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Congress passes FDA Safety and Innovation Act

Congress voted this week to pass the Food and Drug Administration Safety and Innovation Act. The FDA Safety and Innovation Act, otherwise known as Senate Bill 3187, amends the Federal Food, Drug, and Cosmetic Act to establish user-fee programs for generic drugs and biosimilars, and for other purposes, according to GovTrack.

The Senate passed the bill on May 15 and the House passed the bill Tuesday. The bill is sponsored by Sen. Thomas Harkin, D-Iowa.

Besides reauthorizing FDA user fees, the bill also contains several provisions that directly affect children, including:

• Permanent extension and improvement of the Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA).
• Enhanced provider notice before and during drug shortages.
• Clarity on hospital repackaging.
• Incentives for drug manufacturers to address antibiotic-resistant pathogens.
• Incentives for drug manufacturers to develop orphan drugs that address rare pediatric diseases and conditions.

Go to www.govtrack.us/congress/bills/112/s3187 to read more about the bill.