What is the purpose of the Orphan Drug Act of 1983?

Prepare for the Federal Pharmacy Law Exam. Access detailed questions with hints and explanations to boost your understanding and confidence. Get exam ready effectively!

The purpose of the Orphan Drug Act of 1983 is to promote research and marketing for treatments aimed at rare diseases. This legislative act was created to specifically address the challenges faced by pharmaceutical companies in developing drugs for conditions that affect a small number of people, often referred to as "orphan" diseases.

By providing incentives such as tax credits, grants for clinical research, and extended periods of market exclusivity upon approval, the Orphan Drug Act encourages manufacturers to invest in the development of these drugs. This support is vital, as without such initiatives, there would be little motivation for companies to undertake the expensive and lengthy process of bringing orphan drugs to market given the limited patient population.

The other options do not align with the fundamental objective of the Act:

  • Assisting with the marketing of popular drugs does not relate to the intent of the legislation, which focuses on rare diseases rather than widespread conditions.
  • The Act does not address the regulation of pricing for orphaned medications; rather, it incentivizes their development.
  • Controlling the distribution of illegal drugs is outside the scope of the Orphan Drug Act, which is centered on supporting legitimate pharmaceutical development for rare health issues.

Overall, the Act serves a crucial role in ensuring that individuals with

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