Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020
Latest action · Mar 12, 2020 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.
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.
- IntroducedMar 12, 2020
- Passed HouseNot reached
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020
This bill 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- the FDA and listed countries have not withdrawn approval because of safety or effectiveness concerns, and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.
Cosponsors 1
Members who signed on, in the order they did. All signed on Apr 17, 2020.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| R-AZ | David Schweikert | Apr 17, 2020 |
Committees 2
Where it was sent and what each committee and subcommittee did with it, in order.
| Chamber | Committee | What it did |
|---|---|---|
| House | Energy and Commerce Committee | Referred Mar 12, 2020 |
| House | Rules Committee | Referred Mar 12, 2020 |
Actions 2
Everything that happened, newest first.
- Mar 12, 2020Introduced in House
- Mar 12, 2020Referred 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.
Research
What has been written about this bill: committee reports, cost estimates, the sponsor’s authority statement, printed hearings and the Congressional Research Service’s work.
Constitutional authority
The sponsor’s statement, as printed in the Congressional Record, vol. 166, no. 48, March 12, 2020, page H1671.
Related bills 5
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| HR 724 | Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 | Reintroduced Bill | Feb 3, 2021 |
| S 2161 | Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 | Related bill | Jul 18, 2019 |
| S 3545 | Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 | Identical bill | Mar 19, 2020 |
| S 4537 | RECOVERY Act | Related bill | Sep 8, 2020 |
| HR 6258 | Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2020 | Related bill | Mar 12, 2020 |
Titles 2
Every title it has carried, official and short, at each stage.
- Official Title as Introduced
- To amend the Federal Food, Drug, and Cosmetic Act to provide for reciprocal marketing approval of certain drugs, biological products, and devices that are authorized to be lawfully marketed abroad, and for other purposes.
- Short Title(s) as Introduced
- Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020
Subjects
Assigned by the Library of Congress. Policy area: Health.
Text 1
Each version as it was printed, newest first.
- Mar 12, 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; cost estimates are the Congressional Budget Office's, and the hearings are the printed hearings GovInfo publishes, which can appear months after the hearing.
