Ensuring Timely Access to Generics Act of 2023

Bill: 118-s-1067
Sponsor: Sen. Shaheen, Jeanne [D-NH]
Introduced: 2023-03-29 in the Senate
Policy area: Health
Subjects: Drug safety, medical device, and laboratory regulation
Prescription drugs

Summary:
action_date: 2023-03-29
text: 

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 requires the FDA to establish procedures for referring such a 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.

action_date: 2023-06-22
text: 

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.


Legislative actions:
action_date: 2023-06-22
text: Placed on Senate Legislative Calendar under General Orders. Calendar No. 107.
action_date: 2023-06-22
text: Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders with an amendment in the nature of a substitute. Without written report.
action_date: 2023-06-22
text: Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders with an amendment in the nature of a substitute. Without written report.
action_date: 2023-05-11
text: Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
action_date: 2023-03-29
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
action_date: 2023-03-29
text: Introduced in Senate