S.1096 - Preserve Access to Affordable Generics and Biosimilars Act (119th Congress)
Summary
S.1096, the Preserve Access to Affordable Generics and Biosimilars Act, aims to prevent brand-name drug companies from using compensation to delay the market entry of generic and biosimilar drugs. This bill targets "reverse payment" settlement agreements, where brand-name companies pay generic manufacturers to drop patent challenges, thus maintaining higher drug prices. The bill amends the Federal Trade Commission Act to prohibit such anticompetitive agreements and provides the FTC with increased enforcement authority.
Expected Effects
The likely effect of this bill is increased competition in the pharmaceutical market, leading to lower drug prices for consumers. By prohibiting reverse payment settlements, generic and biosimilar drugs are expected to enter the market sooner. This will reduce healthcare costs and increase access to essential medicines.
Potential Benefits
- Lower prescription drug costs for consumers due to increased generic and biosimilar competition.
- Reduced healthcare spending for individuals, families, and the government.
- Increased access to life-saving medications, especially biological drugs.
- Enhanced competition in the pharmaceutical market, fostering innovation and efficiency.
- Prevention of anticompetitive practices that undermine antitrust laws.
Potential Disadvantages
- Potential for increased litigation as companies challenge the interpretation and application of the new regulations.
- Possible reduction in profitability for brand-name drug companies, which could impact investment in research and development of new drugs (although this is debated).
- Complexity in determining what constitutes "reasonable litigation expenses" in settlement agreements.
- Risk of unintended consequences if the regulations are overly broad or poorly defined, potentially hindering legitimate settlements.
- Delayed market entry of some generic drugs if companies choose to litigate patent disputes rather than settle.
Constitutional Alignment
The bill aligns with the Commerce Clause (Article I, Section 8, Clause 3) by regulating interstate commerce in pharmaceuticals to prevent anti-competitive practices. It also indirectly supports the general welfare clause by aiming to lower healthcare costs and improve access to medicines. The bill does not appear to infringe upon any specific constitutional rights or freedoms.
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).