1. Archive

Hard to swallow

When it comes to determining the safety or accuracy of prescription drug advertising, American consumers are increasingly on their own. While the Food and Drug Administration is supposed to regulate the claims made by drug manufacturers, the agency has backed away from that responsibility.

Although complaints about drug promotions have remained constant, the FDA files only a small fraction of the warning letters it sent out a couple of years ago, according to the New York Times. And when the FDA has taken action against a drug manufacturer, it has been in no hurry. For example, a letter telling the maker of Prevacid to stop a misleading ad campaign was reviewed for 78 days by the FDA's chief counsel before being sent. By then, millions of TV viewers had seen the ad.

Federal law prohibits pharmaceutical companies from promoting uses of their drugs that have not been substantiated by extensive medical testing. That standard has been eroded, however, by industry lawsuits and tactics. Another factor could be Daniel Troy, the FDA's current chief counsel, who as a private lawyer sued the agency to weaken its oversight. Troy wouldn't talk to the New York Times for its report.

Drugmakers and food producers lobby for broad First Amendment protection in marketing their products. Last year, under such pressure, the FDA changed its guidelines for allowing food producers to claim health benefits for their products. The agency weakened the standard of proof from "significant scientific evidence" of the benefits to a mere balance of conflicting evidence.

Critics say the FDA's new laxity has emboldened drugmakers, who are attempting to increase sales by expanding the number of medical conditions that can be treated by their products. That appears to be what Cephalon was doing with its drug Provigil, which is approved for treatment of sleepiness caused by narcolepsy. The company sent recorded reports to news outlets that promoted Provigil for childhood attention deficit disorder and adult depression.

Cephalon said it wasn't promoting the new uses, which would be improper without FDA approval, but was merely informing the public of new information. It just so happens that 75 percent of Provigil's sales are for unapproved uses.

FDA Commissioner Mark McClellan told the New York Times the agency is not ignoring "important public health problems." But Dr. Michael Wilkes of the University of California at Davis medical school had a different take. "The current administration is not going to step in unless there are gross violations," he said. "The word has gotten out."

The danger, then, is not only that American consumers will be harmed by improper prescription drug use, but also that the regulatory process will lose its credibility.