What act aimed to reduce the costs associated with orphan drugs?

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The Orphan Drug Act of 1983 was specifically designed to encourage the development of drugs for rare diseases and conditions, often referred to as orphan diseases. By providing various incentives, such as tax credits, grants, and seven years of market exclusivity after approval, the act aims to reduce the financial burden on pharmaceutical companies developing these drugs. This is crucial because the limited market for orphan drugs often makes it economically unfeasible for companies to invest in their development.

The other acts mentioned, while important in the regulation of pharmaceuticals, do not focus specifically on orphan drugs. The Prescription Drug Marketing Act 1987 primarily addresses the distribution and marketing of prescription drugs to ensure their safety and effectiveness, while the FDA Modernization Act 1997 aimed to expedite the approval process for new medications and reforms regarding labeling and advertising. The Durham-Humphrey Amendment 1951 established the prescription-only drug classification but does not relate to orphan drugs or their development incentives. Thus, the Orphan Drug Act is the clear choice as it directly targets the challenges associated with orphan drug development.

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