Short on Competition Act
Summary
The "Short on Competition Act" aims to address drug shortages and marginally competitive drug markets by expediting the approval of generic prescription drugs and allowing for temporary importation of prescription drugs. It amends the Federal Food, Drug, and Cosmetic Act to enable the Secretary to authorize importation of drugs facing shortages or limited competition. The bill also includes provisions for annual reporting on drug shortages, enhancing transparency and accountability.
Expected Effects
The Act is likely to increase the availability of prescription drugs, potentially lowering costs for consumers. It could also stimulate competition within the pharmaceutical market, encouraging innovation and efficiency. The expedited approval process for generics may lead to faster market entry for these drugs.
Potential Benefits
- Increased access to affordable prescription drugs.
- Reduced drug shortages.
- Enhanced competition in the pharmaceutical market.
- Expedited approval of generic drugs.
- Greater transparency through annual reporting on drug shortages.
Potential Disadvantages
- Potential risks associated with imported drugs if safety standards are not rigorously enforced.
- Possible negative impact on domestic pharmaceutical companies due to increased competition from imports.
- Discretionary denial of importation by the Secretary could limit the Act's effectiveness.
- The 3-year termination clause on temporary importation authority may create uncertainty.
- Complex implementation and enforcement may pose challenges.
Constitutional Alignment
The Act aligns with the Constitution's general welfare clause (Preamble), which allows Congress to enact laws promoting the health and well-being of the population. The regulation of interstate commerce related to drugs falls under Congress's authority as defined in Article I, Section 8. The Act 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).