FOOD AND DRUG ADMINISTRATION

Amendments

Agriculture, rural development, FDA, and related agencies programs: making appropriations (H.R. 2744), S10102, S10140, S10145 [15SE], S10175, S10183, S10200 [19SE], S10212, S10214, S10215, S10216, S10217, S10218, S10220, S10221, S10224, S10225, S10227, S10241, S10242, S10243, S10244, S10245 [20SE], S10264, S10270, S10271, S10272, S10273, S10275, S10276, S10277, S10278, S10280, S10281, S10284, S10286, S10309, S10310, S10311, S10312, S10313, S10314, S10315, S10316, S10317, S10318, S10319 [21SE], H4188, H4189 [7JN], H4223, H4224, H4225, H4227, H4237, H4238, H4243, H4244, H4245, H4247, H4252, H4257, H4263, H4264, H4265, H4266, H4268, H4269, H4270 [8JN]

Appointments

Conferees: H.R. 2744, agriculture, rural development, FDA, and related agencies programs appropriations, S10332 [22SE], H9011 [20OC]

Articles and editorials

'91 Memo Warned of Mercury in Shots, H482 [9FE]

Bigger Than the Social Security Crisis—Wasteful Spending on Prescription Drugs, E1162 [8JN]

Deadly Immunity, H5074-H5077 [23JN]

Financing Drug Research—What Are the Issues?, E1159 [8JN]

U.S. Blocks Drugs Sent From Canada, H1329 [10MR]

US Food Safety Under Siege?, E272-E274 [17FE]

Bills and resolutions

Abortion: withdraw approved application for the drug known as RU-486 and review process by which the FDA approved such drug (see S. 511), S2004 [3MR] (see H.R. 1079), H981 [3MR]

Advertising: require prior approval of advertisements for prescription drugs and restricted medical devices (see H.R. 3696), H7812 [8SE]

Agriculture: prohibit products containing dry ultra-filtered milk, milk protein concentrate, or casein from being labeled domestic natural cheese (see S. 827), S3817 [18AP]

Agriculture, rural development, FDA, and related agencies programs: making appropriations (see H.R. 2744), H4185 [7JN]

———making appropriations (H.R. 2744), consideration (see H. Res. 303), H4185 [7JN]

———making appropriations (H.R. 2744), consideration of conference report (see H. Res. 520), H9361 [27OC]

Animals: provide better protection against bovine spongiform encephalopathy (mad cow disease) and other prion diseases (see S. 2002), S12766 [14NO]

Children and youth: protect children from foods that pose a significant choking hazard (see H.R. 3560), H7558 [28JY]

Contraceptives: determine whether to allow marketing of emergency-contraceptive drug Plan B as a prescription drug for women 15 or younger and a nonprescription drug for women 16 or older (see H.R. 4229), H9641 [3NO]

Dept. of HHS: establish Offices of Women's Health (see S. 569), S2245 [8MR] (see H.R. 949), H794 [17FE]

———promulgate regulations for the reimportation of prescription drugs (see S. 109), S144 [24JA]

Dietary Supplement Health and Education Act: authorize appropriations to fully enforce and implement such Act and its amendments (see H.R. 2485), H3693 (see H.R. 2510), H3694 [19MY]

Drugs: ensure autonomy and eliminate conflicts-of-interest relative to drug company fees and advisory panels, improve postmarket drug safety, regulate off-label uses, and clarify liability for approved drugs (see H.R. 2090), H2976 [4MY]

———establish certain restrictions on drugs containing isotretinoin, including the drug marketed as Accutane (see H.R. 2956), H4655 [16JN]

———prohibit the approval of any drug that infringes the right to life (see H.R. 3553), H7558 [28JY]

———withdraw the drug OxyContin from the commercial market (see H.R. 2195), H3054 [5MY]

Federal Food, Drug, and Cosmetic Act: amend relative to dietary supplements (see H.R. 3156), H5600 [30JN]

———amend relative to drug advertising (see H.R. 3950), H8642 [29SE]

———create a three-tiered approval system for drugs, biological products, and devices that is responsive to the needs of seriously ill patients (see S. 1956), S12353 [3NO]

———establish recall authority for drugs and increase criminal penalties for sale or trade of knowingly adulterated or misbranded prescription drugs (see S. 1978), S12606 [9NO] (see H.R. 2345), H3261 [12MY]

———establish recall authority for drugs and increase criminal penalties for sale or trade of prescription drugs knowingly adulterated or misbranded (see H.R. 1396), H1692 [17MR]

———establish requirements to allow sale of prescription drugs over the Internet (see S. 399), S1513 [16FE] (see H.R. 840), H717 [16FE]

———prohibit sale or trade of prescription drugs that were knowingly adulterated or misbranded (see H.R. 2600), H3893 [24MY]

Food additives: reaffirm position on sanitary and phytosanitary guidelines for vitamin and mineral food supplements adopted by the Codex Alimentarius Commission (see H. Res. 562), H10909 [17NO]

Government regulations: improve ability to ensure drug safety (see S. 930), S4398 [27AP] (see H.R. 4429), H11034 [18NO]

Health: establish reasonable legal reforms that will facilitate the manufacture of vital, life-saving vaccines (see H.R. 650), H411 [8FE]

———permit an individual to be treated by a health care practitioner with any method of medical treatment such individual requests (see H.R. 2792), H4295 [8JN]

———require notification by manufacturers before discontinuing production of a vaccine and develop a national vaccine stockpile (see S. 226), S738 [1FE]

———require the FDA to disclose benefits of foods and dietary supplements and ensure the FTC bears the burden of proof in false advertising cases involving dietary supplements (see H.R. 4282), H10145 [9NO]

Medicare: permit negotiation of fair prices for, and allow the reimportation of, prescription drugs (see S. 239), S738 [1FE]

Pharmaceuticals: establish therapeutic equivalence requirements for generic drugs (see H.R. 2299), H3198 [11MY]

———impact of illegal importation of prescription drugs on regulatory protections afforded consumers (see H. Con. Res. 75), H796 [17FE]

———importation of prescription drugs (see S. 334), S1198 [9FE] (see H.R. 328), H194 [25JA] (see H.R. 700), H521 [9FE]

———standardize certification of Internet pharmacies and prohibit certain advertising by, and use of certain bank instruments for purchases from, illegal Internet pharmacies (see H.R. 1808), H2471 [21AP]

Safety: establish a comprehensive program to ensure food safety (see H.R. 2236), H3112 [10MY]

———provide for uniform food safety warning notification requirements (see H.R. 4167), H9361 [27OC]

Taxation: deny deductions for direct-to-consumer advertisements of prescription drugs (see H.R. 575), H351 [2FE]

———treat expenses for certain meal replacement and dietary supplement products that qualify for FDA-approved health claims as medical care expenses (see H.R. 1545), H1893 [12AP]

Tobacco products: provide with certain regulatory authority (see S. 666), S2995 [17MR] (see H.R. 1376), H1691 [17MR]

Conference reports

Agriculture, Rural Development, FDA, and Related Agencies Programs Appropriations (H.R. 2744), H9204-H9240 [26OC]

Factsheets

Dominican Republic-Central America Free Trade Agreement (DR-CAFTA) Impact on Enforcement and Implementation of Dietary Supplement Health and Education Act: Office of U.S. Trade Representative, H6922 [27JY]

Will Lower Drug Prices Jeopardize Drug Research? Donald Light and Joel Lexchin, American Journal of Bioethics, H5523-H5525 [30JN]

Letters

Require manufacturers of dietary supplements to submit reports on certain serious adverse events before allowing sale on military installations: Bruce Silverglade and Ilene R. Heller, Center for Science in the Public Interest, S8637 [21JY]

———Debbie Riggins, S8636 [21JY]

———Janell Mayo Duncan, Consumers Union, S8637 [21JY]

———Kevin S. Riggins, S8636 [21JY]

———Michelle Skinlo, S8636 [21JY]

———Philip Shettle, American Osteopathic Association, S8637 [21JY]

Safety of silicone breast implants: Scott L. Spear, American Society of Plastic Surgeons, E591 [7AP]

Motions

Agriculture, rural development, FDA, and related agencies programs: making appropriations (H.R. 2744), H8940 [19OC]

Pamphlets

Safety of Silicone Breast Implants, E591-E594 [7AP]

Remarks in House

Abortion: withdraw approved application for the drug known as RU-486 and review process by which the FDA approved such drug (H.R. 1079), H1332 [10MR], H6209 [21JY], E357 [3MR]

Agriculture, rural development, FDA, and related agencies programs: across-the-board funding reduction, H4264, H4265 [8JN]

———funding, H12275 [18DE]

———making appropriations (H.R. 2744), H4208-H4273 [8JN], H4301 [9JN]

———making appropriations (H.R. 2744), amendment process, H4251 [8JN]

———making appropriations (H.R. 2744), conference report, H9381-H9394 [28OC], E2366 [15NO]

———making appropriations (H.R. 2744), consideration (H. Res. 303), H4201-H4208 [8JN]

———making appropriations (H.R. 2744), consideration of conference report (H. Res. 520), H9367-H9373 [28OC]

———making appropriations (H.R. 2744), motion to instruct conferees, H8940-H8946 [19OC]

———prohibit promulgation of regulations without consideration of their effect on the competitiveness of U.S. businesses, H4268 [8JN]

Dept. of HHS: ensure prescription drug clinical trials required to be listed in a public database are listed before a drug is approved for market, H4263, H4264 [8JN]

———establish Offices of Women's Health (H.R. 949), E304 [18FE], E925 [10MY], E1034 [20MY]

Dominican Republic-Central America Free Trade Agreement (DR-CAFTA): impact on enforcement and implementation of Dietary Supplement Health and Education Act, H6922 [27JY]

Drugs: discrepancy in prescription drug prices between U.S. and foreign countries, H606 [15FE], H1328 [10MR], H1754 [5AP], H3406 [17MY], H4159 [7JN], H4373 [13JN], H4784 [20JN], H4861 [21JN], H5219 [27JN], E1159, E1162 [8JN]

———ensure autonomy and eliminate conflicts-of-interest relative to drug company fees and advisory panels, H4245-H4247 [8JN]

———establish certain restrictions on drugs containing isotretinoin, including the drug marketed as Accutane, H2950 [4MY], H4477 [14JN]

———improve postmarket drug safety, H4206, H4219, H4221, H4242, H4244 [8JN]

Federal Food, Drug, and Cosmetic Act: amend relative to dietary supplements (H.R. 3156), E1441 [1JY]

———establish recall authority for drugs and increase criminal penalties for sale or trade of knowingly adulterated or misbranded prescription drugs (H.R. 2345), E950 [12MY]

Fish and fishing: delay approval of genetically engineered fish, H4265 [8JN]

Health: link between child vaccinations containing mercury and autism, H481 [9FE], H5074 [23JN], H9451 [1NO]

———require the FDA to disclose benefits of foods and dietary supplements and ensure the FTC bears the burden of proof in false advertising cases involving dietary supplements (H.R. 4282), E2313 [9NO]

Pharmaceuticals: establish uniform standards for restocking of unused drugs, H2652 [28AP]

———health risks associated with non-FDA-approved inhaled compounded drugs in nebulizers, H2788 [3MY]

———importation of prescription drugs, H418 [9FE], H4220 [8JN], H4861 [21JN], H6654 [27JY]

———importation of prescription drugs (H.R. 328), H1945, H1947 [13AP], H3289 [16MY], H4373 [13JN], H9934 [7NO]

———promote competition and drug safety through increased research, E903 [5MY]

Whistleblowing: prohibit use of funds to investigate or take action against employees legally providing information to Congress or the public concerning the FDA, H4266-H4268 [8JN]

Women: safety of silicone breast implants, E590 [7AP]

Remarks in Senate

Abortion: withdraw approved application for the drug known as RU-486 and review process by which the FDA approved such drug (S. 511), S2020 [3MR]

Agriculture: prohibit products containing dry ultra-filtered milk, milk protein concentrate, or casein from being labeled domestic natural cheese (S. 827), S3822 [18AP]

Agriculture, rural development, FDA, and related agencies programs: making appropriations (H.R. 2744), S10080-S10103 [15SE], S10173-S10176 [19SE], S10210-S10227 [20SE], S10264, S10275-S10288 [21SE], S10327-S10332 [22SE]

———making appropriations (H.R. 2744), conference report, S12219-S12228 [2NO], S12287-S12291 [3NO], S12399 [4NO]

———making appropriations (H.R. 2744), conference report—unanimous-consent agreement, S12145 [1NO]

———making appropriations (H.R. 2744), unanimous-consent agreement, S10223 [20SE]

———redirect certain funds for relief for States impacted by Hurricane Katrina, S10272 [21SE]

———reform Federal budget procedures, impose spending safeguards, combat waste, fraud, and abuse, and account for accurate Government agency costs, S10278, S10279 [21SE]

———require appropriations conference report inclusion of limitations, directives and earmarks, S10280 [21SE]

Animals: provide better protection against bovine spongiform encephalopathy (mad cow disease) and other prion diseases (S. 2002), S12767 [14NO]

Crawford, Lester M.: nomination to be FDA Commissioner, S8397-S8399, S8403-S8408 [18JY]

Dept. of Agriculture: funding, S14078 [20DE]

Dept. of HHS: establish Offices of Women's Health (S. 569), S2273 [8MR], S4643 [9MY], S4863 [10MY]

———promulgate regulations for the reimportation of prescription drugs (S. 109), S278 [24JA], S1156 [9FE]

Dietary supplements: require manufacturers to submit reports on certain serious adverse events before allowing sale on military installations, S8635-S8638 [21JY]

———withhold funding from stores on military installations that sell dietary supplements containing stimulants in cases that the manufacturer does not report associated serious adverse events, S11096-S11099 [5OC]

Drugs: discrepancy in prescription drug prices between U.S. and foreign countries, S8397-S8399 [18JY]

———ensure autonomy and eliminate conflicts-of-interest relative to drug company fees and advisory panels, S10217 [20SE]

Federal Food, Drug, and Cosmetic Act: establish requirements to allow sale of prescription drugs over the Internet (S. 399), S1531, S1534 [16FE]

Food: promote food safety and protect the animal feed supply from bovine spongiform encephalopathy (mad cow disease), S81-S84 [20JA]

Government regulations: improve ability to ensure drug safety (S. 930), S4426, S4427 [27AP], S13095 [17NO]

Health: require notification by manufacturers before discontinuing production of a vaccine and develop a national vaccine stockpile (S. 226), S741 [1FE]

———safety of vaccines containing mercury and thimerosal, S11994 [27OC]

Labeling: issue comprehensive labeling guidelines for over-the-counter sunscreen products, S10330 [22SE]

Medicare: permit negotiation of fair prices for, and allow the reimportation of, prescription drugs, S2821-S2825 [16MR], S2921, S2953 [17MR]

———permit negotiation of fair prices for, and allow the reimportation of, prescription drugs (S. 239), S745-S747 [1FE], S877 [2FE], S1152 [9FE], S1252, S1253 [10FE], S1321 [14FE], S1597 [17FE]

Office of the U.S. Trade Representatives: prevent negotiation of trade agreements that prevent the U.S. from changing patent laws to allow the importation of pharmaceutical product, S10077, S10078 [15SE]

Pharmaceuticals: importation of prescription drugs (S. 334), S1206 [9FE], S1253, S1256 [10FE], S10077 [15SE]

———place restrictions on, and study the impact of, direct-to-consumer advertising of prescription drugs, S7876-S7879, S7886 [1JY]

Political ethics: condemn delay of decision on the approval of over-the-counter emergency contraceptives, S10249 [21SE]

Tobacco products: provide with certain regulatory authority (S. 666), S3037-S3054 [17MR]

Reports filed

Agriculture, Rural Development, FDA, and Related Agencies Programs Appropriations: Committee of Conference (H.R. 2744) (H. Rept. 109-255), H9275 [26OC]

———Committee on Appropriations (House) (H.R. 2744) (H. Rept. 109-102), H4185 [7JN]

———Committee on Appropriations (Senate) (H.R. 2744) (S. Rept. 109-92), S7428 [27JN]

Consideration of Conference Report on H.R. 2744, Agriculture, Rural Development, FDA, and Related Agencies Programs Appropriations: Committee on Rules (House) (H. Res. 520) (H. Rept. 109-257), H9361 [27OC]

Consideration of H.R. 2744, Agriculture, Rural Development, FDA, and Related Agencies Programs Appropriations: Committee on Rules (House) (H. Res. 303) (H. Rept. 109-105), H4185 [7JN]

Nomination of Lester M. Crawford To Be FDA Commissioner: Committee on Health, Education, Labor, and Pensions (Senate), S6825 [20JN]

Rulings of the Chair

Agriculture, rural development, FDA, and related agencies programs: making appropriations (H.R. 2744), H4233, H4237, H4244, H4264, H4267, H4270, H4271 [8JN]

Tables

Agriculture, rural development, FDA, and related agencies programs appropriations (H.R. 2744), H4209-H4217 [8JN]

———conference report, H9382-H9389 [28OC]

Committee on the Budget (Senate) scoring of H.R. 2744, agriculture, rural development, FDA, and related agencies programs appropriations, S10175 [19SE]

Texts of

H. Res. 303, consideration of H.R. 2744, agriculture, rural development, FDA, and related agencies programs appropriations, H4201 [8JN]

H. Res. 520, consideration of conference report on H.R. 2744, agriculture, rural development, FDA, and related agencies appropriations, H9367 [28OC]

H.R. 2744, agriculture, rural development, FDA, and related agencies programs appropriations, S10080-S10100 [15SE], S10441-S10453 [26SE]

S. 109, Pharmaceutical Market Access Act, S278-S282 [24JA]

S. 226, Improved Vaccine Supply Act, S741 [1FE]

S. 399, Internet Pharmacy Consumer Protection Act, S1532-S1534 [16FE]

S. 511, RU-486 Suspension and Review Act, S2020 [3MR]

S. 666, Family Smoking Prevention and Tobacco Control Act, S3037-S3053 [17MR]

S. 827, Quality Cheese Act, S3822 [18AP]

S. 1956, Access, Compassion, Care, and Ethics for Seriously Ill Patients (ACCESS) Act, S12355-S12357 [3NO]

S. 2002, BSE and Other Prion Disease Prevention and Public Health Protection Act, S12768-S12770 [14NO]

Transcripts

``We Become Silent,'' Kevin P. Miller, E1649-E1652 [27JY]