Prognosis Negative
No one who seriously examines the FDA reform proposal of the Pharmaceutical Research and Manufacturers of America could characterize it as easy on the FDA ("Prescription Remedies," by Rick Henderson, August/September). PhRMA advocates:
· Requiring the FDA to expedite the review of new drugs that have been approved in the United Kingdom, whose drug-approval agency has standards similar to ours.
· Eliminating much of the red tape FDA now requires by permitting companies to submit certified summaries of clinical tests rather than truckloads of paper.
· Requiring the agency to use outside experts for review of new drug applications.
· Allowing freer dissemination of information about the legitimate uses of medicines.
As to permitting FDA to "maintain its monopoly" over approvals,
in our opinion, only the federal government should make final
approval of new drugs. That does not mean, however, that we do not
want fundamental reform. We believe our proposals would achieve
that.
Gerald J. Mossinghoff
President
Pharmaceutical Research and Manufacturers of America
Washington, DC
Reading "Prescription Remedies," I noted one error and one suspect theory. Someone has drafted comprehensive FDA reform legislation: Rep. Ron Wyden (D-Ore.). His bill (HR 1742) was hailed by a number of industry groups as a significant step forward in the debate.
With regard to rumors about Wyden's alleged senatorial motive for introducing FDA reform legislation, sounds like a goofy theory to me. "Help drug companies get their products to market quicker and cheaper" is hardly the advice a competent Democratic political consultant would give a prospective Senate candidatein Oregon, anyway. Wyden's doing it because he knows a heck of a lot about FDA, it's the right thing to do, and the timing doesn't get any better than this.
Absent those items, an excellent piece. I'll distribute it as a
primer on FDA reform.
Josh Kardon
Chief of Staff
Office of Rep. Ron Wyden
Washington, DC
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