FDA Under Fire Over DTC Pharma Ad Restrictions

11 August 2006

A rightist US think tank is championing the cause of direct-to-consumer pharmaceuticals advertising, claiming drug companies' freedom of speech is being infringed.

The Washington Legal Foundation has been waging a long-running war against the Food and Drug Administration arguing that it has exceeded its regulatory powers vis á vis dtc drugs advertising.

The WLF believes warning letters sent to pharma firms by the watchdog, concerned at a particular ad's potential to mislead patients, contravene the First Amendment of the US constitution. The lobbyist claims this makes it impossible for marketers to advertise information not approved by the FDA, even though it may be truthful and accurate.

The think tank also argues that the regulator does not offer evidence when it determines an ad to be misleading but still demands "corrective" advertising.

The WLF is calling on the FDA to "review their [sic] respective policies and practices for consistency with their regulatory authorities and with the First Amendment" and to cease the issue of warning letters.

The US is one of a handful of nations worldwide that permits the consumer advertising of prescription drugs - a sector worth an estimated $4.1 billion (€3.22bn; £2.21bn) annually.

Until 1997 pharmaceutical ads were directed mainly at doctors and hospitals, but in that year the FDA issued new guidelines for TV advertising, permitting commercials targeting consumers.

However, serious concern over the perceived excesses of such ads has been growing among patients, medical professionals and politicians, some of whom are pressing for mandatory regulation.

Unsurprisingly, industry lobby group PhRMA has been trying to head off the lawmakers by setting up its own advertising accountability unit deal with complaints from the public.

The FDA has remained zip-lipped on the WLF's latest petition and says it is conducting research on consumer understanding of drug ads before it publishes new dtc guidelines.

Data sourced from Adweek (USA); additional content by WARC staff