Orphan Drug Amendments of 1990

Summary

Orphan Drug Amendments of 1990 - Amends provisions of the Federal Food, Drug, and Cosmetic Act (FDCA) relating to designation of drugs for rare diseases or conditions to require that the number of people affected be determined three years after the request for designation as well as on the date of the request. Creates additional exceptions from the protection of exclusive approval, certification, or license for drugs for rare diseases for: (1) drugs which qualified for protection because the disease or condition for which they are used affected less than a specified number of persons, but which have ceased to so qualify; and (2) drugs which were developed simultaneously. Requires that designation of a drug be published in the Federal Register and otherwise made available to the public in a manner designed to notify persons who have the disease or condition involved. Amends the Public Health Service Act to replace provisions establishing the Orphan Products Board with provisions establishing under the Assistant Secretary for Health the Office for Orphan Diseases and Conditions. Expands the functions of the Office (previously the Board) to include medical foods as well as drugs and devices. Establishes an advisory committee to advise the Office. Amends the FDCA to authorize appropriations for grants and contracts for development of drugs for rare diseases and conditions.

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2 official files

• Introduced in Senate (text)

  Introduced in Senate · EN

  ViewDownloadOpen at official source

• Introduced in Senate

  summary · EN · 3 May 1990

  Open at official source

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