FOOD AND DRUG ADMINISTRATION
Amendments
Food: improve capacity to prevent, detect, and respond to food safety problems and the safety of imported food (S. 510), S7980, S7981, S7986, S7989, S7990 [17NO], S8067, S8068, S8069 [18NO], S8131, S8202 [19NO]
Articles and editorials
FDA Lax on Conflicts of Interest, E474 [24MR]
Bills and resolutions
Agriculture, rural development, FDA, and related agencies programs: making appropriations (see S. 3606), S5964 [15JY]
Appropriations: making supplemental (see H.R. 5745), H5674 [15JY]
Charities: encourage pharmaceutical manufacturers and health care providers to donate prescription medications to nonprofit organizations that fill prescriptions for low-income individuals (see H. Res. 1311), H3078 [29AP]
Contraceptives: establish certain duties for pharmacies to ensure provision of FDA-approved contraception (see S. 3357), S3716 [13MY] (see H.R. 5309), H3483 [13MY]
Cosmetics: ensure safe use (see H.R. 5786), H5818 [20JY]
Diseases: help prevent occurrence of cancer resulting from the use of ultraviolet tanning lamps by imposing more stringent controls on the use of such devices (see H.R. 4520), H386 [26JA]
———improve priority review voucher incentive program for expedited review of treatments for tropical and rare pediatric diseases (see S. 3697), S6736 [4AU]
———provide grants to schools for the development of asthma management plans and the purchase of asthma inhalers and spacers for emergency use (see H.R. 4836), H1396 [12MR]
———reduce disparities and improve access to diagnosis and treatment of prostate cancer for underserved populations and men with a family history of prostate cancer (see H.R. 6389), H7394 [29SE]
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. 4816), H1323 [10MR]
———improve safety (see H.R. 6543), H8785 [17DE]
———modify approval of any drug containing controlled-release oxycodone hydrochloride to limit such approval to use for relief of severe-only pain (see H.R. 4956), H2457 [25MR]
———more effectively regulate anabolic steroids (see S. 4032), S10304 [15DE]
———provide additional quality control (see S. 3690), S6651 [3AU]
Federal Food, Drug, and Cosmetic Act: distribution and citation of scientific research in connection with foods and dietary supplements (see H.R. 4913), H2260 [23MR]
Fish and fishing: prevent approval of genetically-engineered fish (see S. 3971), S8062 [18NO] (see H.R. 6265), H7389 [29SE]
———require labeling of genetically-engineered fish (see S. 3969), S8062 [18NO] (see H.R. 6264), H7389 [29SE]
Food: ensure the safety of imported seafood and seafood products (see S. 2934), S51 [20JA]
———establish and enforce a maximum somatic cell count requirement for fluid milk (see S. 3758), S6884 [5AU]
———improve capacity to prevent, detect, and respond to food safety problems and the safety of imported food without creating new Government bureaucracy (see S. 3832), S7420 [23SE]
Government regulations: create a three-tiered approval system for drugs, biological products, and devices that is responsive to the needs of seriously ill patients (see H.R. 4732), H1026 [2MR]
———ensure that the Dietary Supplement Health and Education Act and other requirements for dietary supplements are fully implemented and enforced (see S. 3414), S4211 [25MY]
Health: provide further study of irritable bowel syndrome (IBS) (see H. Res. 1309), H3078 [29AP]
———strengthen regulation of dietary supplements that may pose safety risk unknown to consumers (see S. 3002), S482 [4FE]
Health care professionals: require dentists to provide patients with a factsheet before performing any dental restoration work (see H.R. 4615), H602 [4FE]
Pharmaceuticals: importation of prescription drugs (see S. 3415), S4211 [25MY]
Safety: establish a nanotechnology program (see S. 2942), S122 [21JA]
Taxation: exempt certain emergency medical devices from the excise tax on medical devices (see H.R. 6257), H7389 [29SE]
———repeal excise tax on medical devices (see H.R. 5095), H2798 [21AP] (see H.R. 5615), H4905 [28JN]
Cloture motions
Food: improve capacity to prevent, detect, and respond to food safety problems and the safety of imported food (S. 510), S8049 [18NO], S8229 [29NO]
———improve capacity to prevent, detect, and respond to food safety problems and the safety of imported food (S. 510), motion to proceed, S7730 [29SE], S7929 [17NO]
Letters
Dietary Supplement Full Implementation and Enforcement Act: DeMaurice F. Smith, National Football League Players Association, S4216 [25MY]
———John Gay, Natural Products Association, S4217 [25MY]
———Linda A. Suydam, Consumer Healthcare Products Association, S4218 [25MY]
———Loren D. Israelsen, United Natural Products Alliance, S4217 [25MY]
———Michael McGuffin, American Herbal Products Association, S4218 [25MY]
———Michael S. Weiner, Major League Baseball Players Association, S4217 [25MY]
———Steve Mister, Council for Responsible Nutrition, S4218 [25MY]
FDA Food Safety Modernization Act, S7921 [17NO]
———Carol L. Tucker-Foreman, Consumer Federation of America, S7920 [17NO]
———Jean Halloran and Amy V. Gadhia, Consumers Union, S7920 [17NO]
———Jeffrey Levi, Trust for America's Health (organization), S7919 [17NO]
———Kathleen Sebelius and Margaret A. Hamburg, Dept. of HHS, S7402 [23SE]
———several food and agricultural organizations, S7930 [17NO]
———several food industry, consumers, and public health community organizations, S7920 [17NO]
———Shelley A. Hearne, Pew Charitable Trusts (organization), S7920 [17NO]
Lists
Organizations supporting FDA Food Safety Modernization Act, H8210 [8DE], H8889 [21DE]
Motions
Food: improve capacity to prevent, detect, and respond to food safety problems and the safety of imported food (S. 510), S7730 [29SE], S8230 [29NO]
Remarks in House
AIDS Drug Assistance Programs: funding, H6883 [23SE]
Appropriations: making continuing, E2116 [13DE]
———making supplemental (H.R. 5745), H6630 [14SE]
Contraceptives: establish certain duties for pharmacies to ensure provision of FDA-approved contraception (H.R. 5309), E847 [13MY]
Diseases: help prevent occurrence of cancer resulting from the use of ultraviolet tanning lamps by imposing more stringent controls on the use of such devices (H.R. 4520), E93 [26JA]
Food: improve capacity to prevent, detect, and respond to food safety problems and the safety of imported food, H8148-H8151, H8207-H8213 [8DE], H8820-H8823, H8861-H8890 [21DE], E2098 [9DE]
Health: balance innovation and patient safety when approving medical devices, H3514 [18MY]
———prevent tax increases on medical devices, H1567, H1570 [17MR], H1707 [19MR], H3189 [5MY]
Pharmaceuticals: importation of prescription drugs, H1365 [12MR]
———prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, H5386 [1JY]
Tobacco products: provide with certain regulatory authority (H.R. 1256), E474 [24MR], E1157 [22JN]
Tobacco Products Scientific Advisory Committee: address potential conflicts of interest in selection of members, E474 [24MR]
Remarks in Senate
Appropriations: making continuing, S10351 [16DE]
Drugs: more effectively regulate anabolic steroids (S. 4032), S10305 [15DE]
Food: improve capacity to prevent, detect, and respond to food safety problems and the safety of imported food, S10770 [19DE], S10810 [20DE]
———improve capacity to prevent, detect, and respond to food safety problems and the safety of imported food (S. 510), S6866 [5AU], S7111 [15SE], S7143 [16SE], S7337 [22SE], S7392-S7405 [23SE], S8046, S8049, S8093, S8094 [18NO], S8111 [19NO], S8211-S8213, S8219-S8239 [29NO], S8259-S8268 [30NO], S8545 [6DE]
———improve capacity to prevent, detect, and respond to food safety problems and the safety of imported food (S. 510), motion to proceed, S7730 [29SE], S7877, S7880 [15NO], S7913, S7917-S7923, S7926, S7929-S7932, S7941, S7942 [17NO], S8001, S8008-S8010, S8013-S8017, S8025-S8031 [18NO]
———improve capacity to prevent, detect, and respond to food safety problems and the safety of imported food (S. 510), unanimous-consent agreement, S8222 [29NO]
———improve capacity to prevent, detect, and respond to food safety problems and the safety of imported food (S. 510), unanimous-consent request, S7336 [22SE], S7394 [23SE], S8221, S8222 [29NO], S8267 [30NO]
———improve capacity to prevent, detect, and respond to food safety problems and the safety of imported food without creating new Government bureaucracy, S8232 [29NO], S8263 [30NO]
———improve capacity to prevent, detect, and respond to food safety problems and the safety of imported food without creating new Government bureaucracy (S. 3832), S7397 [23SE]
Government regulations: ensure that the Dietary Supplement Health and Education Act and other requirements for dietary supplements are fully implemented and enforced (S. 3414), S4215, S4216 [25MY]
———permit emergency scheduling of designer anabolic steriods, S8028 [18NO]
Health: exempt pediatric medical devices from the medical device tax, S4728, S4733 [9JN]
———prohibit tax increases on medical devices, S1965, S2001 [24MR]
———strengthen regulation of dietary supplements that may pose safety risk unknown to consumers (S. 3002), S494 [4FE], S613 [22FE]
Pharmaceuticals: importation of prescription drugs (S. 3415), S4218 [25MY]
Safety: establish a nanotechnology program (S. 2942), S123 [21JA]
Reports filed
Agriculture, Rural Development, FDA, and Related Agencies Programs Appropriations: Committee on Appropriations (Senate) (S. 3606) (S. Rept. 111-221), S5963 [15JY]
Consideration of Senate Amendments to H.R. 2751, FDA Food Safety Modernization Act: Committee on Rules (House) (H. Res. 1781) (H. Rept. 111-692), H8940 [21DE]
Preserve Access to Affordable Generics Act: Committee on the Judiciary (Senate) (S. 369) (S. Rept. 111-123), S438 [2FE]
Tables
Pay-as-you-go effects of Harkin substitute amendment to S. 510, FDA Food Safety Modernization Act, S8267 [30NO]
Texts of
S. 510, FDA Food Safety Modernization Act, S8031-S8046 [18NO]