What is the primary purpose of the Orphan Drug Act?

The primary purpose of the Orphan Drug Act is to incentivize the development of drugs for rare diseases, which are conditions that affect a small percentage of the population. This act was enacted to encourage pharmaceutical companies to invest in research and development for treatments that may not be commercially viable due to their limited patient base.

Under the Orphan Drug Act, developers of orphan drugs—those intended to treat rare diseases affecting fewer than 200,000 individuals in the U.S.—receive various incentives. These incentives include tax credits for clinical trial costs, waivers of the user fees associated with the New Drug Application (NDA), and a period of market exclusivity for seven years once the drug is approved. This exclusivity motivates companies to undertake the financial risks involved in bringing these drugs to market, thus addressing unmet medical needs for those suffering from rare conditions.

The correct response focuses on the act's aim to stimulate the pharmaceutical industry to create and market drugs that otherwise might not be developed due to economic factors. It actively contrasts with other purposes such as restricting drug distribution, promoting generics, or regulating marketing, which do not align with the intent and core benefits of the Orphan Drug Act.