New FDA Chief Wants Drug Ad CrackdownDec 11, 2002 | AP
The Food and Drug Administration will act faster to stop misleading drug advertisements and target companies that repeatedly overpromise their medications to patients, the agency's new commissioner pledged Wednesday.
Expect "more aggressive action" against makers of dietary supplements that make untruthful or misleading claims for their products, too, said FDA Commissioner Mark McClellan.
Drug advertising aimed at patients instead of doctors has tripled to $2.7 billion worth a year since the FDA loosened its drug-promotion rules in 1997.
The FDA is responsible for ensuring those ads are fair and accurate. But critics argue the ads too often make pills seem a panacea while downplaying side effects. Just last week, congressional investigators said misleading ads often are off the air by the time FDA gets around to chastising their makers.
One reason: A Bush administration policy change requiring FDA's chief counsel to review every warning letter before it's mailed to drug companies.
Another problem is repeat offenders. Last week's congressional report cited as an example Pfizer's cholesterol-lowering drug Lipitor. Four times over the last four years, the FDA cited Lipitor ads for giving the wrong impression that it can reduce heart disease and falsely claiming it's safer than competing drugs.
The warning letter review was a well-intentioned effort to strengthen FDA's legal hand, and while it initially caused delays, no agency attempt to stop a misleading ad has been rejected, McClellan said Wednesday during his first meeting with reporters since becoming commissioner last month.
"Let me be clear," he said. "We are not backing off on our policy of enforcing the law here. ... We will not be afraid to go to court if necessary."
McClellan, a physician-economist and longtime adviser to President Bush on health policy, noted that drug ads in general can be helpful, if they make people aware there are treatments for an ailment they've been suffering in silence.
But he noted that some misleading ads air for just a few weeks at a time. For repeat offenders, "issuing warning letters is not enough," he stressed, although he wouldn't detail what additional steps FDA might take.
The pharmaceutical industry didn't immediately return a call seeking comment.
Truthful advertising is one piece of what McClellan called a top priority for his tenure at FDA: getting more information to consumers to help them understand the health consequences, good or bad, of the products they choose.
Aside from drug ads, makers of dietary supplements which sell with little federal oversight to ensure they're safe or work frequently make scientifically unproven claims about their products' benefits.
"We should take more aggressive action" to stop that, McClellan said. "You can expect to see more from FDA on this issue."
His other priorities: Improving patient safety, and anti-terrorism work that includes strengthening the security of the food supply and working to bring antidotes for biological, chemical or radiation attacks to market.