Op-Ed Offers Directives for New FDA Leadership

By Rachel Walden — April 6, 2009

Today’s Boston Globe has a great op-ed piece from Marcia Angell on the direction FDA Commissioner nominees Margaret Hamburg and Joshua Sharfstein should take the FDA under their leadership.

Angell offers the following directives:

  • “Congress should repeal the Prescription Drug User Fee Act
  • Consultants for drug companies should no longer be permitted to serve on FDA advisory panels
  • The agency should see that the post-marketing studies it mandates are actually carried out
  • The FDA should review generic drugs as fast as brand-name drugs
  • Congress should give the FDA the authority to require drug companies to compare new drugs with existing drugs of the same type
  • The FDA should stop approving me-too drugs on the basis of surrogate endpoints
  • The FDA should prohibit direct-to-consumer advertising for three years after drugs are approved”

All of these are important issues, and you should read the whole piece for Angell’s rationale. For example, she notes that the Prescription Drug User Fee Act:

“…authorizes drug companies to pay ‘user fees’ to the FDA for every drug the agency considers for approval. That puts the FDA on the payroll of the industry it regulates, and makes it more likely that drugs will be reviewed favorably – a bargain for drug companies. Drug companies should not be considered ‘users’ of the FDA; the public is the user, and it alone should support the agency.”

I would add to the list ensuring that decisions about drug approvals be made based on sound science free of political ideologies – see Christine’s recent post on the FDA’s approach to Plan B emergency contraception access for an example of why attention to this issue is needed.

Relatedly, Angell, a Senior Lecturer on Social Medicine at Harvard Medical School and former editor of The New England Journal of Medicine, is the author of a book I’m going to have to add to my to-read list: The Truth About the Drug Companies: How They Deceive Us and What to Do About It.

An in-depth article on the same topic, published in The New York Review of Books in January, provides more on Angell’s perspective: see “Drug Companies & Doctors: A Story of Corruption.”

And finally, The Boston Globe looks at what the FDA could do to improve the information consumers are given about prescription drugs. The article quotes OBOS’s own Judy Norsigian.

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