Healthy Skepticism Library item: 13863

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Kelly C.
Drug Firms To Adopt AMA Guidelines On Physicians In DTC Ads
FDA Legislative Watch.com 2008 Jun 24
http://www.fdalegislativewatch.com/2008/06/drug-firms-to-a.html

Full text:

Four leading drug companies have pledged to follow American Medical Association guidelines on portraying physicians in direct-to-consumer ads, which may lead to broader adoption of the principles by other firms.

Under the guidelines, an appearance by a real physician must be accompanied by the statement that the physician has been compensated and ads also must disclose when an actor is used to portray a doctor.

Concerns with the portrayal of doctors in DTC ads were heightened recently by Pfizer’s use of artificial heart pioneer Robert Jarvik in TV spots for Lipitor 1(“The Pink Sheet,” March 3, 2008, p. 10).

Pfizer, Merck, Johnson & Johnson and Schering-Plough committed to the guidelines in recent letters to Reps. John Dingell, D-Mich., and Bart Stupak, D-Mich. Writing separately, the Merck/Schering-Plough joint venture also agreed to adhere to the AMA standards.

The letters respond to requests by the two members that the companies commit to six principles that “would reduce misleading and deceptive DTC practices.” The requests followed a May 8 House Energy and Commerce Oversight subcommittee hearing on DTC issues (2“The Pink Sheet,” May 12, 2008, p. 27).

While agreeing to the AMA principles, the companies declined to commit to other actions requested, such as a voluntary two-year moratorium on direct-to-consumer ads for new products. Instead, the companies state they typically wait a minimum of six months before launching DTC ads.

Merck/Schering-Plough drew a distinction for Vytorin (simvastatin and ezetimibe), maintaining “a combination product containing two currently marketed products that are well-known to many physicians may be appropriate to advertise using broadcast DTC sooner.”

The companies declined to refrain from DTC advertising until outcomes research is completed and did not specifically agree to include “black box” warnings in DTC broadcast ads. Instead, the firms noted that all appropriate warnings would be included, based on consultations with FDA.

Pfizer, Merck and Merck/Schering-Plough deferred to pending guidance from FDA on including the agency’s MedWatch number for adverse events in broadcast ads. FDA is conducting a study on whether to make such a requirement.

Schering-Plough said it would include a statement in TV ads directing viewers to print ads for information on reporting adverse events. DTC print ads currently require inclusion of the MedWatch number. J&J said it will add the MedWatch number to its broadcast ads.

All of the companies pointed out they are already barred from advertising off-label uses by law and FDA regulations.

Prodding PhRMA For Changes

Dingell and Stupak also wrote to the Pharmaceutical Research and Manufacturers of America seeking assurances that the six principles would be incorporated into the association’s DTC guidelines, PhRMA is considering updating its two year-old guidelines (3“The Pink Sheet,” March 24, 2008, p. 3).

PhRMA did not commit to specific changes but agreed to consider the members’ concerns as it proceeds with internal discussions. The association also offered to meet with Dingell and Stupak to discuss the issues.

“As a consensus-driven organization comprised of more than 30 member companies, any potential changes to our guiding principles must be carefully considered, so that companies that wish to follow the principles may feasibly implement any new standards that are set,” PhRMA President Billy Tauzin said.

In a June 16 statement, Dingell and Stupak announced plans to pursue changes in DTC practices through discussions with the trade group. “We understand that the companies did not want to place themselves at a competitive disadvantage” but “we hope that PhRMA will be more responsive with an industry position that addresses our significant concerns.”

“Our investigation is not over, as more work clearly needs to be done on this issue,” the members said. Stupak, who chairs the Oversight subcommittee, has expressed interest in holding another hearing, though none has been scheduled as yet.