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Jane E. Henney, M.D. - University of Pennsylvania

This text contains Dr. Henney's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery.

Remarks by:
Jane E. Henney, M.D.
Commissioner of Food and Drugs
U.S. Food and Drug Administration

E-Regulation and Public Health
2000 Leonard Davis Institute of Health Economics
University of Pennsylvania Health Policy Seminar Series

Philadelphia, PA
September 29, 2000

Good afternoon, it is a pleasure to be here to speak to you as one part of your series on E-commerce and E-healthcare. It is no secret that over the past decade, the emergence of new Internet technology has revolutionized our lives in many ways. It has changed the way that we obtain and exchange information, communicate with our friends and families, and buy and sell merchandise. Therefore, it follows that the Internet would also have a profound impact on our healthcare delivery system, particularly regarding therapeutic products that now can be bought, sold, advertised and promoted over this revolutionary new medium.

It is estimated that perhaps 1 million new websites go up onto the Internet each month. Some of the most frequented websites are health-related-consumers have a great deal of interest in obtaining medical information and therapeutic products through the Internet. According to Investor's Business Daily, 43 percent of web surfers access health care data online each year. Conducting searches for information regarding their health concerns is the sixth most common reason that people use the Internet, according to the market research firm, Cyber Dialogue Inc. Of concern is that the sites that are currently available that provide this information and sell their wares vary a great deal in their overall quality. There are the extremely reputable sites that perform a public service through the information that they provide-such as the National Institutes of Health's Medline sites, or the Clinical Trials Database at www.clinicaltrials.gov. Then, there are commercial sites that may provide accurate information, but also contain promotional information...strong on the pitch, but lacking in substance. There are also even less reputable sites-those that provide fraudulent information, or attempt to promote therapies that do not have a scintilla of data to back up the claims that they make.

It is good that people are seeking out reliable information that will help them to live better, longer, healthier lives. On the other hand, product promotion may make it difficult to determine what is good and useful information, versus what is misleading and potentially harmful. For example, we have seen Internet products that purport to remedy "compromised brain function," "cerebral circulation," and promote "cell health."

The explosion of Internet technology in recent years has raised the stakes involved with product promotion, because information and products are now much more readily available to consumers. The Internet also has fostered the globalization of commerce, allowing products to be manufactured, shipped, bought and sold at different ends of the globe, which increases consumer access and convenience and provides greater business opportunities and efficiencies for industry, but also raises complex regulatory issues.

First, let me focus on some of the ways that we at the Food and Drug Administration are harnessing Internet technology in order to further our public health mission. The Internet provides an efficient way for the agency to be more open and transparent in its work. Ideally, government agencies engender credibility and trust. During my own confirmation process, I made a clear commitment to Congress and the American people to foster and facilitate ways in which the decision-making processes and regulatory actions would be as open and transparent as possible.

Openness increases consumer confidence in FDA's ability to protect the public health, while also ensuring that those outside the Agency have greater access to information. Over the past few years, we have also looked at ways to allow greater public participation in the development of regulatory policy through the use of a variety of electronic tools. Such innovations include: using Internet broadcasts in lieu of expensive public meetings in Washington, D.C.; allowing for electronic submissions of comments on regulations and guidance documents; posting more public information on FDA's website; and providing reporting mechanisms such as MedWatch and our Rogue Internet sites reporting page, which allow consumers and health professionals to report problems directly to FDA via the Internet. We are also updating our computer capabilities so that we can streamline our application processes, allowing submissions of applications electronically without compromising security.

In addition to creating means for openness, these innovations are important for other reasons as well. We are better able to steward our scarce resources, making sure to allocate them to areas with the greatest public health need. By making information more readily available, it has become more convenient and inexpensive for those outside the agency as well-the cost of a trip to Washington, both in time and real dollars or FOI request fee is diminished. By posting a great deal of our public information electronically, there is greater assurance that the information is up-to-date and reliable. The posting of regulations, guidance documents, and enforcement information on the Internet has allowed us to make our regulatory expectations clearer to regulated industry and the public. The speed with which we are now able to release information to a wide audience has been instrumental in increasing the rapid dissemination of important public health information to patients, consumers, and health professionals.

Such information includes: public health alert information, including foodborne illness outbreaks and product recalls, product approval information, and "dear doctor" letters that provide crucial information to health professionals who prescribe drugs. Finally, providing information on the Internet is equitable-it makes this data available to all of our constituents-not just those who are located in Washington, or who have large budgets to spend on regulatory affairs.

These improvements have produced tangible, measurable results. As just one example, in the past, the volume of FDA's FOIA submissions was considered to be the second greatest in the Federal government. However, this workload has diminished significantly since the creation of the Freedom of Information Act Electronic Reading Room on FDA's website-from over 43,000 FOI submissions in 1997 to less than 28,000 in 1999. Seeing such positive results has motivated us to explore other ways in which to use the Internet to further our public health mission. For example, we are assessing the "usability" of our home page, and will make format or content changes in order to ensure that those outside the agency can access information as quickly and easily as possible. We are also constantly looking at new computer technology to use in our communications with the outside world.

However, even as we applaud all the merits of this new technology, we need to be cautious about misuse of the Internet to circumvent the traditional public health protections that have been put in place in the United States over the years. As I mentioned, the Internet is playing an important role in the trend toward greater consumer activism in healthcare decisions. However, it is critical that consumers receive reliable information that points them in the right direction, not misleading information that may encourage them to experiment with unsafe or unproven products, or forgo traditional, science-based therapies in order to take an unapproved product.

Therefore, FDA has been devoting a great deal of time and attention to looking at the sale and promotion of medical products on the Internet. Just as sites providing medical information are very diverse, so are the sites that are selling a wide range of therapeutic and other products. There are approved drugs sold by reputable, regulated sites-examples would include Internet versions of mainstream "brick and mortar" pharmacies that are licensed by the states in which they operate. There are also approved drugs that are sold by unregulated sites that circumvent the traditional safeguards in place at a brick and mortar pharmacy. There are sites that provide drugs that are unapproved in the United States, but may approved in other countries and may or may not be safe and effective for their intended uses. There are drugs that have never been approved anywhere, and thus are of dubious safety and effectiveness. Finally, there are sites offering a myriad of other products making unproven claims, including magnets to treat cancer, or "miracle" weight loss products.

As we might expect, even the types of approved drugs sold over the Internet vary as well. Lifestyle drugs are very popular, including Viagra for erectile dysfunction, Propecia for hair loss, and Xenical for obesity. These drugs may have dangerous side effects for certain patients, making their sale without a proper medical assessment a risky approach. We have also seen more traditional drug products that treat illness--including antihistamines, and pain relievers-sold to patients and consumers without a prescription. Finally, it appears that some patients have turned to Internet pharmacies when their doctors have refused to write additional prescriptions, particularly for controlled substances such as valium, codeine, or other painkillers.

We believe that there are several different motivations for why patients and consumers are increasingly shopping online for medical products. First, there are some people who live in remote, or rural areas, and find that it is much more convenient to shop from home via their computer. Such convenience is certainly a factor for those that are homebound or disabled. Second, some patients want the increased privacy of a transaction over the Internet, particularly for the sort of lifestyle drugs that I mentioned. And, some consumers may look to obtain medical products via the Internet due to a lack of trust in the traditional system.

Clearly, another advantage to the sale of medical products via the Internet is the wealth of information available through that medium. Patients and consumers may find that product information or disease state information is more readily available to them from their computer than from the corner drug store. We at FDA appreciate the inherent tension between wanting to respect the desire of consumers to receive needed products from reputable, approved sites-but we also have as part of our mission the charge to protect the public from misleading information, disreputable websites, and dangerous products.

Ironically, some of the Internet's strengths--including anonymity, speed, and ability to transcend state and international borders--are also some of the same factors that make enforcement and policymaking in this area extremely challenging. Historically, States have had the authority to regulate both the practice of pharmacy and the practice of medicine. A Federal regulatory presence should complement this traditional authority of the States, rather than overshadow or undermine it. FDA also has found that most websites selling drug products are actually made up of multiple related sites and links, which often cross state boundaries. There is an appropriate Federal role, but thus far we have found that our investigations are not only very complex, but extremely resource intensive, both overseas and in the U.S. The global nature of the Internet is creating particular problems for effective law enforcement. Different approaches to drug approval and marketing in foreign countries further complicate law enforcement issues for United States' officials. We at FDA--as well as other U.S. government agencies--will need to work extremely closely with foreign governments to share information and to develop mechanisms for cooperative law enforcement.

As you know, under the current system, FDA reviews new drugs to assess their safety and efficacy. In addition, certain types of drugs must be prescribed and dispensed only by licensed health care professionals. The prescribing requirement is based on the principle that certain drugs have risks of such significance associated with them that they should be administered only under the supervision and recommendation of a "learned intermediary" -- that is, a state licensed practitioner with the education and training necessary to oversee the administration of potentially harmful drug products.

Similarly, these products may only be dispensed by a state licensed professional that can help to assure proper dosing and administration and can provide important information on the drug's use to patients. These requirements are crucial components of the risk management system for drugs in the U.S.

We are concerned about the proliferation of sites that substitute a simple online questionnaire for a face-to-face examination and patient supervision by a health care practitioner. According to the American Medical Association, a health care practitioner who offers a prescription for a patient they have never seen before, based solely on an online questionnaire, generally does not meet the appropriate medical standard of care.

Earlier this year, the Federation of State Medical Boards received the report of its Special Committee on Professional Conduct and Ethics, which found that "Prescribing of medications by physicians based solely on an electronic medical questionnaire clearly fails to meet an acceptable standard of care and is outside the bounds of professional conduct." This finding is especially important in light of the primary responsibility of States in regulating the practice of medicine. Additionally, FDA is concerned that the use of such questionnaires may jeopardize the privacy of a patient's medical records. We will continue to play a role in the Administration's efforts with the private sector to implement appropriate protections for patient's medical information.

The Agency is equally concerned that in some Internet transactions, there is an apparent absence of any health professional-patient relationship. This is a particular concern where the prescription involves a first-time use by a patient or where the patient may be taking other medications or dietary supplements. The selection of prescription drug products or treatment regimens for a particular patient needs to 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 a customary physician-patient relationship does not exist, the patient may be essentially practicing self-diagnosis and treatment. The risk of negative outcomes such as harmful drug interactions, contraindications, allergic reactions or improper dosing is greatly magnified.

Over the past several years, FDA has sharpened its focus on the issue of Internet promotion and sale of drugs as online activity has expanded. In the fall of 1996, FDA held a public meeting on the use of the Internet to promote drug products at which we heard from consumers and health professionals on this emerging issue. In February 1999, the Agency hosted a meeting with representatives of health professional organizations to look at the prescribing and dispensing of drugs on the Internet.

In July 1999, FDA developed, and has since been implementing, an Internet Drug Sales Action Plan to expand and improve the activities of the Agency in addressing 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.

Elements of the action plan include: expanding public outreach to inform the public about dangerous practices involving Internet purchases and to explain what compliance and enforcement actions we already have taken. We are working with outside groups on voluntary certification programs that identify which websites are safe for consumer purchasing; are coordinating activities with State and Federal agencies to regulate the sale of both approved and unapproved drugs; are working with foreign governments to bring action against such individuals from other countries who sell unapproved drugs in the United States; and are expanding our enforcement activities by establishing priorities, identifying and monitoring potentially violative websites and making appropriate referrals for criminal prosecution and/or civil enforcement actions.

In addition, last winter, the Administration announced a new initiative to protect consumers from the illegal sale of pharmaceuticals over the Internet. The initiative included a $10 million request in the Administration's FY 2001 budget to enhance FDA's enforcement capabilities, and called for legislation to help ensure that Internet pharmacies comply with State and Federal laws. Specifically, the new funding requested would be used to identify, investigate, and prosecute operators of websites selling prescription drugs without a valid prescription.

Let me summarize by saying that emerging Internet technology will continue to present an array of complex and important opportunities and challenges. Over the past couple of years, many have voiced concern over the need to keep the Internet as free of regulatory constraints as possible. Yet, at the same time, many agree that some sort of regulation is necessary, but that "the devil is in the details"-making the crafting of a comprehensive, effective plan that most can agree on extremely difficult. And, while we may not be able to resolve all of these complex issues today, a heightened awareness of the important tensions in play and interests at stake is clearly a large step in the right direction. Thank you very much for having me here today. I am happy to answer some questions that you may have.