FOOD AND DRUG ADMINISTRATION
Amendments
Agriculture, rural development, FDA, and related agencies programs: making appropriations, H4873 [17JY], H4932 [18JY]
Federal Food, Drug, and Cosmetic Act: provide greater access to affordable pharmaceuticals (S. 812), S6909, S6930, S6960, S6961, S6963 [17JY], S6978, S7048, S7049, S7050, S7060 [18JY], S7232, S7233 [23JY], S7284, S7316, S7317, S7318 [24JY], S7382 [25JY], S7435 [26JY], S7589, S7590, S7591, S7592, S7593, S7594, S7598, S7601, S7611 [30JY]
Analyses
Preservation of Antibiotics for Human Treatment Act (S. 2508), S4283 [13MY]
Research Revitalization Act (S. 3060), S9994 [4OC]
Articles and editorials
More Are Finding Permanent Cures for Hepatitis C, E1017 [12JN]
Bills and resolutions
Advertising: establish authority for the imposition of civil penalties for certain direct-to-consumer advertisements (see H.R. 4833), H3036 [23MY]
Agriculture: provide clarification regarding the market name for bison (see H.R. 3783), H524 [14FE]
Agriculture, rural development, FDA, and related agencies programs: making appropriations (see S. 2801), S7372 [25JY] (see H.R. 5263), H5993 [26JY]
Animals: ensure use of certain antibiotic drugs in agriculture does not compromise human health by contributing to the development of antibiotic resistance (see S. 2508), S4281 [13MY] (see H.R. 3804), H633 [27FE]
Diseases: combat cancer (see S. 1976), S1351 [28FE]
———improve data collection and dissemination between Federal and State registries to enhance the treatment and research of cancer (see S. 2955), S8753 [18SE]
Drugs: correct impediments to allowing importation of prescription drugs into the U.S. by pharmacists and wholesalers for resale and by U.S. citizens for personal use (see H.R. 5534), H6982 [2OC]
———enhance competition for prescription drugs by increasing enforcement of existing antitrust laws relative to brand name and generic drugs (see S. 2677), S6013 [25JN]
———establish requirements relative to the sale of, or the offer to sell, prescription drugs through the Internet (see H.R. 4990), H3824 [21JN]
Federal Food, Drug, and Cosmetic Act: add requirements relative to reprocessing and reuse of medical devices (see S. 3130), S10676 [17OC]
———ensure competition in pharmaceutical industry and increased access to affordable drugs (see S. 2818), S7469 [29JY]
———establish a program of fees relative to animal drugs (see S. 2665), S5851 [20JN] (see H.R. 4955), H3668 [18JN]
———improve regulation of medical devices (see H.R. 5651), H8021 [16OC]
———provide greater access to affordable pharmaceuticals (see H.R. 5272), H5994 (see H.R. 5311), H5996 [26JY] (see H.R. 5350), H6129 [9SE]
———provide greater access to affordable pharmaceuticals (H.R. 1862), consideration (see H. Res. 517), H6085 [5SE]
Food: protect the health and safety of American consumers from seafood contaminated by certain substances (see S. 2759), S7033 [18JY]
———provide authority to recall food when there is a reasonable basis for believing that the food is adulterated and presents health risks (see H.R. 5488), H6776 [26SE]
———require foods containing known allergens to bear labeling that states that fact and the names of the allergens (see S. 2499), S4145 [9MY] (see S. 3001), S9229 [25SE] (see H.R. 4704), H2355 [9MY] (see H.R. 5747), H9023 [14NO]
Food industry: require FDA premarket review and oversight of all genetically engineered foods (see S. 3095), S10359 [10OC]
Government regulations: include a notification period before discontinuing a biological product (see S. 2049), S2260 [21MR]
Health: establish a system independent of the FDA for the review of health claims and to define health claims (see H.R. 3811), H633 [27FE]
———permit an individual to be treated by a health care practitioner with any method of medical treatment such individual requests (see S. 2207), S2950 [18AP]
Labeling: require labeling containing information applicable to pediatric patients (see S. 2394), S3505 [29AP] (see H.R. 4730), H2470 [14MY] (see H.R. 5594), H7738 [9OC]
Medicare: ensure reimbursement for certain FDA-approved cancer drug therapies administered in hospital outpatient settings (see S. 2795), S7372 [25JY] (see H.R. 5218), H5789 [25JY]
Medicine Equity and Drug Safety Act: implementation (see H. Res. 478), H4497 [10JY]
Pharmaceuticals: eligibility of certain applicants for approval of a generic drug for a competition-free period (see H.R. 4998), H3825 [21JN]
———grant waivers permitting individuals to import prescription drugs from Canada and amend laws relative to sale of prescription drugs through the Internet (see H.R. 5217), H5789 [25JY]
———importation of certain prescription drugs (see H.R. 5186), H5194 [23JY]
———permit commercial importation of prescription drugs from Canada (see S. 2244), S3303 [24AP] (see H.R. 4614), H1674 [25AP]
Research: conduct oversight of any entity engaged in the recovery, testing, or handling of human tissue or human tissue-based products (see S. 2531), S4568 [20MY]
Safety: promote safe and ethical clinical trials of drugs, and other test articles, on people overseas (see H.R. 5249), H5993 [26JY]
———provide protections for human participants in research (see S. 3060), S9983 [4OC]
Taxation: limit manufacturers' deduction for advertising of FDA approved prescription drugs to the level of research and development expenditures (see S. 2486), S4064 [8MY] (see H.R. 4821), H2944 [22MY]
———treatment of direct-to-consumer advertisements of prescription drugs (see H.R. 5105), H4552 [11JY]
Tobacco products: eliminate quotas and price support, compensate quota holders and producers, establish Tobacco Quality Board, assess user fees, and grant FDA authority to regulate tobacco (see S. 2764), S7104 [19JY]
———eliminate quotas and price supports, compensate quota holders and producers, and establish a tobacco community reinvestment program (see S. 3004), S9229 [25SE] (see H.R. 5480), H6776 [26SE]
———grant authority to regulate tobacco (see S. 2626), S5584 [14JN]
Cloture motions
Federal Food, Drug, and Cosmetic Act: provide greater access to affordable pharmaceuticals (S. 812), S7299 [24JY], S7462 [29JY], S7633 [31JY]
———provide greater access to affordable pharmaceuticals (S. 812), motion to proceed, S6798 [15JY], S6883 [17JY]
Descriptions
Public Health Security and Bioterrorism Preparedness and Response Act (H.R. 3448): Amendments Relative to Food Enforcement Authorities Provided Under the Federal Food, Drug, and Cosmetic Act, H2857 [22MY]
Excerpts
Legislation on the safety of the reimportation of prescription drugs, S6927 [17JY]
Letters
Certify safety and cost savings relative to commercial importation of prescription drugs from Canada: Donna E. Shalala, Dept. of HHS, S6910 [17JY]
———Lester M. Crawford, FDA, S6913 [17JY]
———Tommy G. Thompson, Sec. of HHS, S6910 [17JY]
Greater Access to Affordable Pharmaceuticals Act: Abbey S. Meyers, National Organization for Rare Disorders, Inc., S7641 [31JY]
———Carl B. Feldbaum, Biotechnology Industry Organization, S6994 [18JY], S7570 [30JY]
———Coalition for a Competitive Pharmaceutical Market, S6845 [16JY], S7641, S7648 [31JY]
———D. Michael Fisher, Attorney General of Pennsylvania, S7636 [31JY]
———Dick Wagoner, Jr., General Motors Corp., S7641 [31JY]
———Eliot Spitzer, Attorney General of New York, S7636 [31JY]
———James E. Rogan, Patent and Trademark Office, S7571 [30JY]
———Janell Mayo Duncan, Consumers Union, S7642 [31JY]
———Jody Hunter, Business for Affordable Medicine (organization), S6845 [16JY], S7648 [31JY]
———Kathleen D. Jaeger, Generic Pharmaceutical Association, S7641 [31JY]
———Michael K. Kirk, American Intellectual Property Law Association, S7346 [25JY]
———Senator Kennedy, S7026-S7028 [18JY]
———Stephen Mulloney, Massachusetts Biotechnology Council, S6995 [18JY]
Labeling and advertising requirements for dietary supplements containing ephedrine alkaloids and prohibit sales of such supplements to minors: Charles W. Fricke, and Kevin and Debra Riggins, S11675 [20NO]
Medical Device User Fee and Modernization Act: Tommy G. Thompson, Sec. of HHS, S11551 [19NO]
Preservation of Antibiotics for Human Treatment Act: Mohammad N. Akhter, American Public Health Association, S4283 [13MY]
Lists
FDA approval of buprenorphine for the treatment of heroin addiction press conference participants, S10658 [17OC]
Opponents and supporters of S. 812, Greater Access to Affordable Pharmaceuticals Act, S7638 [31JY]
Motions
Drugs: consideration of legislation to provide greater access to affordable pharmaceuticals, H6957 [2OC]
Federal Food, Drug, and Cosmetic Act: provide greater access to affordable pharmaceuticals (S. 812), S7206 [23JY], S7283 [24JY], S7534 [30JY], S7633 [31JY]
Proposals
Consideration of legislation to provide greater access to affordable pharmaceuticals, H6856 [1OC], H6955 [2OC]
Remarks in House
Animals: ensure use of certain antibiotic drugs in agriculture does not compromise human health by contributing to the development of antibiotic resistance (H.R. 3804), H2114 [7MY], E1147 [25JN]
Center for Devices and Radiological Health: laboratory construction funding, H5245 [23JY]
Children and youth: labeling requirements to certify that child labor was not used in harvesting of cocoa beans, E1205 [8JY]
Dept. of HHS: antimicrobial resistance activities in the interagency public health action plan (H.R. 1771), H2114 [7MY]
———establish an Office on Women's Health (H.R. 1784), H6262-H6268 [17SE]
Diseases: research and development of new HIV/AIDS treatments, E1612 [19SE]
Drugs: consideration of legislation to provide greater access to affordable pharmaceuticals, H6955-H6958 [2OC]
———discrepancy in prescription drug prices between U.S. and foreign countries, H659 [5MR], H3207 [5JN], H3427 [11JN], H3495 [12JN], H3581 [17JN], H3645, H3646 [18JN], H3815, H3819 [21JN], H4485-H4491 [10JY], H5068 [22JY]
Federal Food, Drug, and Cosmetic Act: improve regulation of medical devices (H.R. 3580), H7153-H7164 [7OC], E1798 [8OC], E1844 [11OC]
———improve regulation of medical devices (H.R. 5651), H7965 [16OC]
———provide greater access to affordable pharmaceuticals (H.R. 1862), H2110 [7MY], H6268 [17SE], H6377, H6387, H6390, H6393, H6394, H6398 [19SE]
———provide greater access to affordable pharmaceuticals (H.R. 5272), H6261, H6268, H6297 [17SE]
Food: facilitate the use of irradiation in improving food safety, E1556 [11SE]
Health: establish a system independent of the FDA for the review of health claims and to define health claims (H.R. 3811), E218 [27FE]
Pharmaceuticals: provide access and choice for use of generic drugs under State Medicaid programs, H539 [26FE]
Women: promote research and disseminate information on the health effects of breast implants and encourage FDA review of implant manufacturers, E1798 [8OC]
Remarks in Senate
Animals: ensure use of certain antibiotic drugs in agriculture does not compromise human health by contributing to the development of antibiotic resistance (S. 2508), S4283, S4284 [13MY]
Children and youth: amend certain laws relative to pediatric studies of drugs, S5192 [6JN]
———labeling requirements to certify that child labor was not used in harvesting of cocoa beans, S224 [29JA]
Dept. of HHS: certify safety and cost savings relative to commercial importation of prescription drugs from Canada, S6910-S6922, S6925-S6930 [17JY]
Dept. of Homeland Security: ensure that information systems be coordinated across agencies who have border security responsibilities, S11406 [19NO]
Diseases: combat cancer (S. 1976), S1361-S1365 [28FE], S4615 [21MY]
———improve data collection and dissemination between Federal and State registries to enhance the treatment and research of cancer (S. 2955), S8757, S8758 [18SE]
Drugs: approval of buprenorphine for the treatment of heroin addiction, S10655-S10658 [17OC]
———correct impediments to allowing importation of prescription drugs into the U.S. by pharmacists and wholesalers for resale, S2637-S2639 [15AP]
———enhance competition for prescription drugs by increasing enforcement of existing antitrust laws relative to brand name and generic drugs (S. 2677), S6019 [25JN]
———review Federal programs on substance abuse, prevention, treatment, education, and research, S10035 [7OC]
Federal Food, Drug, and Cosmetic Act: establish a program of fees relative to animal drugs (S. 2665), S5862-S5866 [20JN]
———improve regulation of medical devices (H.R. 5651), S10619, S10752-S10754 [17OC], S11549-S11551 [19NO]
———provide greater access to affordable pharmaceuticals (S. 812), S6802, S6811 [15JY], S6873 [16JY], S6883-S6931 [17JY], S6968-S6972, S6976-S7016, S7019-S7028 [18JY], S7093-S7100 [19JY], S7127, S7134-S7158 [22JY], S7180-S7189, S7194, S7218 [23JY], S7244-S7246, S7249-S7263, S7282-S7299 [24JY], S7327-S7336, S7340, S7342-S7350, S7366 [25JY], S7398-S7413, S7423, S7424 [26JY], S7457, S7460, S7464 [29JY], S7505, S7514-S7551, S7565-S7571, S7614-S7616 [30JY], S7618-S7651 [31JY], S7849-S7851, S7853-S7858, S7875-S7878 [1AU], S8630, S8631 [17SE], S9182 [25SE], S10407 [15OC]
———provide greater access to affordable pharmaceuticals (S. 812), motion to proceed, S6797-S6801 [15JY], S6818-S6829, S6831-S6858 [16JY], S6878-S6883 [17JY]
———provide greater access to affordable pharmaceuticals (S. 812), unanimous-consent agreement, S7545 [30JY]
Fish and fishing: restrict importation of certain fish and fish products not taxonomically from the catfish family, S4800, S4801 [23MY]
Food: protect the health and safety of American consumers from seafood contaminated by certain substances (S. 2759), S7043 [18JY]
———require foods containing known allergens to bear labeling that states that fact and the names of the allergens (S. 2499), S4163 [9MY]
———require foods containing known allergens to bear labeling that states that fact and the names of the allergens (S. 3001), S9231 [25SE]
Food industry: require FDA premarket review and oversight of all genetically engineered foods (S. 3095), S10371 [10OC]
FTC: study on pharmaceutical industry marketing rules, S7460 [29JY]
Funding, S5171 [6JN], S5284 [10JN]
Government regulations: authorize oversight of any entity engaged in recovery, screening, testing, processing, storage, or distribution of human tissue or human tissue-based products (S. 2531), S4536 [17MY]
———establish labeling and advertising requirements for dietary supplements containing ephedrine alkaloids and prohibit sales of such supplements to minors, S11672-S11675 [20NO]
Health: permit an individual to be treated by a health care practitioner with any method of medical treatment such individual requests (S. 2207), S2965 [18AP]
Labeling: require labeling containing information applicable to pediatric patients (S. 2394), S7861 [1AU]
McClellan, Mark B.: nomination to be FDA Commissioner, S10219 [9OC], S10639 [17OC]
Medicare: ensure reimbursement for certain FDA-approved cancer drug therapies administered in hospital outpatient settings (S. 2795), S7374 [25JY]
Pharmaceuticals: bioequivalence standards for generic drugs, S6993-S6996 [18JY]
———permit commercial importation of prescription drugs from Canada, S4087 [9MY], S6894-S6922, S6925-S6930 [17JY]
———permit commercial importation of prescription drugs from Canada (S. 2244), S3316-S3319 [24AP], S3502 [29AP], S3550-S3552 [30AP], S3793-S3795 [2MY], S5341 [11JN]
———require companies to disclose any gifts or incentives given to doctors or health care providers and require manufacturers to disclose any rebates given to pharmaceutical benefits managers, S7007 [18JY]
Presidential appointments: nominations considered and confirmed en bloc, S10638 [17OC]
Safety: provide protections for human participants in research (S. 3060), S9993 [4OC]
States: clarify authority to enter into drug rebate agreements with manufacturers in order to provide prescription drug coverage to individuals not covered by Medicaid, S6978-S6982, S7010-S7016 [18JY]
Taxation: limit manufacturers' deduction for advertising of FDA approved prescription drugs to the level of research and development expenditures (S. 2486), S4077 [8MY], S4087 [9MY], S4824 [23MY]
Tobacco products: grant authority to regulate tobacco (S. 2626), S5598-S5601 [14JN]
Reports filed
Agriculture, Rural Development, FDA, and Related Agencies Programs Appropriations: Committee on Appropriations (House) (H.R. 5263) (H. Rept. 107-623), H5993 [26JY]
———Committee on Appropriations (Senate) (S. 2801) (S. Rept. 107-223), S7371 [25JY]
Food Allergen Consumer Protection Act: Committee on Health, Education, Labor, and Pensions (Senate) (S. 2499) (S. Rept. 107-322), S10674 [17OC]
Greater Access to Affordable Pharmaceuticals Act: Committee on Health, Education, Labor, and Pensions (Senate) (S. 812), S6649 [11JY]
Labeling Requirement Containing Information Applicable to Pediatric Patients: Committee on Health, Education, Labor, and Pensions (Senate) (S. 2394) (S. Rept. 107-300), S10114 [8OC]
Medical Device Regulation Improvement: Committee on Energy and Commerce (House) (H.R. 3580) (H. Rept. 107-728), H7171 [7OC]
Medical Device User Fee and Modernization Act: Committee on Energy and Commerce (House) (H.R. 3580) (H. Rept. 107-728), H7928 [15OC]
Nomination of Mark B. McClellan To Be FDA Commissioner: Committee on Health, Education, Labor, and Pensions (Senate), S10222 [9OC]
Require Labeling Containing Information Applicable to Pediatric Patients: Committee on Health, Education, Labor, and Pensions (Senate) (S. 2394), S7898 [1AU]
Requirements Relative to the Sale of, or the Offer To Sell, Prescription Drugs Through the Internet: Committee on Energy and Commerce (House) (H.R. 4990) (H. Rept. 107-546), H4064, H4067 [26JN]
Women's Health Office Act: Committee on Energy and Commerce (House) (H.R. 1784) (H. Rept. 107-616), H5789 [25JY]
Rulings of the Chair
Drugs: consideration of legislation to provide greater access to affordable pharmaceuticals, H6957 [2OC]
Statements
FDA Approval of Buprenorphine for the Treatment of Heroin Addiction: Charles R. Schuster, Wayne State University, S10657 [17OC]
———Chris-Ellyn Johanson, Wayne State University, S10657 [17OC]
———Herbert Kleber, Columbia University, S10658 [17OC]
———James H. Woods, University of Michigan, S10657 [17OC]
Greater Access to Affordable Pharmaceuticals Act: David Beier, S7346 [25JY]
———Eliot Spitzer, Attorney General of New York, S7637 [31JY]
Summaries
Medical Device User Fee and Modernization Act (H.R. 5651), S11549-S11551 [19NO]
Texts of
H.R. 1784, Women's Health Office Act, H6262-H6264 [17SE]
H.R. 3580, Medical Device User Fee and Modernization Act, H7153-H7160 [7OC]
H.R. 5651, Medical Device User Fee and Modernization Act, H7965-H7974 [16OC]
S. 812, Greater Access to Affordable Pharmaceuticals Act, S6884-S6887 [17JY], S8007-S8012 [1AU]
S. 2244, Prescription Drug Price Parity for Americans Act, S3316-S3318 [24AP]
S. 2486, Fair Advertising and Increased Research (FAIR) Act, S4077 [8MY]
S. 2499, Food Allergen Consumer Protection Act, S4164 [9MY]
S. 2626, Youth Smoking Prevention and Public Health Protection Act, S5601-S5613 [14JN]
S. 2665, Animal Drug User Fee Act, S5863-S5865 [20JN]
S. 2677, Consumer Access to Prescription Drugs Improvement Act, S6020-S6025 [25JN]
S. 2759, Seafood Safety Enforcement Act, S7044 [18JY]
S. 2764, Tobacco Livelihood and Economic Assistance for Our Farmers Act, S7109-S7126 [19JY]
S. 3001, Food Allergen Labeling and Consumer Protection Act, S9231-S9233 [25SE]
S. 3095, Genetically Engineered Foods Act, S10372-S10375 [10OC]