Waxman Says FDA Plans to Ease Restrictions on Off-Label Marketing

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Waxman Says FDA Plans to Ease Restrictions on Off-Label Marketing

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By Peggy Peck , Executive Editor, MedPage Today

 

WASHINGTON, Nov. 30 -- The FDA is considering a policy change that

would allow pharmaceutical companies to give physicians journal articles that

detail off-label uses of drugs, according to Rep. Henry Waxman (D-Calif).

 

If approved, the FDA proposal " would allow drug and device companies to

short-circuit FDA review and approval by sponsoring drug trials that are

carefully constructed to deliver positive results and then using the results to

influence prescribing patterns, " he said. Waxman has posted a copy of an

FDA draft document that web site, along with his letter to FDA Commissioner

Andrew C. von Eschenbach, M.D., protesting the proposed change. Moreover,

Waxman said, the House Committee on Oversight and Government Reform, which he

chairs, will " be examining the draft guidance and the process that led to [its]

development. " He asked Dr. von Eschenbach to delay implementing the draft

guidance until the committee completes its inquiry. Waxman also asked Dr.

von Eschenbach to provide a detailed chronology of the development of the

document as well as " all documents relating to communications between the FDA

and other executive branch offices and

nongovernmental sources concerning the new draft guidance. " Further, the

congressman wants detailed information about enforcement of the FDA's current

policy on promotion of off-label uses and the plans for oversight and

enforcement of the new policy. Waxman said he was aware that there have

been First Amendment challenges to the FDA's authority to consider dissemination

of reprints about off-label use as marketing, but he said that the FDA's

authority has withstood those tests. Thus, there is no pressing need to change

the policy, he said. " While there may need to be a balance between First

Amendment and protection of public health, the answer is not to open the door to

unrestricted dissemination of potentially questionable information about drug

safety and effectiveness, " Waxman wrote. The draft document is called a

" Guidance for Industry " that deals with " Good Reprint Practices. " It addresses

marketing practices that are prohibited by the

Federal Food, Drug, and Cosmetic Act, namely the off-label marketing of drugs

and devices. In his letter, Waxman said the draft guidance " would carve a

large loophole in the law and create a pathway by which drug and device

manufacturers can promote unapproved uses of their products without first

obtaining FDA approval. " Moreover, Waxman charged, " allowing marketing

through journal articles can reduce the incentive for drug and device companies

to conduct rigorous studies needed to win full FDA review and approval. "

The FDA's proposal does state that distribution of reprints should be limited to

articles from peer-reviewed journals, but Waxman said that puts too much

reliance on the journals to provide balance. " Regrettably, recent

experience shows that is not always the case, " he wrote, citing examples of

journal articles about rofecoxib (Vioxx), celecoxib (Celebrex), antidepressants,

and anti-arrhythmics.

 

 

 

 

 

Related Article(s):

State Oversight of Industry Gifts to Physicians All Bark

 

Lilly Denies Promoting Zyprexa for Off-Label Uses

 

http://www.medpagetoday.com/PublicHealthPolicy/HealthPolicy/dh/7543

 

 

 

 

 

 

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