Generic-Drug Makers Urge Changes To User-Fee Law

By Jeff Overley (June 15, 2015, 6:39 PM EDT) -- The generic-drug lobby on Monday outlined its hopes for improving and renegotiating the 2012 user-fee law that exchanged industry cash for better approvals and inspections at the U.S. Food and Drug Administration, arguing for quicker implementation, relaxed fees and other tweaks.

Corporate officials and regulators both spoke throughout the five-hour hearing hosted by the FDA, which analyzed the impact of the Generic Drug User Fee Amendments of 2012 and set the stage for early talks this fall on required reauthorization of the statute in 2017. Both sides acknowledged problems and successes, with business interests emphasizing the former and FDA staffers concentrating...

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