Biotech Values

[ghmm]

OT: General Drug Safety/Review Info from NEJM

Basically more criticisms of Vioxx and why the government is so bureaucratic. OK I'll admit put me in the camp that supports easier approval and early access. I do support the enforcement of post-marketing studies (UTHR did theirs so others should too :) ) and am not all that much against making drug companies pay more fees (if it speeds up the process), maybe it will even cut down on some of the very marginal submissions? Don't know about the proposal cosponsored by the honorable Senator from Massachusetts as I am generally leery of him :)

Paying for Drug Approvals — Who's Using Whom?
Jerry Avorn, M.D.
http://content.nejm.org/cgi/content/full/NEJMp078041

Drug Safety Reform at the FDA — Pendulum Swing or Systematic Improvement?
Mark McClellan, M.D., Ph.D.
http://content.nejm.org/cgi/content/full/NEJMp078057

PDUFA Reauthorization — Drug Safety's Golden Moment of Opportunity?
Sean Hennessy, Pharm.D., Ph.D., and Brian L. Strom, M.D., M.P.H.
http://content.nejm.org/cgi/content/full/NEJMp078048