The Associated Press
December 11, 2002
FDA Says It Will Stop Misleading Drug
By LAURAN NEERGAARD (AP Medical Writer)
The Associated Press
WASHINGTON (AP) - The new chief of the powerful Food and Drug Administration promised faster action Wednesday to stop drug advertisements that mislead patients into thinking a medication is better or safer than it really is.
Expect more aggressive action against makers of dietary supplements that make unproven health claims, too, said FDA Commissioner Mark McClellan.
But McClellan will have to make a big change, said a consumer advocate who tallied FDA's attempts to stop untruthful drug ads - and found warning letters to the offending manufacturers have dropped by almost two-thirds in the last year alone.
"The bottom line is they're not doing enforcement," said Dr. Sidney Wolfe of the advocacy group Public Citizen. Misleading advertising "can make the difference between someone getting the right drug and the wrong drug. ... It's a health and safety issue."
The FDA is responsible for ensuring that the $2.7 billion worth of drug ads aimed at patients each year are fair and accurate. But critics argue that ads too often make the 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 this year that required FDA's chief counsel to review every warning letter before it's mailed to drug companies.
So far this year, the FDA has issued only 27 letters ordering drug companies to stop a misleading ad, down from 73 such warnings last year and a high of 157 in 1998, Wolfe said.
This year's policy change "had a chilling effect" on an already weakening regulatatory process, Wolfe said. "If you're one of these companies, you can't help but notice."
McClellan, a physician-economist and longtime adviser to President Bush on health policy, said drug ads in general can be helpful if they make people aware of treatments for an ailment they've been suffering in silence.
The warning letter review was an attempt to strengthen FDA's legal hand, and while it initially caused delays, the chief counsel hasn't blocked any attempt to stop a misleading ad, 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."
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.
For repeat offenders, "issuing warning letters is not enough," McClellan stressed. "We will not be afraid to go further in cases of recurrent patterns of abuse."
But he wouldn't detail what additional steps FDA might take. Wolfe called the options unclear, saying FDA can't even fine companies over ads.
Misleading ads are "exceptions to the rule" that FDA should target, said Jeff Trewhitt of the industry's Pharmaceutical Research and Manufacturers Association.
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.