Orphan Drug Act of 1983

• Orphan drugs are theoretically developed for the treatment of rare disorders that have a narrow clinical scope and limited economic prospects

  • fewer than 200,000 individuals affected in the USA
  • domestic sales would not recoup development costs

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These features create important disincentives for manufacturers.

The largest disincentive relates to the size of the marketavailable for orphan products.

Because the market generated by potential users is small, recovering the high costs of research and development is difficult.