FDA Unveils Proposals to Liberalize US Drug Ads

06 February 2004

US regulators plan to cut back the small print in press ads for prescription medicines under a series of new proposals.

After a lengthy inquiry into the rapidly growing direct-to-consumer drug advertising sector, the Food and Drug Administration this week unveiled three draft guidelines.

The first of these would reduce the amount of information pharmaceutical companies have to include in print ads, while encouraging the use of language the public can understand.

At present, DTC drug ads have to list all the side effects of the advertised drug, effectively doubling the amount of space pharmaceutical companies must buy to place an ad. However, FDA research in 2002 suggested that 73% of consumers ignore or look only briefly at these details.

The regulator believes that "technical, scientific terms or jargon" should be left out of ads. It is also proposing that only the three to five most common non-serious side-effects be listed, with details such as dosage information excluded. However, all the major precautions would still have to appear.

"Less is more for consumers, because they can actually get more out of this information," declared FDA commissioner Mark McClellan.

The watchdog's second proposal is for pharmaceutical firms to pay for ads that educate the public about illnesses and conditions without touting a particular drug. And its third draft guideline concerns the promotion of medical gadgets such as hearing aids.

The FDA will finalise its guidelines once it has received public comment on the proposals.

The regulator has been investigating the DTC pharma advertising market for several months, and in September held a two-day public hearing on the subject [WAMN: 24-Sep-03]. This is now a major sector, and was worth $2.64 billion (€2.10bn; £1.44bn) in adspend in 2002.

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.

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