This bill, titled the Drug Shortage Prevention Act of 2025, aims to prevent critical drug shortages by amending the Federal Food, Drug, and Cosmetic Act. It significantly expands the circumstances under which manufacturers of covered drugs must notify the Secretary of Health and Human Services about potential supply issues. The goal is to provide earlier and more comprehensive information to mitigate disruptions.

Under the revised provisions, manufacturers must now notify the Secretary of a permanent discontinuance or interruption in drug or active pharmaceutical ingredient (API) manufacturing. Crucially, new triggers for notification include any circumstance, such as increased demand or export restrictions, that is likely to leave the manufacturer unable to meet demand without a meaningful shortfall or delay. Notifications must also include reasons for the issue, API sources, and the expected duration of interruptions.

The timing for these notifications is also updated, requiring submission at least six months prior to a discontinuance or interruption, or as soon as practicable (within 10 business days) for increased demand or other new circumstances. The Secretary is directed to distribute this information to appropriate organizations, including physician, health provider, and patient groups. A "covered drug" is defined as a life-supporting, life-sustaining, or critical drug for debilitating conditions, excluding certain radiopharmaceuticals and biological products.

Furthermore, the bill enhances supply chain transparency by amending reporting requirements for drug manufacturers. It mandates that manufacturers report to the Secretary twice annually, in March and September, instead of just once a year. This reporting must now include the legal names and other required information regarding suppliers of active pharmaceutical ingredients and intermediate materials, along with the amount of drug manufactured using materials from each supplier.