Drugmakers to pay for FDA review of TV ads
Drugmakers will have to pay $6.25 million in new fees next year to help fund a U.S. Food and Drug Administration review of television commercials for their products, the agency said Thursday Pharmaceutical companies have been warned in the past about misleading claims.
The advertising plan accompanies an agreement for proposed legislation to renew industry funding for FDA drug reviews through 2012. The FDA also receives money from the federal budget.
The plan includes about $392.8 million in fees for fiscal year 2008, but it was not immediately clear what the charges would be in following years.
About $29.3 million of those fees would be used next year to modernize the agency’s ability to monitor drug safety after a product hits the market, the FDA said.
The proposal will also require drug companies to pay a one-time fee on top of charges for each television ad submitted for review.
Drugmakers are not required to have FDA approval before running commercials, but many companies submit them ahead of time to avoid possible penalties for content.
The number of ads submitted has been increasing, the FDA said, but resources for reviewing them have not kept pace.
“As a result, it is impossible for FDA to review all of the direct-to-consumer television advertisement advisory submissions it receives in a timely manner,” the proposal said.
The plan would allow the agency to hire 27 additional staff reviewers who would evaluate the ads in 45 days, the FDA said.
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