S.1414 - Expedited Access to Biosimilars Act (119th Congress)
Summary
S.1414, the Expedited Access to Biosimilars Act, aims to amend the Public Health Service Act. The amendment focuses on streamlining the clinical study requirements for biosimilar licensure. Specifically, it seeks to remove the mandatory assessment of immunogenicity, pharmacodynamics, or comparative clinical efficacy in certain cases.
Expected Effects
The bill, if enacted, would potentially reduce the cost and time associated with bringing biosimilars to market. This could lead to increased competition and potentially lower drug prices. However, it also raises concerns about ensuring the safety and efficacy of biosimilars without these assessments.
Potential Benefits
- Potentially lower healthcare costs due to increased biosimilar availability.
- Faster market entry for biosimilars, increasing patient access to medications.
- Reduced regulatory burden on biosimilar manufacturers.
- Encourages innovation by reducing the cost of biosimilar development.
- May free up resources for the FDA to focus on other critical drug evaluations.
Potential Disadvantages
- Potential compromise in safety and efficacy monitoring of biosimilars.
- Increased risk of adverse reactions due to reduced immunogenicity assessment.
- Uncertainty regarding the long-term effects of biosimilars without comprehensive clinical data.
- May lead to a decline in public confidence in biosimilars if safety concerns arise.
- Possible legal challenges related to the interpretation of "sufficient" safety and efficacy data.
Most Disadvantaged Areas:
Constitutional Alignment
The bill falls under the purview of Congress's power to regulate interstate commerce (Article I, Section 8, Clause 3), as it affects the manufacturing and distribution of pharmaceuticals. The Public Health Service Act is a creation of Congress, and this bill seeks to amend it, which is within Congress's legislative authority. There are no apparent violations of individual rights or freedoms as defined in the Constitution or its amendments.
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).