The New York Times today has an article on approval of medical devices. The take is that venture capitalists want a more efficient process. The tradeoff mentioned is between faster approval for investor returns versus safety of devices if they are approved faster. There is no mention in the article of the benefits to patients and consumers of more rapid availability of medical devices. The entire literature following the Peltzman analysis delays in drug approval is totally ignored.
FDA Medical Device Approval
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November 7, 2011
[…] FDA defends itself against rising criticism on drug and device approval [NYT] NYT aproaches the issue with a curious slant [Paul Rubin] […]
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Well, it is a Business Day article, not one in Science/Health. The focus is on the tussle between the VCs and the “patient advocates and some doctors, who have been calling on the F.D.A. to intensify its oversight of devices, particularly in light of some all-metal artificial hips that are failing prematurely at an unusually high rate.” Where patients and consumers have spoken out in this process, they were mentioned: “Since February, four House panels have held hearings on the impact of F.D.A. procedures on device approval. At those sessions, 19 of the 26 listed witnesses were investors, entrepreneurs, industry consultants, trade group officials or patients who said that agency delays in approving a device had harmed them or a loved one.“
What about the patients who have been harmed. Didn’t they have something to add?
See http://meshmedicaldevicenewsdesk.com to read some of their stories.