S. 355: FDA Modernization Act 3.0

This bill, titled the FDA Modernization Act 3.0, aims to update regulations regarding testing methods for pharmaceuticals and medical products. Specifically, it requires the Secretary of Health and Human Services, through the Commissioner of Food and Drugs, to implement certain changes related to nonclinical testing within one year of enactment. Here are the main components of the bill:

Interim Final Rule

The bill mandates an interim final rule to be published that will make immediate changes to the way nonclinical tests are regulated, allowing for faster adjustments to the regulations without needing to demonstrate good cause for the changes. This rule is connected to updates made earlier in the Federal Food, Drug, and Cosmetic Act.

Changes to Terminology

The bill will replace specific references to “animal” tests and related terms in various sections of the regulations, substituting them with “nonclinical” tests. This change seeks to reflect a shift towards broader non-animal testing methodologies and may include updates in the following areas:

• Section 312.22(c)
• Section 312.23(a)(3)(iv)
• Section 312.23(a)(5)(ii)
• Section 312.23(a)(5)(iii)
• Section 312.23(a)(8)
• Section 314.50(d)(2)
• Section 314.50(d)(5)(i)
• Other relevant sections as necessary

Definition of Nonclinical Test

The bill aims to define "nonclinical test" in various sections of the regulations to ensure clarity and consistency in how these tests are regarded under law.

Technical Amendments

Additionally, the bill makes technical amendments to categorize certain existing provisions differently, specifically related to clinical trial diversity action plans. This change aims to organize the regulations more effectively.

Implementation Flexibility

The Secretary of Health and Human Services is also granted the authority to make necessary additional changes to ensure that all amendments and updates are fully implemented and coherent throughout the regulations.

Relevant Companies

• ABT (Abbott Laboratories): As a major healthcare company that develops medical devices and pharmaceuticals, changes in testing regulations may affect their product development timelines and approaches.
• PFE (Pfizer Inc.): A leading pharmaceutical company, Pfizer could see impacts in their clinical testing processes and regulatory submissions as they adapt to the new nonclinical testing standards.
• NVS (Novartis AG): With a strong portfolio in pharmaceuticals, Novartis may need to revise testing methodologies to comply with the new regulations.
• MRK (Merck & Co.): Merck's research and development of new drugs could be influenced by the faster implementation of nonanimal testing requirements.