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Faster Access to Generic Drugs: Ending Delays

This act aims to speed up the market entry of more affordable generic drugs. It introduces new rules that make it harder for pharmaceutical companies to intentionally delay the approval of generics, potentially leading to lower drug prices for citizens and greater choice. The changes are designed to prevent the misuse of legal procedures to block competition.
Key points
Facilitating access to cheaper generic drugs by eliminating unjustified delays in their approval.
Introducing clear criteria to assess whether pharmaceutical company petitions are intended to delay competition.
Enabling referrals to the Federal Trade Commission for companies intentionally delaying generic drug entry.
Requiring exhaustion of administrative remedies before filing civil actions, streamlining legal processes.
article Official text account_balance Process page
Expired
Citizen Poll
No votes cast
Additional Information
Print number: 117_S_562
Sponsor: Sen. Shaheen, Jeanne [D-NH]
Process start date: 2021-03-03
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Summarized by: gemini-2.5-flash-preview-05-20
Source data: api.congress.gov
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OFFICIAL LEGAL TITLE

Ensuring Timely Access to Generics Act of 2021

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 117_S_562.

Which chamber initiated this legislation?

This legislation was initiated in the Senate.

When did the legislative process begin?

The process officially started on 2021-03-03.

What are the main provisions?

Key points include:

  • Facilitating access to cheaper generic drugs by eliminating unjustified delays in their approval.
  • Introducing clear criteria to assess whether pharmaceutical company petitions are intended to delay competition.
  • Enabling referrals to the Federal Trade Commission for companies intentionally delaying generic drug entry.
  • Requiring exhaustion of administrative remedies before filing civil actions, streamlining legal processes.
What is the specific legal status?

The current status is Expired.

Where can I read the full text of this legislation?

The full official text is available at: View full text

Who is the primary sponsor?

The primary sponsor is Sen. Shaheen, Jeanne [D-NH].

What is the latest detailed status?

The latest detailed status is: Introduced in Senate

Is this summary verified?

Yes. This content was analyzed by AI and verified by the Lustra Judge System on 2025-12-29.

CATEGORIES

Health Courts and Law Economy