FOOD AND DRUG ADMINISTRATION

Addresses

Young People and Tobacco: David A. Kessler, S5915-S5917 [1MY]

Amendments

Agriculture, rural development, FDA, and related agencies programs: authorizing appropriations (H.R. 1976), S13694, S13696, S13697, S13699, S13701, S13702, S13711, S13718, S13744 [18SE], S13806, S13808, S13816, S13817, S13820, S13830, S13833, S13834, S13837, S13838, S13839, S13867, S13868 [19SE], S13912, S13914 [20SE], H6736 [10JY], H6831 [11JY], H6913, H6914 [12JY], H7012, H7013 [13JY], H7068 [17JY], H7179, H7180 [18JY], H7248, H7257, H7258 [19JY], H7311, H7315, H7318, H7319, H7322, H7331, H7332, H7333, H7334, H7337, H7338, H7346, H7354, H7357, H7358, H7359, H7363, H7368, H7371, H7373, H7374 [20JY], H7414, H7415, H7416, H7427, H7429, H7431 [21JY]

Appointments

Conferees: H.R. 1976, agriculture, rural development, FDA, and related agencies programs appropriations, S13919 [20SE], H9328 [20SE]

Articles and editorials

Alzheimer's Patients Need FDA Reform, E1932 [12OC]

Battle Over Bonanza for Drug Companies, S15426 [23OC]

Costly Oversight—Fine Print in GATT Law Could Cost Zantac Users Millions, S18202 [7DE]

Drug Company Preserves Tax Break in Senate Committee, S15425 [23OC]

Drug Firms at Odds Over Patent Extension, S15427 [23OC]

Drug Firms Fight To Preserve Windfall, S15425 [23OC]

Drugs Get Extra Patent Time, S15424 [23OC]

Fair's Fair on Fowl, S13764 [19SE]

FDA's ``Caution'' Is Killing People, E1273 [16JN]

GATT Delayed New Generic Drugs, S15429 [23OC]

GATT Puts Generic Drugs on Hold, S15429 [23OC]

Generic-Drug Talks Stall in Committee, S15425 [23OC]

Glaxo Rolls Out ``Big Bucks'' Card in GATT Battle on Capitol Hill, S15427-S15429 [23OC]

Ruling Shortens Branded Drugs' Monopoly, S15430 [23OC]

Senate Panel—No Vote on Drug Loophole, S15426 [23OC]

Senator From Glaxo?, S15426 [23OC]

Simpson Abstains Because of Stock, S15424 [23OC]

Three Drug Makers Win Suit To Extend Protection of Patents, S15422 [23OC]

Zantac Windfall, S18203 [7DE], E2436 [21DE]

Bills and resolutions

Agriculture, rural development, FDA, and related agencies programs: authorizing appropriations (see H.R. 1976), H6697 [30JN]

———authorizing appropriations (H.R. 1976), consideration (see H. Res. 188, 235), H6913 [12JY], H9737 [29SE]

Animals: improve animal drug approval process (see S. 773; H.R. 2508), S6337 [9MY], H10484 [19OC]

Blood Products Advisory Committee: increase the voting consumer representation (see H.R. 1021), H2176 [23FE]

Drugs: ensure availability of generic drugs (see S. 1191), S12370 [11AU]

———establish Federal standards to ensure integrity of testing programs (see H.R. 153, 1706), H167 [9JA], H5571 [24MY]

———reporting requirements on deaths resulting from the prescribing, dispensing, or administration of drugs (see H.R. 1914), H6269 [22JN]

———revise drug approval process (see H.R. 1742), H5622 [6JN]

Food: labeling of pesticide use (see H.R. 1771), H5690 [7JN]

Foreign trade: expand authority for the export of drugs or medical devices (see S. 572, 593; H.R. 1300), S4094 [16MR], S4365 [22MR], H3572 [22MR]

Health: accessibility of alternative treatments and medicines (see S. 1035; H.R. 2019), S9998 [14JY], H6913 [12JY]

———allow marketing of Sensor Pad medical device to aid in breast self-examination (see H.R. 2753), H14239 [7DE]

———approval of the Sensor Pad medical device to aid in breast self-examination (see H.R. 2752), H14239 [7DE]

Health care professionals: facilitate the dissemination to physicians of scientific information on drug therapies and medical devices (see S. 1197), S12370 [11AU]

Medical devices: facilitate the approval process (see S. 1369), S16421 [31OC]

Patents: extend protection for nonsteroidal anti-inflammatory drug (see H.R. 2467), H9897 [11OC]

———extend protection for nonsteroidal anti-inflammatory drugs (see S. 1496), S19110 [21DE]

Pesticides: reform registration of antimicrobial pesticides (see S. 1491), S18999 [20DE]

Pharmaceuticals: improve the regulation of drugs (see H.R. 1995), H6698 [30JN]

———provide equitable relief for the generic drug industry (see S. 1277), S14408 [27SE]

Sports: prohibit regulation of sponsorship or advertising relative to rodeo events (see S. 1453), S18232 [7DE]

Tobacco products: establish Federal authority to regulate tobacco and other nicotine containing products (see H.R. 2414), H9670 [28SE]

———prohibit regulation of tobacco industry (see H.R. 2283), H8684 [7SE]

Water: bottled water contaminant level requirements (see S. 412), S2647 [14FE]

———modify bottled drinking water standards (see H.R. 2601), H12084 [9NO]

Women: establish offices of women's health within certain Federal agencies (see S. 427; H.R. 1736), S2822 [16FE], H5608 [25MY]

Conference reports

Agriculture, Rural Development, FDA, and Related Agencies Programs Appropriations (H.R. 1976), H9628-H9638 [28SE]

Letters

Agricultural export programs: Dan Glickman, Sec. of Agriculture, H7376 [20JY]

Agriculture, rural development, FDA, and related agencies programs appropriations: Representative Roberts, Committee on Agriculture (House), S13917 [20SE]

Consumer Access to Prescription Drugs Act, S12390 [11AU]

———Jesse Brown, Sec. of Veterans Affairs, S12391 [11AU]

———Jim Firman, Generic Drug Equity Coalition, S12391 [11AU]

———Michael Kantor, U.S. Trade Representative, S12390 [11AU]

FDA regulations on drugs and devices: John D. Siegfried, Pharmaceutical Research and Manufacturers of America (organization), S6453 [10MY]

———National Family Planning and Reproductive Health Association, S6454 [10MY]

———several former Chief Counsels of the FDA, S6454 [10MY]

GATT implementation relative to generic drugs: C. Everett Koop, S18104 [6DE], S18209, S18211 [7DE]

———Clayton Yeutter, S18213 [7DE]

———Daniel Perry, Alliance for Aging Research, S18206 [7DE]

———Eugene P. Schonfeld, National Kidney Association, S18205 [7DE]

———Judith Simpson, United Patients' Association for Pulmonary Hypertension, Inc., S18205, S18212 [7DE]

———Leon Brittan, European Commission, S18213 [7DE]

———Patti Munter, National Organization on Fetal Alcohol Syndrome, S18205 [7DE]

———Robert J. Beall, Cystic Fibrosis Foundation, S18205 [7DE]

———Senators Dodd and Hatch, S18211 [7DE]

———several Senators, S18210 [7DE]

———William Brock, S18213 [7DE]

Pharmaceutical patent extension: Cynthia Pearson, National Women's Health Network, S15430 [23OC]

———Edmund Mierzwinski, U.S. Public Interest Research Group, S15431 [23OC]

———Esther Peterson and Edmund H. Worthy, Jr., United Seniors Health Cooperative, S15431 [23OC]

———James Firman, Generic Drug Equity Coalition, S15430 [23OC]

———James Firman, National Council on the Aging, Inc., S15430 [23OC]

———James P. Love, Consumer Project on Technology, S15432 [23OC]

———Jordan Clark, United Homeowners Association, S15432 [23OC]

———Karen Fennell, American College of Nurse-Midwives, S15431 [23OC]

———Kim Youngblood, National Black Women's Health Project (organization), S15431 [23OC]

———Martha A. McSteen, National Committee To Preserve Social Security and Medicare, S15431 [23OC]

———Max Starkloff, Paraquad Inc., S15432 [23OC]

———Mern Horan, Consumer Federation of America, Gene Kimmelman, Consumers Union, and Cathy Hurwit, Citizen Action (organization), S15430 [23OC]

———Michael Calabrese, Public Citizen (organization), S15431 [23OC]

———Michael Kantor, U.S. Trade Representative, S15423 [23OC]

———Richard Fitzpatrick, National Coalition for Homeless Veterans, S15432 [23OC]

Standards for labeling poultry: Ann R. Stasch, S13759 [19SE]

———several Senators, S13757 [19SE]

Lists

Generic Drug Equity Coalition, S12391 [11AU]

Memorandums

Standards for Labeling Poultry: Matthew Sloan, S13763 [19SE]

Messages

Radiation Control for Health and Safety Act: President Clinton, S1757 [30JA], H884 [30JA]

Motions

Agriculture, rural development, FDA, and related agencies programs: authorizing appropriations (H.R. 1976), S13805, S13820 [19SE], H9327 [20SE], H9921 [12OC]

Papers

Background on the Impact of GATT Patent Extensions on the Potential Availability of Generic Zantac, S18826 [18DE]

Remarks in House

Agriculture: limitation on subsidies for certain income levels, H7362-H7367 [20JY]

———market promotion program for sale or export of alcohol or alcoholic beverages, H7429-H7431 [21JY]

———tribute to tobacco farmers, H7080 [18JY]

Agriculture, rural development, FDA, and related agencies programs: authorizing appropriations (H.R. 1976), H7083, H7135 [18JY], H7239, H7240-H7250 [19JY], H7262, H7307-H7377 [20JY], H7412-H7446 [21JY], H7543-H7548 [24JY], H9327 [20SE], E1517 [26JY], E1538, E1539, E1541, E1552 [28JY]

———authorizing appropriations (H.R. 1976), conference report, H9905-H9922 [12OC], E1941 [12OC], E1975 [18OC]

———authorizing appropriations (H.R. 1976), consideration (H. Res. 188), H7017-H7021 [17JY]

———authorizing appropriations (H.R. 1976), consideration of conference report (H. Res. 235), H9904, H9905 [12OC]

———authorizing appropriations (H.R. 1976), motion to instruct conferees, H9327 [20SE]

Animals: improve animal drug approval process (H.R. 2508), E1993 [20OC]

Appropriations: funding for research of childhood diseases, H485 [23JA]

Courts: liability of drugs or medical devices approved by the FDA, H2941-H2948 [9MR]

Crime: investigation of counterfeit baby formula, H1748 [14FE]

Dept. of Agriculture: construction funding, H7373, H7374 [20JY]

———market promotion programs personnel salary funding, H7427-H7429, H7431-H7435 [21JY]

Diseases: approval of the use of Hydroxyurea relative to sickle cell anemia, H976 [1FE]

Drugs: approval process, H6683 [30JN]

———availability of generic Zantac, E2435 [21DE]

———reporting requirements on deaths resulting from the prescribing, dispensing, or administration of drugs (H.R. 1914), E1321 [22JN]

———revise drug approval process, H5686 [7JN], E1273 [16JN], E1932 [12OC]

———revise drug approval process (H.R. 1742), E1157 [6JN]

Health: accessibility of alternative treatments and medicines (H.R. 2019), E1424 [12JY]

Insurance: cancer coverage reform, E2042 [26OC]

Maryland: relocation of operations, H957 [31JA]

Native Americans: Indian reservation food programs, H7376 [20JY]

Public buildings: funding for construction of a buildings complex for FDA consolidation, H7200-H7206 [19JY]

Tobacco products: authority, E1656 [5AU]

———classification of nicotine as a drug, H7155 [18JY]

———prohibit regulation of tobacco industry (H.R. 2283), E1736 [7SE]

———regulation of tobacco industry to alleviate health risks to children, H7470-H7476 [24JY], H7993, H8007-H8010 [31JY], H11834, H11908 [8NO], E1649, E1658 [5AU]

Women: establish offices of women's health within certain Federal agencies (H.R. 1736), E1145 [26MY]

Remarks in Senate

Agriculture, rural development, FDA, and related agencies programs: authorizing appropriations (H.R. 1976), S12367 [11AU], S13653 [15SE], S13680-S13708, S13710-S13724 [18SE], S13752, S13804-S13810, S13814-S13841 [19SE], S13911-S13919 [20SE]

———authorizing appropriations (H.R. 1976), conference report, S15097-S15100 [12OC], S15501 [23OC], S17513 [27NO]

———authorizing appropriations (H.R. 1976), unanimous-consent agreement, S13883 [20SE]

Animals: improve animal drug approval process (S. 773), S6351, S6352 [9MY]

Board of Tea Experts: funding, S13694-S13699 [18SE], S19196, S19197, S19205 [22DE]

Conservation of energy: require agencies to implement measures to reduce energy consumption, S13806 [19SE], S14384 [27SE]

Dept. of Agriculture: transportation and categorization of poultry, S13756-S13770, S13804, S13805 [19SE]

Drugs: availability of generic Zantac, S18826 [18DE]

———ensure availability of generic drugs (S. 1191), S12388 [11AU], S15421 [23OC], S16593 [2NO]

Foreign trade: expand authority for the export of drugs or medical devices (S. 572), S4104 [16MR]

———expand authority for the export of drugs or medical devices (S. 593), S4374-S4376 [22MR]

———expand authority for the export of pharmacological and biological products, and medical devices, S10748, S10749, S10751 [27JY]

GATT: implementation relative to generic drugs, S15421 [23OC], S16593 [2NO], S18004 [5DE], S18199-S18222 [7DE]

Government regulations: reform regulatory process (S. 343), S9830-S9832 [13JY]

Health: accessibility of alternative treatments and medicines (S. 1035), S9999-S10002 [14JY]

Health care professionals: facilitate the dissemination to physicians of scientific information on drug therapies and medical devices (S. 1197), S12401-S12403 [11AU]

Medical devices: facilitate the approval process (S. 1369), S16422 [31OC]

Patents: extend protection for nonsteroidal anti-inflammatory drugs (S. 1496), S19117 [21DE]

Pesticides: reform registration of antimicrobial pesticides (S. 1491), S19009 [20DE]

Sports: prohibit regulation of sponsorship or advertising relative to rodeo events (S. 1453), S18233 [7DE]

Tobacco industry: regulation, S13919, S13920 [20SE]

Water: bottled water contaminant level requirements (S. 412), S2656, S2657 [14FE]

———regulations relative to contaminants in bottled drinking water, S9975 [14JY]

Women: establish offices of women's health within certain Federal agencies (S. 427), S2823 [16FE]

Reports filed

Agriculture, Rural Development, FDA, and Related Agencies Programs Appropriations: Committee of Conference (H.R. 1976) (H. Rept. 104-268), H9670 [28SE]

———Committee on Appropriations (House) (H.R. 1976) (H. Rept. 104-172), H6697 [30JN]

———Committee on Appropriations (Senate) (H.R. 1976) (S. Rept. 104-142), S13620 [14SE]

Consideration of H.R. 1976, Agriculture, Rural Development, FDA, and Related Agencies Programs Appropriations: Committee on Rules (House) (H. Res. 188) (H. Rept. 104-185), H6913 [12JY]

———Committee on Rules (House) (H. Res. 235) (H. Rept. 104-261), H9737 [29SE]

FDA Food Additive Review Process—Backlog and Failure to Observe Statutory Deadline: Committee on Government Reform and Oversight (House) (H. Rept. 104-436), H15574 [21DE]

Rulings of the Chair

Agriculture, rural development, FDA, and related agencies programs: authorizing appropriations (H.R. 1976), H7347 [20JY]

Summaries

Consumer Access to Prescription Drugs Act (S. 1191), S12390 [11AU]

Economic Impact of GATT Patent Extension on Currently Marketed Drugs: University of Minnesota College of Pharmacy, S15424 [23OC]

Tables

Agriculture, rural development, FDA, and related agencies programs appropriations (H.R. 1976), H7436, H7443 [21JY], H9913-H9920 [12OC]

Committee on the Budget (Senate) scoring of H.R. 1976, conference report on agriculture, rural development, FDA, and related agencies programs appropriations, S15100 [12OC]

Texts of

H. Res. 188, consideration of H.R. 1976, agriculture, rural development, FDA, and related agencies programs appropriations, H7017 [17JY]

H. Res. 235, consideration of conference report on H.R. 1976, agriculture, rural development, FDA, and related agencies programs appropriations, H9904 [12OC]

H.R. 1976, agriculture, rural development, FDA, and related programs appropriations, S13680-S13690 [18SE]

S. 1035, Access to Medical Treatment Act, S10000 [14JY]

S. 1191, Consumer Access to Prescription Drugs Act, S12389 [11AU]

S. 1197, facilitate the dissemination to physicians of scientific information on drug therapies and medical devices, S12401 [11AU]

S. 1369, Medical Technology, Public Health, and Innovation Act, S16422-S16425 [31OC]

S. 1453, Rodeo Freedom Act, S18233 [7DE]

Transcripts

Pharmaceutical Patent Extension: Lisa Meyers, NBC Nightly News, S15426 [23OC]