KHN Morning Briefing

Summaries of health policy coverage from major news organizations

FDA Urges Doctors To Police Drug Ads

A new Federal Drug Administration program will urge doctors to blow the whistle on misleading drug advertisements.

The "bad ad program," announced Tuesday, is "part of the agency's latest effort to police the pharmaceutical industry's multibillion-dollar marketing machine," The Associated Press reports. "Drug companies are legally required to present a balanced picture of a drug's benefits and risks in promotions, though critics charge that many TV and magazine ads fail to do so. Currently the FDA relies on a few dozen staffers to review hundreds of pharmaceutical ads, brochures and presentations voluntarily submitted by companies or reported to the agency by drug industry personnel. The agency issues warning letters to companies using misleading materials, but because of the volume of submissions those letters often aren't sent until months after the ad is released - and in some cases after the ad is no longer in circulation" (Perrone, 5/11).

Reuters: "Starting this month, FDA staff will set up booths at major medical conferences to tell doctors how to spot questionable pitches. The agency also is sending a letter to about 33,000 healthcare providers about the campaign. … Drug companies make major investments in promoting drugs directly to doctors, a practice called detailing. ... The idea came from two former drug company pitchmen who now work in the FDA office that polices promotions. ... The industry spent nearly three times more -- $12 billion -- on detailing as it did on ads aimed at consumers in 2008, the Congressional Budget Office found. The FDA under President Barack Obama has vowed to boost enforcement against drugmakers and others. Warnings to companies for problematic promotions nearly doubled in the year after Obama took office" (Richwine, 5/11).

Meanwhile, "[b]lowing the whistle on drugmakers is becoming a habit for a salesman and a psychiatrist splitting a $45 million award after AstraZeneca Plc settled claims of illegally marketing a schizophrenia drug," Bloomberg Businessweek reports. "James Wetta, a former company sales representative, sued in 2004 claiming AstraZeneca marketed Seroquel to children, prisoners and the elderly for uses not approved by regulators. Stefan Kruszewski, a psychiatrist, sued two years later, saying the company misrepresented Seroquel's risks and benefits. The U.S. Justice Department joined their cases and settled April 27 with the company for $520 million under the False Claims Act. The men received payments after years of waiting. Each previously won awards in such litigation..." The men don't know each other (Voreacos and Fisk, 5/12).

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