FDA Proposal Could Ease Drug Marketers' Pain

Drug marketers could see a welcome end to warning letters, forced ad revamps and ad campaigns they have to pull after airing if Congress approves a proposal from the Food & Drug Administration that would result in speedier FDA pre-review of direct-to-consumer television ads for prescription drugs.

"It would be a win-win," said Stu Klein, president of KPR, an Omnicom agency specializing in professional health care advertising.

Pharmaceutical companies ranging from Pfizer for its Viagra "devil horn" ads to Bayer/Schering-Plough for Levitra and Barr Pharmaceuticals for Seasonale are just a few of the marketers whose drug campaigns had to be tweaked or pulled in the recent past.

The FDA is proposing a 29% increase in the annual user fees paid by drug companies for new drug applications and for drug review and approval. The increase in fees would be in exchange for improved oversight of drug safety and to reduce approval times for new drugs or new uses.

In addition, the potential increase in user fees would also include something new: pre-review of direct-to-consumer (DTC) television ads on prescription drugs. The proposal comes just a little more than a month after the pharmaceutical industry reached a tentative agreement to pay the FDA fees to review ad campaigns in the first place. The purpose of these fees is a faster turnaround to review campaigns before they air.



If the new proposal goes through, drug makers will pay the FDA about $393 million in user fees in 2008, which is $98 million more than what will come in this year. Part of the extra money would be used to hire 82 new FDA staffers to review drugs and drug ads.

Drug companies aren't required by the FDA to get approval for direct-to-consumer drug ads before airing spots. Nonetheless, it had become common practice for drug companies to run the actual ads or concepts by DDMAC, which is the FDA's Division of Drug Marketing, Advertising, and Communications.

Last year, DDMAC's review task became even greater after the Pharmaceutical Manufacturers Association of America adopted new guidelines--one of them being to submit TV ads to the FDA prior to hitting the airwaves.

If approved, the new arrangement could start as soon as October.

Drug marketers are generally pleased with a fee-for-ad-review setup. "This will ensure that the patient Web sites, print ads, TV ads and professional ads and all other information is consistent," says Gil Bashe, executive vice president and head of the healthcare group at Makovsky & Co, a public relations consultancy.

Currently, ad review can take about four months, says KPR's Klein--which is a long time, considering that it generally takes about a year to develop a concept and produce an ad, he says. In comparison, in 1998 when DTC advertising was new, the initial guidance from the FDA was for a quick 20-working-day review.

Creative concepts for ads have become more imaginative. But because of the time lag in getting the FDA to respond to ad wording, marketers sometimes go ahead, Bashe says.

"What happens is--often ads are put on the air before the FDA approves them, and if there's a problem thereafter, ads get pulled or corrected," Bashe says. "That's costly to the company, and it can also influence consumers because the first impression is often the lasting impression, so corrections or ad changes are not remembered.

"If ad reviews are accelerated, the quality of information will improve as will our nation's healthcare," he says.

A Democratic Congress however, may put a damper on the proposed plans. Certain industry critics view any new arrangements between the pharmaceutical industry and the agency as another indication of a relationship that's too close for comfort.

"We are opposed to any fees [for ad review]," says Sydney Wolff, director of the Washington-based advocacy group Public Citizen. "The [FDA] hiring more staff is a good idea, but it shouldn't be funded by the drug industry because there's too much potential for conflict," he says. In addition, Wolff says, "user fees for new drug applications aren't a good idea either," because they only encourage situations in which drugs get approved that perhaps shouldn't.

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