FOOD AND DRUG ADMINISTRATION

Amendments

Agriculture, rural development, FDA, and related agencies programs: making appropriations (H.R. 4766), H5402 [8JY], H5471 [9JY], H5536, H5537 [12JY], H5552, H5554, H5559, H5560, H5561, H5562, H5564, H5566, H5567, H5582, H5583, H5584, H5585, H5587, H5589, H5595, H5598, H5599, H5600, H5602, H5606, H5607, H5655 [13JY]

Federal Food, Drug, and Cosmetic Act: technical corrections relative to amendments made by the Medical Device User Fee and Modernization Act (S. 1881), S2821 [12MR]

Oceans: establish an interagency research program to improve understanding of the role of the oceans and human health and a similar program at NOAA (S. 1218), S3099, S3110 [24MR]

Analyses

Oceans and Human Health Act (S. 1218), S3114 [24MR]

Articles and editorials

Choose Someone Else, H728 [2MR]

FDA's Indecision on `Morning After' Pill Stirs Concern, S3443 [31MR]

Morning After/FDA Contrived Excuse To Deny Women Contraception, H5604 [13JY]

Morning-After Pill—Politics Stall `Plan B', H5603 [13JY]

Morning-After Roadblock, H5604 [13JY]

New Plans, H5603 [13JY]

Plan B Scrapped—Facts Lose Out, Again, H5604 [13JY]

Plan B Stall, H5603 [13JY]

Politics of Contraception, H5605 [13JY]

President and Women, H5603 [13JY]

Senate's Chance on Drug Costs, S10412 [5OC]

Shielding the Drug Industry, S10411 [5OC]

With More Than 600 Lobbyists, There's Little Chance on Drug Prices, E291 [3MR]

Wrong To Limit Contraception Pill, H5604 [13JY]

``Yes'' to Drugs From Canada, E810 [11MY]

Bills and resolutions

Agriculture, rural development, FDA, and related agencies programs: instruct conferees to appropriations legislation relative to the Conservation Security Program and treatment of agricultural disaster assistance (see S. Res. 465), S11305 [11OC]

———making appropriations (see S. 2803), S9220 [14SE] (see H.R. 4766), H5330 [7JY]

———making appropriations (H.R. 4766), consideration (see H. Res. 710), H5401 [8JY]

———making appropriations (H.R. 4766), request Senate to return bill to the House of Representatives (see H. Res. 719), H5908 [15JY]

Animals: provide better protection against bovine spongiform encephalopathy (mad cow disease) and other prion diseases (see S. 2007), S52 [20JA] (see H.R. 3714), H88 [21JA]

Business and industry: prohibit price gouging during a shortage of a covered vaccine (see H.R. 5404), H10078 [19NO]

Contraceptives: review decision process to disapprove commercial distribution of the emergency-contraceptive drug Plan B as an over-the-counter drug (see H.R. 4377), H3093 [17MY]

Controlled Substances Act: regulation of ephedrine alkaloids, including ephedrine and pseudoesphedrine (see H.R. 4395), H3390 [19MY]

Dept. of HHS: establish Offices of Women's Health (see H.R. 4354), H2917 [12MY]

———promulgate regulations for the reimportation of prescription drugs (see S. 2137), S1683 [26FE]

Dietary Supplement Health and Education Act: authorize appropriations to fully enforce and implement such Act and its amendments (see H.R. 4747), H5150 [25JN] (see H.R. 4760), H5195 [6JY]

Drugs: develop and require dissemination of a meta-analysis of scientific data on the safety and health risks of marijuana and the clinically-proven effectiveness of medical marijuana (see H.R. 5429), H10926 [6DE]

———establish certain restrictions on drugs containing isotretinoin, including the drug marketed as Accutane (see H.R. 4598), H4286 [16JN]

———prohibit the approval of any drug that infringes the right to life (see H.R. 4013), H1369 [23MR]

Federal Food, Drug, and Cosmetic Act: amend regulations on direct-to-consumer prescription drug advertising (see S. 2445), S5799 [19MY]

———establish requirements to allow sale of prescription drugs over the Internet (see S. 2464), S5949 [20MY] (see H.R. 3880), H830 [3MR]

Food: ensure safety of imported foods by requiring that notices include vital information about the manufacturers and prevent automatic rejection solely on the basis of incomplete notices (see H.R. 4665), H4893 [23JN]

Food industry: require FDA premarket review and oversight of all genetically engineered foods (see S. 2546), S6997 [17JN]

Health: establish system independent of the FDA to review health claims relative to the benefits of foods and dietary supplements (see H.R. 4004), H1322 [18MR]

Medicare: permit negotiation of fair prices for, and allow the reimportation of, prescription drugs (see S. 2053), S689 [6FE]

Pharmaceuticals: importation of prescription drugs (see S. 2307), S4024 [8AP] (see S. 2328), S4225 [21AP] (see H.R. 3710), H35 [20JA]

———permit importation of prescription drugs from Canada and certain other countries (see H.R. 4790), H5470 [9JY]

———standardize certification of Internet pharmacies and prohibit certain advertising activities and the use of certain bank instruments for purchases associated with illegal Internet pharmacies (see H.R. 4612), H4579 [18JN]

Product safety: increase public availability of information on clinical trials to determine the safety and effectiveness of drugs, biological products, and devices (see H.R. 5252), H8857 [7OC]

Research: conduct oversight of any entity engaged in the recovery, testing, or handling of human tissue or human tissue-based products (see H.R. 4151), H2152 [2AP]

Tobacco products: provide with certain regulatory authority (see S. 2461), S5949 [20MY] (see S. 2974), S11090 [10OC] (see H.R. 4433), H3438 (see H.R. 4433), H3538 [20MY]

Cloture motions

Agriculture, rural development, FDA, and related agencies programs: making appropriations (H.R. 2673), conference report, S20 [20JA], S156 [22JA]

Letters

Enforce Federal laws prohibiting the use of marijuana for medicinal purposes: Arthur T. Dean, Community Anti-Drug Coalitions of America, H5613 [13JY]

FDA authority to regulate tobacco products: Andrew Carter, Ohio Children's Hospital Association, S10936 [9OC], S11022 [10OC]

———John F. Scruggs, Altria Group, Inc., S11207 [11OC]

———John L. Kirkwood, American Lung Association, S10936 [9OC], S11023 [10OC]

———M. Cass Wheeler, American Heart Association, S10937 [9OC], S11023 [10OC]

———Matthew L. Myers, Campaign for Tobacco-Free Kids (organization), S10937 [9OC], S11022 [10OC]

———several individuals, S10939, S10940 [9OC]

———Sharon I.S. Rounds, American Thoracic Society, S10936 [9OC], S11023 [10OC]

———Steven C. Parrish, Altria Group, Inc., S11207 [11OC]

FDA Center for Drug Evaluation and Research funding through reductions in FDA Office of the Chief Counsel funding: several former FDA Chief Counsels, S8657 [22JY], E1505 [22JY]

FDA Center for Veterinary Medicine opinions relative to certain antibiotics: Stephen F. Sundlof, FDA Center for Veterinary Medicine, H5586 [13JY]

Importation of prescription drugs: Tommy G. Thompson, Sec. of HHS, S8213 [15JY]

Medical Devices Technical Corrections Act: Representatives C.W. Bill Young and Bonilla, Committee on Appropriations (House), H892 [9MR]

Provide FDA with certain authority to regulate tobacco products: Allison R. Shulman, National Association of Convenience Stores, S8175 [15JY]

———American Conservative Union, S8175 [15JY]

———Association of National Advertisers, American Association of Advertising Agencies, and American Advertising Federation, S8175 [15JY]

———Scott Ramminger, American Wholesale Marketers Association, S8177 [15JY]

Lists

Supporters of DeWine/Kennedy amendment to H.R. 4520, Jumpstart Our Business Strength (JOBS) Act, to provide the FDA with certain authority to regulate tobacco products, S8177 [15JY]

Questions and answers

Importation of prescription drugs (S. 2307), S4045 [8AP]

Remarks in House

Agriculture, rural development, FDA, and related agencies programs: making appropriations (H.R. 2673), conference report, H256 [3FE], E65 [28JA]

———making appropriations (H.R. 4766), H5501-H5515 [12JY], H5552-H5615 [13JY], E1380, E1388 [15JY], E1393, E1398, E1405 [16JY], E1411, E1414 [19JY], E1426 [20JY], E1505 [22JY]

———making appropriations (H.R. 4766), consideration (H. Res. 710), H5485-H5488 [12JY]

———making appropriations (H.R. 4766), request Senate to return bill to the House of Representatives (H. Res. 719), H5895 [15JY]

———making appropriations (H.R. 4766), unanimous-consent request, H5546 [13JY]

Birth control: prohibit funding to restrict prescription use of any contraceptive determined to be safe and effective, H5602-H5606 [13JY], E1414 [19JY]

Center for Drug Evaluation and Research: funding through reductions in Office of the Chief Counsel funding, H5598, H5599 [13JY], E1505 [22JY]

Center for Veterinary Medicine: funding, H5585 [13JY]

Dept. of HHS: promulgate regulations for the reimportation of prescription drugs, H6622, H6623 [22JY], H7078 [14SE]

———promulgate regulations for the reimportation of prescription drugs (H.R. 2427), H5168 [6JY]

Drugs: discrepancy in prescription drug prices between U.S. and foreign countries, H1624-H1630 [29MR]

———enforce Federal laws prohibiting the use of marijuana for medicinal purposes, H5612 [13JY]

———establish certain restrictions on drugs containing isotretinoin, including the drug marketed as Accutane, H11043 [7DE]

———establish certain restrictions on drugs containing isotretinoin, including the drug marketed as Accutane (H.R. 4598), H7821 [29SE], H7940 [30SE], H9992 [18NO], H10003 [19NO], E1364 [14JY], E1465 [22JY]

Federal Food, Drug, and Cosmetic Act: amend relative to new animal drugs (S. 741), H6093-H6101 [20JY], E1462 [22JY]

———technical corrections relative to amendments made by the Medical Device User Fee and Modernization Act (H.R. 3493), H109-H112 [27JA], E70 [28JA], E116 [4FE]

———technical corrections relative to amendments made by the Medical Device User Fee and Modernization Act (S. 1881), H890-H892 [9MR], E357 [11MR]

Food: ensure safety of imported foods by requiring that notices include vital information about the manufacturers and prevent automatic rejection solely on the basis of incomplete notices (H.R. 4665), E1217 [23JN]

———reassessment of labeling laws, E1926 [11OC]

Health: establish system independent of the FDA to review health claims relative to the benefits of foods and dietary supplements (H.R. 4004), E391 [17MR]

———safety of vaccines containing mercury and thimerosal, H415 [10FE], H1615 [29MR]

———study link between child vaccinations and autism, H415 [10FE], H1615 [29MR], H4564-H4568 [18JN]

McClellan, Mark B.: appointment to lead Government study on reimportation of prescription drugs, H728 [2MR]

Medicare: permit negotiation of fair prices for, and allow the reimportation of, prescription drugs, H485 [11FE], H534 [24FE], H3610 [2JN], H3945, H3946 [14JN]

National objectives: priority assignments, H503-H508 [11FE]

Pharmaceuticals: congressional inquiry on addictiveness, safety, and effectiveness of certain pain medications, E831 [12MY]

———importation of prescription drugs, H918 [9MR], H2191 [20AP], H2230 [21AP], H2521 [4MY], H2701 [6MY], H2991 [13MY], H3056 [17MY], H3378 [19MY], H3586, H3587, H3588 [1JN], H5615 [13JY], H5658, H5662-H5668, H5698-H5719 [14JY], E367 [16MR], E810 [11MY], E1885 [11OC]

———importation of prescription drugs (S. 2328), E1516 [22JY]

———permit commercial importation of prescription drugs from Canada, E291 [3MR]

Product safety: increase public availability of information on clinical trials to determine the safety and effectiveness of drugs, biological products, and devices (H.R. 5252), E1882 [11OC]

Tobacco products: provide with certain regulatory authority, H7582 [28SE]

Remarks in Senate

Agriculture, rural development, FDA, and related agencies programs: instruct conferees to appropriations legislation relative to the Conservation Security Program and treatment of agricultural disaster assistance (S. Res. 465), S11229, S11278-S11280 [11OC]

———making appropriations (H.R. 2673), conference report, S1 [20JA], S66-S104 [21JA], S128-S157 [22JA], S209, S216, S217 [23JA], S280 [27JA], S363 [2FE]

———making appropriations (H.R. 2673), conference report—unanimous-consent agreement, S104 [21JA]

———making appropriations (H.R. 2673), conference report—unanimous-consent request, S155 [22JA]

———making appropriations (H.R. 4766), unanimous-consent agreement, S8492 [20JY]

Animals: provide better protection against bovine spongiform encephalopathy (mad cow disease) and other prion diseases (S. 2007), S54 [20JA]

Appropriations: reduce for unrequested, low-priority, unnecessary, and wasteful spending programs, S84-S92 [21JA]

Center for Drug Evaluation and Research: funding through reductions in Office of the Chief Counsel funding, S8657 [22JY]

Contraceptives: approval of postcoital emergency contraception for over-the-counter sales, S3442 [31MR]

Dept. of HHS: promulgate regulations for the reimportation of prescription drugs, S9161-S9164 [14SE], S9540, S9541 [23SE]

———promulgate regulations for the reimportation of prescription drugs (S. 2137), S1702 [26FE], S1897 [27FE]

Dietary supplements: establish guidelines and review safety of dietary supplements, S3545-S3548 [1AP]

———fully enforce and implement Dietary Supplement Health and Education Act and require Dept. of HHS to develop a plan for mandatory serious adverse event reports, S7077-S7086 [21JN]

———require manufacturers to submit reports on certain serious adverse events before allowing sale on military installations, S7033, S7034 [18JN], S7077-S7086 [21JN]

FDA: provide with certain authority to regulate tobacco products, S10944 [9OC]

Federal Food, Drug, and Cosmetic Act: amend relative to new animal drugs (S. 741), S2365-S2375 [8MR]

———establish requirements to allow sale of prescription drugs over the Internet (S. 2464), S5983-S5985 [20MY]

———technical corrections relative to amendments made by the Medical Device User Fee and Modernization Act (S. 1881), House amendment, S2821, S2822 [12MR]

Food industry: require FDA premarket review and oversight of all genetically engineered foods (S. 2546), S7019 [17JN]

Foreign trade: country of origin labeling requirements implementation, S5053 [10MY]

Government regulations: ensure fairness and prevent waste in Federal regulatory agencies, S6432 [3JN]

Medicare: permit negotiation of fair prices for, and allow the reimportation of, prescription drugs, S6301 [2JN]

———permit negotiation of fair prices for, and allow the reimportation of, prescription drugs (S. 2053), S628 [5FE], S1276 [12FE]

Oceans: establish an interagency research program to improve understanding of the role of the oceans and human health and a similar program at NOAA (S. 1218), S3110-S3115 [24MR], S3176 [25MR]

Pharmaceuticals: importation of prescription drugs, S2700 [11MR], S2760, S2761 [12MR], S3524 [1AP], S3741 [6AP], S5053 [10MY], S8096 [14JY], S8179, S8180, S8185, S8191, S8196-S8199, S8207, S8211, S8214 [15JY], S9156-S9158 [14SE], S10961 [9OC], S11551 [19NO]

———importation of prescription drugs (S. 2307), S4042-S4044 [8AP]

———importation of prescription drugs (S. 2328), S4227-S4230 [21AP], S8498 [21JY], S8932 [8SE], S9072 [10SE], S10411, S10412 [5OC]

———permit importation of prescription drugs from Canada and certain other countries (H.R. 4790), S8932 [8SE]

Tobacco products: provide with certain regulatory authority, S8151-S8178, S8217, S8219 [15JY], S10934-S10942, S10959, S10969-S10972, S10977 [9OC], S11021-S11025, S11030, S11034 [10OC], S11205, S11216, S11243, S11244 [11OC]

———provide with certain regulatory authority (S. 2461), S5961-S5963, S5979 [20MY]

———provide with certain regulatory authority (S. 2974), S11068, S11091 [10OC]

Reports

Insider—FDA Can't Protect Public: CBS News, H9993 [18NO]

Reports filed

Agriculture, Rural Development, FDA, and Related Agencies Programs Appropriations: Committee on Appropriations (House) (H.R. 4766) (H. Rept. 108-584), H5330 [7JY]

———Committee on Appropriations (Senate) (S. 2803) (S. Rept. 108-340), S9220 [14SE]

Consideration of H.R. 4766, Agriculture, Rural Development, FDA, and Related Agencies Programs Appropriations: Committee on Rules (House) (H. Res. 710) (H. Rept. 108-591), H5401 [8JY]

Medical Devices Technical Corrections Act: Committee on Energy and Commerce (House) (S. 1881) (H. Rept. 108-433), H926 [9MR]

Minor Use and Minor Species Animal Health Act: Committee on Energy and Commerce (House) (S. 741) (H. Rept. 108-608), H5907 [15JY]

———Committee on Health, Education, Labor, and Pensions (Senate) (S. 741) (S. Rept. 108-226), S1457 [23FE], S1518 [24FE]

National Uniformity for Food Act: Committee on Energy and Commerce (House) (H.R. 2699) (H. Rept. 108-770), H9047 [8OC]

Rulings of the Chair

Agriculture, rural development, FDA, and related agencies programs: making appropriations (H.R. 4766), H5560, H5565, H5579, H5582, H5602 [13JY]

Summaries

Importation of Prescription Drugs (S. 2307), S4044 [8AP]

Pharmaceutical Market Access and Drug Safety Act (S. 2328), S4228 [21AP]

Tables

Agriculture, rural development, FDA, and related agencies programs appropriations (H.R. 4766), H5503-H5511 [12JY]

Texts of

H. Res. 710, consideration of H.R. 4766, agriculture, rural development, FDA, and related agencies programs appropriations, H5485 [12JY]

H. Res. 719, request Senate to return H.R. 4766, agriculture, rural development, FDA, and related agencies programs appropriations to the House of Representatives, H5895 [15JY]

H.R. 3493, Medical Devices Technical Corrections Act, H109 [27JA]

S. 741, Minor Use and Minor Species Animal Health Act, S2365-S2374 [8MR], H6093-H6099 [20JY]

S. 1218, Oceans and Human Health Act, S3110-S3113 [24MR]

S. 1881, Medical Devices Technical Corrections Act, S2821 [12MR], H890 [9MR]

S. 2461, Family Smoking Prevention and Tobacco Control Act, S5963-S5979 [20MY]

S. 2546, Genetically Engineered Foods Act, S7020-S7023 [17JN]

S. 2974, Family Smoking Prevention and Tobacco Control Act, S11068-S11084, S11091-S11107 [10OC]

S. Res. 465, instruct conferees to agriculture, rural development, FDA, and related agencies programs appropriations legislation relative to the Conservation Security Program and treatment of disaster assistance, S11229, S11280, S11310 [11OC]