S. 1067 · 118th Congress
Ensuring Timely Access to Generics Act of 2023
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Never voted on. It didn't reach a floor vote before the 118th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
ShaheenSponsor5 cosponsors · 2 D, 3 R
5 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
This bill establishes additional requirements related to citizen petitions concerning applications for generic drug or biosimilar market approval. ( Citizen petitions are petitions submitted by third parties requesting that the Food and Drug Administration (FDA) take certain actions, such as requiring additional warnings on a drug.)
What it does: CRS summary · Reported to Senate · Jun 22, 2023
Ensuring Timely Access to Generics Act of 2023
This bill establishes additional requirements related to citizen petitions concerning applications for generic drug or biosimilar market approval. (Citizen petitions are petitions submitted by third parties requesting that the Food and Drug Administration (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 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 2023
Latest action (Jun 22, 2023): Placed on Senate Legislative Calendar under General Orders. Calendar No. 107.
Policy area: Health · Origin: Senate · Introduced: Mar 29, 2023
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.