To revise the orphan drug provisions of the Federal Food, Drug, and Cosmetic Act and the Orphan Drug Act, and for other purposes.
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.
Committee on Labor and Human Resources. Ordered to be reported with an amendment in the nature of a substitute favorably.
Motion to reconsider laid on the table Agreed to without objection.
Received in the Senate and read twice and referred to the Committee on Labor and Human Resources.
Senate Committee on Labor and Human Resources discharged by Unanimous Consent.
Senate Committee on Labor and Human Resources discharged by Unanimous Consent.
Amendment SP 2977 proposed by Senator Armstrong for Senator Hatch.
Amendment SP 2977 agreed to in Senate by Voice Vote.
Passed/agreed to in Senate: Passed Senate with an amendment by Voice Vote.
Passed Senate with an amendment by Voice Vote.
Message on Senate action sent to the House.
Mr. Waxman moved that the House suspend the rules and agree to the Senate amendment.
Mr. Bliley demanded a second on the motion to suspend the rules. Without objection a second was ordered.
DEBATE - The House proceeded with forty minutes of debate.
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Resolving differences -- House actions: On motion that the House agree to the Senate amendment Agreed to by voice vote.
On motion that the House agree to the Senate amendment Agreed to by voice vote.
Motion to reconsider laid on the table Agreed to without objection.
Measure Signed in Senate.
Presented to President.
Presented to President.
Pocket Vetoed by President.
Pocket Vetoed by President.