House Approves Key Drug Shortage Provisions

The U.S. House of Representatives last week approved the final version of legislation to address drug shortages, according to a report from the American Society of Anesthesiologists.

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The legislation, the “Food and Drug Administration Safety and Innovation Act,” was written to reauthorize the FDA’s prescription drug user fee program, which allows the FDA to collect fees from drug manufacturers to support the agency’s operations.

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 U.S. Senate will vote on the legislation this week, and the president is expected to sign the bill into law soon afterwards.

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