FDA pledges faster generics review

Could the steady trickle [1] of generics approvals out of the FDA suddenly become a rapid stream? Not without a major overhaul, considering the current approval time of 16 to 17 months, which is more than twice the mandated six-month lag. But today, the agency is touting a less-than-major initiative to speed up approvals called--in true bureaucratic acronyms-R-us fashion--GIVE (Generic Initiative for Value and Efficiency).

The FDA says it will hire more staff to review generic apps, use computers to streamline the process, and "when possible," divert resources from other departments to the effort--worthy moves that might help. It's also going to expedite apps for first generics.

But all this won't change much, the Generic Pharmaceutical Association says. In a statement, GphA President Kathleen Jaeger said this new "initiative" is just ineffectual tinkering, and what the FDA really needs is a wholesale restructuring of its generics office, plus many more inspectors.

- see the press release [2] from the FDA
- check out the statement [3] from GphA
- read the article [4] from the Star Ledger

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FDA backlog slows generic drug approval. Report [1]
Generics beat down drug price inflation. Report [6]