A legal watchdog group says the Food and Drug Administration routinely tramples the First Amendment and oversteps its authority in policing drug advertising.
The Washington Legal Foundation, a nonprofit public interest law and policy center founded in 1977 that promotes individual rights, is concerned especially about warning letters that a division of the FDA regularly sends to drug companies when it thinks their advertising is false or misleading.
“The FDA has never issued regulations on advertising,” foundation chief counsel Richard A. Samp said. His group contends that the FDA has “invented” much of its power in that area.
The legal foundation told the trade publication Brandweek.com last week that the FDA is acting “outside its legal authority” when it writes these warning letters and shows “disregard for the First Amendment by alleging that materials are misleading with no evidence of how consumers understand them.”
The FDA released no comment regarding the accusations.
The conservative legal group has started a program, DDMAC Watch, that targets the FDA’s Division of Drug Marketing, Advertising and Communications. The division oversees promotional and advertising activities by the pharmaceutical industry.
“The FDA said two years ago it will review all [drug advertising] regulations to make sure they comply with the First Amendment.” The drug industry is still awaiting that update, and the FDA has lost some legal cases on the basis of infringement of free speech, Mr. Samp said.
The legal foundation objected to a DDMAC letter last month asking Eli Lilly & Co. to pull a television ad for a drug for adults with attention deficit disorder.
“The complaint of the DDMAC reviewer was that distracting things were going on the ad, while warnings on possible side effects were being given,” Mr. Samp said, adding that the reviewer felt this could make it difficult for consumers to understand the warnings.
“So the reviewer thought the ad was illegal and the product subject to seizure. Yet no regulations say how much action can go on in a [drug] ad.”
Lilly has said the media buy for that ad has ended, and it does not plan to re-air it.
In a letter sent Thursday to DDMAC Director Thomas Abrams, Mr. Samp criticized that FDA office for finding an advertisement that a Dutch ophthalmic firm placed in a medical journal and at its Web site to be improper and for demanding “corrective” promotional messages. The ad is for a blue dye used in eye surgery.
Mr. Samp told Mr. Abrams that DDMAC’s request for remedy is “unauthorized by statute, unconstitutional and imprudent.” Mr. Samp held that the Federal Food, Drug and Cosmetic Act “conspicuously omits any authority for DDMAC (or any other FDA component) to request or require that a firm disseminate ’corrective’ promotional messages to anyone.”
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