DTC industry fears FDA pre-approval

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[Washington, D.C.] While last week's Food and Drug Administration public hearings centered on whether direct-to-consumer advertising should be subject to stricter guidelines, whispers in the hallways and back rooms spoke of a sea change for the pharmaceutical industry: mandatory pre-submission of DTC ads for FDA approval.

"It would have to be a dire situation for it to come to that," said Thomas Abrams, director of the Division of Drug Marketing, Advertising & Communication. "But I also think anything could happen."

Although the topic did not make it to the floor of the two-day forum, and although it would take some monumental maneuvering-literally, an act of Congress to change the law-the idea was very much on the minds of the attendees.

"At the very least," said one FDA official, "somebody is going to propose it."

The FDA heard more than 25 presentations last week from parties that have conducted research on DTC advertising. FDA Commissioner Dr. Mark McClellan said the agency will use the findings from the public hearings, as well as its own research, to determine new guidelines on DTC messages.

current regulations

Currently, pharmaceutical companies face no federal laws that restrict how they promote their products directly to consumers, and there is no limit on the amount of money that can be spent on those promotions. Last year, drug companies spent a combined $2.5 billion on DTC ads.

"The duty of the FDA is only to regulate the content of the promotion to ensure it is truthful and balanced," Mr. Abrams said.

But that duty, as well as the time lag between the introduction of an ad and possible FDA action, has come under fire from members of Congress who would like to see stricter policing of DTC messages. And that has prompted talk of the mandatory pre-submission of ads.

Mike Guarini, managing director of WPP Group's Ogilvy Healthcare Practice, New York, said: "My feeling is, barring other provisions, pre-submission is not out of the realm of possibility."

Whether Congress would be amenable to such a change remains to be seen. Efforts to place limits on DTC drug advertising were rejected in the Senate on consecutive days in June. One was an amendment to the Medicare prescription-drug benefit bill, sponsored by Sen. John Edwards, D-N.C. The second, a proposal to require DTC drug ads to include information on how each drug compared with others on the market, was also defeated.

Even if heavy lobbying persuaded Congress to change the laws allowing the FDA final approval on DTC drug ads, several other obstacles would remain. Most notably, FDA staffing issues and the question of who would foot the bill.

"That's going to become an issue of whether or not it gets paid for through tax dollars or some other kind of proposal," said the FDA official. "Because there's no way the pharmaceutical industry gets involved in that. You just can't have an industry paying for a government initiative that approves part of its livelihood. It just doesn't fly."

Most pharmaceutical companies and their respective ad agencies voluntarily submit ads to DDMAC, which then offers comments and suggestions. But even that practice has its detractors.

"DDMAC can be very capricious," said a CEO at an agency that specializes in pharmaceutical advertising. "Things have been pre-submitted that DDMAC has signed off on, and we've run them, and then they come back and say, `Well, wait a minute ...'. "

But at least one ad agency executive said the threat of having an advertising campaign pulled is enough for the pharmaceutical industry to police itself.


"I don't think pre-submission happens because I think the system is self-regulated now," said Andrew Schirmer, managing director of McCann HumanCare, part of Interpublic Group of Cos.' McCann-Erickson. "People are cognizant of the fact that you don't want to put together a $40 million campaign and have it pulled a month or two later. The number of [warning letters] and cease-and-desist letters from the FDA is a small percentage compared to the number of DTC ads out there."

Mr. Schirmer was the only advertising agency representative to make a presentation at the FDA hearings last week. He addressed another hot-button issue among pharmaceutical marketers: the brief summary. A listing of side effects and usage information, the brief summary is required by the FDA for all DTC ads. But, as one presenter pointed out, it is anything but brief as he showed a one-page print ad that appeared in an issue of TV Guide, followed by three pages for the brief summary.

"My conjecture is that at least one thing that comes out of [the public hearings] is a revamp of the brief summary to make it more consumer-friendly," Mr. Schirmer said.

Mr. Abrams of DDMAC agreed, saying that the risk information is often obliterated by catchy graphics or characters on TV ads, or is too long and difficult to read in print ads. The FDA expects to announce its new DTC guidelines by the end of the year.

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