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Agencies review Net drug market

The United Nations and the Food and Drug Administration are examining sites that that peddle drugs online.

Just as the United Nations-sponsored World Health Organization is taking a hard look at Web sites that push pills, U.S. officials are preparing guidelines for online drug advertisements to come out this summer.

The Food and Drug Administration is working on revised rules to address the marketing and selling of drugs over the Net, practices that are now virtually unmonitored. At a meeting in Geneva yesterday, WHO declared the practice a "hazard for the public health."

While some doctors and patients are taking advantage of the wealth of medical information on the Net, the safety of online health advice and drug promotions is raising concerns among regulatory agencies.

WHO adopted a resolution this week "to collaborate with the drug regulatory authorities and national and international enforcement agencies" to develop policies that address the "advertising, promotion and sale [of drugs] through the Internet [which] might result in uncontrolled across-the-border trade of medical products or fraudulent imitations that may be unevaluated, nonapproved, unsafe, or ineffective or used inappropriately."

The FDA has been working on new rules about advertising drugs on the Net since it held a conference last October with representatives from drug companies, advocacy groups, regulatory bodies, and health care providers to discuss the issue. The agency will release a policy by summer.

In addition to allowing anyone to publish medical information, the Net brings up new issues for drug companies that want to market their products online.

For example, drug companies can't promote products for uses that aren't approved by the FDA. Even linking to sites that offer alternative uses for a product could result in a violation of this FDA regulation.

"The industry has asked us to give them some guidance in this area as to what links are appropriate," said Ilisa Bernstein, senior science policy adviser for the FDA. "If a product is being promoted or advertised for a use that isn't approved and hasn't been deemed safe--consumers can be harmed."

Publishing information about drug research on the Net is also an issue the agency is examining. The FDA wants to ensure that drugs still being tested aren't promoted online for use by consumers.

Currently, the agency sends warning letters to pharmaceutical and other health-related information sites that are in violation of truth-in-advertising laws or FDA policies. But applying an international standard for selling drugs in cyberspace will be complicated, as every country has their own standards offline.

"If a company wants to put something on a Web page in the U.S., and someone can access it in France, this brings up a lot of issues from a regulatory standpoint about safety," Bernstein said. "But we're happy that WHO is doing something because the U.S. can't do this alone."

Until WHO and the FDA release their plans, surfers who read drug pitches and ask for medical advice on the Net will have to use plain-old common sense, said Dr. William Lloyd, who dispenses advice as "Dr. Bill" on the Thrive health site.

"I do get a fair number of questions relating to drugs, especially if there is a current fad like these new weight-loss drugs. I answer them on the Thrive site the same way I would in the office: giving the pros, cons, side effects, and saying how effective the drug is," Lloyd said.

Unlike drug companies, doctors can suggest uses for drugs that aren't approved by the FDA. But the practice is risky, he said, especially if your doctor is providing diagnosis by modem.

"Anyone who is trying to get medical information on the Net should be very skeptical and consider the source," he warned. "People should try to get a lot background on the person giving out the information. Many drugs are used for non-FDA approved purposes in the doctor's office, and that is quite legal. I'm not sure how the FDA would control the safety of this on the Net."