ADVERTISING DRUGS

Even after being warned that their advertising was inaccurate, some pharmaceutical companies have persisted in using deceptive ads in print or on the air, a study from the General Accounting Office concluded this week. The study also showed the ads were effective in attracting consumers to these products and the government was too slow to react to misleading ads, suggesting an expensive and potentially harmful combination to which regulators should respond aggressively.

Five members of Congress, including Sen. Susan Collins, requested the GAO study, which showed the industry’s promotional budget was 19.1 billion in 2001, and was growing considerably faster than its research budget, which was $30 billion that year. Most of the promotional money – more than $15 billion – was aimed at physicians, so although the study was focused on direct-to-consumer advertising, further work on how this money influences choices by doctors and the health implications of those choices also is needed.

For this study, the advertising prompted 8.5 million Americans to ask for and receive a specific drug, according to the study, a conclusion that must make advertising agencies feel good about their work. Direct-to-consumer advertising also likely increases utilization – best-selling pharmaceuticals are among the most heavily advertised, the study found, with 22 of the 50 drugs with the highest spending among the top 50 in sales. But the study also explained that when the Food and Drug administration found the ads inaccurate, misleading or incomplete in violation of federal law, the time it took to notify the errant drug company often exceeded the life of the ad. This problem has worsened, apparently, since the Bush administration increased the amount of time required to issue a notice of violation. Specific ads are in magazines or on television for a month or two and then gone before the FDA has had approval to act.

And even when the FDA does act, the problem isn’t always corrected. Although in almost all cases, FDA letters cause the companies to comply with federal laws, subsequent ads can be just as misleading. During the last five years, the study said, the FDA “has issued repeated regulatory letters to several pharmaceutical, including 14 to GlaxoSmithKline, 6 to Schering Corporation and 5 to Merck & Co.,” and some companies have received multiple letters for new advertising of the same drug. For enforcement, the FDA could in theory initiate court action to seize a drug that has been falsely advertised, but it never has.

Instead, it relies on the potential for public embarrassment through warning letters. That is an excellent reason for the Bush administration to reverse its course on taking longer to review the regulatory letters and emphasize speed. Just knowing that a government warning could arrive at the beginning of an ad campaign will make the manufacturers more careful about their claims.