Drugmakers to help fund review of TV ads

updated 4:17 p.m. ET Jan. 11, 2007

WASHINGTON - Drugmakers have agreed to pay millions of dollars in new fees next year to allow U.S. health officials to review TV commercials before they reach consumers, the industry and government officials announced Thursday as part of a larger funding proposal.

Under the plan, companies would pay the Food and Drug Administration a one-time fee on top of charges for each TV ad submitted for review — totaling $6.25 million in fiscal year 2008.

The deal accompanies proposed legislation to renew other industry funding for FDA drug reviews through 2012. Some of that money would target the agency’s drug safety system, which has come under scrutiny in recent years amid several withdrawn medicines.

The funds would be used to boost the FDA’s own database to track drug use once products hit the market, the FDA said.

While the FDA also receives money from the federal budget, Congress first passed legislation in 1992 for industry fees aimed at speeding the FDA’s review process. It has been renewed several times since but not without controversy.

Critics have said the fees allow industry influence to seep into the agency and pressure staff to work more for the companies instead of consumers.

But FDA Commissioner Dr. Andrew von Eschenbach said the arrangement works well.

The fees “have brought enormous public health gains to our and, indeed, the world’s consumers, by helping FDA make increasingly complex medications available to patients faster than was ever possible before without sacrificing quality,” he said in a statement.

The FDA released the proposal after consulting with industry, consumer and patient groups, but Congress must still approve it.

Drug advertising has also been controversial with various groups, including the Institutes of Medicine, calling for limitations or an outright ban.

Companies do not need FDA approval to run commercials, but many submit them ahead of time to avoid possible fines and other penalties for misleading content. Various drugmakers have been warned in the past about misleading claims.

In 2005, the drug industry said it would voluntarily submit its advertising, including television commercials. But that has made more work without resources to keep pace, the FDA said.

“As a result, it is impossible for FDA to review all of the DTC (direct-to-consumer) television advertisement advisory submissions it receives in a timely manner,” it said.

The ad fees would allow for 27 additional staff reviewers who would evaluate the ads in 45 days.

Billy Tauzin, head of the industry group Pharmaceutical Research and Manufacturers of America, welcomed the plan.

“The FDA would have more resources to develop comments for companies before their ads are broadcast, which would help to ensure the advertising’s accuracy, balance and compliance with all regulatory requirements,” he said in a statement.

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