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.
As an example of slow action, the report discussed a consumer ad for Taxotere, a cancer treatment sold by Aventis. The ad first ran in People magazine in October 2002, but the agency did not send a warning letter to Aventis until more than a year later.
The agency said that the headline in the ad, "The next move may be the key to survival," falsely implied that Taxotere was essential for patients to survive, when, in fact, other treatments were available.
A spokeswoman for Aventis, Lisa Kennedy, said in a statement that the company was committed to complying with F.D.A. requirements and that it provided doctors and patients with important, accurate information on its products.
The report also said that more than three months passed before the F.D.A. sent a letter to Purdue Pharma complaining that an ad for the painkiller OxyContin directed at doctors grossly overstated the drug's safety.
Robin Hogen, vice president for public affairs at Purdue Pharma in Stamford, Conn., said there had been an honest misunderstanding about where to place risk information in the ad.
Delays in sending letters have grown because they are now vetted by the agency's chief counsel, said Mr. Pitts, the drug agency official. He added that the huge volume of ads on television and in magazines can cause a time lag as the agency must rely, in part, on complaints to help it identify offenders.
At Pfizer, executives said that the agency was improving its efforts to ensure that ads make legitimate claims.
"Speaking directly to consumers for pharmaceuticals is a relatively new thing in the past 7 to 10 years, and I think that's true for the F.D.A. as well," said Dorothy Wetzel, the company's vice president for United States consumer marketing of pharmaceuticals. "They're getting better and better at it as we get better at it as well."
But critics of the drug agency found new ammunition in the report.
"The F.D.A. is in a semi-lawless mode with respect to enforcing drug advertising rules," said Sidney M. Wolfe, director of the Health Research Group at Public Citizen in Washington, an advocacy group. "It began in the Clinton administration, but it's gotten much worse. The amount of enforcement has gone down when the amount of advertising has gone significantly up."
Mindy Tucker Fletcher, a Republican strategist who worked for the Bush campaign in 2000, said that it was hard to predict the eventual fallout of the continuing controversy over drug advertising. "In politics, it's all about timing," she said. "None of us know what is going to be a really salient point in November."
In the meantime, the wait continues for the drug agency's latest thinking on direct-to-consumer advertising. There is a general expectation that the F.D.A. will amend the way risk information is displayed, no longer requiring ads for some drugs to include as much small print about side effects.
The agency, which initially planned to propose any changes by December, now expects to release its proposals in early February.
Posted on aef.com: February 2, 2004
Nat Ives, New York Times. January 30, 2004
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