To anyone with access to the Web, a dizzying array of drug and therapeutic offerings is just a few clicks away. And the force behind it--an intricate global network of chemical and drug manufacturers, distributors, and buyers--may be threatening the ability of the U.S. Food and Drug Administration to provide its traditional public health "safety net" for Americans.
FDA commissioner and physician Jane Henney spoke last month at the University of Pennsylvania's Leonard Davis Institute of Health Economics about the challenges facing the FDA as Internet sales of prescription drugs have taken off worldwide. Henney said that while the FDA appreciates consumers' desire to receive needed products from reputable sites, "we have, as part of our mission, the charge to protect the public from misleading information, disreputable Web sites and dangerous products."
She detailed some of the ways the FDA is increasing its scrutiny of online drug sales and trying to educate consumers, and spoke also of the FDA's own use of the Internet as a way to further its public health goals.
In remarks introducing Henney, Penn provost Robert Barchi reminded the audience of the agency's critical role in consumer protection. "FDA-regulated products account for about 25 cents of every consumer dollar spent in the U.S. today," he said, "ranging from cell phones to cardiac assist devices, from drugs to breakfast cereal."
Much of that commerce now takes place on the Web. "Consumers have a great deal of interest in obtaining medical information over the Internet," Henney said in her talk, titled, "E-Regulation and Public Health: FDA in the Information Age." "It's estimated that 1 million new Web sites go up each month. Some of the most frequented ones are health-related. According to (outside reports), 43 percent of Web surfers access health care data online each year, and conducting searches for health care information is the sixth most common reason people use the Internet."
As one might expect, the quality of these thousands of Web sites varies tremendously. Henney acknowledged that reputable sites--such as those of the National Institutes of Health and the Clinical Trials Database--actually constitute a public service. But she also pointed to the many commercial sites that mix accurate information with advertising, making it, she said, "difficult to determine what is good and useful information, vs. what is misleading and potentially harmful."
Sites may be "strong on the pitch, but lacking in substance," or even flat-out fraudulent. Some, said Henney, "attempt to promote therapies that have not even a scintilla of data to back up their claims." Among such problematic sites she mentioned were ones promising to remedy "compromised brain function" and "cerebral circulation," and to promote "cell health."
Web sites selling pharmaceuticals can be confusingly diverse, too. Henney gave an overview of the booming market of Internet drugstores:
Reputable, regulated sites selling approved drugs, such as Internet versions of state-licensed brick-and-mortar pharmacies
Unregulated sites that sell approved drugs but circumvent traditional pharmacy safeguards
Sites that provide drugs unapproved in the United States but approved in other countries, which may not be safe or effective for their intended use
Sites that provide drugs never approved anywhere, which are of questionable safety and effectiveness
Sites offering myriad other products making unproven claims, such as miracle weight-loss drugs.
Henney said that "lifestyle" drugs--such as Viagra for erectile dysfunction, Propecia for hair loss and Xenecal for obesity--are very popular on the Web. While legal, they may have dangerous side effects for certain patients, making their use without a prescription risky. She also listed antihistamines and painkillers among frequently ordered Internet pharmaceuticals. "It appears that some patients turn to the Internet when their doctors refuse to write additional prescriptions."
Circumventing your doctor aside, why are so many consumers now shopping for their medical products online? Henney listed several different motivations:
Convenience: Many people--especially those who live in remote or rural areas, have a disability, or are homebound--find it easier to shop at home.
Privacy: Some patients prefer the anonymity of a Web transaction--as Henney put it, "if you simply don't want your local pharmacist announcing your disease in front of a long line of people."
Distrust of conventional medicine: Some consumers order medical products via the Internet because they don't trust the traditional system.
Accessibility of product information: Some consumers feel they can get product information more easily on their computer screen than at the corner drugstore.
One audience member asked Henney if she thought that the current political rhetoric about the high cost of prescription drugs was perhaps sending even more people to their computers in hopes of getting a price break.
"There's a great myth about the Internet that there are cost savings to be had; some say yes, some no," Henney said. "I think many people do it for that reason; but once all the charges come in, true cost savings become balanced out. And some would argue, 'Well, at least I didn't have the cost of a doctor visit,' but if you get into health troubles because of what you ordered, it becomes a much more costly proposition."
Henney characterized the traditional way that drugs have been dispensed in the United States--that is, only by state-licensed health care practitioners--as a crucial "risk management system." She conveyed the FDA's concern about Web sites that substitute an online medical questionnaire for a face-to-face examination. Besides constituting substandard health care, she said, such questionnaires might jeopardize the confidentiality of medical records.
Then there are online medical transactions in which a health professional seems to be completely absent: "Patients may be essentially practicing self-diagnosis and treatment, and the risk of negative outcomes such as harmful drug interactions, allergic reactions or improper dosing is greatly magnified."
The Internet's ability to cross state and international lines with anonymity and lightning speed presents an additional nightmare of regulatory issues for the FDA and for law enforcement, according to Henney. "Historically, states have had the authority to regulate both the practice of pharmacy and of medicine," she said. "But the FDA has found that most Web sites selling drug products are made up of multiple related sites and links which often cross state boundaries."
An audience member asked how the FDA intends to regulate sites overseas. "There's no international law or treaty in place, so we have had to work through our informal but very cordial relationship with our counterparts in other countries," Henney said. "We have also tried to work through the World Health Organization, so countries can share what their regulatory paradigm is and monitor what's going on in other countries." But she admitted that is one of the biggest challenges her agency faces.
What actions has the FDA taken so far to curb unlawful Internet drug sales? As for enforcement activities, Henney listed 80 warning letters, 25 of which are now known as cyberletters, 18 seizures and 11 recall actions. The agency has also set in motion seven arrests on criminal charges related to the Internet and two pharmacy convictions. And it recently implemented a wide-ranging Internet Drug Sales Action Plan. The main elements are:
Expanding the FDA's outreach to inform the public about dangerous practices involving Internet purchases, and to explain what compliance and enforcement actions have already been taken
Working with outside groups on a voluntary certification program that identifies Web sites safe for consumer purchases
Working on coordinating the activities of state and federal agencies to regulate the sale of both approved and unapproved drugs
Working with foreign governments to bring actions against individuals from other countries who sell unapproved drugs in the United States
Expanding enforcement activities by establishing priorities, identifying and monitoring Web sites in potential violation, and making referrals for civil or criminal prosecution
In addition, last winter the Clinton administration announced a new initiative to protect consumers from the illegal sale of pharmaceuticals on the Internet. The initiative included a $10 million request in the government's 2001 budget to enhance the FDA's enforcement capabilities and called for related legislation.
Paradoxically, the same Web technology that is rocking the FDA's boat is, in many ways, filling its sails. "The Internet provides an efficient way for the agency to be more open and transparent in its work," Henney said. "Over the past few years, we have developed electronic tools to allow greater public participation in the development of regulatory policy." Such innovations include:
Using Internet broadcasts in lieu of expensive public meetings in Washington
Allowing for electronic submissions of comments on regulations and guidance documents
Posting more public information on the FDA's Web site and keeping it up-to-date
Providing mechanisms such as MedWatch and a rogue Internet sites reporting page, which allow consumers and health professionals to report problems directly to the FDA via the Internet
The Internet also enables the FDA to speedily broadcast public health alerts about food-borne illnesses and product recalls, as well as "product approval information," such as that for RU486, the "abortion pill," Henney said. Another tangible benefit has been the steep reduction in the number of Freedom of Information submissions to the FDA, which until recently had more requests than any other federal agency except for one. Henney explained that providing a Freedom of Information Act electronic reading room on the FDA's Web site has helped reduce FOI requests from over 43,000 in 1997 to less than 28,000 in 1999.
Clearly, for the FDA, the Internet is a mixed blessing. Henney asserted that while many agree that some sort of Web regulation is necessary, "the devil is in the details, making the crafting of a comprehensive, effective plan that most can agree on extremely difficult." But she believes that "a heightened awareness of the important interests at stake is a big step in the right direction."
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