Preventing Drug Shortages Act

Preventing Drug Shortages Act

This bill expands existing manufacturer reporting requirements related to shortages of life-saving drugs and contains other related provisions.

The bill requires a manufacturer of an active pharmaceutical ingredient of a life-saving drug to notify the Food and Drug Administration (FDA) of an interruption that is likely to lead to a meaningful disruption in the ingredient's supply, whereas under current law this requirement generally applies only to the manufacturer of a life-saving drug that faces a supply disruption.

The notification must contain specified information, including any alternative sources for the ingredient.

The bill also requires a manufacturer of a life-saving drug or an active pharmaceutical ingredient for such a drug to include in its annual product registration the specific facilities where the drug or ingredient is manufactured. The FDA may also require the manufacturer to conduct periodic risk assessments to address vulnerabilities in its supply chain.

The Government Accountability Office shall report to Congress on the FDA's intra-agency coordination in assessing drug shortage risks.