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Healthy Skepticism Library item: 14800

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

Dingell, Stupak React to PhRMA's DTC Policy Revisions
Pharma Live 2008 Dec 10


Lawmakers commend progress, call for further action to protect consumers

Full text:

Reps. John D. Dingell (D-MI), Chairman of the Committee on Energy and Commerce, and Bart Stupak (D-MI), Chairman of the Subcommittee on Oversight and Investigations, today commended the Pharmaceutical Research and Manufacturers of America (PhRMA) for revising their voluntary guidelines on Direct-to-Consumer (DTC) advertising.

PhRMA’s revised DTC guidelines directly address some of the concerns expressed in a letter from Dingell and Stupak dated May 20, 2008. Notably, the new PhRMA code restricts the use of physicians and actors in DTC ads, prohibits DTC ads that market off-label uses of prescription drugs, and supports the inclusion of “black-box” warnings in DTC ads.

However, the new code does not endorse a 2-year prohibition on DTC ads for newly approved drugs, as recommended by the Institute of Medicine, nor does the code propose the completion of valid clinical outcomes studies on a drug prior to its being advertised to the general public or the inclusion of the FDA’s toll-free MedWatch number in all DTC television ads.

“I commend PhRMA on taking our investigation seriously,” said Dingell. “Although this revision is the first step toward protecting American consumers, there is much more that can be done. We look forward to working with PhRMA to add further consumer protections into their policies.”

“On one hand, PhRMA has taken our Committee’s concerns seriously by revising parts of their DTC code; on the other hand, some of these changes are merely a rewording of prior policy that does nothing to increase consumer protection,” said Stupak. “Our investigation will continue, and we will be keeping a watchful eye on how well the industry follows these guidelines.”

The Committee on Energy and Commerce began investigating misleading and deceptive DTC advertising in January 2008. On May 8, 2008, the Oversight and Investigations Subcommittee held a hearing on DTC advertising, which focused specifically on three broadcast DTC ads: Pfizer’s ads for Lipitor featuring Dr. Robert Jarvik, Merck/Schering-Plough’s “Food & Family” ads for Vytorin, and Johnson & Johnson’s ads for Procrit. During the hearing, representatives from these companies failed to provide any assurances regarding future business practices, citing a lack of authority. However, the witnesses invoked the PhRMA guidelines on DTC advertising for their policy. Both the Jarvik Lipitor ads and the Vytorin “Food and Family” ads were voluntarily withdrawn shortly after the investigation began. PhRMA’s revisions to their DTC policy are yet another result of the Committee’s investigation.


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