Drug ads to get more FDA scrutiny

[Pharma Newshound]

Source: USA Today

By Julie Schmit, USA TODAY

The Food and Drug Administration's current budget for reviewing consumer drug advertisements is larger than in the previous five years combined.

But whether that level of funding will be sustained and continue to come from taxpayers — or will be raised from drugmakers through new user fees — is likely to be battled out in Congress as it addresses future FDA funding.

The FDA received $6.1 million for the current fiscal year to check the fairness and accuracy of consumer drug ads. That's up from $2.2 million the previous year and $1 million the year before.

The FDA says it plans to hire more people so it can review more ads. It has 13 workers devoted to policing direct-to-consumer ad materials. Six are primary reviewers. Last year, the FDA received 12,616 drug ad materials directed to consumers.

The FDA has long been so overwhelmed by drug industry ad materials that only a "small portion" is reviewed, the Government Accountability Office said in a 2006 report. The FDA often didn't declare consumer ads false or misleading until after ad campaigns were over, the GAO said.

The boost in 2008 funds came after Congress approved user fees for drug ad reviews, but the program wasn't launched amid funding issues and opposition from some lawmakers, including Rep. Rosa DeLauro, D-Conn., who chairs a subcommittee overseeing FDA funds.

President Bush seeks to resurrect the fees. The proposed 2009 budget he sent to Congress this month calls for $14 million from fees to fund 27 FDA positions devoted to the consumer-ad-review program. In exchange, the FDA would review TV drug ads within 45 days of getting them from drugmakers — which is faster than many reviews occur now — and before the ads are seen by millions of viewers.

The drugmakers' trade association, Pharmaceutical Research and Manufacturers of America, supports user fees.

Timely FDA review would help drugmakers meet marketing goals and lessen the risk of running ads later cited by the FDA for false or misleading content.

The FDA can recommend changes in an ad it considers misleading. Drugmakers can be fined if they run ads without changes.

The FDA already collects user fees for reviews of new human and animal drugs and medical devices. In Bush's proposed budget, a quarter of the FDA's funds would come from fees paid by industries the FDA regulates.

DeLauro is likely to continue to be a staunch opponent. "I believe Congress should provide a direct appropriation in order to minimize industry influence in the FDA," she says.