Summary of HR 4388 - PREP Repeal Act

Overview

The PREP Repeal Act (HR 4388) was introduced in the House of Representatives on July 15, 2025, by Representative Thomas Massie, with Warren Davidson and Paul A. Gosar as cosponsors. The bill seeks to repeal specific sections of the Public Health Service Act that provide liability immunity to pharmaceutical manufacturers during public health emergencies.

Purpose and Intent

The primary intent of the PREP Repeal Act is to:
- Revoke liability protections that have been granted to pharmaceutical companies under the Public Readiness and Emergency Preparedness Act (PREP Act).
- Restore the ability of individuals to seek legal recourse for injuries or harm resulting from the use of pandemic-related products.

Key Provisions

The bill includes several significant provisions:

1. Repeal of Liability Immunity:

   • The bill proposes the repeal of Sections 319F–3 and 319F–4 of the Public Health Service Act, which currently provide liability protections for manufacturers of covered countermeasures during public health emergencies.

2. Rescission of Funds:

   • It rescinds unobligated balances in the Covered Countermeasure Process Fund, which is established under Section 319F–4.

3. Preservation of Rights:

   • The bill explicitly states that it does not limit individuals' rights to pursue civil remedies under federal or state law for injuries related to drugs, devices, biological products, or covered countermeasures.

4. Application of the Act:

   • The provisions of the Act will apply to any actions, claims, or proceedings that are pending or commenced after the enactment of the Act.

5. Severability Clause:

   • If any part of the Act is found to be invalid, the remaining provisions will continue to be in effect.

Impact

The PREP Repeal Act aims to:
- Enhance Accountability: By removing liability shields, the bill seeks to restore public trust and accountability in the pharmaceutical industry during health emergencies.
- Empower Individuals: It allows citizens to seek justice and compensation for injuries caused by pandemic-related products, reinforcing the principle of due process.

Procedural Aspects

• The bill was referred to the House Committee on Energy and Commerce on the same day it was introduced.
• As of now, it is in the early stages of the legislative process and will require further discussion and approval from the committee before moving forward.

Conclusion

The PREP Repeal Act represents a significant shift in the legal landscape surrounding public health emergencies, aiming to balance the need for rapid response to health crises with the rights of individuals to seek redress for harm. The outcome of this bill could have lasting implications for public health policy and the pharmaceutical industry.