Enhancing the Security of the U.S. Pharmaceutical Supply Chain Act of 2020
Latest action · Dec 16, 2020 Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedDec 16, 2020
- Passed HouseNot reached
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
Enhancing the Security of the U.S. Pharmaceutical Supply Chain Act of 2020
This bill provides tax credits for manufacturing certain priority medicines and establishes an expedited review procedure for drug manufacturers seeking to transition from foreign manufacturing to domestic manufacturing.
The Department of Health and Human Services (HHS) must publish annually a list of priority drugs and active pharmaceutical ingredients that (1) are necessary for use in a public health emergency, (2) are at high risk of becoming in short supply, and (3) have a vulnerable global supply chain. The bill provides a tax credit for 50% of a manufacturer's direct and indirect costs incurred in a taxable year for the production of a drug or active ingredient that was on this list in any of the five preceding years.
Furthermore, the Food and Drug Administration (FDA) must expedite the review and approval of a supplemental application that seeks to transfer manufacturing of an already-approved drug or active pharmaceutical ingredient to a domestic establishment. (A supplemental application generally involves a change, such as a manufacturing change, to an existing application for FDA market approval.) The bill imposes various requirements for this expedited review, including a deadline for the FDA to take action on such a supplemental application within six months of submission.
HHS shall also establish the Facility Transfer Working Group to assist with evaluating such applications and provide advice and feedback to applicants upon request.
Cosponsors
Members who signed on, in the order they did.
Actions 2
Everything that happened, newest first.
- Dec 16, 2020Introduced in House
- Dec 16, 2020Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Subjects
Assigned by the Library of Congress. Policy area: Health.
- Business expenses
- Department of Health and Human Services
- Drug safety, medical device, and laboratory regulation
- Emergency medical services and trauma care
- Executive agency funding and structure
- Health
- Health promotion and preventive care
- Income tax credits
- Infectious and parasitic diseases
- Manufacturing
- Medical tests and diagnostic methods
- Public contracts and procurement
Text 1
Each version as it was printed, newest first.
- Dec 16, 2020Introduced in House
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov.