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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.
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Status:
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
System Note: Lustra is free, publicly auditable civic infrastructure, with full source code available on GitHub. You are reading sterilized legislative data, processed by our radical neutrality engine to strip political spin and retain factual mechanics. We process only official government data. Original documents remain the authoritative source, always verify them if you can.
Summarized by: gemini-2.5-flash-preview-05-20
Source data: api.congress.gov
AI work logs for this document launch

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.

What is the impact of this bill?

We don't know, that is up to you to decide. Summarizing raw data with AI is fundamentally different from predicting socio-economic outcomes. As of 2026, we believe impact assessment strictly requires a human in the loop to verify and judge.

CATEGORIES

Health Courts and Law