H.R.1532 - Scientific External Process for Educated Review of Therapeutics Act of 2025; Scientific EXPERT Act of 2025 (119th Congress)
Summary
H.R. 1532, the Scientific EXPERT Act of 2025, aims to amend the Federal Food, Drug, and Cosmetic Act by establishing a process for externally led, science-focused drug development meetings. These meetings would provide a platform for medical experts, drug sponsors, scientific organizations, and patient organizations to discuss challenges and opportunities in developing drugs for rare diseases and conditions. The bill mandates the Secretary of Health and Human Services to collaborate with the Reagan-Udall Foundation to convene at least four such meetings annually, each focusing on different rare diseases.
Expected Effects
The bill seeks to expedite the development, review, and approval of drugs for rare diseases by fostering collaboration and alignment among stakeholders. It establishes a steering committee to recommend meeting topics and ensures public availability of meeting transcripts and summaries. The FDA is required to participate in these meetings and incorporate the input into risk-benefit assessments for drug approvals.
Potential Benefits
- Accelerated Drug Development: Facilitates faster development and approval of drugs for rare diseases.
- Enhanced Collaboration: Promotes collaboration among experts, sponsors, and patient groups.
- Improved Regulatory Flexibility: Encourages increased regulatory flexibility to facilitate product development.
- Increased Transparency: Ensures public access to meeting transcripts and summaries.
- Better Risk-Benefit Assessments: Incorporates input from meetings into FDA's risk-benefit assessments.
Potential Disadvantages
- Potential for Conflicts of Interest: Steering committee members may face conflicts of interest despite policies.
- Increased Workload for FDA: Participation in meetings may strain FDA resources.
- Limited Scope: Focuses primarily on rare diseases, potentially neglecting other areas of drug development.
- Dependence on Foundation: Relies heavily on the Reagan-Udall Foundation for convening meetings.
- No Guarantee of Outcomes: The meetings may not always lead to concrete advancements in drug development.
Constitutional Alignment
The bill aligns with the Constitution's general welfare clause (Preamble) by promoting public health through improved drug development. Congress's authority to regulate interstate commerce (Article I, Section 8) provides the basis for regulating drugs and medical devices. The bill does not appear to infringe upon any specific constitutional rights or limitations.
Impact Assessment: Things You Care About ⓘ
This action has been evaluated across 19 key areas that matter to you. Scores range from 1 (highly disadvantageous) to 5 (highly beneficial).