S.1954 - Biosimilar Red Tape Elimination Act (119th Congress)
Summary
The Biosimilar Red Tape Elimination Act aims to streamline the process for determining the interchangeability of biosimilar biological products with their reference products. It amends Section 351(k) of the Public Health Service Act, modifying requirements for interchangeability determinations and related exclusivity periods. The bill also mandates the Secretary to update existing guidance documents to reflect these changes.
Expected Effects
The likely effect of this bill is to accelerate the approval and market entry of biosimilar drugs. This could lead to increased competition and potentially lower drug prices. The bill also clarifies the transition process for existing biosimilars with unexpired exclusivity periods.
Potential Benefits
- Potentially lower drug costs due to increased competition from biosimilars.
- Faster access to biosimilar medications for patients.
- Reduced administrative burden for biosimilar manufacturers.
- Clarified regulatory pathways for biosimilar approval.
- Encourages innovation in the biosimilar market.
Potential Disadvantages
- Potential for reduced incentives for manufacturers to invest in demonstrating interchangeability if the requirements are significantly relaxed.
- Possible confusion or uncertainty during the transition period for existing biosimilars.
- Risk of unintended consequences from altering the exclusivity provisions.
- May require significant resources for the Secretary to update guidance documents.
- Potential for litigation or disputes over the interpretation of the amended regulations.
Constitutional Alignment
The bill appears to align with the general welfare clause of the US Constitution, as it aims to improve healthcare access and affordability. Congress has the power to regulate interstate commerce, which includes the regulation of pharmaceuticals. (Article I, Section 8). The specific amendments to the Public Health Service Act fall under Congress's authority to legislate on matters related to public health and drug regulation.
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).