FEDERAL FOOD, DRUG, AND COSMETIC ACT

Amendments

Pharmaceuticals: improve safety and efficacy for children (S. 838), S10816, S10844, S10848 [18OC]

Bills and resolutions

Animals: amend relative to new animal drugs (see S. 1346), S8705 [2AU]

———increase the availability of drugs for minor species and rare diseases in all animals (see H.R. 1956), H2678 [23MY]

Children and youth: amend certain laws relative to pediatric studies of drugs (see H.R. 3047), H6379 [4OC]

Consumers: safeguard public health and provide food that is safe, unadulterated, and honestly presented (see H.R. 1816), H2141 [10MY]

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. 58), H26 [3JA]

———distribution chain of prescription drugs (see S. 1132), S7083 [28JN] (see H.R. 68), H26 [3JA]

———permit individuals to import prescription drugs in limited circumstances (see S. 1229), S8123 [24JY]

———regulate receipt of donated prescription drug samples by charitable health care entities (see H.R. 2740), H5334 [2AU]

———study approved drugs for whether their use affects women differently than men (see H.R. 2783), H5336 [2AU]

FDA: ensure protection of the U.S. food supply (see S. 1551), S10693 [15OC] (see H.R. 3184), H7529 [30OC]

———grant authority to regulate tobacco (see S. 190), S568 [25JA] (see S. 247), S1062 [6FE] (see H.R. 1043), H953 [15MR] (see H.R. 1097), H1010 [20MR] (see H.R. 2180), H3201 [14JN]

———permit import of prescription medications sold in certain foreign countries and correct impediments in implementation of the Medicine Equity and Drug Safety Act (see S. 215), S707 [30JA]

———provide greater access to affordable pharmaceuticals (see S. 812), S4100 [1MY] (see H.R. 1862), H2280 [16MY]

———require manufacturers of dietary supplements to register and require submission of reports on adverse experiences regarding such supplements (see H.R. 3065), H6458 [9OC]

———uniform food safety warning notification requirements (see H.R. 2649), H4723 [26JY]

Fish and fishing: provide clarification regarding the market name for the fish Pangasius bocourti and compliance with the Federal Food, Drug, and Cosmetic Act (see S. 1494), S10154 [3OC] (see H.R. 2964), H6055 [25SE]

Food: consumer access to information on the health benefits of foods and dietary supplements (see H.R. 2265), H3463 [21JN]

———require foods containing known allergens to bear labeling that states that fact and the names of the allergens (see H.R. 1356), H1408 [3AP]

Food industry: freshness dates on food (see H.R. 2611), H4539 [24JY]

———require Dept. of Agriculture report on safety and monitoring of genetically engineered foods (see H.R. 713), H398 [14FE]

Government regulations: establish labeling and advertising requirements for dietary supplements containing ephedrine alkaloids and prohibit sales of such supplements to minors (see H.R. 3066), H6458 [9OC]

Health: improve access to prescription drugs under Medicare and the Federal Food, Drug, and Cosmetic Act, and health care coverage for seniors, the self-employed, and children (see H.R. 1387), H1481 (see H.R. 1387), H1491 [4AP]

Labeling: require fragrances containing known toxic substances or allergens to be labeled accordingly (see H.R. 1947), H2570 [22MY]

Medical devices: improve regulation (see H.R. 3580), H10964 [20DE]

Pharmaceuticals: amend relative to clinically superior modifications to previously approved or licensed drugs (see H.R. 386), H165 [31JA]

———establish therapeutic equivalence requirements for generic drugs (see H.R. 1685), H1860 [2MY]

———importation of certain prescription drugs by pharmacists and wholesalers (see H.R. 698), H397 [14FE]

———improve safety and efficacy for children (see S. 838), S4416 [7MY] (see S. 1301), S8575 [1AU] (see S. 1789), S12682 [7DE] (see H.R. 2887), H5615 [13SE] (see H.R. 3452), H9239 [11DE]

Science: prohibit the cloning of humans (see H.R. 2608), H4539 [24JY]

Women: protect breastfeeding by new mothers, establish performance standard for breast pumps, and allow tax credit for enabling mothers to breastfeed or express milk at work (see H.R. 285), H110 [30JA]

Letters

Importation of prescription drugs into the U.S. by U.S. citizens for personal use: William B. Simpkins, DEA, H3892, H3895 [11JY]

———William K. Hubbard, FDA, H3893 [11JY]

Memorandums

Approval of Generic Versions of Drugs Without Pediatric Labeling, H10209 [18DE]

———Laurence H. Tribe, E2286-E2288 [13DE]

———Wilmer, Cutler & Pickering (law firm), H8106 [13NO]

Remarks in House

Animals: increase the availability of drugs for minor species and rare diseases in all animals (H.R. 1956), E904 [23MY]

Drugs: allow importation of prescription drugs into the U.S. by pharmacists and wholesalers for resale and by U.S. citizens for personal use, H3598 [26JN], H3624 [27JN], H3756 [28JN], H3880-H3889 [11JY], E1345 [17JY]

———allow importation of prescription drugs into the U.S. by U.S. citizens for personal use, H3494 [25JN], H3789 [28JN], H3871, H3890-H3897 [11JY], E1345 [17JY]

———distribution chain of prescription drugs (H.R. 68), E2 [3JA]

FDA: food safety programs for foodborne threats funding through reductions in Medicine Equity and Drug Safety Act funding, H3918 [11JY]

———grant authority to regulate tobacco (H.R. 1097), H914-H918 [14MR]

———grant authority to regulate tobacco (H.R. 2180), E1117 [14JN]

———Office of Generic Drugs funding, H3778, H3779 [28JN]

———prohibit funding to prevent importation into the U.S. of certain approved drugs, H3690 [27JN]

———reallocation of funding to the Office of Generic Drugs to evaluate and review potential patent abuses, H3919-H3921 [11JY]

———require manufacturers of dietary supplements to register and require submission of reports on adverse experiences regarding such supplements (H.R. 3065), E1833 [9OC]

———require new drug applications include a statement specifying the total cost of research and development, H3921 [11JY]

Fish and fishing: provide clarification regarding the market name for the fish Pangasius bocourti and compliance with the Federal Food, Drug, and Cosmetic Act, H6267, H6268, H6269 [4OC]

Food: consumer access to information on the health benefits of foods and dietary supplements (H.R. 2265), E1175 [21JN]

Food industry: require Dept. of Agriculture report on safety and monitoring of genetically engineered foods, H3765-H3767 [28JN], H6266 [4OC]

Government regulations: establish labeling and advertising requirements for dietary supplements containing ephedrine alkaloids and prohibit sales of such supplements to minors (H.R. 3066), E1833 [9OC]

Health: improve access to prescription drugs under Medicare and the Federal Food, Drug, and Cosmetic Act, and health care coverage for seniors, the self-employed, and children (H.R. 1387), H1474 [4AP], H1834 [2MY]

Pharmaceuticals: approval of generic versions of drugs without pediatric labeling relative to exclusive marketing rights agreements, H8551 [28NO], H10209 [18DE], E2286 [13DE]

———improve safety and efficacy for children (H.R. 2887), H7562 [31OC], H7727 [6NO], H8094-H8107 [13NO], H8166 [14NO], H8551 [28NO], E2073 [14NO], E2103 [15NO], E2114 [16NO], E2286 [13DE]

———improve safety and efficacy for children (S. 1789), H10200-H10212 [18DE], E2368, E2389 [20DE]

Women: protect breastfeeding by new mothers, establish performance standard for breast pumps, and allow tax credit for enabling mothers to breastfeed or express milk at work (H.R. 285), E360 [14MR]

Remarks in Senate

Animals: amend relative to new animal drugs (S. 1346), S8768 [2AU]

Drugs: allow importation of prescription drugs into the U.S. by pharmacists and wholesalers for resale and by U.S. citizens for personal use, S7440 [11JY], S7871 [18JY], S11071 [25OC]

———distribution chain of prescription drugs (S. 1132), S7104 [28JN]

———permit individuals to import prescription drugs in limited circumstances (S. 1229), S8131 [24JY]

FDA: ensure protection of the U.S. food supply, S13902, S13903 [20DE]

———grant authority to regulate tobacco (S. 247), S1063 [6FE], S2972 [27MR]

———permit import of prescription medications sold in certain foreign countries and correct impediments in implementation of the Medicine Equity and Drug Safety Act (S. 215), S775 [30JA], S7440 [11JY]

Pharmaceuticals: improve safety and efficacy for children (S. 838), S4422-S4425 [7MY], S10816-S10819, S10826-S10831 [18OC], S10871-S10873 [23OC]

———improve safety and efficacy for children (S. 1301), S8597-S8599 [1AU]

———improve safety and efficacy for children (S. 1789), S12752 [7DE], S12755 [10DE], S13070 [12DE]

Surgeon General: release of ``Women and Smoking'' report, S2972 [27MR]

Reports filed

Best Pharmaceuticals for Children Act: Committee on Energy and Commerce (House) (H.R. 2887) (H. Rept. 107-277), H8034 [9NO]

———Committee on Health, Education, Labor, and Pensions (Senate) (S. 838) (S. Rept. 107-79), S10286 [4OC]

Summaries

National Youth Smoking Reduction Act (H.R. 2180), E1118 [14JN]

Tables

Drug price comparison, H3495 [25JN]

Estimated cost to consumers of exclusivity extensions for certain pediatric drugs, H8102 [13NO]

Texts of

H.R. 2887, Best Pharmaceuticals for Children Act, H8094-H8098 [13NO]

S. 215, Medication Equity and Drug Savings Act, S776 [30JA]

S. 247, Kids Deserve Freedom From Tobacco Act, S1063-S1066 [6FE]

S. 838, Best Pharmaceuticals for Children Act, S4422-S4424 [7MY]

S. 1789, Best Pharmaceuticals for Children Act, S13071-S13076 [12DE], H10200-H10204 [18DE]