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FDA bolsters drug ad commitment

A huge increase in the number of warning letters sent to pharma companies about their advertising campaigns is evidence of a stronger commitment from the FDA

The number of warnings sent to pharma companies by the Food and Drug Administration (FDA) regarding misleading advertisements has more than tripled in the last 12 months, according to Thomas Abrams, head of the regulator's drug marketing and communications unit.

Some 17 warning letters were sent by the agency in the year ended August 31, compared with an average of four or five in recent years, Abrams told regulatory lawyers at a conference in Washington.

While Abrams said that the marked increase was evidence that the regulator is monitoring pharma companies' advertising output more stringently, he also said that firms were not doing enough to ensure that product information is balanced.

About 82 per cent of the letters were sent because pharma companies had failed to include details about the side effects in product information aimed at both patients and doctors. While around 50 per cent of the letters criticised companies for making false claims about drug efficacy. Last year, the FDA took issue with Pfizer over its television campaign for Viagra, saying that it was misleading in that it had suggested that the drug was more effective than trials had proved.

At the conference on Monday, Abrams said that pharma companies should make more of an effort to comply with advertising regulations. His call follows the publication in August of the Pharmaceutical Research and Manufacturers of America (PhRMA) Guiding Principles, a 15-point document outlining the dos and don'ts of pharmaceutical product advertising on television and in print.

FDA head, Lester Crawford welcomed the document last month, but stressed that the regulator would continue to monitor the pharma industry's promotional activities - a sentiment that was reiterated by Abrams.

Despite continued calls for pharma to clean up its promotional act by providing more balanced advertising that clearly states the risks and benefits of taking products, the FDA is still keen for companies to comply voluntarily to Guiding Principles and other guidelines Abrams hinted would be introduced by the end of the year. It would seem that the regulator is still not ready to enforce guidelines.

2nd September 2008

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