ADAPT Act
Bill journey · stage 2 of 5
Under committee review
What it doesSummary introduced in senate (Mar 5, 2019)
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.
What just happenedMar 5, 2019
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Who’s behind it
- Introduced in SenateMar 5, 2019
- Mar 5, 2019IntroReferral
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Health, Education, Labor, and Pensions Committee - Mar 5, 2019IntroReferral10000
Introduced in Senate