Think Tank Challenges FDA

NEW YORK The Washington Legal Foundation, a conservative think tank, has filed a petition with the Food and Drug Administration challenging the FDA’s authority to send warning letters to drug companies whose advertising it finds misleading.

The WLF believes the letters (which carry no legal weight but are routinely obeyed by drug marketers) contravene the First Amendment by making it impossible for drug marketers to advertise information that is not reviewed by the FDA, even though it may be truthful and accurate.

“These policies are illegal and serve no valid health-related purpose,” WLF said in a statement.

The petition is the latest step in WLF’s quixotic campaign to convince the FDA that it has little to no jurisdiction to regulate direct-to-consumer drug advertising [Brandweek, April 10].

The administration writes two types of correspondence to drug marketers chiding them about their ads: so-called “Warning” and “Untitled” letters. Both serve a similar function: they tell drug marketers that the FDA has problems with their promotional materials.

The WLF cites three major concerns with these letters. The organization argues that when the FDA claims an ad is misleading, it does not offer any evidence to prove its case, and requires the company to publish “corrective” advertising; that the FDA cites advertisers for using studies it has not reviewed without taking into account that those studies may be accurate; and that the FDA often requires that risk information be presented twice in the same ad.

The petition calls for the FDA to “review their respective policies and practices for consistency with their regulatory authorities and with the First Amendment” and for the letter writing to end.

The FDA declined to comment on the petition. Its most common complaints about drug advertising are lack of risk information scientific studies being cited inappropriately and claims being made about conditions that the drug has not yet been approved to treat.

The WLF has a long history of fighting against the grain on drug regulations, and this campaign is no different. Drug industry lobby group PhRMA tightened its advertising code last August, and most pharmaceutical companies have complied. Last November, the FDA began a review of direct-to-consumer rules that seemed to call into question whether certain media such as TV were even appropriate for drug advertising.

The FDA said Monday that it was conducting three experimental studies, all of which are designed to find out what consumers actually grasp and understand when they see drug advertising, and what they don’t.

Between November and August, however, the political momentum that seemed to be running in favor of stricter drug ad regulations has stalled.

Congress has not moved to make drug laws tighter. And PhRMA’s DTC guidelines have been violated without consequence by at least one major drug company, Sepracor, which continued to run so-called “reminder” ads (in which no risk information is presented), even though it signed PhRMA’s agreement pledging not to.

Concerning when the FDA will finally publish new DTC guidelines, it said Monday, “We do not have anything to say about policy development at this point since we are currently reviewing comments.”