- The Washington Times - Friday, August 17, 2007

Drug companies are advertising more and being called to account less.

A study released this week found that pharmaceutical industry’s direct-to-consumer advertising increased more than 300 percent in the past 10 years, while regulatory scrutiny of the ads’ claims has declined. The study is yet another impetus for Congress to pass legislation tightening control over the ads.

The study in the New England Journal of Medicine found that total spending on advertising by the pharmaceutical industry increased by an average of 10.6 percent annually since 1996. While direct-to-consumer television, radio and print ads increased substantially, the policing of the content of the ads has not, according to the study.

Direct-to-consumer advertising has been a hot-button issue in Congress. Critics of the practice, concerned about safety and that the prescribing of some drugs can drive up costs on the health care system, appear to have made some progress in putting in place additional controls for the Food and Drug Administration to more closely monitor the ads.

In a bill that is moving through Congress this year, drug companies would pay user fees for the FDA to review their ads ahead of airing them — if the agency doesn’t like the ad, it is unlikely to air. A more heavy-handed approach that attempted to put in place new authority for the FDA to place a moratorium on the ads if they felt the ad was misleading failed.

Researchers found that the FDA has sent fewer letters to drug companies warning them their commercials are minimizing risks or exaggerating the effectiveness of the drugs. This is a concern because these mass-media advertising blitzes generally start before a drug’s safety record has been established in the marketplace.

“In 2004, four [FDA] staffers were reviewing such advertisements, even though spending on this form of advertising (and probably the volume of ads to review) had increased by 45 percent, from $2.9 billion to $4.2 billion,” researchers said in the study.

The heartburn drug Nexium, otherwise known as “the little purple pill,” was the top drug in direct-to-consumer advertising in 2005, with spending totaling $224 million, according to the study. Others in the top five were the sleep aid Lunesta, the cholesterol-lowering drugs Vytorin and Crestor, the asthma medication Advair and the allergy drug Nasonex.

The result of fewer staffers reviewing direct-to-consumer ads was a total of 21 warning letters sent out last year. Compare that with 142 such letters in 1997, the study found. In addition, 64 percent of the ads broadcast on television in 1999 were reviewed by the FDA, but in 2004, that percentage declined to 32 percent.

The fear of harmful drugs being sold to consumers is highlighted by Merck’s Vioxx. In 2004, the arthritis drug was one of the most heavily promoted medications ever to go on the market, subsequently it had to be withdrawn because of serious cardiovascular risks.

Health Care runs on Fridays. Contact Gregory Lopes at 202/636-4892 or glopes@washingtontimes.com.