Proposal:ADAPT Act

This proposal is archived and closed to further debate. It was introduced in the 116th Congress, which has concluded, and the bill was not enacted into law.

Bill	S 658
Type of Legislation	Senate Bill
Congress	116
Source	View original on Congress.gov

Geographic Scope

National

Description

Accelerated Drug Approval for Prescription Therapies Act or the ADAPT Act

This bill authorizes the Food and Drug Administration (FDA) to create an expedited drug approval process specifically for drugs that are currently approved for sale in certain countries (i.e., a European Economic Area member country, Australia, Canada, Israel, Japan, New Zealand, South Africa, or Switzerland) and meet certain criteria. Such criteria shall include establishing that (1) the drug is safe and effective, (2) all relevant U.S. patents or legal exclusivities have expired, and (3) the United States has a public health or unmet medical need for the drug.

The FDA must process and review an application under this bill within 180 days of submission.

Bill Title

ADAPT Act

Linked Goals

• Goal:Promote General Welfare

Steps

• 2019-03-05: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
• 2019-03-05: Introduced in Senate

Projected Outcome

A more informed proposal or public response aligned with the Promote General Welfare goal.