FDA seeks stricter rules for TV ads

Acting commissioner says government 'fed up' with noncompliant commercials

The federal government is poised to step up its regulation of television advertisements for drugs, the acting commissioner of the Food and Drug Administration said Wednesday.

Lester Crawford, in Lawrence for a public health summit at Kansas University’s Adams Alumni Center, said his agency would be doing more to police ads that don’t comply with the FDA’s broadcast regulations.

“We are fed up with it,” Crawford said. “I think the thing that was the tipping point were the erectile dysfunction drugs and other sexual health drugs. That’s not a funny issue. It’s not a flippant issue.”

The FDA already ordered drugmaker Pfizer to pull ads for Viagra, an erectile dysfunction drug, in November because it failed to disclose negative side effects of the medication.

That ad posed the questions, “Remember that guy who used to be called ‘Wild Thing?'” and “The guy who wanted to spend the entire honeymoon indoors?” before blue horns sprouted from a man’s forehead.

The FDA has sent “a large number” of warning letters about commercials that don’t fit the agency’s requirements, Crawford said. Such requirements call for a disclosure of “major risks” associated with a drug, a balance of information on effectiveness and risks and a lack of information that could be deemed false or misleading.

“It can play a very useful role if done right,” Crawford said, of direct-to-consumer advertising. “The public does have a right to know, and it would be very hard for the public to depend entirely on the physicians to tell them by word of mouth.”

Pharmaceutical Research and Manufacturers of America, a trade group, is working on a set of self-regulatory measures on TV pharmaceutical advertisements.

Crawford is hoping that the group’s efforts will take care of the problem. If not, he said, stricter laws may be necessary.

Several of the 60 people attending the conference – which was organized by state Rep. Tom Sloan, R-Lawrence, – said they would support scaling back TV ads.

Dan Flynn, co-founder of Deciphera Pharmaceuticals in Lawrence, said he thought the advertising could open the door to more problems with drug safety, with physicians feeling more pressure to prescribe the drugs seen on TV.

“I think this notion of a well informed public is more of a myth than a reality,” Flynn said. “I think this direct-to-consumer advertising is silly, and it’s enflaming the problem.”

But Russ Middaugh, a KU professor of pharmaceutical chemistry, warned of eliminating drug advertising altogether.

“The other side of this is the way it used to be,” he said. “We can all remember when the patient was ignorant, and the ignorance led to an equal number of problems in the pharmaceutical industry. Moving back to where the physician has too much control has its own problems.”