F.D.A. Rules on Drug Ads Sow Confusion as Applied to Web

WHEN the Food and Drug Administration sent letters to 14 major pharmaceutical companies late last month, the warning was strong. The companies’ search advertisements — the short text ads that run beside Google results — had to start including risk information about each drug or else be rewritten or removed.

Just how the companies were supposed to comply was not so clear. In the 95 characters that Google allowed for search ads, there was no way to include all the required information, the companies argued.

Now, as the companies change their search ads to comply with the letters, industry executives say the solution is worse than the problem: their ads are even more confusing and misleading now, they say. And they worry that regulators will enforce standards that were created for magazines and television, rather than making new rules that acknowledge how Internet ads have evolved.

The letters were sent to almost all of the major pharmaceutical companies, including GlaxoSmithKline, Pfizer, Merck and Eli Lilly. The letters said ads for widely prescribed drugs, including Celebrex, Propecia and Yaz, did not include the paragraphs of precautions the agency required.

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Father blames son's suicide on 'telemedicine'

In August 2005, John McKay, a 19-year-old Stanford student and former high school debate champion, committed suicide by rolling up the windows in a car at his mother's Menlo Park home and piping in exhaust fumes.

In the next few weeks, a Colorado doctor who had prescribed a generic form of Prozac for McKay after receiving his request over the Internet, without ever seeing or examining him, will go on trial in Redwood City on possibly precedent-setting charges of practicing medicine in California without a license.

A conviction of Dr. Christian Hageseth, 67, "would send a clear message to those individuals who are blindly writing prescriptions to patients they know nothing about," said the youth's father, David McKay, a former Stanford professor now living in Colorado. They would have to ask themselves, he said, "whether quick and easy money is worth the risk of a criminal conviction and permanent loss of their medical license."

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DEA seeks new restrictions on Internet pharmacies

Illicit Internet pharmacies are helping abusers obtain controlled drugs such as the anti-anxiety medication Xanax, the painkiller Vicodin and anabolic steroids, the Drug Enforcement Administration told a House subcommittee on Tuesday.

The DEA wants Congress to require that drugs be sold over the Internet only on the basis of "valid prescriptions" that are written after face-to-face medical evaluations or, under special circumstances, through telemedicine.

Patrick Egan, a Philadelphia lawyer who specializes in Internet pharmacy regulations, countered that the DEA's proposed requirements would impose a hardship on rural and poor patients who use Internet pharmacies to reduce prescription drug costs. Telemedicine might solve part of the problem, he said, but not for patients who can't afford a consultation.

Other witnesses before the House Subcommittee on Crime, Terrorism and Homeland Security said that federal regulation of Internet drug sites is needed. State regulations vary widely, said William Winsley, the executive director of the Ohio State Board of Pharmacy, and illicit Internet drug site operators seek out the least regulated ones.

READ MORE @ MCCLATCHY WASHINGTON BUREAU