For immediate release: December 10, 2008
Contact: Jodi Seth or Brin Frazier, 202-225-5735
Dingell, Stupak React to PhRMA's DTC Policy Revisions
Lawmakers commend progress, call for further action to protect consumers
Washington, D.C. - 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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