The US has long been a leader in drug research and development, and the availability of transformational pharmaceutical treatments has led to longer, higher-quality lives for individuals with many diseases. Researchers at PORTAL study this ecosystem of drug development and seek to optimize the discovery, testing, and availability of innovative treatments that deliver health benefits to patients.
Research Areas We Explore:
- Patents and Exclusivities: Documenting how FDA market exclusivities and patent protections shape the availability of brand-name drugs, and the strategies manufacturers employ to impact timely competition.
- Generic and Biosimilar Competition: Identifying the regulatory, market, and policy barriers that affect generic and biosimilar entry and use in the US, and the effectiveness of market competition in lowering prices.
- Targeted Development Incentives: Examining whether policies that Congress and the FDA have implemented to incentivize targeted innovation of drugs for certain therapeutic areas, including priority review vouchers and market exclusivity extensions, are meeting their intended goals, and other outcomes of such incentives.
- Anticompetitive Practices: Understanding how intellectual property protections and innovation incentives can be exploited to disrupt competition, including through patent thickets, improper listing of patents with the FDA, product hopping, misuse of citizen petitions, and pay-for-delay settlements, and the effectiveness of federal actions to address these practices.
- Public Investment in Drug Development: Highlighting the integral role of the federal government in drug development, including the public funding of research by the National Institutes of Health and other agencies that underpins the development of nearly all new drugs, and whether taxpayers are getting a fair return on that investment.
