Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019
Latest action · Jul 18, 2019 Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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.
- IntroducedJul 18, 2019
- Passed SenateNot reached
- Passed HouseNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019
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 and there is an unmet need.
Specifically, the bill requires the product's sponsor to demonstrate, among other things, that their product has been approved in one of the specified countries, the FDA and listed countries have not withdrawn approval because of safety or effectiveness concerns, and there is a public health or unmet medical need for the product.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 3
Members who signed on, in the order they did. Signatures ran from Jul 18, 2019 to Jun 3, 2020, with 2 there on the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| R-UT | Mike Lee | Original | Jul 18, 2019 |
| R-WI | Ron Johnson | Original | Jul 18, 2019 |
| R-IA | Joni Ernst | Jun 3, 2020 |
Actions 2
Everything that happened, newest first.
- Jul 18, 2019Introduced in Senate
- Jul 18, 2019Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Related bills 4
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| S 3545 | Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 | Related 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 |
| HR 6260 | Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 | Related bill | Mar 12, 2020 |
Subjects
Assigned by the Library of Congress. Policy area: Health.
Text 1
Each version as it was printed, newest first.
- Jul 18, 2019Introduced in Senate
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.