Direct-to-consumer ads may face FDA scrutiny

November 1, 2003

Pharmaceutical Representative

Prescription drug ads directed at consumers may face greater scrutiny as part of a five-part strategic plan released by the FDA.

Prescription drug ads directed at consumers may face greater scrutiny as part of a five-part strategic plan released by the Food and Drug Administration.

While the FDA concedes that direct-to-consumer advertising benefits consumers by providing them with information about the availability of new treatments, the agency also cited statistics showing the ads' downside. According to an FDA survey, 75% of doctors surveyed felt the ads made the drugs seem like they would work for everyone, and seem more efficacious than they really were. Half the doctors surveyed felt the ads created unnecessary anxieties in consumers, and more than half felt pressured to prescribe the specific medication. To alleviate these concerns, the FDA plans to develop guidance for the industry on the information that must be contained in ads.

Up in the air

But what this guidance will contain has yet to be determined, according to the Washington-based Pharmaceutical Research and Manufacturers of America. "At this point, we don't exactly know what they're talking about," said Jeff Trewhitt, a spokesperson for PhRMA. "We've only heard generalities."

Trewhitt speculated that there had been concerns that not enough people were calling the toll-free number provided at the end of specific direct-to-consumer advertisements and that as a result, the FDA may change the rules governing DTC ads. "They are contemplating requiring companies to provide more information [in the ads]," he said. PhRMA expected to learn more details at an FDA advisory meeting that was scheduled for the end of September.

The FDA has said it plans to work with the industry on the issue. "The FDA has announced this effort in a spirit of collaboration," Trewhitt said. "They have stuck to their word and we have been as cooperative as we can be, and we will certainly discuss this particular issue." PR

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