Securing America’s Medicine Cabinet Act of 2021
Latest action · Feb 2, 2021 Referred to the Subcommittee on Health.
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.
- IntroducedJan 4, 2021
- Passed HouseNot reached
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
Securing America's Medicine Cabinet Act of 2021
This bill encourages the development and approval of advanced pharmaceutical manufacturing technologies and designates certain university research centers to assist in developing such technologies.
The Food and Drug Administration (FDA) must continue to evaluate and approve new drug manufacturing technologies included in an application for drug approval and expedite the development and implementation of such technologies. The FDA must designate such a technology as an advanced manufacturing technology if it is likely to (1) prevent or resolve a drug shortage, (2) maintain an adequate supply of critical medications for national emergencies, or (3) promote the adoption of innovative approaches to drug design and manufacturing.
The sponsor of such a designated technology must provide the FDA with certain related scientific evidence. After receiving this evidence, if the FDA validates the technology for a proposed use, then the sponsor may use the validated technology across multiple manufacturing product lines within the same use context without obtaining additional FDA validation.
The FDA must designate certain institutions of higher education as National Centers of Excellence in Advanced Pharmaceutical Manufacturing. Among other requirements, such centers must demonstrate the ability to provide federal agencies with technical assistance and to train a future workforce in such technologies.
Cosponsors
Members who signed on, in the order they did.
Committees 1
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 Jan 4, 2021 |
| Health Subcommittee | Referred Feb 3, 2021 |
Actions 3
Everything that happened, newest first.
- Feb 2, 2021Referred to the Subcommittee on Health.
- Jan 4, 2021Introduced in House
- Jan 4, 2021Referred to the House Committee on Energy and Commerce.
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. 167, no. 2, January 4, 2021, page H52.
Related bills 1
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| HR 6708 | Securing America’s Medicine Cabinet Act of 2020 | Reintroduction of | May 5, 2020 |
Titles 2
Every title it has carried, official and short, at each stage.
- Official Title as Introduced
- To support the advanced manufacturing technologies program of the Food and Drug Administration, to establish National Centers of Excellence in Advanced Pharmaceutical Manufacturing, and for other purposes.
- Short Title(s) as Introduced
- Securing America’s Medicine Cabinet Act of 2021
Subjects
Assigned by the Library of Congress. Policy area: Health.
- Advanced technology and technological innovations
- Congressional oversight
- Drug safety, medical device, and laboratory regulation
- Educational facilities and institutions
- Emergency medical services and trauma care
- Government information and archives
- Health
- Health technology, devices, supplies
- Higher education
- Manufacturing
- Medical research
- Prescription drugs
- Research and development
- Technology assessment
Text 1
Each version as it was printed, newest first.
- Jan 4, 2021Introduced 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.
