Ex-NEJM chief has tasks for the new FDA

Joshua Sharfstein has his marching orders--from Dr. Marcia Angell, former New England Journal of Medicine editor-in-chief and current Harvard Medical School lecturer. In a Washington Post column, Angell set out a list of seven goals for Sharfstein, who's acting commissioner of the FDA while Margaret Hamburg awaits Senate confirmation as permanent chief, and his future boss.

Now, Angell has a particular point of view; she's published a book called The Truth About the Drug Companies: How They Deceive Us and What to Do About It. But that doesn't mean her recommendations should automatically be pooh-poohed by pharma as, well, anti-pharma. Several of her ideas have been advanced by plenty of not-so-anti-pharma folk. And all of them have been bandied about in recent months by one expert or another. But enough preamble; here they are, for your critique.

  • Congress should repeal the Prescription Drug User Fee Act because it "puts the FDA on the payroll of the industry it regulates." Drug companies shouldn't be considered the FDA's "users," Angell writes. The public is the user, so the public should support the agency.

  • Consultants for drug companies should be banned from advisory committees; there's "no reason to tolerate any conflicts of interest in such key positions."

  • FDA should enforce its mandates on post-marketing studies. Enough said.

  • The agency should review generics as quickly as it checks out branded meds. Right now, FDA takes about twice as long on generics, Angell says.

  • Congress should give FDA the power to require drugmakers to compare their new drugs with similar existing meds. Angell isn't fond of me-too meds, obvously.

  • FDA should stop approving me-too drugs on the basis of surrogate endpoints. The agency should use outcomes as endpoints when same-class drugs are already on the market, she contends.

  • The agency should bar DTC ads for three years after a new drug is approved, to give any unanticipated risks time to become apparent.

So, what do you think? Any additions or subtractions? Any of these recommendations patently unfair or potentially ruinous? Or do you love them all?

- read the Post column

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