Representative Henry Waxman (D-CA), America’s very own Oversighter-in-Chief, wants to require drug companies to submit reprints of journal articles that discuss off-label use to the FDA before said companies can provide them to physicians.
A modest proposal.
You know what would be even better – what about this – all medical journals have to submit their manuscripts to Mr. Waxman's officebefore they’re even published in the first place. After all, shouldn’t we address the problem in its most nascent stage?
(Yes, of course, after peer review.)
Better yet, maybe congressionally-appointed health care commissars should sit in on the peer review process of every medical publication? Why not? And, while we're at it, these new comrade commissars should also attend all pre-NDA agency meetings that discuss clinical trial designs. Needless to say, a statutory voting seat (with veto authority!) on all advisory committies should be de rigueur.
Better still, perhaps PDUFA fees should cover the hiring of FDA political commissars who would have veto power over agency decisions?
These ideas are perfectly consistent with so many other congressional efforts at improving our health care system – just like “academic detailers” – health care commissars of another sort.
Welcome to the Comrade Commissars of Government Heath Care.
And caveat emptor.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.