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Pharmaceutical Export Amendments of 1986

Introduced: November 13, 1985 See on congress.gov
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 Everywhere this bill has been 16 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Oct 18, 1986
Provisions of This Bill Were Incorporated in S.1744.
May 30, 1986
Referred to Subcommittee on International Economic Policy and Trade.
May 22, 1986
Referred to Subcommittee on Health and the Environment.
May 20, 1986
Referred to House Committee on Energy and Commerce.
May 20, 1986
Referred to House Committee on Foreign Affairs.
May 14, 1986
Passed Senate with amendments by Yea-Nay Vote. 91-7. Record Vote No: 99.
May 14, 1986
Passed/agreed to in Senate: Passed Senate with amendments by Yea-Nay Vote. 91-7. Record Vote No: 99.
May 14, 1986
Considered by Senate.
May 13, 1986
Considered by Senate.
May 12, 1986
Considered by Senate.
May 8, 1986
Measure laid before Senate by unanimous consent.
Dec 18, 1985
Placed on Senate Legislative Calendar under General Orders. Calendar No. 493.
Dec 18, 1985
Committee on Labor and Human Resources. Reported to Senate by Senator Hatch with an amendment in the nature of a substitute. With written report No. 99-225. Minority views filed.
Nov 19, 1985
Committee on Labor and Human Resources. Ordered to be reported with an amendment in the nature of a substitute favorably.
Nov 13, 1985
Read twice and referred to the Committee on Labor and Human Resources.
Nov 13, 1985
Introduced in Senate
 Plain-English summary Congressional Research Service

Pharmaceutical Export Amendments of 1985 - Amends the Federal Food, Drug, and Cosmetic Act to permit the export of certain drugs (including biological products) intended for human or animal use even though such drugs have not been approved or licensed for use in the United States.

Directs the Secretary of Health and Human Services to establish and update a two-tiered list of countries with adequate governmental health authorities which in the first tier includes developed regulatory procedures and tests with experienced scientific personnel and in the second tier includes sufficient ability to assure consistency of labeling information. Permits shipments to nonlist countries where differing health conditions make such shipments desirable, e.g. tropical diseases.

Permits the export of an unapproved drug to a second tier country if such drug is approved for use in any first-tier country and not banned for use in any first-tier country.

Prohibits the export of drugs denied approval on the basis of safety and efficacy or whose manufacture in the United States has been determined to be contrary to U.S. health and safety.

Sets forth other criteria and restrictions on the export of such drugs, including notice requirements on shipments and notice of and opportunity to cure deficiencies in such shipments. Permits the Secretaries of Agriculture and Health and Human Services to prohibit noncomplying shipments and shipments otherwise permitted if either Secretary determines a shipment would present an imminent hazard to the public health of the recipient country.

Requires the Comptroller General to report biennially to the Secretary of Health and Human Services and the Congress on the extent to which drugs unauthorized for a country are being received by such country and the extent to which labeling is consistent.

Directs the Secretary to contract for a study to be submitted to the Congress within five years on the economic and international health impact of this Act.

Includes condition prevalent in a developing country among the criteria for orphan drugs.

What's happening now October 18, 1986

Provisions of This Bill Were Incorporated in S.1744.

 Committees of jurisdiction 5
 Cosponsors 1
All 1 Republican 1