Draft FDA Guideline Could Curb TV Ad Spending
Draft guidelines published by the Food and Drug Administration this week could curb TV ad spending by drugmakers, a lawyer who represents some pharmaceutical marketers said. The FDA proposed a set of guidelines drugmakers should follow for submitting their ads to the agency for review before they run on TV, with five categories of direct-to-consumer prescription drug ads subject to review, including new drugs and those with serious risks relative to benefits (http://xrl.us/bmx227). Although there appears to be a limited set of circumstances that would trigger FDA review of drug ads, in practice the guidance would impose a near-blanket requirement on direct-to-consumer TV drug commercials, said John Kamp of Wiley Rein, who represents the Coalition for Healthcare Communication. That may make drugmakers think twice about buying TV spots, he said.
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"If you give drug companies even more disincentive to advertise on TV, the return on investment is different,” Kamp said. “The harder it is to advertise on TV, the more likely it is that an advertiser may look to alternative media.” The draft guidance was a result of a 2007 Food and Drug Administration Amendments Act giving the FDA authority to require drug companies to submit their direct-to-consumer TV ads for review at least 45 days before airing them, the draft guidance said. The draft calls for drug marketers to submit an annotated storyboard of the proposed TV ad, a video of the ad if available and other information. Drugmakers may still run the spot without FDA approval, but would risk an enforcement action if the ad is found to violate federal law, it said.
Another concern is whether the FDA will have the financial resources to review all the spots. If the agency doesn’t, it could be overwhelmed with ads to review and lead to a bottleneck that would hinder a spot’s path to TV, said Jim Davidson, an attorney with Polsinelli Shughart who works on drug marketing issues. “Without sufficient resources, it could become a prior restraint on advertising for medicines.” The draft guidance should be revised to reflect language in the 2007 law that cautions the FDA against making or directing changes to ads it reviews, Davidson said.
The proposed guidelines aren’t all that different from voluntary guidelines adopted by the Pharmaceutical Research and Manufacturers of America (PhRMA), the industry’s trade association, Kamp said. “But it’s one thing to voluntarily not advertise in certain ways,” he said. “It’s another thing for the government to ban it."
Current law already requires drugmakers to submit direct-to-consumer (DTC) ads for prescription drugs to the government upon its first use, PhRMA Senior Vice President Matthew Bennett said. But PhRMA’s 2009 principles (http://xrl.us/bmx6mn) stipulate the companies give the FDA ads before airing them, he said. “In other words PhRMA member companies are already providing the FDA with the opportunity to comment on DTC television advertisements prior to airing.” Comments on the draft guidance are due to the FDA by May 12.