• by Wayne Friedman , August 3, 2005

In what is likely to weaken an increasingly anemic TV advertising market, pharmaceutical companies will let the Food and Drug Administration preview their TV commercials as well as submit to other new guidelines restraining so-called direct-to-consumer ads for prescription drugs.

The growth of the DTC advertising business--now estimated to be at $3.8 billion a year--will take a hit, say media buying executives. The new process should take full force by the end of the year, and should be reflected by then in TV commercials. The drug companies' agreement will also mean a specific waiting period for the introduction of DTC ads.

Johnson & Johnson, Merck, Novartis, and 20 other companies have already signed on through the industry's lobbying trade arm, the Pharmaceutical Research and Manufacturers of America (PhRMA). Erectile dysfunction TV commercials received major criticism during the 2004 Super Bowl and at other times, and prompted some of the most recent concerns over so-called direct-to-consumer advertising. Critics say TV ads for such drugs can sometimes oversell benefits and undersell risks.

The deal is meant to slow down the rapid rise of marketing for such Cox-2 painkiller inhibitor drugs such as Vioxx and Celebrex. Vioxx was removed from the market last October after it was found that the drug doubled the risk of heart attacks and strokes. Celebrex remained on the market--but pulled all its advertising.

The deal averted, according to executives, a move by some Congressman to take more drastic action--including that of Senate majority leader Bill Frist in calling for a two-year moratorium on DTC ads for prescription drugs, then an FDA review of TV ads after that. Frist said the ads lead to "inappropriate prescribing."

The Association of National Advertisers in a statement said the new guidelines stop a potential threat of government regulation of DTC ads.