S.Amdt. 6294

This amendment, submitted by Ms. Klobuchar, aims to improve how the government is notified when there is an increased demand for critical drugs. It proposes changes to the Federal Food, Drug, and Cosmetic Act to ensure better tracking and communication regarding drug supplies.

Changes to Notification Requirements

The amendment changes the rules for when manufacturers of "covered drugs" must notify the Secretary about supply issues. Manufacturers must now provide notice for:

• Permanent discontinuance or interruptions in the manufacture of the drug or its active pharmaceutical ingredient that could lead to a meaningful disruption in the U.S. supply.
• Other situations, such as export restrictions or increased demand, that would make the manufacturer unable to meet demand without a delay or shortfall.

Notification Details and Timing

The amendment specifies what must be included in these notices and when they must be sent:

• Contents: Notices must include the reasons for the disruption, the expected duration, and information regarding the source of active pharmaceutical ingredients or associated devices used for the drug.
• Timing: Notices for discontinuance or interruptions must be submitted at least 6 months in advance. For other circumstances like increased demand, notice must be given as soon as practicable or within 10 business days.
• Distribution: The Secretary must share this information with appropriate organizations (such as patient and health provider organizations) and notify the Secretary of Defense.

Updates to Definitions and Reporting

The amendment also updates the following:

• Covered Drugs: Defines "covered drug" as those used for life-supporting, life-sustaining, or treating debilitating diseases, including those used in surgery, emergency care, or public health emergencies (excluding most biological products and radio pharmaceutical drug products).
• Supply Chain Reporting: Changes reporting requirements so that they occur twice a year (March and September) instead of annually. It also requires reporting the legal names of suppliers for active pharmaceutical ingredients and other materials, as well as the amount of drug produced using those sources.