Mr. Chairman and Members of the Committee, I am Dr. Janet Woodcock, Director, Center
for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA or Agency). I
am pleased to have this opportunity to participate in this discussion of the benefits and
risks of pharmaceutical sales over the Internet. The sale of consumer products over the
Internet has grown rapidly, including the sale of drugs. While the growth in online drug
sales by reputable pharmacies is a trend that can benefit consumers, online drug sales
also present risks to unsuspecting purchasers and some unique challenges to regulators,
law enforcement and policymakers. FDA is concerned about the public health implications of
Internet drug sales, and we are responding to these concerns as part of our overall goal
of developing and implementing risk-based strategies to protect public health and safety.
It is important to recognize that other products regulated by the Agency, such as
medical devices, biological products, and foods, including dietary supplements, also are
sold online, and when sold unlawfully, may pose risks to the public health. This
testimony, however, will focus on the advantages and risks of online pharmaceutical sales,
outline the authority and enforcement activities of FDA in this area, and discuss new
initiatives that FDA is taking to better respond to the regulatory challenges. FDA
believes these initiatives are consistent with the Administrations July 1, 1997
Framework for Global Electronic Commerce (Framework) and the Presidents
November 30, 1998 Memorandum on Successes and Further Work on Electronic Commerce.
The Framework suggested a set of principles to guide the governments
approach as we face the new and ever changing challenges posed by the Internet. Five
principles were articulated that apply to the policy questions raised by Internet
prescription drug sales.
- The private sector should lead.
- Governments should avoid undue restrictions on electronic commerce.
- Where governmental involvement is needed, its aim should be to support and enforce a
predictable, minimalist, consistent and simple legal environment for commerce.
- Governments should recognize the unique qualities of the Internet.
- Electronic Commerce over the Internet should be facilitated on a global basis.
In the context of prescription drug sales over the Internet, government should
encourage private sector leadership in achieving a safe marketplace. The private sector
has an important role to play in promoting consumer education and in providing seals of
approval and other verification for legitimate sales. Government should refrain from
imposing any unnecessary regulations, but should protect consumer health and safety
through effective enforcement of existing law on illegal drug sales. If new regulations
are needed these should be designed to support a predictable, minimalist, consistent and
simple legal environment for commerce. Rapid technological developments will change the
nature of the challenges we face today and we must remain flexible in developing
solutions. Finally, the global nature of electronic commerce poses particular problems in
the area of Internet drug sales and we should strive for consistent principles across
State, national, and international borders that lead to safe and predictable results
regardless of the jurisdiction in which a particular buyer or seller resides.
As I will describe in more detail later in my testimony, FDA has developed and begun
implementing an action plan to address the problems associated with online drug sales. The
steps FDA is taking under its action plan include:
- The expansion of enforcement efforts against illegal online sales. FDA has established
priorities for taking enforcement actions involving online sales, expanded its capability
to monitor violative Internet sites through advanced technology search tools, and
established a process to triage and monitor ongoing cases. Using existing resources,
through this process, FDA expects to establish a higher profile enforcement presence
regarding unlawful online sales.
- FDA is working with other Federal agencies and State agencies to better coordinate
enforcement efforts. FDA worked closely with the Federal Trade Commission (FTC) in
developing the cases announced as part of Operation Cure-All and has been working with the
Department of Justice (DOJ) and others regarding online sales issues.
- FDA has initiated a series of meetings with State regulatory bodies and other
organizations to discuss better ways to regulate online sales.
- FDA will expand public outreach efforts to warn consumers about the dangerous practices
involving online purchases.
As described below, the Agency will seek to enforce existing statutory and regulatory
provisions when illegal online drug sellers engage in unlawful conduct without imposing
burdensome restrictions on legitimate sellers. Therefore, the Agencys efforts should
help foster consumer confidence in electronic commerce through effective consumer
protection online without imposing undue restrictions on legitimate electronic commerce.
BENEFITS OF ONLINE DRUG SALES
The growth and development of the Internet in recent years has opened up vast new
opportunities for the exchange of information and for the enhancement of commerce.
Electronic mail and chat groups have facilitated communications dramatically.
Information gathering that once took hours or days of research, whether for a highly
technical scientific paper or an elementary student's homework assignment, can now be
accomplished in minutes.
The Internet is rapidly transforming the way we live, work, and shop in all sectors of
the economy. In the health sector, telemedicine allows people in remote areas to access
the expertise of doctors in urban hospitals. The Internet permits increasing numbers of
individuals to obtain medical information helping them to better understand health issues
and treatment options. In fact, more than 22 million Americans used the Internet last year
to find medical information. According to Investors Business Daily, 43
percent of web surfers access health care data online each year. Health concerns are the
sixth most common reason that people use the Internet, and according to the market
research firm, Cyber Dialogue Inc., this number is growing by 70 percent a year.
Legitimate prescription drug sales on the Internet can provide tremendous benefits to
consumers. These benefits could include: lower prices through increased competition among
licensed sellers; greater availability of drugs to shut-in people for whom going to the
pharmacy can be difficult; increased availability to people who may live a great distance
from the pharmacy; the ease of comparative shopping among many sites to find the best
prices and products; and, greater convenience and variety of products for all customers
who prefer online ordering of prescription drugs.
Perhaps the chief attractions to purchasing consumer goods online are the speed and
ease of choosing and ordering products. Many reputable online pharmacies allow patients to
consult with a pharmacist from the privacy of their home. Moreover, online pharmacies are
able to provide customers with written product information and references to other sources
of information much more easily than in the traditional storefront. Finally, as the use of
computer technology to transmit prescriptions from doctors to pharmacies expands, a
reduction in prescription errors is possible.
While online sales will be important for some customers, the more traditional
pharmacies can offer benefits and services often not available through the Internet. Such
pharmacies are an essential component in the delivery of effective health care.
We are not aware if composite sales figures for online pharmacies have been compiled.
But the increasing recognition of the Internet as a legitimate and important vehicle for
drug sales is evidenced by the recent activity of major drugstore companies and Internet
retailers in financing, supporting and sponsoring online pharmaceutical outlets. Earlier
this year, for example, CVS Corporation acquired the online pharmaceutical retailer
Soma.com, and announced last month that the online retail sites of the two companies will
merge. Also last month, Rite-Aid Corporation announced a partnership with Drugstore.com to
combine the benefits of online ordering with access to traditional retail locations and
insurance reimbursement services. We expect this expansion of the online drug sales
industry to continue over the next few years.
As beneficial as this new technology is, however, there are some concerns. The Internet
also creates a new marketplace for sales that are already illegal in the non-wired world
(and wired world), such as unapproved new drugs (including counterfeit drugs),
prescription drugs marketed without a valid prescription, and products marketed with
fraudulent health claims. The unique qualities of the Internet, including its broad reach
and ability for anonymity, pose new challenges for the enforcement of existing laws. The
global nature of the Internet creates particular problems for effective law enforcement.
Different approaches to drug approval and marketing in foreign countries further
complicate law enforcement issues for U.S. officials. FDA and other U.S. government
agencies will need to work closely with foreign governments to share information on the
drug approval process and develop mechanisms to cooperate on law enforcement with respect
to certain prosecutions.
The challenge for government is to promote policies that will allow legitimate
electronic commerce to flourish by creating a marketplace where consumers can have
confidence in the quality of the medical prescription and of the medicine delivered. A
safer marketplace can be fostered through effective enforcement of existing laws and by
taking steps to encourage programs that provide certification, or seals of approval, to
legitimate doctors and pharmacists operating in the virtual world.
CONCERNS ABOUT ONLINE SALES
As you know, the establishment of FDA as it exists today grew out of a time early in
the century when consumers were victimized by dishonest purveyors of fraudulent potions
and compounds that were ineffective, dangerous, or both. A system of drug regulation was
established in this country that has served us well. Under this system, FDA reviews new
drugs to ensure their safety and effectiveness. In addition, certain types of drugs must
be prescribed and dispensed by health care professionals licensed and overseen by the
State in which they practice. But even with this system in place, there are those who
still try to sell unapproved or unsafe drug products, and the Internet provides them with
new opportunities for reaching unsuspecting and vulnerable consumers and undermining
established safeguards. It is fair to say that the speed and ease of ordering products on
the Internet that attract consumers likewise entices some unscrupulous sellers to use the
Internet as their new medium of choice. Unlike some other forms of electronic commerce,
the unauthorized sale of prescription and unapproved drugs poses a potential threat to the
health and safety of consumers. Moreover, consumers who are desperate for a cure to a
serious medical problem are particularly vulnerable. Thus, they may be more susceptible to
the hype surrounding an unapproved product or more likely to fall prey to the sale of an
Internet drug sales raise public health issues similar to those raised by sales, in
other contexts, of unapproved new drugs (including counterfeit drugs); the sale of
prescription drugs without a valid prescription; the sale of expired or illegally diverted
pharmaceuticals; and the marketing of products based on fraudulent health claims.
Congress and State legislatures have enacted laws to protect patients from harm
resulting from the use of unsafe drugs, counterfeit drugs, and the improper practice of
medicine and pharmacy. Under these laws, to receive a prescription drug for the first
time, generally a patient must be physically examined by a licensed health care
practitioner who determines the appropriate treatment and issues a prescription for an
FDA-approved drug. The patient then has the prescription filled by a registered pharmacist
working in a licensed pharmacy that meets State practice standards. However, the Internet
makes it easy for individuals to bypass these safeguards when selling drugs to patients. A
web site can be easily created to look like a legitimate pharmacy when in fact both the
seller and product are illegitimate.
Patients who buy prescription drugs from an illegitimate site are at risk of suffering
life-threatening adverse events. For example, one type of dangerous product commonly sold
on the Internet is a kit for preparing gamma hydroxy butyrate (GHB). This unapproved drug,
which is sold for bodybuilding and recreational use and is used also in sexual assaults to
incapacitate the victims, is a clear threat to public health when sold in this manner.
Other risks include potential side effects from inappropriately prescribed medications,
dangerous drug interactions and contaminated drugs, as well as the possible ill effects of
impure or unknown ingredients found in drugs manufactured under substandard conditions.
Further risk to patients is posed by their inability to know what they are really getting
when they buy these drugs. Although some patients may be purchasing the real thing, some
may be buying counterfeit copies that contain inert ingredients, outdated legitimate drugs
that have been diverted to illegitimate resellers, or dangerous sub-potent or super-potent
versions that were improperly manufactured.
Besides magnifying existing problems by reaching millions of consumers worldwide,
online drug sales create unique issues for regulatory and law enforcement bodies. Internet
technology can obscure the source of the product as well as the persons responsible for
making and shipping the product. The participants in a transaction can be widely dispersed
geographically and they may well never meet. For example, a consumer in one State, using
an Internet site emanating from a computer in a second State, may order a drug actually
dispensed from a third State, under a prescription from a doctor in a fourth State. Thus,
issues cross traditional regulatory boundaries as well as Federal and State jurisdictional
lines. If one or more participants in the transaction are located outside of the United
States, the task of regulating the activity is further complicated. Similarly, the fact
that sellers can easily change the location and appearance of their Internet sites makes
enforcement all the more difficult.
The Agency is particularly concerned about the apparent absence of a doctor-patient
relationship in some Internet transactions. FDA believes that the selection of
prescription drug products or treatment regimens for a particular patient should be made
with the advice of a licensed health care practitioner familiar with the patients
current health status and past medical history. In situations where the customary
physician-patient relationship does not exist, the patient is essentially practicing
self-diagnosis. Consequently, the risk of negative outcomes such as harmful drug
interactions, allergic reactions, contraindications, or improper dosing is greatly
magnified. We also are concerned about the proliferation of sites that substitute a simple
questionnaire for a face-to-face examination and patient supervision by a health care
practitioner. Another concern in such situations is that the legal protections for privacy
of medical records, which the Administration strongly supports, may not be available.
According to the American Medical Association, a health care practitioner who offers a
prescription for a patient they have never seen before and based solely on an online
questionnaire has generally not met the appropriate medical standard of care.
The sale of drugs to U.S. residents via foreign web sites is another area of concern to
the Agency. Some medications sold on the Internet may be legal in foreign countries but
not approved for use in the United States
, and some products may include addictive and
dangerous substances. Products not approved for sale in the United States
generally do not
conform to the good manufacturing practices and quality assurance procedures required by
U.S. laws and regulations. Generally, the prescription drug available from a foreign
pharmacy is either a product for which there is no U.S. approved counterpart or a foreign
version of an FDA-approved drug. It is illegal for a foreign pharmacy to ship such drugs
into the U.S. Additional requirements, enforced by the Drug Enforcement Administration,
are imposed on the importation of controlled substances. Foreign sales pose a difficult
challenge for U.S. law enforcement because the seller is not within U.S. jurisdiction.
FDA AUTHORITY AND ENFORCEMENT ACTIVITY
The types of unlawful conduct involving online drug sales that FDA has identified are
similar to unlawful activities that occur in other sales contexts. Under the Federal Food,
Drug, and Cosmetic (FD&C) Act, FDA has the legal authority to take action against:
- the importation, sale, or distribution of an adulterated or misbranded drug;
- the importation, sale, or distribution of an unapproved new drug;
- illegal promotion of a drug;
- the sale or dispensing of a prescription drug without a valid prescription; and,
- counterfeit drugs.
When the Internet is used for an illegal sale, FDA must establish the same elements of
a case, bring the same charges, and take the same actions as it would if another medium,
such as a storefront or a magazine, had been used.
FDA already has investigated and referred cases for criminal prosecution and civil
enforcement actions against some online sellers of drugs and other FDA-regulated products,
particularly sellers of drugs not approved by the Agency. FDA intends to significantly
expand its enforcement activities regarding online sales. The Office of Regulatory Affairs
(ORA) and the Office of Compliance in the Center for Drug Evaluation and Research (CDER)
are the primary organizations within FDA with responsibility for regulating online drug
sales. These offices review web sites that consumers, industry, health professionals or
government personnel report as appearing violative. Since June 1998, the Agency has taken
numerous compliance actions based on violative labeling claims. In at least 27 of these
cases, the violative claims had an Internet component. To date, the Agency has identified
over 60 cases related to suspected illegal Internet sales, with the first Internet
prosecution having been undertaken in 1994. Actions included sending warning letters to
firms illegally selling unapproved new drugs online and issuing Import Alerts to online
sellers of illegal foreign pharmaceuticals. FDA has also contacted web site managers and
asked for their voluntary cooperation in removing violative sites. Warning letters to
online pharmacies based in foreign countries are shared with the government of that
country. Additionally, CDERs Division of Drug Marketing, Advertising, and
Communications has taken steps against online drug promotion that violates the FD&C
Act by making unsubstantiated claims or misrepresentations of drugs, or by a lack of fair
balance in describing risks and benefits.
The Office of Criminal Investigations (OCI) is the entity within FDA
responsible for conducting and coordinating investigations of suspected criminal
violations of the FD&C Act, the Federal Anti-Tampering Act (FATA), and other statutes
including applicable U.S. Criminal Code violations. OCI maintains liaison and cooperative
investigative efforts with other Federal, State, Local, and international law enforcement
In November 1998, a defendant in California began serving a five year Federal prison
term after being convicted of selling online unapproved HIV home test kits which used
fabricated test results. For the first time in FDA history, the individual was convicted
on wire fraud charges stemming from the use of the Internet to sell an illegal medical
product. Previous wire fraud charges involving illegal medical products were based only on
telephone and facsimile use.
In another case, in November 1998, a police department in Illinois advised OCI it had
discovered an unconscious male individual in a hotel parking lot. The subject was taken to
a local hospital and treated for a drug overdose. Police contacted family members and
determined that the individual had been taking GHB. Police found suspected GHB in the
subject's possession and found additional suspected GHB in his hotel room. Police
requested OCI assistance with lab work and a technical computer search as they suspected
the subject had obtained GHB kits and preparation instructions from the Internet. OCI
identified the subjects source of supply, which was on an Internet site located in
Canada. The investigation by OCI and the police department established that the subject
had purchased a quantity sufficient to warrant a GHB felony distribution charge under
Illinois law. The individual was found guilty of possession of a controlled substance in
Illinois and sentenced to two years state probation.
In a third case, OCI was advised by a State Board of Pharmacy that an Internet site was
offering prescription drugs to U.S. customers from foreign manufacturers, by Acting
authorized "buyers club" using the "personal importation policy" of
FDA. OCI notified the U.S. Customs Service (USCS) at a particular U.S. international mail
facility to watch for suspicious shipments bound for the operator of this Internet site.
As a result, USCS intercepted what appeared to be steroid shipments to the web sites
address. Search warrants were obtained and over a period of approximately four weeks, nine
incoming shipments of steroids were searched and control delivered by USCS and OCI agents.
Deliveries coordinated with surveillance of the suspect revealed a sophisticated operation
centered out of an apartment building. OCI and USCS arrested the suspect and
simultaneously served a search warrant at the business location. The primary suspect was
sentenced in Federal court.
As a last example, in July of 1996, OCI headquarters was contacted by a womens
health care provider to advise that several clients had directed her to an Internet site
promoting an abortion kit. She believed the site contained several unfounded statements.
The FDA Division of Urology and Reproductive Drug Products reviewed the Internet site and
determined that the drugs in the kits presented a serious health risk to women when used
without a doctor's supervision because of a possibility of heavy vaginal bleeding and
death. Using computer technology and the help of computer security companies, OCI traced
the site to Easy Life Labs in Colombia, South America. OCI placed an anonymous order for
the kit. The company responded and FDA laboratory analysis showed the drugs to be those
warned against by the Agencys experts. The companys web site temporarily went
off line, but in March of 1997, the original health care provider called back to say the
company was operating again using a different name. One of the drugs provided was
unapproved for use in the U.S. OCI contacted the foreign drug companys U.S. Internet
service provider (ISP) and told them that one of their subscribers was using its service
to promote and sell this unapproved drug. Additionally, the ISP was informed of FDAs
public health concerns about the proposed use of the unapproved drug and that this was in
criminal violation of the FD&C Act. The service provider voluntarily removed the
Although FDA has taken action against unapproved drugs sold over the Internet and will
continue to do so in the future, as you know, FDA does not generally regulate the practice
of pharmacy or the practice of medicine -- the States traditionally have regulated both
the prescribing and dispensing of drugs. Several States, however, have found it difficult
to identify and locate violators and to bring effective enforcement actions because the
seller and the purchaser of a drug may reside in different States and because it is often
difficult to identify the persons responsible for a web site. As a result, FDA and State
agencies need to work cooperatively to enforce the FD&C Act and State laws in this
FDA has initiated contacts with other agencies and States to address these issues. For
example, on February 8 of this year, the Agency hosted a meeting with representatives of
health professional organizations that looked at the prescribing and dispensing of drugs
on the Internet. FDA, the Federation of State Medical Boards of the United States
National Association of Boards of Pharmacy (NABP), the American Medical Association and
the Association of Food and Drug Officials gave presentations. Discussions centered on the
roles that each organization plays in regulating prescribing and dispensing on the
Internet and how the various roles could better compliment each other. At that meeting,
the NABP announced a new program to verify the legitimacy of Internet sites dispensing
prescription drugs. The program, known as the Verification of Internet Pharmacy Practice
Sites, or VIPPS, will provide a NABP "seal of approval" to sites meeting the
organization's standards. Over time, this seal of approval may assure consumers that the
designated sites are offering FDA approved pharmaceuticals.
FDA believes that by working with the States, we can regulate the domestic sale of both
approved and unapproved drugs (except for controlled substances where the Drug Enforcement
Administration generally takes the lead for the Federal government), as well as the sale
of prescription drugs without a valid prescription. When a sale involves health fraud,
multiple Federal agencies have authority to take action, including the Department of
Justice, the Federal Bureau of Investigation, the Federal Trade Commission, the Postal
Service, the Office of the Inspector General in the Department of Health and Human
Services and FDA. The States also have similar authority. FDA has worked with many of
these agencies in bringing cases involving health fraud and will continue to do so.
The most difficult problem to address is the online sale of drugs to U.S. residents by
sellers in foreign countries. FDA, and the other Federal agencies and State bodies,
possess limited jurisdiction over sellers in foreign countries and must work with foreign
governments to bring action against such individuals. FDA, the Customs Service, the Postal
Service, and the Drug Enforcement Administration have greater authority to stop drugs
imported illegally into the United States
when the product reaches the U.S. border. These
agencies have been successful in stopping some products from entering the country. The
difficulty of finding these products at the border makes this a very challenging task. The
sale of drugs to U.S. residents by foreign sellers poses the greatest challenge for the
FDAs INTERNET DRUG SALES ACTION PLAN
FDA has drafted an action plan outlining expanded activities the Agency will take to
address the unlawful sale of drugs over the Internet. This plan is based on internal
deliberations, meetings with Federal and State regulatory and law enforcement bodies, as
well as organizations representing consumers, health care practitioners, and the
pharmaceutical and pharmacy industries. FDA has identified five major areas of focus
pertaining to the regulation of online drug sales, which are to:
- customize and expand the Agencys regulatory and criminal enforcement efforts;
- identify when and with which Federal agencies FDA should partner in joint activities;
- partner with State bodies to address domestic Internet sales;
- engage in public outreach; and,
- provide input to Congress regarding legislation.
Customize Enforcement Efforts
FDAs role in regulating online drug sales should be consistent with its
traditional regulatory role. We also believe that, given the Agencys current limited
resources, our existing approaches to enforcement should be adapted to focus more
effectively on the problems posed by online drug sales. An effective Internet enforcement
process requires establishing priorities, identifying and monitoring potentially violative
web sites and making appropriate referrals for criminal prosecution and/or refer/pursue
civil enforcement. The Internet action plan calls for FDA to enhance its enforcement
efforts by undertaking the following actions.
Establish Priorities -- FDA will initially focus its online drug sales-related
enforcement activities to the following areas, particularly where there is a significant
public health risk:
- Health fraud,
- Prescription drugs sold without a valid prescription.
Increase Data Acquisition -- FDA will expand its capability to monitor the Internet
and identify violative sites by acquiring an advanced search tool and upgrading its data
capabilities. This will allow the Agency to determine the kind and extent of unlawful
conduct on the Internet and provide a measurement by which the Agency can judge whether
its enforcement efforts have had an impact on illegal Internet behavior.
Coordinate Triage -- The Agency has established a three-member case assessment team
with representatives from the Office of Enforcement and OCI within the Office of
Regulatory Affairs (ORA) and from CDER. This team will evaluate violative sites; and make
appropriate referrals for criminal prosecution and/or refer/pursue civil enforcement; and,
ensure that criminal and civil enforcement actions are efficiently coordinated. Any Agency
employee who identifies a potential violation on the Internet will refer the information
to the team. This process should ensure that decisions are made in a timely way with
appropriate balance in terms of achieving a maximum deterrent effect while taking action,
if needed, to remove harmful products from the market. The team will continue to oversee
Internet-related enforcement activities while they are being investigated and will ensure
that they are brought to appropriate completion.
Increase Enforcement Presence -- FDA believes that to effectively curb unlawful
conduct involving online drug sales, more cases must be pursued. To do this, the Agency
will draw from existing activities to increase its current enforcement efforts because we
believe that illegal online drug sales pose a significant public health risk. The Agency
will begin this effort with a modest reallocation of current fiscal year funds.
- Identify Federal Agency Partners
Several Federal agencies, as well as the States, have the authority to regulate
and/or enforce U.S. laws related to the sale of drug products online. Due to the growth of
potential cases involving the Internet, there may be instances when working with another
agency or State could result in a more effective enforcement action. In fact, FDA worked
closely with FTC in developing the Operation Cure-All cases and also has been working with
DOJ and State regulatory bodies.
To ascertain whether and when FDA should coordinate efforts with one or more
governmental bodies, above and beyond the relationships that exist today, the Agency has
researched the roles that the various Federal and State bodies should play regarding
online drug sales. FDA also has met with several of those agencies, as described above, to
identify opportunities for partnering in enforcement actions.
FDA believes that an important area where cooperation among Federal agencies can be
quite beneficial is the sale of drugs to U.S. residents by foreign sellers. The Customs
Service, the Postal Service, FDA, and the Drug Enforcement Administration all play
important roles in taking action against the illegal importation of drugs. However, the
Federal government's limited ability to bring enforcement actions against sellers in other
countries, as well as the feasibility of stopping drugs from entering the United States
pose difficult challenges for law enforcement. Generally, a determination of when and with
whom FDA would engage in joint enforcement should be based on the kinds and severity of
violative conduct identified through continuous Internet monitoring. Although FDA is
expanding its Internet monitoring capabilities, the Agency also is developing partnering
arrangements with other agencies. In addition, FDA will participate in any
Administration-led working groups that address online drug sales.
- Partner with State Bodies and Other Organizations
FDA has met with and continues to meet with organizations representing State regulatory
and law enforcement bodies, consumers, health care practitioners and industry. The purpose
of these meetings is to gather information on 1) how issues relating to online drug sales
should be addressed, 2) who should regulate and how they should regulate,
3) whether and what changes to the current law should be enacted, and 4) when to
develop partnering arrangements. These organizations include:
- the National Association of Boards of Pharmacy,
- the Federation of State Medical Boards,
- the National Association of Attorneys General,
- the American Medical Association,
- the American Pharmaceutical Association,
- the American Association of Retired Persons,
- the National Consumers League,
- the American Society of Health-Systems Pharmacists,
- the National Association of Chain Drug Stores,
- the National Community Pharmacists Association, and,
- the Pharmaceutical Research and Manufacturers Association.
FDA believes that illegal selling and prescribing of approved prescription drugs over
the Internet can be effectively addressed through cooperative efforts by FDA and the
States. FDA is drafting partnering agreements with several State bodies to coordinate
Federal and State activities aimed at illegitimate sellers and prescribers of prescription
- Engage in Public Outreach
Every drug sale involves at least a purchaser and a seller. Although different
purchasers buy drugs on the Internet for different reasons, all may be targets of
unscrupulous business practices, such as the selling of unsafe, expired, or counterfeit
drugs. Public outreach offers one mechanism by which the Agency can help protect consumers
from dangerous or inappropriate drugs. Using the following media, FDA will expand its
public outreach to explain what compliance and enforcement actions we already have taken
and to inform the public about dangerous practices involving Internet purchases:
- Articles in FDA Consumer Magazine
- Information on FDAs web site to inform consumers about what to avoid if purchasing
drugs online, for example, buying prescription drugs without a prescription
The Agency also chairs the public education subgroup of the Interagency Internet Sales
Working Group. The subgroup met last week to begin addressing whether and in what
coordinated outreach activities the Federal agencies could engage. Some agencies have
already issued educational materials. The subgroup will seek to build on existing
activities and avoid pursuing duplicative efforts.
Finally, the Agency will keep working with consumer groups, health care practitioner
organizations, and industry to encourage these parties to keep their constituents and the
public informed about safe practices for purchasing drugs online.
- Provide Input to Congress Regarding Legislation
Congress did not enact the current laws governing drug sales with the Internet in mind.
Additional fact-finding will be needed to determine whether and to what extent existing
regulatory and law enforcement frameworks do not adequately address Internet-related
conduct. FDA believes that any decision to pursue new legislation should be made only
after a careful and thorough analysis of the issues based on sufficient information,
including discussions with relevant non-governmental bodies. FDA has met with and
continues to meet with Federal and State governmental bodies and non-governmental
organizations to obtain their perspectives on how online drug sales should be regulated.
Where appropriate, the Agency will provide input to Congress regarding whether and what
legislation is needed in this area.
Mr. Chairman, online shopping for pharmaceutical products clearly provides certain
benefits for consumers. But it also has a number of risks. Additionally, the nature of
this technology presents law enforcement and policy makers with unique challenges. FDA is
grappling with the challenges posed by online drug sales, and with our need to carefully
balance consumer access to information and products with protecting the public health. We
believe we can adapt our compliance and enforcement techniques to the new electronic
marketplace, and we will continue to assess what changes in our procedures or the law
might be appropriate. We look forward to working with Congress on this important issue.
I would be happy to answer any questions you may have.