for every drug purchase that is made in the U.S. by a consumer in a pharmacy. 

Azar – I know you weren’t here earlier today, but Mr. Roberts, our first witness today, testified about counterfeit drugs that he had received for his AIDS treatment. And the question that he had asked that I found fairly significant was, “Who will be responsible?”. Who does he go to, to get compensation, and is he going to have to hire an international tort lawyer to go after compensation and trace down the source of the drugs that he’s gotten – the counterfeit drugs? It’s something that I think consumers – as we think about importation -- are concerned about and very worried about. Another thing that has come up, Dr. Rodriguez testified earlier today, and we had a witness at the first hearing also, representing a Hispanic group also, that testified expressing concern that, if we simply allow importation of drugs that are not FDA-approved, that haven’t been subject to the distribution controls throughout the entire process, that we really would be creating a two-tiered system of drug safety in America. One for people who can afford the gold standard FDA drugs, and one for people who can’t – a lower standard of safety for drugs. I was wondering because I think position is that we ought to just let the importation of drugs as they are now, occur, under the existing assumption that the drugs are safe, so we ought to just let them in.  What is your perspective on this idea that there’s a two-tiered system of safety?

Doyle – We believe that the reimportation should be of FDA-approved drugs, and every drug on our list is one that is FDA-approved. Now, you may argue that the reimportation of that drug is not approved, but the drug itself, you could walk into … every drug on our list, you could walk into an American pharmacy and purchase in an American pharmacy, fully-approved by the FDA. I believe that the FDA has a very important role in this, and that’s why I’m here with respect for the FDA and the process that you’re all in. I believe, if we really get on this, and we all work together to develop a reimportation system, we can do something really good that’s going to drive the costs down and answer many of the questions that you’re asking right now. But to just say, you know, there are all these problems, and we’re not going to do it,  plays right into where drug companies want us all, and doesn’t help us with the basic issue. That’s why I am.. but, as I say, what we have on our list are FDA-approved drugs.

Azar – Thank you, Governor.

Carmona – Dr. McClellan first, then Dr. Duke.

McClellan – Thank you for testimony and I want to thank you as well for your deep concern about the problems of drug affordability in the U.S. This is obviously a major issue that all of us who are involved in health policy for the nation should have at the front of our agenda. And, clearly, this commitment is behind your work on the website. Just following up on some of the other questions from other task force members. I’m wondering if, in addition to the task force itself, if there are other steps you are interested in pursuing – in addition to the website, if there are other steps that you are interested in pursuing, beyond referring Wisconsinites to three Canadian pharmacies that your staff has visited? I guess, on this point, I do think that all of the drugs on that list are probably not FDA-approved, in the sense that they were manufactured in U.S. facilities and subject to U.S. manufacturing processes and the like. It may have the same name of the drug, but very often, drugs that are sold in other countries are not subject to the same FDA review for bioequivalence and evaluation of whether the drugs meet – have the same effects on the body as drugs that are approved in other countries. So, I don’t think that’s generally the case, but that’s something we’d like to find out more about as part of this task force effort. My question, though, goes to whether you regard this as doing enough in itself, and whether there might be other things that might be necessary. For example, bipartisan members of Congress are interested in finding a way to give FDA and U.S. government more authorities to assure the safety of imported drugs. Authorities like requiring foreign sites to register with us; allowing inspections to occur without advance notice and sort of the full level of government authority that they can be done in the U.S.; steps like making sure that the products that are coming into this country have a reliable pedigree, something that we’ve heard a lot about from other presenters before this task force. These ideas are more in line with what the U.S. has for food inspection and food imports coming into the country, and they don’t really exist today for drugs. Is that, do you have any views on this kind of legislation and whether it’s an important part of assuring the safety of imports and preventing that kind of two-tiered system that we’ve heard about from other presenters?

Doyle – Yes, let me just talk about, if I could mention the first and, Dr. McClellan, I don’t presume to have your level of expertise on this. But, I will say this, the FDA could take care of that first issue for us in three days as to whether these are American manufactured to FDA standards. There are many Canadian pharmacies that are ready to give you any assurance you want that they were manufactured  in perfect accordance with FDA standards. All it would take would be for you to go you there and work it out. So, that could be done very easily and very quickly. On the other steps, I’m willing to look at anything, but not if, if what the condition is that you are going to prohibit people from going to Canada. I mean, this has now been going on for ten, twenty years and it’s growing and growing. I think the American public, like the Wisconsin public, would be very cynical about some of the efforts that you have discussed which might be fine on their face. But, if the condition that comes with them is that you are going to cut off the ability of all of the people who are currently going to Canada, of their ability to go there.

McClellan – So, you wouldn’t support legislation like that introduced by Senator Kennedy or Senator Grassley? You think that would be too restrictive, or?

Doyle – Well, what you laid out. … I’m interested in working on any option, and working with you on any option that we can come up with. But, what I’m saying is that legislation that conditions those options on shutting off Canada for Wisconsin consumers, I couldn’t support.

McClellan – And, in terms of working with us, on other steps, in my current role as the Administrator of the Center of Medicare and Medicaid Services, we are trying very hard to implement some other new programs. So, that will bring relief to seniors who need help the most, those who are choosing between food and drugs, or rent or other urgent needs, and taking the prescriptions they need. Staring next month, there will be a new Medicare program that provides financial assistance and discounts to all seniors with limited incomes who don’t have drug coverage now. And in addition can be used by seniors – like those in your state – who qualify for Wisconsin’s low income program, to add to that and make sure they don’t have to make that impossible choice between meeting their medical needs and meeting their other basic needs of living. We are launching a major website, we are engaged in a major outreach effort to get people enrolled in these programs which can provide literally billions of dollars through financial relief directly and through lower prices for drugs right away. I’d be interested in finding out a way to work more closely with the state of Wisconsin to get people enrolled in those programs to help meet the needs that they have now.

Doyle – We would look forward to that. And let me also say, we very much appreciate your efforts and those of your new agency. We do, in Wisconsin, I believe, have probably the best senior care program, under a waiver, in the U.S. And it is really significant. Most of our low and even low to moderate income seniors do not go to Canada, in Wisconsin, because we have such an effective senior care program. Now I would like to be able to buy those drugs for the senior care program from Canada, it would sure save us all a lot of money. But the program itself, and again, we have worked very well with your agency on that waiver and I appreciated it – it really is a life-saver for many seniors. One point, though that – I know you know this, but I want to emphasize it -- this discussion often quickly turns to seniors. And, at least low-income seniors do have some options available to them. Many younger people have nothing available to them and for their children and to themselves. And, if we were just dealing with seniors, which is a huge issue, Canada would be a very important option, but there are some other options as well.  For many of the non-seniors, there really is no option for them right now, except Canada.

McClellan – That’s right. And we are concerned about that in our Medicaid programs and our other state programs, to work with you on the waivers, as you mentioned. And I think there’s even more we can do to make our dollars go further in helping those low-income populations (other than seniors), through generic substitution programs, through drug management programs and other steps to help states get lower prices for their drugs through negotiation. We stand ready to work with you on all of those steps and I am very pleased to hear about this interest in collaborating in finding a whole set of solutions to people who most need them. I agree with you that people in this country should not be forced to choose between food and other needs – especially those with limited incomes, and I agree completely with you that we have an unfair system of drug pricing around the world that is putting too much of the burden on Americans. I am very much looking forward to working with you on some of these other steps that can be taken to address these concerns in addition to endorsing websites.

Doyle – Does that mean all our waivers will be granted? (Laughter.) 

McClellan – Ah, we’re doing all we can.

Carmona – Dr. Duke?

Duke – You have mentioned that your website directs the citizens of Wisconsin to three drugstores that you found to be safe, reputable, and reliable. The question I have is, as you said there are more firms that would be willing to sign up for your website. Were the other 49 Governors to chose the same route, would there be sufficient supply of drugs and drug stores available in Canada to meet that need?

Doyle – Well, it depends on whether the American drug companies are prepared to sell to the Canadian pharmacies. There will be as many drugs available as they are prepared to make. Unfortunately, even while it is now Wisconsin and Minnesota that have websites up, Rhode Island has linked to our website, I believe New Hampshire has announced that they are going to do it. I may be missing some here, but, even with those limited number of states, the threats are already being made to restrict the sale of drugs to Canadian pharmacies. You know we are dealing with some pretty hardball tactics when you shut down MasterCard and Visa and you threaten the supply of the Canadian drugs over this. But, you know, I don’t see that I really have any other choice. As I say, in Wisconsin, people have been doing this for years and they are going to continue to do it. We have actually introduced a way that they can have some assurances on what the price is and they can have some assurance of the pharmacies that they are going to. Again, the supply is going to be for the drug companies to decide.

Carmona – Ms. Willis.

Willis – What you have described is at the state level. At a national level, if this task force were to recommend importation of prescription drugs, do you think it would be more feasible to have importation at the wholesale level, direct to the retail pharmacy level, or direct to the consumer? And, as a follow-up question, if you think it is most effective to go directly to the consumer, would this importation pertain to all types of prescription drugs, or should there be any restrictions on the availability directly to the consumer?

Doyle – My great preference for this is that you would approve wholesale purchase, and then we could go back, in Wisconsin, to the way I’d like it to be. I’ve often said that there are two sets of victims of the situation that have right now that the drug companies are putting on us. One is the biggest number, and the one I have to look out for most importantly, are the citizens of the state of Wisconsin, the consumers. But, the other is the pharmacists. They’re not the ones – they’re just caught in the middle in this thing. My preference would be, if we’re all sitting down with a goal, is that there would be Canadian importation; that we would be setting up a system that every one of those drugs are FDA-approved and it would be done at the wholesale level. That would be my, if I could just sit down and design it, that’s how I would do it. But, right now, I have to make a very hard choice and it’s not, in many ways, a fair choice, between pharmacists in our state. And… by the way, in our system, on our website, if you are filling out one of the forms from our website, it is only for… it is not for the original prescription. You have to go to a Wisconsin pharmacist and get an original prescription; these are for refills. But, I would prefer that that be done through Wisconsin pharmacists who are good, local businesspeople who I would like to make sure are part of this. But, they are caught in the squeeze. I can’t say, my interest right now has to be the consumer; that’s who I have to look out for, as Governor of Wisconsin.

Carmona – Governor, last question. Clearly, it seems, you’ve thought through this quite a bit and you are serving your constituents as best you can under these difficult issues before you. Certainly, this is a short-term remedy, assuming that it can be done safely as you say. Have you given any thought to the long-term consequences of such a policy of importation for the U.S., not just for your state, but for the U.S. We’re looking at this more globally; Southern states also might want to be dealing with Mexico and other countries in South and Central America. And so, the future consequences – intended or unintended -- of such a policy, where we become more dependent on other countries for our pharmaceutical supplies. Have you given any thought to that?

Doyle – Well, I believe we can become significantly less dependent if we introduced some competition here. And, I can’t speak about other countries; Canada’s the one I know best. I will tell you, this whole sell that’s trying to be made, is not going over. People in Wisconsin do not believe that the Canadian system is unsafe or unreliable. They just don’t believe it, as much as that stuff is getting put out there, it just doesn’t sell in a state like Wisconsin. You know, we know Canada pretty well and we don’t believe it. I believe that the long-term effect of reimportation, as I said earlier, is really a market effect. It’s going to say to these companies that you have to respond to the consumer demand to bring the prices down. If it means taking those ads off the air  -- I which they are trying to convince me to go to my doctor to convince my doctor that he should prescribe a drug to me -- to help lower the prices, then that’s what they should do. They’ve got to start responding to the consumer pressure. If what we’re talking about is always government responses, the FDA w