H.R. 399599th CongressHouse Bill

Pharmaceutical Export Amendments of 1986

Introduced in the HouseDead

This bill died when its Congress ended.

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Pharmaceutical Export Amendments of 1986 - 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 if differing health conditions there 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 conditions prevalent in a developing country among the criteria for orphan drugs.

Introduced Dec 19, 1985
1
Introduced

Filed in the House

2
Passed House
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Passed Senate
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Became Law

This house bill has been filed and is working its way through Congress. It will need to pass both the House and the Senate, then be signed by the President to become law.

Who introduced this

EM

Edward Madigan

Republican

U.S. Representative · IL-15

Bipartisan — 74 cosponsors (27 D, 47 R)

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