GAIN Act Should Benefit Antibiotic Makers

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"The bill was designed to accelerate reviews of novel drugs for infectious diseases, to mandate electronic NDA submissions and to improve communications between manufacturers and the FDA to prevent drug shortages."

Seeking Alpha, Jason Napodano

On June 26, 2012, the U.S. Senate overwhelmingly (92-4) passed the FDA Safety and Innovation Act (FDASIA), which reauthorizes the Prescription Drug User Fee Act (PDUFA) for the fifth time. This follows the House of Representatives unanimously passing the bill last week. All that's left is for President Obama to sign the bill into law, which will become effective October 1, 2012.

The bill was designed to accelerate reviews of novel drugs for infectious diseases, to mandate electronic NDA submissions, and to improve communications between manufacturers and the FDA to prevent drug shortages. Within PDUFA-V are some important provisions. Specifically, PDUFA-V includes two new fees, a generic drug user fee and a biosimilar user fee that seek to speed generic and biosimilar drug application approvals. PDUFA-V also contains measures to permanently authorized the Pharmaceuticals for Children Act and the Pediatric Research Equity Act, two measures to standardize and monitor drug use in children. . .View Full Article

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