FEDERAL FOOD, DRUG, AND COSMETIC ACT

Amendments

Drug industry: establish conditions for exports (S. 1848), 2741-2744 [25FE], 4086 [7MR], 10302, 10333, 10336 [12MY], 10390, 10393, 10396, 10428 [13MY], 10571, 10574, 10576, 10629, 10630 [14MY]

Analyses

Food Safety Modernization Act (S. 2512), 12488-12491 [4JN]

Articles and editorials

Biotechnology Industry (excerpt), 10330 [12MY]

Cost of Exporting Trouble, 10327 [12MY]

Exporting Trouble, 10328 [12MY]

Should the FDA Regulate the Rest of the World?, 10332 [12MY]

Bills and resolutions

Alkyl nitrites and their isomers: treatment as drugs (see H.J. Res. 660)

Animals: authorize abbreviated new drug applications (see H.R. 5069)

Commissioner of Food and Drugs: appointment (see S. 2025)

Drug industry: ban reimportation of drugs produced in U.S. (see S. 2875)

———restrictions on samples (see S. 2875)

Drugs: fees for review of applications for marketing approval (see S. 2739)

FDA: Senate confirmation of Commissioner (see H.R. 4754)

Foreign trade: ban reimportation of drugs produced in U.S. (see H.R. 4820)

Hospitals: ban certain resales of drugs purchased by medical facilities (see S. 2875)

Irradiated food: labeling (see H.R. 4762)

Medical instruments and apparatus: improve regulations (see H.R. 5516)

Tax-exempt organizations: registration when providing medical care and prescription drugs (see H.R. 4482)

Letters

Food safety standards: AMA, 12483 [4JN]

Infant formula regulations: Carol Laskin and Lynne Pilot (excerpt), 10334 [12MY]

Lists

Problems with infant formulas since 1982: Formula (organization), 10334 [12MY]

Memorials of legislature

California, 27266 [30SE], 27551 [1OC]

Remarks in House

Commissioner of Food and Drugs: require appointment to be subjected to Senate confirmation (H.R. 4754), 23370 [16SE]

Remarks in Senate

Drug industry: establish conditions for exports (S. 1848), 2744 [25FE], 10028-10051, 10060 [8MY], 10326-10337 [12MY], 10376-10401 [13MY], 10571 [14MY]

———obtain information about the export of drugs, 10336 [12MY]

———prohibit shipment to U.S. if drug is found to be present in a country to which shipment is not authorized, 10395-10399 [13MY]

———reform certain regulatory procedures governing the export of banned and severely restricted substances, 10393-10395 [13MY]

———require that any unapproved drug must be subject to new drug application, 10391-10393 [13MY]

———require that the same conditions apply to the export of antibiotic drugs as apply to other drugs, 10336 [12MY]

———requirements relative to exports to developing countries, 10576 [14MY]

———study of labeling for foreign produced drugs, 10571 [14MY]

Drugs: export of biologics, 33887 [6NO]

Food Safety Modernization Act: enact (S. 2512), 12482 [4JN]

Infant formulas: requirements, 10333-10336 [12MY]

Prescription Drug Marketing Act: enact (S. 2875), 25848-25851 [24SE]

Reports

Competitive Assessment of the U.S. Pharmaceutical Industry: Dept. of Commerce (excerpt), 10329 [12MY]

Export of Unapproved Antibiotics: Committee on Labor and Human Resources (excerpt), 10386 [13MY]

Pharmaceutical Export Amendments: sundry, 10386 [13MY]

Resistance of Bacteria to Antibacterial Agents: sundry, 10387 [13MY]

Statements

Biotechnology Industry: Harvey Price, 10330 [12MY]

Food Safety Standards: AMA, 12483-12486 [4JN]

Foreign Shipments of Unauthorized Drugs: FDA, 10397 [13MY]

Indiscriminate Use of Antimicrobial Drugs: WHO, 10384 [13MY]

Infant Formula Regulations: sundry, 10379 [13MY]

U.S. Export of Untested Drugs: Alexander M. Schmidt (excerpt), 10385 [13MY]

———Australian Conference for Overseas Aid, 10040 [8MY]

———Australian Ministry, 10037 [8MY]

———Chinese Dominican General Vicariate, 10040 [8MY]

———Coordinating Committee for Primary Health Care of Thai NGOs, 10040 [8MY]

———David B. Sharrock, 10330 [12MY]

———European Economic Community Commission, 10037 [8MY]

———FDA, 10383, 10391 [13MY]

———Federation of Malaysian Consumers Association, 10037 [8MY]

———Frank E. Young, 10391 [13MY]

———Health Action International, 10039, 10040 [8MY]

———Histadrut Consumers Protection Authority, Israel, 10038 [8MY]

———International Chemical Workers Union, 10329 [12MY]

———International Organization of Consumer Unions, Netherlands, 10038 [8MY]

———Israeli Consumers Association, 10039 [8MY]

———Kalpavriksh Environmental Action Group, India, 10038 [8MY]

———Kimidi Multi-Sectoral Development Society, 10039 [8MY]

———Member of Australian Parliament, 10037 [8MY]

———Richard M. Furland, 10330 [12MY]

———sundry, 10377, 10378 [13MY]

———U.N., 10385 [13MY]

———University College of London, 10037 [8MY]

———Voluntary Health Association of India, 10038, 10040 [8MY]

U.S. Pharmaceutical Companies Committed To Carrying Out Research Toward Developing Tropical Disease Drugs: OTA, 10034 [8MY]

Use of Antibiotics in the Third World: NIH (excerpt), 10387 [13MY]

Testimonies

Food Safety Standards: Arthur H. Haves, 12482 [4JN]

———Donald Kennedy, 12482 [4JN]

———Fred Robbins, 12482 [4JN]

———Gerald Wogan, 12482 [4JN]

———Jere Govan, 12482 [4JN]

———Kenneth D. Fisher, 12482 [4JN]

———Paul Newberne, 12482 [4JN]

———Vincent DeVita, 12482 [4JN]

Texts of

H.R. 4754, amend, to require appointment of Commissioner of Food and Drugs to be subject to Senate confirmation, 23370 [16SE]

S. 1848, establish conditions for drug exports, 10583 [14MY]

S. 1848, establish conditions for drug industry exports, 10028-10031 [8MY]

S. 2512, Food Safety Modernization Act, 12487 [4JN]

S. 2875, Prescription Drug Marketing Act, 25849 [24SE]