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Enhanced Drug Safety and Data Transparency: Stricter Penalties for Falsification

New regulations aim to improve drug safety by imposing stricter penalties for falsifying, concealing, or destroying data related to drug production and approval. This means pharmaceutical companies will need to be more transparent, potentially leading to greater public trust in available medications and better health protection for citizens.
Key points
Prohibition of altering, falsifying, or destroying drug-related data from development to approval.
Introduction of high financial penalties, up to $1 million per violation and up to $10 million for all violations in a single proceeding.
Additional, escalating penalties for continued violations after written notice, aiming to enforce prompt correction of issues.
article Official text account_balance Process page
Expired
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Additional Information
Print number: 117_HR_6431
Sponsor: Rep. Schrier, Kim [D-WA-8]
Process start date: 2022-01-19
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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

Data Transparency and Drug Safety Act of 2022

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 117_HR_6431.

Which chamber initiated this legislation?

This legislation was initiated in the House of Representatives.

When did the legislative process begin?

The process officially started on 2022-01-19.

What are the main provisions?

Key points include:

  • Prohibition of altering, falsifying, or destroying drug-related data from development to approval.
  • Introduction of high financial penalties, up to $1 million per violation and up to $10 million for all violations in a single proceeding.
  • Additional, escalating penalties for continued violations after written notice, aiming to enforce prompt correction of issues.
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 Rep. Schrier, Kim [D-WA-8].

What is the latest detailed status?

The latest detailed status is: Referred to the Subcommittee on Health.

Is this summary verified?

Yes. This content was analyzed by AI and verified by the Lustra Judge System on 2025-12-28.

CATEGORIES

Health Courts and Law