News & Events
Drug Sales Over the Internet
Janet Woodcock, M.D.
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
the Subcommittee on Oversight and Investigations
House Committee on Commerce
Julu 30, 1999
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 Administration's July 1, 1997 Framework for Global Electronic Commerce (Framework) and the President's November 30, 1998 Memorandum on Successes and Further Work on Electronic Commerce.
The Framework suggested a set of principles to guide the government's 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. These are:
- 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 Agency's 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 Investor's 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 adulterated product.
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 patient's 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, CDER's 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 agencies.
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 subject's 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 as an 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 site's 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 women's 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 Agency's experts. The company's 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 company's 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 FDA's 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 violative ads.
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 area.
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, the 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 Federal government.
FDA's 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 Agency's 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.
1) Customize Enforcement Efforts
FDA's role in regulating online drug sales should be consistent with its traditional regulatory role. We also believe that, given the Agency's 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:1
- Unapproved new drugs,
- 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.
2) 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.
3) 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 drugs.
4) 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:
- Talk papers
- Articles in FDA Consumer Magazine
- Information on FDA's web site to inform consumers about what to avoid if purchasing drugs online, for example, buying prescription drugs without a prescription
- Work with the media.
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.
5) 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.
1 A significant public health risk exists when a consumer is at risk for harm (1) from the use of the product, (2) as the result of not taking approved drugs for a specific disease or condition, or (3) by delaying medical treatment recognized as safe and effective for a specific disease or condition.