DRUG INDUSTRY

Addresses

Shaping Tomorrow Today: Charles M. West, 7206-7207 [10AP]

Amendments

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

Articles and editorials

Biotechnology Industry (excerpt), 10330 [12MY]

Confronting the Other Drug Problem, 29178 [7OC]

Cost of Exporting Trouble, 10327 [12MY]

Exporting Trouble, 10328 [12MY]

FDA Politicization Called Hazardous to Health, 791 [29JA]

Firm Will Nearly Triple Price of DPT Vaccine—Lederle Blames Liability Problems, 12272 [3JN]

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

What's at Stake—Immediate Case for Animal Research, 31340 [15OC]

Who Will Live, Who Will Die, 31336-31340 [15OC]

Bills and resolutions

Animal Drug Amendments and Patent Term Restoration Act: enact (see S. 2407)

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

———extend patents for animal drug products (see H.R. 5069)

Bacteria: EPA standards for antimicrobial agents used to control pest microorganisms (see S. 2659; H.R. 5458)

Bovine growth hormone: condition for approval (see H.R. 5122)

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

Crime and criminals: penalties for intentional poisoning or adulteration of food and drugs (see H.R. 4481)

Cyanide: protection against wrongful use (see S. 2704)

Cyclosporine: duty-free treatment (see H.R. 5034)

Drug samples: restrictions (see H.R. 4820)

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

FDA: establish statute by law (see S. 2154)

———reclassification of transitional devices (see S. 2771)

Foreign trade: ban reimportation of drugs produced in U.S. (see S. 2875; H.R. 4820)

Hospitals: ban certain resales of drugs (see H.R. 4820)

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

Medicare: additional insurance options for coverage of certain gaps (see H.R. 5320)

New drug application: 7-year exclusive marketing privilege for other companies due to simultaneous development (see S. 2772)

Samples: restrictions (see S. 2875)

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

Transplantation of organs: immunosuppressive drugs (see H.R. 5146)

Letters

Commendation of Pharmaceutical Manufacturers Association: Africare (organization), 14831 [20JN]

Tax credit for clinical testing of orphan drugs: Dept. of HHS, 14362 [18JN]

U.S. export of untested drugs: sundry, 10040-10046 [8MY]

Memorandums

Tax Credit for Clinical Testing of Orphan Drugs: Fairlea Sheehy, 14363 [18JN]

Remarks in House

Alkyl nitrites: require to be treated as a drug (H.J. Res. 660), 14470 [18JN]

Childhood Vaccine Protection Act: enact (H.R. 5260), 18030 [29JY]

Cyclosporine: suspension of duty (H.R. 5034), 13894 [16JN]

Drug Export Amendments Act: enact (S. 1744), 33932 [6NO]

FDA: Center for Devices and Radiological Health, 12019 [22MY]

Generic Animal Drug and Patent Term Restoration Act: enact (H.R. 5069), 14870 [20JN]

Prescription Drug Marketing Act: enact (H.R. 4820), 10722 [14MY]

Upjohn Pill and Granule Co.: anniversary, 11115 [15MY]

Remarks in Senate

Animal Drug Amendments and Patent Term Restoration Act: enact (S. 2407), 9652 [6MY]

Bacteria: EPA standards for antimicrobial agents used to control pest microorganisms (S. 2659), 17108 [21JY]

Dept. of HHS: establish fee for new drug applications (S. 2739), 20923 [12AU]

Developing countries: requirements relative to exports, 10576 [14MY]

Drugs: establish fee for new drug applications (S. 2739), 20923 [12AU]

EPA: study distribution of cyanide, 26772 [27SE]

———study distribution of cyanide (S. 2704), 18428 [31JY]

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

FDA: establish by law, 10574 [14MY]

———reclassification of transitional devices (S. 2771), 21932 [15AU]

Foreign trade: export of certain antibiotics, 10383 [13MY]

———export of drugs unapproved by FDA (S. 1848), 1933 [6FE]

———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]

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

Laboratories: animal rights and need for research, 31336 [15OC]

New drug application: 7-year marketing privilege for other companies due to simultaneous development (S. 2772), 21933 [15AU]

Pharmaceutical Manufacturers Association: tribute, 14831 [20JN]

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

Tariff: suspend duty on terfenadone (S. 2509), 12240 [3JN]

Taxation: credit for clinical testing of orphan drugs, 14362-14363 [18JN]

Reports

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

Reports filed

Animal Drug Amendments and Patent Term Restoration Act: Committee on Labor and Human Resources (S. 2407) (S. Rept. 99-448), 23819 [17SE]

Statements

Biotechnology Industry: Harvey Price, 10330 [12MY]

Foreign Shipments of Unauthorized Drugs: FDA, 10397 [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]

Summaries

New Drug Application Fee Amendments (S. 2739), 20924 [12AU]

Testimonies

Childhood Vaccine Protection Act: Representative Bill Young, 18030 [29JY]

Texts of

H.J. Res. 660, require alkyl nitrites to be treated as a drug, 14471 [18JN]

H.R. 4820, Prescription Drug Marketing Act, 10722 [14MY]

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

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

S. 2407, Animal Drug Amendments and Patent Term Restoration Act, 9652-9656 [6MY]

S. 2704, EPA study on distribution of cyanide, 18428 [31JY]

S. 2739, establish fee for new drug applications to the Dept. of HHS, 20923 [12AU]

S. 2771, reclassification of transitional devices, 21933 [15AU]

S. 2772, Orphan Drug Act amendments, 21934 [15AU]

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