FEDERAL FOOD, DRUG, AND COSMETIC ACT

Amendments

FDA: clarify certain responsibilities relative to importation of drugs into the U.S. (H.R. 3240), H5428 [28JN]

Bills and resolutions

Animals: increase the availability of drugs for minor species and rare diseases in all animals (see S. 3169), S9944 [5OC] (see H.R. 4780), H5435 [28JN]

Dept. of HHS: allow officers and employees to issue detention orders on certain foods (see H.R. 5591), H11445 [27OC]

Drugs: allow importation of prescription drugs into the U.S. by pharmacists and wholesalers for resale and by U.S. citizens for personal use (see S. 2520), S3691 [9MY]

———distribution of prescription drugs (see H.R. 4301), H2338 [13AP]

———enhance consumer protection in the purchase of prescription drugs from Internet pharmacies (see S. 3208), S10619 [17OC] (see H.R. 5476), H10036 [17OC]

FDA: compel compliance with court decision relative to disclosure of certain information on the labeling of dietary supplements (see H.R. 4604), H4120 [8JN]

———establish a tolerance for the presence of methyl mercury in seafood (see H.R. 5514), H10472 [19OC]

———grant authority to regulate tobacco (see S. 2333), S1986 [30MR] (see S. 2379), S2347 [6AP] (see S. 2566, 2568), S4014 [16MY] (see H.R. 4042), H1163 [21MR] (see H.R. 4207), H1956 [6AP]

———provide greater access to affordable pharmaceuticals (see S. 3051), S8585 [14SE] (see H.R. 5247), H7990 [21SE]

———restrict authority to issue clinical holds on investigational drugs or to deny patients expanded access to such drugs (see H.R. 3677), H509 [16FE]

Food: improve safety of imported foods (see S. 2480), S3023 [27AP] (see S. 2692), S4669 [7JN]

———require foods containing known allergens to bear labeling that states that fact and the names of the allergens (see H.R. 5532), H10808 [24OC]

———require labels on food that contains, or is produced with, a genetically engineered material (see S. 2080), S680 [22FE]

Food industry: require Dept. of Agriculture report on safety and monitoring of genetically engineered foods (see H.R. 5095), H7209 [27JY]

———require FDA premarket review and oversight of all genetically engineered foods (see S. 3184), S10252 [11OC]

———safety of genetically engineered foods (see S. 2315), S1884 [29MR] (see H.R. 3883), H920 [9MR]

Pharmaceuticals: abbreviate applications for the approval of new drugs (see H.R. 5231), H7932 [20SE]

———clinically superior modifications to previously approved or licensed drugs (see H.R. 4242), H2122 [11AP]

Letters

Facilitate the importation into the U.S. of certain FDA approved drugs: several Representatives, H5428 [28JN]

Grant FDA authority to regulate tobacco, and reduce youth smoking, increase tobacco-related research, and develop safer tobacco products: John R. Garrison, American Lung Association, E371 [21MR]

Importation of prescription drugs into the U.S. by pharmacists and wholesalers for resale and by U.S. citizens for personal use: David A. Kessler, S9258 [26SE]

———Michael E. Baroody, National Association of Manufacturers, H9702 [11OC]

———Michael M. Faenza, National Mental Health Association, H9702 [11OC]

———Mike Dugan, National Multiple Sclerosis Society, H9702 [11OC]

———Nancy Sander, Allergy and Asthma Network-Mothers of Asthmatics, Inc., H9703 [11OC]

———Representative Archer, S10685 [18OC]

———Representative Dingell, Committee on Commerce (House), S10684 [18OC]

———Representative Hyde, Committee on the Judiciary (House), S10688 [18OC]

———Senator Hatch, Committee on the Judiciary (Senate), S10688 [18OC]

———Thomas J. Donohue, U.S. Chamber of Commerce, H9702 [11OC]

———several Representatives, H9703 [11OC]

———several patient and survivor organizations, H9703 [11OC]

Internet Prescription Drug Consumer Protection Act: Carla J. Stovall, National Association of Attorneys General, S10621 [17OC]

———Henri R. Manasse, Jr., American Society of Health-Systems Pharmacists, S10622 [17OC]

———John A. Gans, American Pharmaceutical Association, S10621 [17OC]

———Linda F. Golodner, National Consumers League, S10622 [17OC]

———Peter M. Neupert, drugstore.com, Inc., S10622 [17OC]

Medicare coverage of outpatient prescription drugs and allow importation of prescription drugs into the U.S. by pharmacists and wholesalers for resale and by U.S. citizens for personal use: President Clinton, S10524 [13OC]

Prescription drug importation into the U.S. by pharmacists and wholesalers for resale: John M. Rector, National Community Pharmacists Association, S7377 [20JY]

———Representative Dingell, S7206 [19JY]

———Ronald J. Streck, National Wholesale Druggists' Association, S7206 [19JY]

Memorandums

Facilitate the Importation Into the U.S. of Certain FDA Approved Drugs: Christopher J. Sroka, Congressional Research Service, H5430 [28JN]

Remarks in House

Animals: increase the availability of drugs for minor species and rare diseases in all animals (H.R. 4780), E1146 [29JN]

Drugs: allow importation of prescription drugs into the U.S. by pharmacists and wholesalers for resale and by U.S. citizens for personal use, H7875 [20SE], H7937, H7938 [21SE], H8206 [27SE], H9638, H9639, H9670, H9672-H9680, H9693-H9708 [11OC], H10394 [19OC], E1866 [19OC], E1891 [24OC], E1903 [25OC]

———distribution of prescription drugs (H.R. 4301), E586 [13AP]

———enhance consumer protection in the purchase of prescription drugs from Internet pharmacies (H.R. 5476), E1808 [17OC]

FDA: clarify certain responsibilities relative to importation of drugs into the U.S. (H.R. 3240), H360 [14FE], H1731 [4AP], H2096 [11AP], H2635 [8MY], H3858 [25MY], H5426-H5434 [28JN], E1235 [14JY]

———establish a tolerance for the presence of methyl mercury in seafood (H.R. 5514), E1860 [19OC]

———facilitate the importation into the U.S. of certain approved drugs (H.R. 1885), H1945, H1946 [6AP], H5428, H5430 [28JN], H7913, H7915 [20SE], E1235 [14JY]

———grant authority to regulate tobacco, H7087-H7090 [26JY], E1169 [30JN]

———grant authority to regulate tobacco (H.R. 4042), H1127 [21MR], E371 [21MR]

———grant authority to regulate tobacco (H.R. 4207), H1847-H1849 [5AP], H2114 [11AP], H2503 [3MY]

———prohibit funding to prevent importation into the U.S. of certain approved drugs, H5696-H5700, H5705-H5709 [10JY], E1198 [11JY]

———restrict authority to issue clinical holds on investigational drugs or to deny patients expanded access to such drugs (H.R. 3677), E2230 [15DE]

———Supreme Court decision relative to jurisdiction over tobacco, H1288 [23MR]

———testing and recall of genetically engineered livestock feed sold for human consumption, H7741 [19SE]

Food: require labels on food that contains, or is produced with, a genetically engineered material, H5782, H5783 [11JY]

Food industry: safety of genetically engineered foods (H.R. 3883), E2054 [1NO], E2072 [2NO]

Pharmaceuticals: eliminate barriers to improve access to generic drugs, H7742 [19SE], E1527, E1528, E1529 [19SE]

Remarks in Senate

Animals: increase the availability of drugs for minor species and rare diseases in all animals (S. 3169), S9950 [5OC]

Drugs: allow importation of prescription drugs into the U.S. by pharmacists and wholesalers for resale, S7142 [18JY], S7194-S7216 [19JY], S7377 [20JY]

———allow importation of prescription drugs into the U.S. by pharmacists and wholesalers for resale and by U.S. citizens for personal use, S9029 [22SE], S9255, S9258 [26SE], S10523 [13OC], S10669, S10675-S10678, S10681-S10688, S10691-S10698, S10732 [18OC]

———allow importation of prescription drugs into the U.S. by pharmacists and wholesalers for resale and by U.S. citizens for personal use (S. 2520), S3693-S3695 [9MY]

———discrepancy in prescription drug prices between U.S. and foreign countries, S2320 [6AP]

———enhance consumer protection in the purchase of prescription drugs from Internet pharmacies (S. 3208), S10620-S10623 [17OC]

FDA: facilitate the importation into the U.S. of certain approved drugs, S7142 [18JY]

———facilitate the importation into the U.S. of certain approved drugs (S. 1191), S132-S134 [31JA], S707, S708 [23FE], S840 [28FE]

———grant authority to regulate tobacco, S2411 [7AP]

———grant authority to regulate tobacco (S. 2333), S1990-S1993 [30MR]

———grant authority to regulate tobacco (S. 2379), S2350, S2351 [6AP]

———grant authority to regulate tobacco (S. 2566), S4016-S4018 [16MY]

———grant authority to regulate tobacco (S. 2568), S4018 [16MY]

———Office of Generic Drugs funding, S7329, S7330, S7376 [20JY]

Food: improve safety of imported foods (S. 2692), S4685, S4689 [7JN]

———require labels on food that contains, or is produced with, a genetically engineered material (S. 2080), S683-S685 [22FE]

Food industry: require FDA premarket review and oversight of all genetically engineered foods (S. 3184), S10253 [11OC]

———safety of genetically engineered foods (S. 2315), S1894 [29MR]

Reports

Prescription Drugs with Foreign Labels, H9674 [11OC]

Reports filed

National Uniformity for Food Act: Committee on Agriculture, Nutrition, and Forestry (Senate) (S. 1155) (S. Rept. 106-504), S10619 [17OC]

Summaries

Imported Products Safety Improvement and Disease Prevention Act (S. 2692), S4689 [7JN]

Internet Prescription Drug Consumer Protection Act (S. 3208), S10621 [17OC]

Tables

Prescription drug import provisions in agriculture appropriations legislation, S10525 [13OC]

Texts of

H.R. 3240, Drug Import Fairness Act, H5426 [28JN]

S. 2080, Genetically Engineered Food Right-To-Know Act, S685 [22FE]

S. 2315, Genetically Engineered Food Safety Act, S1894-S1897 [29MR]

S. 2333, Tobacco Regulatory Fairness Act, S1991 [30MR]

S. 2692, Imported Products Safety Improvement and Disease Prevention Act, S4686-S4689 [7JN]

S. 3051, Greater Access to Affordable Pharmaceuticals Act, S8590 [14SE]

S. 3169, Minor Animal Species Health and Welfare Act, S9951-S9955 [5OC]

S. 3184, Genetically Engineered Foods Act, S10254-S10256 [11OC]