S.Amdt. 6557

The purpose of SA 6557, submitted by Ms. Klobuchar, is to improve how the government is notified when there is an increased demand for critical drugs. It aims to change and add the following to the Federal Food, Drug, and Cosmetic Act:

Notification Requirements

• Manufacturers of "covered drugs" must notify the Secretary about permanent discontinuances, interruptions in manufacturing (including active pharmaceutical ingredients), or other issues like export restrictions and increased demand that could lead to a meaningful disruption in supply.
• These notifications must include the reasons for the disruption, information on active pharmaceutical ingredient sources, whether associated devices are a risk factor, and the expected duration of the interruption.

Timing and Distribution

• Notices for discontinuances or interruptions must be sent at least 6 months in advance.
• Notices regarding other circumstances (like increased demand) must be sent as soon as possible, or within 10 business days.
• The Secretary must distribute this information to appropriate organizations, such as patient and health provider organizations, and must notify the Secretary of Defense.

Definitions and Reporting

• A "covered drug" is defined as a drug for human use that is life-supporting, life-sustaining, or used to treat/prevent a debilitating disease (including emergency or surgical use and public health emergency drugs), excluding biological products and radiopharmaceutical drug products unless designated by the Secretary.
• Supply chain reporting to the Secretary is increased from annually to twice a year (March and September).
• Reporting must now include the legal names of suppliers for active pharmaceutical ingredients and intermediate/in-process materials, as well as the amount of drug produced using those materials.