FDA Delays New US Drug Ad Code

24 December 2003

America's Food and Drug Administration will now wait until January to issue its new code for direct-to-consumer drug advertising.

The FDA had intended to release its revised guidelines this month, but has decided to delay publication into the new year. It has been investigating the DTC pharma sector for several months, and in September held a two-day public hearing on the subject [WAMN: 24-Sep-03].

Among the expected revisions are new regulations for DTC print ads. Under the current code, these must list all the side effects of the advertised drug, effectively doubling the amount of space pharmaceutical companies must buy to place an ad.

Naturally, big pharma is opposed to this requirement -- and so, it appears, is the Federal Trade Commission, which recently wrote to the FDA arguing that DTC print ads should be forced to include only a "brief summary" of the risks [WAMN: 03-Dec-03]. Publishers, on the other hand, are eager to continue the current practice, though the FTC argues they are losing out as drug advertisers shun print outlets in favour of broadcasters.

The level of disclosure required for internet ads is also likely to be changed in the new year, but other revisions remain unclear. The FDA is under pressure from consumer groups to tighten the code, while pharmaceutical companies want fewer restrictions.

Critics of DTC advertising claim it fails to give an accurate portrayal of the risks associated with prescription medicine. They also argue that consumers are not sufficiently well-informed to understand the content. Supporters, however, insist the ads educate the public and aid patients' relationships with doctors.

There is big money at stake. Around $2.4 billion (€1.9bn; £1.4bn) per annum is now spent on DTC advertising, just six years after the rules governing the sector were first relaxed.

One thing that seems certain is that calls for an outright ban on DTC ads will fall on deaf ears. That proposal was dismissed in September by Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, who observed: "The genie is already out of the bottle."

Data sourced from: AdAge.com; additional content by WARC staff