H.R. 6080 · 116th Congress
Preventing Drug Shortages Act
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Never voted on. It didn't reach a floor vote before the 116th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
PetersSponsor8 cosponsors · 3 D, 5 R
7 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
This bill expands existing manufacturer reporting requirements related to shortages of life-saving drugs and contains other related provisions.
What it does: CRS summary · Introduced in House · Mar 4, 2020
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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Preventing Drug Shortages Act
Latest action (Mar 4, 2020): Referred to the House Committee on Energy and Commerce.
Policy area: Health · Origin: House · Introduced: Mar 4, 2020
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.