Trying to Police Misleading Drug Ads
By NAT IVES

Published: January 30, 2004

THE Food and Drug Administration is increasingly failing to enforce its own rules on prescription drug advertising, according to a report released yesterday by the ranking Democrat on the House Committee on Government Reform.

The report, issued by Representative Henry A. Waxman, Democrat of California, found that the drug agency was sending fewer warning letters to pharmaceutical companies and taking longer to send them than in previous years.

Weak enforcement, Mr. Waxman said in a phone interview yesterday, contributes to unneeded or risky prescriptions for consumers and higher health care costs.

"We've issued this report in order to be constructive, because we want the F.D.A. to enforce the law," he added.

But F.D.A. officials said that the report overlooked the agency's new focus on other actions it considers more constructive, like clarifying its guidelines and sponsoring educational forums for pharmaceutical companies. They said focusing on the number of enforcement letters missed the bigger picture.

"The most important thing to note is that numbers games don't advance the public health," said Peter J. Pitts, the drug agency's associate commissioner for external relations. "We don't really have the luxury to say 'gotcha.' What we can do is make sure we have clear and effective communications."

In the glare of an election year, some Democrats said the report's findings could help illustrate larger campaign themes.

David Doak, a Democratic media consultant in Washington, said, "I'm not sure that this in and of itself will be an issue, but the air of permissiveness towards big business by this administration, and the ramifications that has on the public, could well be an issue, and I would argue already is."

The report examines a vital sales tool for pharmaceutical companies. The companies spent $2.5 billion in consumer advertising last year, according to an estimate by TNS Media Intelligence/CMR, which tracks marketing spending. That is about double the amount spent in 1998.

Mr. Waxman's staff found that the number of notices of violation or warning letters to pharmaceutical companies for misleading ads fell to 24 last year from 108 in 1999.

When the agency did contact companies about ads it found misleading or incomplete, moreover, it took longer to send its complaints, the report said. For 14 of the ads that generated letters last year, the agency sent letters an average of six months after the ads first appeared. By way of comparison, the report cites a General Accounting Office study of a five-month period in 2002, when the agency took an average of 41 days to send warning letters.