US Congress Urges FDA to Boost Drug Ads Scrutiny

15 December 2006

WASHINGTON DC: US pharmaceuticals watchdogs are taking too long to scrutinize direct-to-consumer advertising and punishing too few companies for false and misleading ads, say lawmakers.

A Congressional report found that between 2002 and 2005, the Food and Drug Administration agency took four months on average to send warning letters and other correspondence to pharma companies violating the rules.

In the period from 1997 through 2001 the FDA took two weeks on average to issue the letters. The number of letters fell off by around 50% half between the two time periods.

The Health and Human Services Department admits the FDA's six reviewers cannot scrutinize everything, so they focus on those ads with the greatest potential to affect public health.

Just last month the FDA and pharmas reached a provisional accord that will see the drug firms pay to obtain fast-track approval of their TV advertising [WARC News: 22-Nov-06].

Although the agreement has to be ratified by Congress, it seems likely it will go hand in hand with a pact whereby pharmas pay more to the FDA to review new medicines. The money will fund drug safety initiatives.

Annual spending on DTC ads is at $4.2 billion (€3.18bn; £2.13bn) and growing. But the industry is under intense pressure to clean up its advertising following high profile safety debacles such as Vioxx.

Many Democrat politicians are pressing for legislation to curb the worst excesses of DTC ads, which the industry has been resisting fiercely through a variety of self-regulation plans.

Data sourced from Wall Street Journal Online; additional content by WARC staff