US HB6260 | 2019-2020 | 116th Congress
Status
Spectrum: Partisan Bill (Republican 2-0)
Status: Introduced on March 12 2020 - 25% progression, died in committee
Action: 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.
Pending: House Energy And Commerce Committee
Text: Latest bill text (Introduced) [PDF]
Status: Introduced on March 12 2020 - 25% progression, died in committee
Action: 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.
Pending: House Energy And Commerce Committee
Text: Latest bill text (Introduced) [PDF]
Summary
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disease of epidemic potential, the approval is in one of the specified countries, the FDA and listed countries have not withdrawn approval because of safety or effectiveness concerns, and there is a public health or unmet medical need for the product.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.
Title
Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020
Sponsors
Rep. Chip Roy [R-TX] | Rep. David Schweikert [R-AZ] |
History
Date | Chamber | Action |
---|---|---|
2020-03-12 | House | 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. |
2020-03-12 | House | 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. |
2020-03-12 | House | Introduced in House |
Same As/Similar To
SB2161 (Related) 2019-07-18 - 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.
SB3545 (Same As) 2020-03-19 - 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.
HB6258 (Related) 2020-03-12 - Referred to the House Committee on Energy and Commerce.
SB3545 (Same As) 2020-03-19 - 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.
Subjects
Cardiovascular and respiratory health
Congressional oversight
Drug safety, medical device, and laboratory regulation
Emergency medical services and trauma care
Health
Infectious and parasitic diseases
Congressional oversight
Drug safety, medical device, and laboratory regulation
Emergency medical services and trauma care
Health
Infectious and parasitic diseases
US Congress State Sources
Type | Source |
---|---|
Summary | https://www.congress.gov/bill/116th-congress/house-bill/6260/all-info |
Text | https://www.congress.gov/116/bills/hr6260/BILLS-116hr6260ih.pdf |