FOOD AND DRUG ADMINISTRATION

Amendments

Agriculture, rural development, FDA, and related agencies programs: making appropriations (H.R. 4461), S7167 [18JY], S7193, S7195, S7218, S7246, S7247, S7248, S7249, S7250, S7259, S7260, S7263 [19JY], S7307, S7314, S7325, S7332, S7334, S7337, S7342, S7344, S7348, S7351, S7353, S7354, S7355, S7356, S7358, S7361, S7365, S7366, S7367, S7368, S7369, S7370, S7400, S7401, S7402, S7403, S7404, S7405, S7406, S7407 [20JY], S7456 [21JY], S7490 [24JY], H3413 [18MY], H3475 [19MY], H3523, H3524, H3526 [22MY], H3650 [23MY], H3814 [24MY], H3869, H3870 [25MY], H3927 [6JN], H4122 [8JN], H4221 [12JN], H4337 [13JN], H4593 [15JN], H4784 [20JN], H4818 [21JN], H5037 [22JN], H5085 [23JN], H5169 [26JN], H5241, H5242 [27JN], H5436, H5437 [28JN], H5534, H5536, H5538, H5540, H5541, H5549, H5552, H5556, H5562, H5574, H5577, H5581, H5585, H5588, H5591, H5593, H5594, H5657, H5658 [29JN], H5684, H5687, H5689, H5692, H5693, H5694, H5696, H5700, H5701, H5705, H5709, H5710, H5712, H5714, H5738 [10JY], H5773, H5775, H5776, H5777, H5779, H5787 [11JY]

———making appropriations (H.R. 4461), consideration of conference report (H. Res. 617), H9679 [11OC]

———making appropriations (S. 2536), S5364 [19JN]

Drugs: clarify certain responsibilities relative to importation of drugs into the U.S. (H.R. 3240), H5428 [28JN]

Appointments

Conferees: H.R. 4461, agriculture, rural development, FDA, and related agencies programs appropriations, H8431 [28SE]

Articles and editorials

Complex Drug Labels Bury Safety Message, E1027 [15JN]

What's So Great About Canada's Medical System?, E1460 [13SE]

Women Can't Count on the FDA, H5815 [11JY]

Bills and resolutions

Agriculture: prohibit products containing dry ultra-filtered milk or casein from being labeled domestic natural cheese (see S. 2630), S4459 [25MY] (see H.R. 4652), H4484 [14JN]

Agriculture, rural development, FDA, and related agencies programs: making appropriations (see S. 2536), S3831 [10MY] (see H.R. 4461), H3171 [16MY] (see H.R. 5426), H9504 [6OC]

———making appropriations (H.R. 4461), consideration (see H. Res. 513), H3812 [24MY] (see H. Res. 538), H5239 [27JN]

———making appropriations (H.R. 4461), consideration of conference report (see H. Res. 617), H9634 [10OC]

———making appropriations (H.R. 4461), corrections in enrollment (see H. Con. Res. 420), H9635 [10OC] (see H. Con. Res. 424), H9767 [11OC]

Animals: increase the availability of drugs for minor species and rare diseases in all animals (see S. 3169), S9944 [5OC] (see H.R. 4780), H5435 [28JN]

Children and youth: protect the health and welfare of children involved in research (see S. 2809), S6015 [28JN] (see H.R. 5198), H7722 [18SE]

Dept. of HHS: allow officers and employees to issue detention orders on certain foods (see H.R. 5591), H11445 [27OC]

Drugs: allow importation of prescription drugs into the U.S. by pharmacists and wholesalers for resale and by U.S. citizens for personal use (see S. 2520), S3691 [9MY]

———discrepancy in prescription drug prices between U.S. and foreign countries (see H. Res. 477), H2340 [13AP]

———restrict authority to issue clinical holds on investigational drugs or to deny patients expanded access to such drugs (see H.R. 3677), H509 [16FE]

Federal Food, Drug, and Cosmetic Act: clinically superior modifications to previously approved or licensed drugs (see H.R. 4242), H2122 [11AP]

———provide greater access to affordable pharmaceuticals (see S. 3051), S8585 [14SE] (see H.R. 5247), H7990 [21SE]

Food: improve safety of imported foods (see S. 2480), S3023 [27AP] (see S. 2692), S4669 [7JN]

Food industry: require Dept. of Agriculture report on safety and monitoring of genetically engineered foods (see H.R. 5095), H7209 [27JY]

———require FDA premarket review and oversight of all genetically engineered foods (see S. 3184), S10252 [11OC]

———safety of genetically engineered foods (see S. 2315), S1884 [29MR]

Government regulations: compel compliance with court decision relative to disclosure of certain information on the labeling of dietary supplements (see H.R. 4604), H4120 [8JN]

Health care professionals: establish restrictions relative to the qualifications of physicians prescribing the abortion drug known as RU-486 (see S. 3157), S9861 [4OC] (see H.R. 5385), H8799 [4OC]

Pharmaceuticals: abbreviate applications for the approval of new drugs (see H.R. 5231), H7932 [20SE]

———provide access and choice for use of generic drugs under Federal health care programs (see S. 2501), S3328 [3MY]

Seafood: establish a tolerance for the presence of methyl mercury (see H.R. 5514), H10472 [19OC]

Taxation: treatment of direct-to-consumer advertisements of prescription drugs that fail to provide certain information to the consumer (see H.R. 4686), H4591 [15JN]

Telephones: study health effects of radiofrequency emissions from wireless telephones (see H.R. 4610), H4120 [8JN]

Tobacco products: grant authority to regulate tobacco (see S. 2333), S1986 [30MR] (see S. 2379), S2347 [6AP] (see S. 2566, 2568), S4014 [16MY] (see H.R. 4042), H1163 [21MR] (see H.R. 4207), H1956 [6AP]

———increase legal age for smoking (see H.R. 4432), H2966 [11MY]

Conference reports

Agriculture, Rural Development, FDA, and Related Agencies Programs Appropriations (H.R. 4461), H9461-H9502 [6OC]

Letters

Children's Research Protection Act: David M. Krol, S6023 [28JN]

———Donald E. Cook, American Academy of Pediatrics, S6023 [28JN]

———Lawrence A. McAndrews, National Association of Children's Hospitals, S6024 [28JN]

———Raymond L. Woosley, American Society for Clinical Pharmacology and Therapeutics, S6024 [28JN]

———Sheila S. Mulvey, S6023 [28JN]

———Stephen P. Spielberg and Alan Goldhammer, Pharmaceutical Research and Manufacturers of America (organization), S6024 [28JN]

Facilitate the importation into the U.S. of certain FDA approved drugs: several Representatives, H5428 [28JN]

FDA facility construction in Los Angeles, CA: Grocery Manufacturers of America (organization), H1613 [30MR]

FDA investigation of drug manufacturer pricing practices: Representative Stark, E1656 [3OC], E1764 [12OC], E1792 [13OC]

FDA investigation of drug manufacturer pricing practices relative to Medicare and Medicaid: Fred Hassan, Pharmacia Corp., E1883 [23OC]

———Representative Stark, E2033, E2037-E2039 [31OC]

Grant FDA authority to regulate tobacco, and reduce youth smoking, increase tobacco-related research, and develop safer tobacco products: John R. Garrison, American Lung Association, E371 [21MR]

Importation of prescription drugs into the U.S. by pharmacists and wholesalers for resale and by U.S. citizens for personal use: David A. Kessler, S9258 [26SE]

———Michael E. Baroody, National Association of Manufacturers, H9702 [11OC]

———Michael M. Faenza, National Mental Health Association, H9702 [11OC]

———Mike Dugan, National Multiple Sclerosis Society, H9702 [11OC]

———Nancy Sander, Allergy and Asthma Network-Mothers of Asthmatics, Inc., H9703 [11OC]

———Representative Archer, S10685 [18OC]

———Representative Dingell, Committee on Commerce (House), S10684 [18OC]

———Representative Hyde, Committee on the Judiciary (House), S10688 [18OC]

———Senator Hatch, Committee on the Judiciary (Senate), S10688 [18OC]

———Thomas J. Donohue, U.S. Chamber of Commerce, H9702 [11OC]

———several Representatives, H9703 [11OC]

———several patient and survivor organizations, H9703 [11OC]

Medicare coverage of outpatient prescription drugs and allow importation of prescription drugs into the U.S. by pharmacists and wholesalers for resale and by U.S. citizens for personal use: President Clinton, S10524 [13OC]

Prescription drug importation into the U.S. by pharmacists and wholesalers for resale: John M. Rector, National Community Pharmacists Association, S7377 [20JY]

———Representative Dingell, S7206 [19JY]

———Ronald J. Streck, National Wholesale Druggists' Association, S7206 [19JY]

Transfer of appropriations from other Federal departments and agencies to fund Dept. of Justice litigation against tobacco industry: several veterans organizations, H4496 [15JN]

Lists

Amendments to H.R. 4461, agriculture, rural development, and FDA appropriations, S7314 [20JY]

Memorandums

Facilitate the Importation Into the U.S. of Certain FDA Approved Drugs: Christopher J. Sroka, Congressional Research Service, H5430 [28JN]

Motions

Agriculture, rural development, FDA, and related agencies programs: making appropriations (H.R. 4461), S7307, S7323, S7328, S7348 [20JY], H8426 [28SE]

Remarks in House

Agriculture: prohibit products containing dry ultra-filtered milk or casein from being labeled domestic natural cheese, H5683, H5684 [10JY]

Agriculture, rural development, FDA, and related agencies programs: making appropriations (H.R. 4461), H5442-H5460, H5533-H5598 [29JN], H5683-H5723, H5724 [10JY], H5766-H5792 [11JY], H8426 [28SE], E1169 [30JN], E1198, E1206, E1209, E1211, E1212 [11JY], E1235 [14JY], E1305 [24JY]

———making appropriations (H.R. 4461), conference report, H9638, H9639, H9681-H9709 [11OC], E1760 [12OC], E1784 [13OC], E1866 [19OC], E1891 [24OC], E1903 [25OC]

———making appropriations (H.R. 4461), consideration (H. Res. 538), H5415-H5423 [28JN]

———making appropriations (H.R. 4461), consideration of conference report (H. Res. 617), H9670-H9680 [11OC]

———making appropriations (H.R. 4461), motion to instruct conferees, H8426-H8431 [28SE]

Animals: increase the availability of drugs for minor species and rare diseases in all animals (H.R. 4780), E1146 [29JN]

Center for Veterinary Research: funding for antibiotic drugs for livestock, H5684, H5685 [10JY], H5817 [11JY], E1209 [11JY], E1760 [12OC]

Committee on Appropriations (House): appropriations allocation revisions to H.R. 4461, agriculture, rural development, FDA, and related agencies programs, H3292 [17MY]

Drugs: allow importation of prescription drugs into the U.S. by pharmacists and wholesalers for resale and by U.S. citizens for personal use, H7875 [20SE], H7937, H7938 [21SE], H8206 [27SE], H9638, H9639, H9670, H9672-H9680, H9693-H9708 [11OC], H10394 [19OC], E1866 [19OC], E1891 [24OC], E1903 [25OC]

———clarify certain responsibilities relative to importation of drugs into the U.S. (H.R. 3240), H360 [14FE], H1731 [4AP], H2096 [11AP], H2635 [8MY], H3858 [25MY], H5426-H5434 [28JN], E1235 [14JY]

———discrepancy in prescription drug prices between U.S. and foreign countries, H5427-H5433 [28JN], H5849 [12JY], H7875, H7907-H7914 [20SE], H8052, H8053 [25SE], H11753 [1NO], E1460 [13SE]

———facilitate the importation into the U.S. of certain approved drugs (H.R. 1885), H1945, H1946 [6AP], H5428, H5430 [28JN], H7913-H7915 [20SE], E1235 [14JY]

———investigation of drug manufacturer pricing practices relative to Medicare and Medicaid, E1882 [23OC], E2033, E2037 [31OC]

———prohibit funding for research, development, and approval of any drug for chemical inducement of abortion, H5693, H5694 [10JY], E1212 [11JY]

———prohibit funding to prevent importation into the U.S. of certain approved drugs, H5696-H5700, H5705-H5709 [10JY], E1198 [11JY]

———reductions in prescription drug prices, H2096 [11AP]

———restrict authority to issue clinical holds on investigational drugs or to deny patients expanded access to such drugs (H.R. 3677), E2230 [15DE]

Food: assessment of allergenicity of genetically engineered foods, H5594-H5596 [29JN]

Food industry: testing and recall of genetically engineered livestock feed sold for human consumption, H7741 [19SE]

Guam: allow importation of betel nuts from Guam, H11574 [30OC]

Health: review of immunization and vaccine programs, E2230 [15DE]

Los Angeles, CA: facility construction funding, H1611-H1614 [30MR]

Medicare: coverage of outpatient prescription drugs, H8732-H8734 [3OC]

———investigate drug manufacturer pricing practices, E1655 [3OC], E1764 [12OC]

Persian Gulf Conflict: review of Tulane University Medical School research on the presence of squalene antibodies in the blood of Persian Gulf Conflict veterans, H5534 [29JN]

Pharmaceuticals: eliminate barriers to improve access to generic drugs, H7742 [19SE], E1527, E1528, E1529 [19SE]

Public buildings: consolidation of offices funding, H6652-H6654 [20JY], E1374 [27JY]

Science: prohibit funding to vaccine-related advisory committees that grant conflicts of interest waivers, H5777-H5779 [11JY]

Seafood: establish a tolerance for the presence of methyl mercury (H.R. 5514), E1860 [19OC]

Supreme Court: decision relative to FDA jurisdiction over tobacco, H1288 [23MR]

Taxation: treatment of direct-to-consumer advertisements of prescription drugs that fail to provide certain information to the consumer (H.R. 4686), E1026 [15JN]

Telephones: study health effects of radiofrequency emissions from wireless telephones (H.R. 4610), E934 [9JN]

Tobacco products: grant authority to regulate tobacco, H7087-H7090 [26JY], E1169 [30JN]

———grant authority to regulate tobacco (H.R. 4042), H1127 [21MR], E371 [21MR]

———grant authority to regulate tobacco (H.R. 4207), H1847-H1849 [5AP], H2114 [11AP], H2503 [3MY]

———regulation of tobacco industry to alleviate health risks to children, H1847-H1849 [5AP]

Women: promote research and disseminate information on the health effects of silicone breast implants (H.R. 1323), H7562 [13SE]

Remarks in Senate

Agriculture: prohibit products containing dry ultra-filtered milk or casein from being labeled domestic natural cheese (S. 2630), S4461 [25MY], S6107 [29JN]

Agriculture, rural development, FDA, and related agencies programs: making appropriations (H.R. 4461), S6344 [10JY], S7143-S7145 [18JY], S7174, S7193-S7216, S7218 [19JY], S7303-S7308, S7310-S7349, S7351-S7379, S7387 [20JY], S7437-S7441, S7456 [21JY], S7490 [24JY], S9019, S9029, S9030 [22SE]

———making appropriations (H.R. 4461), conference report, S10063-S10065 [6OC], S10147 [10OC], S10518-S10526 [13OC], S10608-S10611 [17OC], S10648, S10669-S10701, S10732 [18OC], S10792 [19OC]

———making appropriations (H.R. 4461), conference report—unanimous-consent agreement, S10334 [12OC], S10614 [17OC]

———making appropriations (H.R. 4461), conference report—unanimous-consent request, S10229 [11OC]

———making appropriations (S. 2536), S3937 [15MY]

Animals: increase the availability of drugs for minor species and rare diseases in all animals (S. 3169), S9950 [5OC]

Children and youth: protect the health and welfare of children involved in research (S. 2809), S6021-S6025 [28JN]

Drugs: allow importation of prescription drugs into the U.S. by pharmacists and wholesalers for resale, S7142 [18JY], S7194-S7216 [19JY], S7377 [20JY]

———allow importation of prescription drugs into the U.S. by pharmacists and wholesalers for resale and by U.S. citizens for personal use, S9029 [22SE], S9255, S9258 [26SE], S10523 [13OC], S10669, S10675-S10678, S10681-S10688, S10691-S10698, S10732 [18OC]

———allow importation of prescription drugs into the U.S. by pharmacists and wholesalers for resale and by U.S. citizens for personal use (S. 2520), S3693-S3695 [9MY]

———discrepancy in prescription drug prices between U.S. and foreign countries, S2320 [6AP], S8781-S8785 [20SE]

———facilitate the importation into the U.S. of certain approved drugs, S7142 [18JY]

———facilitate the importation into the U.S. of certain approved drugs (S. 1191), S132-S134 [31JA], S707, S708 [23FE], S840 [28FE]

Food: improve safety of imported foods (S. 2692), S4685, S4689 [7JN]

Food industry: require FDA premarket review and oversight of all genetically engineered foods (S. 3184), S10253 [11OC]

———safety of genetically engineered foods (S. 2315), S1894 [29MR]

Health: adverse event monitoring system for dietary supplements funding, S7371 [20JY]

Office of Generic Drugs: funding, S7329, S7330, S7376 [20JY]

Pharmaceuticals: direct-to-consumer advertisements of prescription drugs, S11489 [1NO]

———provide access and choice for use of generic drugs under Federal health care programs (S. 2501), S3328 [3MY], S11564 [5DE]

Safety: food safety initiative activities funding, S7368, S7375 [20JY]

Tobacco products: grant authority to regulate tobacco, S2411 [7AP]

———grant authority to regulate tobacco (S. 2333), S1990-S1993 [30MR]

———grant authority to regulate tobacco (S. 2379), S2350, S2351 [6AP]

———grant authority to regulate tobacco (S. 2566), S4016-S4018 [16MY]

———grant authority to regulate tobacco (S. 2568), S4018 [16MY]

Reports

Prescription Drugs with Foreign Labels, H9674 [11OC]

Reports filed

Agriculture, Rural Development, FDA, and Related Agencies Programs Appropriations: Committee of Conference (H.R. 4461) (H. Rept. 106-948), H9504 [6OC]

———Committee on Appropriations (House) (H.R. 4461) (H. Rept. 106-619), H3171 [16MY]

———Committee on Appropriations (Senate) (S. 2536) (S. Rept. 106-288), S3831 [10MY]

Consideration of Conference Report on H.R. 4461, Agriculture, Rural Development, FDA, and Related Agencies Programs Appropriations: Committee on Rules (House) (H. Res. 617) (H. Rept. 106-953), H9634 [10OC]

Consideration of H.R. 4461, Agriculture, Rural Development, FDA, and Related Agencies Programs Appropriations: Committee on Rules (House) (H. Res. 513) (H. Rept. 106-641), H3812 [24MY]

———Committee on Rules (House) (H. Res. 538) (H. Rept. 106-704), H5239 [27JN]

National Uniformity for Food Act: Committee on Agriculture, Nutrition, and Forestry (Senate) (S. 1155) (S. Rept. 106-504), S10619 [17OC]

Rulings of the Chair

Agriculture, rural development, FDA, and related agencies programs: making appropriations (H.R. 4461), H5540, H5565 [29JN], H5689, H5690, H5692, H5711 [10JY]

Statements

Agriculture, Rural Development, FDA, and Related Agencies Programs Appropriations: OMB, S7363 [20JY]

Agriculture, Rural Development, FDA, and Related Agencies Programs Appropriations Conference Report (H.R. 4461): OMB, H9695 [11OC]

Summaries

Imported Products Safety Improvement and Disease Prevention Act (S. 2692), S4689 [7JN]

Tables

Agriculture, rural development, FDA, and related agencies programs appropriations (H.R. 4461), H5444-H5449 [29JN]

———conference report, H9682-H9689 [11OC]

Committee on the Budget (Senate) scoring of H.R. 4461, agriculture, rural development, FDA, and related agencies programs appropriations, S7376 [20JY]

Prescription drug import provisions in agriculture appropriations legislation, S10525 [13OC]

Texts of

H. Res. 538, consideration of H.R. 4461, agriculture, rural development, FDA, and related agencies programs appropriations, H5415 [28JN]

H. Res. 617, consideration of conference report on H.R. 4461, agriculture, rural development, FDA, and related agencies programs appropriations, H9670 [11OC]

H.R. 3240, Drug Import Fairness Act, H5426 [28JN]

H.R. 4461, agriculture, rural development, FDA, and related agencies programs appropriations, S7556-S7573 [25JY]

S. 2315, Genetically Engineered Food Safety Act, S1894-S1897 [29MR]

S. 2333, Tobacco Regulatory Fairness Act, S1991 [30MR]

S. 2501, Generic Pharmaceutical Access and Choice for Consumers Act, S3329-S3331 [3MY]

S. 2692, Imported Products Safety Improvement and Disease Prevention Act, S4686-S4689 [7JN]

S. 2809, Children's Research Protection Act, S6022 [28JN]

S. 3051, Greater Access to Affordable Pharmaceuticals Act, S8590 [14SE]

S. 3169, Minor Animal Species Health and Welfare Act, S9951-S9955 [5OC]

S. 3184, Genetically Engineered Foods Act, S10254-S10256 [11OC]