S. 562 · 117th Congress
Ensuring Timely Access to Generics Act of 2021
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Never voted on. It didn't reach a floor vote before the 117th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
ShaheenSponsor3 cosponsors · 1 D, 2 R
3 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
This bill imposes requirements related to third-party petitions concerning an application for Food and Drug Administration (FDA) approval to market a generic drug or biosimilar.
What it does: CRS summary · Introduced in Senate · Mar 3, 2021
Ensuring Timely Access to Generics Act of 2021
This bill imposes requirements related to third-party petitions concerning an application for Food and Drug Administration (FDA) approval to market a generic drug or biosimilar. (The current statute refers to these petitions as citizen petitions, which typically involve requests that the FDA take certain actions, such as requiring additional warnings on a drug.)
Under the bill, the FDA may deny a citizen petition that (1) was submitted primarily to delay the approval of the relevant application, or (2) does not on its face raise valid scientific or regulatory issues. Currently, the FDA may deny a petition as an attempt at delay only if the petition meets both of these requirements. The bill also requires the FDA to establish procedures for referring such a delaying petition to the Federal Trade Commission.
The bill also expressly requires a third party, before filing a lawsuit to force the FDA to set aside or prevent market approval of a generic drug or biosimilar, to first file a citizen petition with the information and arguments that form the basis of the lawsuit. A citizen petition must be filed within 60 days of when the filer knew or reasonably should have known the information that forms the basis of the petition.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Ensuring Timely Access to Generics Act of 2021
Latest action (Mar 3, 2021): Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Policy area: Health · Origin: Senate · Introduced: Mar 3, 2021
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.