FEDERAL FOOD, DRUG, AND COSMETIC ACT

Amendments

Medical Device User Fee and Modernization Act: technical corrections relative to amendments (S. 1881), S2821 [12MR]

Articles and editorials

Senate's Chance on Drug Costs, S10412 [5OC]

Shielding the Drug Industry, S10411 [5OC]

``Yes'' to Drugs From Canada, E810 [11MY]

Bills and resolutions

Advertising: amend regulations on direct-to-consumer prescription drug advertising (see S. 2445), S5799 [19MY]

Drugs: amend relative to market exclusivity for cancer drugs and extend the patent term on such drugs equal to the regulatory review period (see H.R. 5306), H9048 [8OC]

———protect the public from unsafe importation of prescription drugs and from counterfeit prescription drugs (see S. 2493), S6348 [2JN] (see H.R. 4923), H6701 [22JY]

FDA: prohibit the approval of any drug that infringes the right to life (see H.R. 4013), H1369 [23MR]

Food: ensure consumers receive information about the nutritional content of restaurant food and vending machine food (see S. 2108), S1518 [24FE]

Food industry: require FDA premarket review and oversight of all genetically engineered foods (see S. 2546), S6997 [17JN]

Hazardous substances: reduce human exposure to mercury through vaccines (see H.R. 4169), H2153 [2AP]

Health: establish system independent of the FDA to review health claims relative to the benefits of foods and dietary supplements (see H.R. 4004), H1322 [18MR]

Pharmaceuticals: establish requirements to allow sale of prescription drugs over the Internet (see S. 2464), S5949 [20MY] (see H.R. 3880), H830 [3MR]

———importation of prescription drugs (see S. 2307), S4024 [8AP] (see S. 2328), S4225 [21AP] (see H.R. 3710), H35 [20JA]

———permit importation of prescription drugs from Canada and certain other countries (see H.R. 4790), H5470 [9JY]

———standardize certification of Internet pharmacies and prohibit certain advertising activities and the use of certain bank instruments for purchases associated with illegal Internet pharmacies (see H.R. 4612), H4579 [18JN]

Product safety: increase public availability of information on clinical trials to determine the safety and effectiveness of drugs, biological products, and devices (see H.R. 5252), H8857 [7OC]

States: establish prescription drug monitoring programs, impose requirements on Internet pharmacies, require manufacturers to implement chain-of-custody procedures, and restrict exemption on importation of certain drugs (see H.R. 3870), H752 [2MR]

Letters

Importation of prescription drugs: Tommy G. Thompson, Sec. of HHS, S8213 [15JY]

Medical Devices Technical Corrections Act: Representatives C.W. Bill Young and Bonilla, Committee on Appropriations (House), H892 [9MR]

Questions and answers

Importation of prescription drugs (S. 2307), S4045 [8AP]

Remarks in House

Animals: amend relative to new animal drugs (S. 741), H6093-H6101 [20JY], E1462 [22JY]

Courts: allow civil action against food manufacturers or sellers who negligently violate Federal or State statues causing injury relative to a person's weight gain, obesity, or related health condition, H961-H964 [10MR]

Food: ensure that consumers receive information about the nutritional content of restaurant foods (H.R. 3444), H936 [10MR]

———reassessment of labeling laws, E1926 [11OC]

———require foods containing known allergens to bear labeling that states that fact and the names of the allergens (H.R. 3684), E1496, E1507 [22JY]

Health: establish system independent of the FDA to review health claims relative to the benefits of foods and dietary supplements (H.R. 4004), E391 [17MR]

Medical Device User Fee and Modernization Act: technical corrections relative to amendments (H.R. 3493), H109-H112 [27JA], E70 [28JA], E116 [4FE]

———technical corrections relative to amendments (S. 1881), H890-H892 [9MR], E357 [11MR]

Pharmaceuticals: importation of prescription drugs, H918 [9MR], H2191 [20AP], H2230 [21AP], H2521 [4MY], H2701 [6MY], H2991 [13MY], H3056 [17MY], H3378 [19MY], H3586, H3587, H3588 [1JN], H5615 [13JY], H5658, H5662-H5668, H5698-H5719 [14JY], E367 [16MR], E810 [11MY], E1885 [11OC]

———importation of prescription drugs (S. 2328), E1516 [22JY]

———permit commercial importation of prescription drugs from Canada, E291 [3MR]

Product safety: increase public availability of information on clinical trials to determine the safety and effectiveness of drugs, biological products, and devices (H.R. 5252), E1882 [11OC]

Remarks in Senate

Animals: amend relative to new animal drugs (S. 741), S2365-S2375 [8MR]

Dietary supplements: fully enforce and implement Dietary Supplement Health and Education Act and require Dept. of HHS to develop a plan for mandatory serious adverse event reports, S7077-S7086 [21JN]

———require manufacturers to submit reports on certain serious adverse events before allowing sale on military installations, S7033, S7034 [18JN], S7077-S7086 [21JN]

Drugs: protect the public from unsafe importation of prescription drugs and from counterfeit prescription drugs (S. 2493), S6339 [2JN]

FDA: establish guidelines and review safety of dietary supplements, S3545-S3548 [1AP]

Food: ensure consumers receive information about the nutritional content of restaurant food and vending machine food (S. 2108), S1523 [24FE]

Food industry: require FDA premarket review and oversight of all genetically engineered foods (S. 2546), S7019 [17JN]

Medical Device User Fee and Modernization Act: technical corrections relative to amendments (S. 1881), House amendment, S2821, S2822 [12MR]

Pharmaceuticals: establish requirements to allow sale of prescription drugs over the Internet (S. 2464), S5983-S5985 [20MY]

———importation of prescription drugs, S2700 [11MR], S2760, S2761 [12MR], S3524 [1AP], S3741 [6AP], S5053 [10MY], S8096 [14JY], S8179, S8180, S8185, S8191, S8196-S8199, S8207, S8211, S8214 [15JY], S9156-S9158 [14SE], S10961 [9OC], S11551 [19NO]

———importation of prescription drugs (S. 2307), S4042-S4044 [8AP]

———importation of prescription drugs (S. 2328), S4227-S4230 [21AP], S8498 [21JY], S8932 [8SE], S9072 [10SE], S10411, S10412 [5OC]

———permit importation of prescription drugs from Canada and certain other countries (H.R. 4790), S8932 [8SE]

Reports filed

Medical Devices Technical Corrections Act: Committee on Energy and Commerce (House) (S. 1881) (H. Rept. 108-433), H926 [9MR]

Minor Use and Minor Species Animal Health Act: Committee on Energy and Commerce (House) (S. 741) (H. Rept. 108-608), H5907 [15JY]

———Committee on Health, Education, Labor, and Pensions (Senate) (S. 741) (S. Rept. 108-226), S1457 [23FE], S1518 [24FE]

National Uniformity for Food Act: Committee on Energy and Commerce (House) (H.R. 2699) (H. Rept. 108-770), H9047 [8OC]

Summaries

Importation of Prescription Drugs (S. 2307), S4044 [8AP]

Pharmaceutical Market Access and Drug Safety Act (S. 2328), S4228 [21AP]

Texts of

H.R. 3493, Medical Devices Technical Corrections Act, H109 [27JA]

S. 741, Minor Use and Minor Species Animal Health Act, S2365-S2374 [8MR], H6093-H6099 [20JY]

S. 1881, Medical Devices Technical Corrections Act, S2821 [12MR], H890 [9MR]

S. 2546, Genetically Engineered Foods Act, S7020-S7023 [17JN]