Summary: H.R.4638 — 101st Congress (1989-1990)All Information (Except Text)

Bill summaries are authored by CRS.

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Passed Senate amended (10/12/1990)

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.

Directs the Secretary of Health and Human Services to request the Institute of Medicine of the National Academy of Sciences to enter into a contract to study the effect caused by this Act on the development of drugs for rare diseases or conditions. Declares that, if the Institute declines to conduct such study, the Secretary shall conduct the study through another public or nonprofit entity.

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 FY 1991 through 1993 for grants and contracts, under provisions for development of drugs for rare diseases and conditions.