FDA offers accelerated review for select generics

Under intense pressure to deal with a backlog of applications for generic medications, the FDA has come up with a plan to accelerate some approvals as it drops its first come, first serve approach. An accelerated six-month approval schedule will be given to generics that are used in public health emergencies, are in short supply or where there is no generic alternative. The FDA's Scott Gottlieb outlined the initiative at a conference in Washington. The accelerated schedule doesn't do as much as some public health advocates have called for. Critics want the FDA to clear up the backlog and get generics out on the market as fast as possible, knowing that the more generic competitors are in the field the lower prices will fall. A single generic drug in a category can often hold on to higher retail prices while the FDA takes its time on the remaining applications. It also gives drug manufacturers more time to capitalize on authorized generics.

- read the AP's report on the new FDA policy

PLUS: The fallout from Wal-Mart's $4 generics campaign could be much more dramatic than we thought. A new study from the Wall Street Journal Online and survey firm Harris Interactive predicts that not only will Wal-Mart-style cheap generics attract customers to stores, they could potentially shift long-term U.S. prescribing and purchasing patterns. Editorial and Report

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