New FDA Chief Vows Tougher Action on Deceptive Drug Ads

The new commissioner of the often-maligned Food and Drug Administration, declaring his agency independent of both drug manufacturers and consumer advocates, pledged Wednesday to take tougher and quicker action against misleading drug ads and dietary supplement labels.

“We do have authority and we intend to use it,” said Dr. Mark B. McClellan, a Texas-born physician and economist named by President Bush to fill the almost 2-year-old vacancy at the helm of the FDA. “We will not be afraid to go to court when necessary.”

In his first extended conversation with reporters since taking over the FDA last month, McClellan said he also would work to streamline the “science-driven” agency’s drug-approval process, shortening the time and reducing the cost of getting new drugs to market. With a budget of $2.7 billion for regulating food safety, drug safety and efficacy and -- most recently -- licensing vaccines and antidotes to bioterrorism agents such as smallpox and anthrax, the FDA has regulatory authority over products comprising nearly a quarter of the nation’s economy.

And with technical advances in almost every area, including genetically engineered foods and new medical treatments, the complexity of the agency’s tasks is only increasing, McClellan said.

Among the areas where the FDA’s work touches consumers most directly are labeling of food and dietary supplements and testing, approval and advertising of drugs.

The question of cracking down on misleading advertising responds directly to a government report issued last week and goes to the heart of what McClellan described as the FDA’s key mission: promoting and protecting public health.

The report by the General Accounting Office, the investigative arm of Congress, concluded that the agency’s process for taking action against companies that aired or printed misleading advertisements about their drugs was so slow as to be ineffective.

In many cases, the report found, a company’s ad campaign ran its course during the time the general counsel’s office of the FDA reviewed letters warning companies to stop running the deceptive ads -- a process lengthened under the Bush administration.

Drug companies spent $2.7 billion last year on so-called direct-to-consumer ads, which are aired on television and printed in newspapers and magazines. That is triple the amount spent on such ads in 1997, when the FDA loosened its rules.

Studies have linked the ads to a huge increase in the number of patients who ask their doctors for a specific drug by name.

As an example, the anti-cholesterol drug Lipitor, manufactured by Pfizer, was the nation’s second-best selling drug in 2000, ringing up more than $41 billion in sales. Yet the FDA has cited Pfizer four times over the past four years for suggesting, misleadingly, that Lipitor could also reduce the risk of heart disease.

McClellan defended the drug ads aimed directly at consumers, saying they lead to increased visits for such under-treated diseases as depression, high blood pressure and diabetes.

But “we are not backing off on our policy of enforcing the law” against deceptive advertising, he said. “If we see patterns of misleading advertising we are going to take more action.”

He said he hoped to improve the process of drug safety.

By conducting early tests to see if drug formulas contain “markers” -- chemical properties known to cause dangerous side effects, such as liver damage -- McClellan said the agency could speed up later testing phases and make them less costly.

He said he also wants to improve the FDA’s collection of information about dangerous side effects so that drugs causing such damage can be withdrawn from the market more quickly.

McClellan cited America’s ballooning obesity problem and said he also wants to help Americans make better health-care choices.