FDA's Approval Processes Scrutinized in JAMA — Physician’s First Watch

Medical News |
January 22, 2014

FDA's Approval Processes Scrutinized in JAMA

By Joe Elia

Three JAMA studies of the FDA's approval processes may stir conversation. Examined are the agency's criteria for drug approval, the strength of evidence supporting its decisions, and the vagaries of cardiac device approval.

In exploring the FDA's decision criteria, a group of FDA-based authors examined the reasons for delay or nonapproval of half the new molecular entities proposed between 2000 and 2012. Most often, it was efficacy — and not safety — that was at issue.

Strength of evidence "varied widely," another set of authors found. They observe that roughly one third of approved indications were based on a single pivotal trial. Pivotal trials enrolled a median of 760 patients per indication.

The third study's authors examined device approval through the lens of implantable cardiac devices. They found that the more rigorous approach — that is, through premarketing approval — was used far less often than the approval of "supplements" to existing devices (77 vs. 5829 applications).

Reader Comments (1)

Philip Bond Other, Psychiatry, Government run facility.

A marketing phenomena used within the software sector is to place the product into the market allowing the user to bug fix. Methinks a cost benefit analysis is completed by the pharmaceutical companies to determine the cheapest way to market. Sometimes its less expensive to pay compensation than test.

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