US Congress Senate Bill 3545 (Prior Session Legislation)

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Spectrum: Partisan Bill (Republican 3-0)
Status: Introduced on March 19 2020 - 25% progression, died in committee
Action: 2020-03-19 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Pending: Senate Health, Education, Labor, And Pensions Committee
Text: Latest bill text (Introduced) [PDF]

Establishes a reciprocal marketing approval process that allows for the sale of a drug, biological product, or medical device that has not been approved by the Food and Drug Administration (FDA) if the product is approved for sale in another country for the treatment or prevention of COVID-19 (i.e., coronavirus disease 2019) and there is an unmet need relative to certain diseases. Specifically, the bill requires the product's sponsor to demonstrate, among other things, that the product has been approved for the treatment or prevention of COVID-19 or another disease of epidemic potential, the approval is in one of the specified countries, the FDA and listed countries have not withdrawn approval because of safety or effectiveness concerns, and there is a public health or unmet medical need for the product. The FDA may only decline approval if the FDA determines that the product is not safe or effective. The FDA must make such a determination not later than 30 days after receiving a request. Congress may pass a joint resolution to grant reciprocal marketing approval of a product that the FDA declines to approve through the reciprocal process.

Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Co­ro­na­vi­rus Patients Act of 2020

Sen. Ted Cruz [R-TX]

Sen. Mike Lee [R-UT]

Sen. Mike Braun [R-IN]

Date	Chamber	Action
2020-03-19	Senate	Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

HB6258 (Related) 2020-03-12 - Referred to the House Committee on Energy and Commerce.
HB6260 (Same As) 2020-03-12 - Referred to the Committee on Energy and Commerce, and in addition to the Committee on Rules, 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.
SB2161 (Related) 2019-07-18 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
SB4537 (Related) 2020-09-08 - Read twice and referred to the Committee on Finance.

Type	Source
Summary	https://www.congress.gov/bill/116th-congress/senate-bill/3545/all-info
Text	https://www.congress.gov/116/bills/s3545/BILLS-116s3545is.pdf