Improved Access to Affordable Medications Act
Latest action · Mar 30, 2023 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.
- IntroducedMar 30, 2023
- Passed SenateNot reached
- Passed HouseNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
Improved Access to Affordable Medications Act
This bill modifies provisions relating to the ability of generic drug manufacturers to obtain samples of brand-name drugs for purposes of generic drug development.
Under current law, brand-name drug manufacturers must provide sufficient quantities of their products on commercially reasonable, market-based terms to generic drug manufacturers upon request for purposes of generic drug development. Brand-name drug manufacturers are subject to civil actions if they fail to do so. The bill modifies provisions relating to this requirement and the criteria needed for related civil actions, such as specifying that generic drug manufacturers may use certain delivery services to make their requests.
Additionally, under current law, generic drug manufacturers must obtain authorization from the Food and Drug Administration (FDA) in order to request sufficient quantities of brand-name drugs that are subject to a Risk Evaluation and Mitigation Strategy (REMS) with elements to ensure safe use (ETASU). The bill requires the FDA to approve an authorization request within 60 days (rather than 120 days), if testing and development does not involve human clinical trials. (The FDA sometimes requires a REMS program for certain drugs with safety risks, which may include restrictions on a drug's distribution through ETASU, such as special requirements for pharmacies that dispense the drug.)
The bill also requires brand-name drug manufacturers to post their policies on evaluating and responding to requests from generic drug manufacturers for their products, including relevant contact information and procedures.
Cosponsors 1
Members who signed on, in the order they did. All signed on Mar 30, 2023.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| R-IN | Mike Braun | Original | Mar 30, 2023 |
Actions 2
Everything that happened, newest first.
- Mar 30, 2023Introduced in Senate
- Mar 30, 2023Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Subjects
Assigned by the Library of Congress. Policy area: Health.
Text 1
Each version as it was printed, newest first.
- Mar 30, 2023Introduced 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.