In the United States, which act provides special incentives for the development of drugs for rare diseases?

The Orphan Drug Act of 1983 is specifically designed to encourage the development of drugs for rare diseases, which are conditions that affect a small percentage of the population. This act provides various incentives to pharmaceutical companies, including tax credits for clinical research, reduced fees for the New Drug Application (NDA) submission process, and seven years of market exclusivity upon approval. The goal of these incentives is to make it financially viable for companies to invest in the research and development of treatments for diseases that might not otherwise be prioritized due to their limited market potential.

Other acts, while important in the broader context of drug regulation and development, do not specifically target the development of therapies for rare diseases in the same way. The Federal Food, Drug, and Cosmetic Act of 1938 laid the foundational framework for drug approval and safety, but it does not provide specific incentives for rare diseases. The Drug Price Competition and Patent Term Restoration Act of 1984 focuses on patent restoration and generic drug approval rather than on rare disease drug development. The Biologics Price Competition and Innovation Act of 2009 regulates the approval of biologics and aims to create an abbreviated pathway for biosimilars but does not directly incentivize rare disease drug development.