Bill summaries are authored by CRS.

Shown Here:
Passed Senate amended (05/14/1986)

(Measure passed Senate, amended, roll call #99 (91-7))

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: (1) assure consistency of labeling information; (2) obtain information on such drugs, including their legal status in the U.S.; and (3) monitor and remove from the market drugs presenting a serious safety problem. Permits shipments to nonlist countries if differing health conditions in such countries 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 Secretaries to notify the countries involved and the U.S. shipper whenever a drug is shipped to an importer who then ships such drug to a country where such drug is not authorized and presents an imminent health hazard. Requires the Secretaries to prohibit shipments to importers who continue unauthorized shipments.

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.

Eliminates any limitation on the use of alcohol in confectionary.

Revises infant formula manufacturer distribution recordkeeping requirements. Revises regulatory authority to: (1) require the Secretary of Health and Human Services to prescribe quality control regulations (under current law such prescription is discretionary); and (2) require regular independent audits and predistribution testing of each batch of formula.

Requires the application notifying the Secretary of changes in formulation or processing to be made before distribution (rather than before processing as provided under current law) and to include full testing reports and records.

Requires a manufacturer to notify the Secretary of nutritional inadequacy, adulteration, or misbranding of formula whether or not such discrepancies present a risk to human health and to immediately start a recall.

Requires the Director of the Office of Management and Budget to prepare an annual report for the Department of State for transmittal to foreign governments concerning Federal agency actions taken concerning banned or severely restricted substances. Prohibits the export of such substances without notice and clearance from the Federal agency responsible and the country of destination. Includes among such substances: (1) adulterated food; (2) ulterated, misbranded, unapproved new, or unapproved new animal drugs; (3) uncertified antibiotic or insulin-containing drugs; (4) adulterated, misbranded or otherwise unapproved devices; (5) adulterated cosmetics; (6) unsafe food or color additives; (7) biological products from unlicensed establishments; (8) specified electronic and consumer products in violation of specified Federal laws or standards; (9) fabric or products in noncompliance with flammability standards; (10) banned hazardous substances under the Federal Hazardous Substances Act; (11) certain pesticides; and (12) certain toxic chemicals.

Establishes the Food and Drug Administration in the Department of Health and Human Services, to be headed by a Commissioner of Food and Drugs appointed by the President with the advice and consent of the Senate.