Drug Shortage Prevention Act of 2025

Increased Transparency Regarding Drug Shortages: Manufacturers must notify the Secretary of permanent discontinuances, production interruptions, or circumstances like increased demand or export restrictions that could cause a shortage (Section 2(a)(1)(A)).

Better Information for Healthcare Providers and Patients: The Secretary is tasked with distributing information regarding drug supply disruptions to appropriate organizations, such as physician, health provider, and patient organizations (Section 2(a)(3)).

Early Warning for Supply Disruptions: The bill requires manufacturers to provide notice at least 6 months prior to a discontinuance or interruption in many cases (Section 2(b)(1)).

Detailed Insight into Supply Risks: Notification requirements include details on the expected duration of an interruption and, if applicable, the source of active pharmaceutical ingredients and any alternative sources (Section 2(a)(2)).

Increased Reporting Burdens on Manufacturers: Manufacturers are now required to provide specific details including reasons for disruptions, the source of ingredients, the role of associated devices, and the expected duration of the issue (Section 2(a)(2)).

Strict Notification Timelines: Manufacturers must adhere to specific deadlines, such as submitting notice at least 6 months in advance or within 10 business days of an event like increased demand, which may be difficult to meet if compliance is not possible (Section 2(b)).

Increased Reporting Frequency for Supply Chains: The frequency of reporting to the Secretary is increased to twice a year—once in March and once in September (Section 3(1)).