FDA Releases DTC Guidances; "Not The Last Word" On Ads, Commissioner McClellan Says

The agency pledges further review of its guidance on direct-to-consumer advertising. Broadcast ads for drugs and enforcement actions against repeat offenders could see more attention.

FDA Commissioner McClellan is pledging to continue to review the agency's policies on direct-to-consumer advertisements following the release of three draft guidances Feb. 4.

"We are going to keep looking at the science and the evidence on ways to help get accurate information to consumers in all types of ads, including broadcast ads," McClellan said Feb. 4 in a conference call announcing the draft guidances.

"So this is certainly not the last word from FDA on this important topic," McClellan added.

The three DTC draft guidances are: "Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertising"; "'Help-Seeking' and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms"; and "Consumer-Directed Broadcast Advertising of Restricted Devices."

During the teleconference, McClellan was asked why FDA did not update its broadcast advertising guidance for drugs in issuing the new draft guidances.

"We've got limited resources at the FDA and we need to use them as effectively as possible based on what the science has to say about how we can improve the public health," McClellan said.

"We felt that the top priorities based on the discussion" at a September public meeting on DTC issues were "first, getting more utility out of the brief summary," he said.

"We also heard a lot about the potential value of help-seeking ads, and we want to provide a clear path for those ads, too."

"And we also heard concerns about broadcast ads for devices where no guidance was in place. Those are our top priorities. We will obviously keep working to make sure that broadcast ads for prescription drugs convey accurate information, as well."

Updating broadcast ad guidance is a lower priority, for now, because such ads generally convey risk information more effectively than print ads, CDER Office of Medical Policy Deputy Director Rachel Behrman, MD, maintained.

"In a broadcast ad, it's much easier to follow the less is more philosophy. They're very short and in general, the ads do a better job emphasizing just those key important points in a way that's very understandable and in a way that the information can be easily retained. We felt there was a significantly bigger problem in print," Behrman said.

Print ads were the focus of the "vast majority" of FDA's DTC enforcement actions in 2003, Behrman added.

McClellan was questioned about the agency's enforcement activities during his tenure, specifically about concerns raised by Rep. Henry Waxman (D-Calif.) in a Jan. 29 letter to FDA.

Waxman's letter cited a decrease in the overall number of enforcement actions, delays in actions taken and the need for stricter action against repeat offenders.

Regarding repeat offenders, "we're certainly considering further actions along those lines," McClellan said.

"But in terms of enforcement, we have stepped up our across-the-board enforcement activities on many types of promotion and other steps that companies take to inappropriately encourage use of their products in many ways."

Warning and "untitled" letters "are by no means the only enforcement tool that we have. We have guidances, we have other kinds of informal interactions with companies to try to get them to do the right thing in the first place, and we have other enforcement actions that we can take as well," McClellan said.

- Steele Thomas