Orphan Drug Amendments of 1992

Summary

Orphan Drug Amendments of 1991 - 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 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. Provides for the termination of orphan drug status for drugs having cumulative sales over a certain amount, provided the costs of developing the drug in the United States are not over the same amount. Amends the Public Health Service Act to replace provisions establishing the Orphan Products Board with provisions establishing the Office for Orphan Diseases and Conditions. Includes in the functions of the Office dealing with drugs, devices, and medical foods (currently, the Board deals with drugs and devices). Establishes an advisory committee within 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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Documents

4 official files

• Reported to Senate (text)

  Reported to Senate · EN

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• Introduced in Senate (text)

  Introduced in Senate · EN

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• Reported to Senate with amendment(s)

  summary · EN · 4 August 1992

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• Introduced in Senate

  summary · EN · 26 November 1991

  Open at official source

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