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April 20, 2008

New England Journal –Says no to Journal Article Distribution

In preparation for the FDA call for comments (due April 21st) on Journal Article distribution the New England Journal of Medicine published the following article Pharmaceutical Promotion to Physicians and First Amendment Rights by Aaron S. Kesselheim, M.D., J.D., and Jerry Avorn, M.D (that’s right last month Avorn was the key promoter on capitol hill on academic detailing, this week he is an expert on constitutional law, he is such a diverse guy).  The writing team of Avorn and Kesselheim in 2006 recommended government takeover of patents by eminent domain. (Biomedical patents and the public's health: is there a role for eminent domain?  JAMA. 2006 Jan 25;295(4):434-7).

FDA Draft Guidance for Industry: Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices (See FDA Press Release and Draft Guidance)

There are some very heavy weight constitutional lawyers working on a rebuttal it will be interesting to see if they too get a sounding board on NEJM.  Do you thing NEJM will stop selling reprints -- we may want to ask their advertising department.

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