Us Congress House Bill HB9979

Us Congress 2023-2024 Regular Session

• Introduced: 10/11/24
• Refer: 10/11/24

Caption

Scientific EXPERT Act of 2024 Scientific External Process for Educated Review of Therapeutics Act of 2024

Impact

The bill puts forth a framework that requires the U.S. Food and Drug Administration (FDA) to endorse and participate in regular meetings organized by the Reagan-Udall Foundation. These meetings are to be conducted at least four times a year, focusing specifically on various rare diseases, thereby ensuring that the voices of those impacted by these conditions are heard in the drug development process. The initiative is expected to enhance the scrutiny of clinical trial designs and metrics, ultimately facilitating more efficient and patient-responsive drug development processes.

Summary

House Bill 9979, titled the 'Scientific EXPERT Act of 2024', is designed to amend the Federal Food, Drug, and Cosmetic Act with the goal of establishing a structured process for externally-led, science-focused drug development meetings. These meetings aim to facilitate dialogue among medical experts, drug sponsors, and patient organizations regarding the science-related challenges involved in developing drugs for rare diseases. By doing so, the bill seeks to foster collaboration and identify innovative solutions to accelerate the development and approval of therapeutics for conditions with significant unmet medical needs.

Contention

While the bill has garnered support for its potential to streamline drug development for rare conditions, concerns have been raised regarding the implications of the FDA's role in these discussions. Some critics argue that shelling out resources for such meetings may divert attention from traditional pathways of regulatory review, potentially leading to delays in the approval of necessary medicines. Stakeholder engagement models have also drawn scrutiny as they could skew representation away from broader patient populations in favor of those funding such initiatives.