PART Act

Pharmaceutical Accountability, Responsibility, and Transparency Act or the PART Act

This bill expands requirements for manufacturers of certain drugs and medical devices to report information to the Food and Drug Administration (FDA) and contains related provisions.

A manufacturer of a life-saving drug or medical device must notify the FDA of certain issues that may affect the drug or device's availability, such as an increase in demand that the manufacturer is likely unable to meet or an export restriction imposed by a foreign country where the drug or device is being manufactured. The manufacturer must notify the FDA within five days of becoming aware of the issue.

The bill also expands the types of foreign manufacturers of drugs and medical devices that must register with the FDA. Additionally, the bill expands a requirement for registered manufacturers to submit periodic reports to the FDA by (1) increasing the frequency of such reports, and (2) requiring the reports to include additional information about the amounts of drugs and medical devices being manufactured.