FOOD AND DRUG ADMINISTRATION

Articles and editorials

Clinical Equivalence of Generic and Brand-Name Drugs Used in Cardiovascular Disease—A Systematic Review and Meta-analysis, S10863-S10875 [10DE]

Bills and resolutions

Advertising: implement safeguards in direct-to-consumer advertising following FDA approval of prescription drugs and medical devices (see H.R. 6151), H4830 [22MY]

Agriculture: provide emergency financial assistance to producers and first handlers of fresh tomatoes for losses incurred as a result of the FDA public health advisory regarding tomatoes (see H.R. 6581), H7057 [23JY]

Agriculture, rural development, FDA, and related agencies programs: making appropriations (see S. 3289), S6972 [21JY]

Animals: establish a program of fees relative to generic new animal drugs (see H.R. 6433), H6229 [8JY]

———revise and extend the animal drug user fee program (see H.R. 6432), H6229 [8JY]

Dept. of HHS: educate the public on the importance of adequate iodine intake (see H. Con. Res. 347), H3403 [8MY]

———expand authority to impose debarments in order to ensure the integrity of drug, biological product, and device regulation (see H.R. 6376, 6378), H6173 [26JN]

———implement a National Neurotechnology Initiative (see S. 2989), S3891 [7MY] (see H.R. 5989), H3186 [7MY]

Diseases: establish a comprehensive interagency response to reduce lung cancer mortality in a timely manner (see S. 3187), S6158 [25JN]

Drugs: clarify priority review voucher laws (see S. 3151), S5753 [18JN]

———improve safety (see H.R. 5839), H2486 [17AP]

———mandate early access by patients to new drugs under clinical investigation for a serious or immediately life-threatening condition for which no comparable or satisfactory drug or other therapy is available (see H.R. 6047), H3884 [14MY]

Federal Food, Drug, and Cosmetic Act: amend relative to the safety of the food supply (see S. 3385), S7904 [31JY]

———distribution and citation of scientific research in connection with foods and dietary supplements (see H.R. 7120), H10129 [26SE]

———ensure safety and quality of medical products and enhance authorities of FDA (see S. 3409), S7905 [31JY]

———preserve ability to file State product liability lawsuits relative to defective medical devices (see S. 3398), S7904 [31JY] (see H.R. 6381), H6173 [26JN]

Food: ensure safety (see H.R. 5827), H2442 [16AP]

———ensure the safety of imported seafood and seafood products (see S. 2914), S3401 [24AP]

———improve safety by providing for improved information technology to identify high-risk imports and enhanced use of science to identify and address food safety issues (see H.R. 5904), H2759 [24AP]

———provide for enhanced food-borne illness surveillance and food safety capacity (see S. 3358), S7629 [29JY]

Government regulations: amend policies relative to postmarket surveillance of devices (see S. 3020), S4282 [15MY]

———create a three-tiered approval system for drugs, biological products, and devices that is responsive to the needs of seriously ill patients (see S. 3046), S4621 [21MY] (see H.R. 6270), H5407 [12JN]

———finalize proposed rule on sunscreen product labeling (see S. 3425), S8035 [1AU]

Health: ensure a sufficient supply of vaccines (see H.R. 4991), H294 [16JA]

———evaluate scientific evidence on whether to add more folic acid to enriched grain products and expand folic acid fortification into cornmeal and corn-based food products to help prevent further serious birth defects (see H. Res. 1487), H9085 [23SE]

House of Representatives: provide funding for select committee established to investigate vote on motion to recommit H.R. 3161, agriculture, rural development, FDA, and related agencies programs appropriations (see H. Res. 1148), H2759 [24AP]

Pharmaceuticals: reverse policy eliminating access to medication containing estriol (see S. Con. Res. 88), S5447 [10JN] (see H. Con. Res. 342), H3108 [6MY]

Product safety: recognize impact of U.S. trade policies on the number and safety of imports and improve inspection of imported food and products (see H. Res. 926), H295 [16JA]

Safety: establish a program to assure the safety of fresh produce intended for human consumption (see H.R. 5620), H1701 [13MR]

Seafood inspection regime: authorize appropriations (see H.R. 5219), H557 [29JA]

Letters

Determination of GlaxoSmithKline, PLC, action after receiving study on the potential health risks associated with diabetes drug Avandia: Senator Grassley, Committee on Finance (Senate), S486 [30JA]

Family Smoking Prevention and Tobacco Control Act: Representative Conyers, Committee on the Judiciary (House), H7576 [30JY]

———Representative Dingell, Committee on Energy and Commerce (House), H7576, H7577 [30JY]

———Representative Rahall, Committee on Natural Resources (House), H7577 [30JY]

———Representative Rangel, Committee on Ways and Means (House), H7576 [30JY]

Preserve Access to Affordable Generics Act: Brian A. Benczkowski, Dept. of Justice, S1195 [26FE]

Sunscreen Labeling Protection (SUN) Act: Daniel E. Smith and Dick Woodruff, American Cancer Society Cancer Action Network, S8038 [1AU]

———Richard Wiles, Environmental Working Group (organization), S8038 [1AU]

———Robert F. Hurley, Citizens for Sun Protection (organization), S8038 [1AU]

Remarks in House

Animals: revise and extend the animal drug user fee program (H.R. 6432), H7534-H7541 [30JY], E1683 [1AU]

Diseases: link between child vaccinations containing mercury and autism, H1996 [3AP]

Federal Food, Drug, and Cosmetic Act: preserve ability to file State product liability lawsuits relative to defective medical devices (H.R. 6381), E1387 [26JN], E1402 [8JY], E1523 [22JY]

House of Representatives: investigation by select committee of events surrounding vote on motion to recommit H.R. 3161, agriculture, rural development, FDA, and related agencies programs appropriations, E732 [24AP], E2031 [26SE]

———provide funding for select committee established to investigate vote on motion to recommit H.R. 3161, agriculture, rural development, FDA, and related agencies programs appropriations (H. Res. 1148), H2737 [24AP]

Reimschuessel, Renate: Partnership for Public Service (organization) Service to America Homeland Security Medal nominee, E1350 [25JN]

Research: exempt medical devices from reporting adverse events in clinical trials, E1683 [1AU]

Rockville, MD: tribute to U.S. Pharmacopeial Convention (organization) new headquarters, E267 [28FE]

Tibotec Therapeutics (business): tribute for development of new FDA-approved HIV treatment drug, E64, E66, E71 [23JA]

Tobacco products: provide with certain regulatory authority (H.R. 1108), H7546-H7577 [30JY], H7636 [31JY], E1663, E1699 [1AU]

Remarks in Senate

Animals: revise and extend the animal drug user fee program (H.R. 6432), S7983 [1AU], S8115 [8SE], S8170 [9SE]

Dept. of HHS: implement a National Neurotechnology Initiative (S. 2989), S3899, S3900 [7MY]

Dept. of Homeland Security: agriculture and food security and inspections jurisdiction, S4236 [15MY]

Drugs: clarify priority review voucher laws (S. 3151), S5760 [18JN]

———increase access to lower-cost, generic versions of drugs, S10862 [10DE]

———increase in prices for prescription drugs, S7440 [25JY]

Federal Food, Drug, and Cosmetic Act: amend relative to the safety of the food supply (S. 3385), S7933 [31JY]

———ensure safety and quality of medical products and enhance authorities of FDA (S. 3409), S7968 [31JY]

———preserve ability to file State product liability lawsuits relative to defective medical devices (S. 3398), S7953 [31JY], S8022 [1AU]

Food industry: improve public health and food safety through enhanced food traceability and inspection systems, S7471 [25JY]

Government regulations: create a three-tiered approval system for drugs, biological products, and devices that is responsive to the needs of seriously ill patients (S. 3046), S4625 [21MY], S7620 [29JY], S8021 [1AU]

———finalize proposed rule on sunscreen product labeling (S. 3425), S8037 [1AU]

Pharmaceuticals: importation of prescription drugs, S2087 [13MR]

———potential health risks associated with anxiety drug Paxil, S5519 [11JN]

———potential health risks associated with diabetes drug Avandia, S486 [30JA]

Safety: food safety program funding, S1986 [12MR]

Reports filed

Agriculture, Rural Development, FDA, and Related Agencies Programs Appropriations: Committee on Appropriations (Senate) (S. 3289) (S. Rept. 110-426), S6971 [21JY]

Animal Generic Drug User Fee Act: Committee on Energy and Commerce (House) (H.R. 6433) (H. Rept. 110-805), H7627 [30JY]

Family Smoking Prevention and Tobacco Control Act: Committee on Energy and Commerce (House) (H.R. 1108) (H. Rept. 110-762), H6725 [17JY]

FDA Animal Drug User Fee Program Revision and Extension: Committee on Energy and Commerce (House) (H.R. 6432) (H. Rept. 110-804), H7627 [30JY]

Statements

Delay of Report Relative to Investigation of Record Vote of Motion To Recommit for H.R. 3161: Representatives Delahunt and Pence, Committee on Voting Irregularities (House, Select), E1768 [11SE]

Dept. of Homeland Security Agriculture and Food Security and Inspections Jurisdiction, S4237 [15MY]

Family Smoking Prevention and Tobacco Control Act: Congressional Black Caucus, H7572 [30JY]

Summaries

Setting Forth the Federal Budget for 2008-2013 (S. Con. Res. 70): Vitter Amendment on Importation of Prescription Drugs, S2299 [1AP]

Texts of

H. Res. 1148, funding for select committee established to investigate vote on motion to recommit H.R. 3161, agriculture, rural development, FDA, and related agencies programs appropriations, H2737 [24AP]

H.R. 1108, Family Smoking Prevention and Tobacco Control Act, H7546-H7568 [30JY]

H.R. 6432, FDA animal drug user fee program revision and extension, H7534-H7539 [30JY]

S. 3385, FDA Food Safety Modernization Act, S7934-S7946 [31JY]

S. Con. Res. 88, reverse FDA policy eliminating access to medication containing estriol, S5455 [10JN]