Congress Passes FDA Safety and Innovation Act With Drug Shortage Provisions

Congress yesterday approved the Food and Drug Administration Safety and Innovation Act, which includes important provisions to address drug shortages.

The legislation was written to reauthorize the FDA's prescription drug user fee program, which allows the organization to collect fees from drug manufacturers. The Act also includes incentives to pursue antibiotic research and development and calls for the use of antimicrobial stewardship programs to protecting existing antibiotics.

Title X of the bill includes provisions to help prevent drug shortages, including a requirement that manufacturers notify the FDA when the production of certain drugs would be interrupted and a requirement that the Drug Enforcement Administration provides timely updates on drug quota increases to manufacturers.

The House approved the Act last week, and the president is expected to sign it into law in the days ahead.

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