FEDERAL FOOD, DRUG, AND COSMETIC ACT

Amendments

Animals: establish a program of fees relative to animal drugs (S. 313), S7165 [23MY], S7262 [3JN], S14279 [7NO]

FDA: provide authority to require certain research into drugs used in pediatric patients (S. 650), S9809, S9811, S9815 [23JY]

Bills and resolutions

Animals: amend relative to new animal drugs (see S. 741), S4512 [27MR] (see H.R. 2079), H4011 [13MY]

———establish a program of fees relative to animal drugs (see S. 313), S1977 [5FE] (see H.R. 1260), H1900 [13MR]

Consumers: safeguard public health and provide food that is safe, unadulterated, and honestly presented (see H.R. 1495), H2471 [27MR]

Dietary supplements: amend relative to dietary supplements (see H.R. 3377), H9981 [28OC]

———amend relative to dietary supplements containing ephedrine alkaloids (see H.R. 1075), H1515 [4MR]

———establish labeling and advertising requirements for supplements containing ephedrine alkaloids and prohibit sales of such supplements to minors (see H.R. 725), H460 [12FE]

———require manufacturers to register and require submission of reports on adverse experiences regarding such supplements (see H.R. 724), H460 [12FE]

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. 780), H700 [13FE]

———distribution chain of prescription drugs (see H.R. 2232), H4735 [22MY]

———establish recall authority for drugs and increase criminal penalties for sale or trade of prescription drugs knowingly adulterated or misbranded (see H.R. 3297), H9477 [15OC]

———require that each prescription drug sold at retail bear a label that states full retail price of the drug (see H.R. 3677), H12919 [8DE]

FDA: establish voluntary certification program for Internet and mail-order pharmacies and authorize, subject to conditions, importation of prescription drugs from Canada for personal use (see H.R. 2717), H6706 [14JY]

———provide authority to require certain research into drugs used in pediatric patients (see S. 650), S3881 [18MR] (see H.R. 2857), H7615 [24JY]

———provide greater access to affordable pharmaceuticals (see S. 7), S34 (see S. 54), S36 [7JA] (see S. 1225), S7619 [10JN] (see H.R. 2491), H5467 [17JN] (see H.R. 2640), H6262 [26JN]

———require manufacturers of dietary supplements submit reports on adverse experiences with dietary supplements (see S. 722), S4434 [26MR]

———uniform food safety warning notification requirements (see H.R. 2699), H6602 [10JY]

Food: amend inspection laws to notify consumers of products produced from crops, livestock, or poultry raised on sewage sludge-treated land (see H.R. 186), H58 [7JA]

———ensure safety of genetically engineered foods (see H.R. 2917), H7782 [25JY]

———ensure that consumers receive information about the nutritional content of restaurant foods (see H.R. 3444), H10457 [5NO]

———facilitate procurement of safe food by hospitals, nursing homes, schools, and child care facilities (see H.R. 3628), H12308 [21NO]

———require foods containing known allergens to bear labeling that states that fact and the names of the allergens (see H.R. 467), H243 [29JA] (see H.R. 3684), H12919 [8DE]

———require labels on food that contains, or is produced with, a genetically engineered material (see H.R. 2916), H7782 [25JY]

Food industry: freshness dates on food (see H.R. 468), H243 [29JA]

Health: improve access to prescription drugs, prohibit tax deductions for direct-to-consumer prescription drug advertisements, and ban campaign contributions from pharmaceutical company chief executive officers (see H.R. 1733), H3301 [10AP]

Medical Device User Fee and Modernization Act: technical corrections relative to amendments (see S. 1881), S15061 [18NO] (see H.R. 3493), H11358 [17NO]

National Organization for Rare Disorders: anniversary (see H. Con. Res. 147), H3304 [10AP]

Noncorrective contact lenses: regulate as medical devices (see S. 1747), S12737 [16OC] (see H.R. 2218), H4734 [22MY]

Orphan Drug Act: anniversary (see H. Con. Res. 147), H3304 [10AP]

Pharmaceuticals: eligibility of certain applicants for approval of a generic drug for a competition-free period (see H.R. 828), H702 [13FE]

———establish requirements to allow sale of prescription drugs over the Internet (see H.R. 2652), H6263 [26JN]

———establish therapeutic equivalence requirements for generic drugs (see H.R. 3401), H10129 [29OC]

———impact of illegal importation of prescription drugs on regulatory protections afforded consumers (see H. Con. Res. 225), H5663 [19JN]

———permit commercial importation of prescription drugs from Canada (see H.R. 847), H703 [13FE]

———preserve effectiveness of medically important antibiotics used in treatment of human and animal diseases (see S. 1460), S9959 [25JY] (see H.R. 2932), H7782 [25JY]

———prohibit sale or trade of prescription drugs that were knowingly adulterated or misbranded (see H.R. 2936), H7783 [25JY]

———require prescription drug manufacturers, packers, and distributors to disclose certain gifts provided in connection with promotional or marketing activities (see S. 948), S5484 [29AP]

Science: prohibit the cloning of humans (see H.R. 801), H701 [13FE]

Factsheets

Animal Drug User Fee Act Performance Goals and Procedures: FDA Center for Veterinary Medicine, S14791 [12NO]

Letters

Animal Drug User Fee Act: Tommy G. Thompson, Sec. of HHS, S14791 [12NO]

Dept. of HHS certification of safety and cost savings relative to commercial importation of prescription drugs from Canada: Asa Hutchinson, DEA, S8206 [19JN]

———Donna E. Shalala, S8204 [19JN]

———Mark B. McClellan, FDA, S8203, S8205 [19JN]

———Tommy G. Thompson, Sec. of HHS, S8204 [19JN]

Lists

Votes on point of order against Greater Access to Affordable Pharmaceuticals Act (2002), S15702 [24NO]

Proposals

Treatment of biological products and generic drugs relative to patent challenges and exclusivity rules, S16106 [9DE]

Remarks in House

Animals: amend relative to new animal drugs (H.R. 2079), E940 [13MY]

———establish a program of fees relative to animal drugs (H.R. 1260), H9054-H9059 [1OC], E462 [13MR]

———establish a program of fees relative to animal drugs (S. 313), H10293-H10297 [4NO]

Dietary supplements: amend relative to dietary supplements (H.R. 3377), E2150 [28OC], E2192 [31OC]

———establish labeling and advertising requirements for supplements containing ephedrine alkaloids and prohibit sales of such supplements to minors (H.R. 725), E218 [13FE]

———require manufacturers to register and require submission of reports on adverse experiences regarding such supplements (H.R. 724), E218 [13FE]

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, H8002 [5SE]

FDA: provide authority to require certain research into drugs used in pediatric patients (S. 650), H11567-H11572 [19NO]

Food: facilitate procurement of safe food by hospitals, nursing homes, schools, and child care facilities (H.R. 3628), E2447 [23NO]

National Organization for Rare Disorders: anniversary (H. Con. Res. 147), H4215-H4217 [19MY], E1000 [21MY]

Noncorrective contact lenses: regulate as medical devices (H.R. 2218), H11565-H11567 [19NO]

Orphan Drug Act: anniversary (H. Con. Res. 147), H4215 [19MY], E1000 [21MY]

Pharmaceuticals: establish requirements to allow sale of prescription drugs over the Internet (H.R. 2652), E1617 [25JY]

———improve safety and efficacy for children, H11570 [19NO]

———permit commercial importation of prescription drugs from Canada, H6620 [14JY], E1489 [15JY]

———permit commercial importation of prescription drugs from Canada (H.R. 847), H4768 [2JN]

———require manufacturers to sell FDA-approved prescription drugs to U.S. wholesalers and retailers on the same terms as Canadian purchasers, H12752 [8DE]

Remarks in Senate

Animals: amend relative to new animal drugs (S. 741), S4530 [27MR]

———establish a program of fees relative to animal drugs (S. 313), S7165 [23MY], S7266 [3JN], S14279-S14282 [7NO], S14791 [12NO]

Dept. of HHS: certify safety and cost savings relative to commercial importation of prescription drugs from Canada, S8203-S8215 [19JN], S8266-S8268 [20JN]

FDA: provide authority to require certain research into drugs used in pediatric patients (S. 650), S3897 [18MR], S9811-S9819 [23JY]

———provide greater access to affordable pharmaceuticals, S8187-S8198, S8200 [19JN]

———provide greater access to affordable pharmaceuticals (S. 7), S134-S136 [9JA]

———provide greater access to affordable pharmaceuticals (S. 54), S58 [7JA], S7966 [17JN]

———provide greater access to affordable pharmaceuticals (S. 812), S1506 [28JA]

———provide greater access to affordable pharmaceuticals (S. 1225), S8689-S8692 [26JN]

———review safety of dietary supplements containing ephedrine, S14002 [5NO]

Government regulations: prohibit sales of products such as dietary supplements containing ephedra or ephedrine alkaloids, S2511-S2513 [14FE], S2674-S2676 [25FE]

Medical Device User Fee and Modernization Act: technical corrections relative to amendments (S. 1881), S16057-S16060 [25NO]

Noncorrective contact lenses: regulate as medical devices (S. 1747), S12745 [16OC]

Pharmaceuticals: permit commercial importation of prescription drugs from Canada, S8186, S8203-S8215 [19JN], S8265, S8269 [20JN]

———preserve effectiveness of medically important antibiotics used in treatment of human and animal diseases (S. 1460), S9968 [25JY]

———require manufacturers to sell FDA-approved prescription drugs to U.S. wholesalers and retailers on the same terms as Canadian purchasers, S8332-S8335, S8341-S8343 [23JN], S8403 [24JN]

———treatment of biological products and generic drugs relative to patent challenges and exclusivity rules, S16104-S16107 [9DE]

Reports filed

Animal Drug User Fee Act: Committee on Energy and Commerce (House) (H.R. 1260) (H. Rept. 108-287), H9032 [30SE]

———Committee on Health, Education, Labor, and Pensions (Senate) (S. 313) (S. Rept. 108-51), S6851 [21MY]

Pediatric Research Equity Act: Committee on Health, Education, Labor, and Pensions (Senate) (S. 650) (S. Rept. 108-84), S8722 [26JN]

Texts of

H. Con. Res. 147, anniversary of Orphan Drug Act and National Organization for Rare Disorders, H4215 [19MY]

H.R. 1260, Animal Drug User Fee Act, H9054-H9057 [1OC]

H.R. 2218, regulate noncorrective contact lenses as medical devices, H11565 [19NO]

S. 54, Greater Access to Affordable Pharmaceuticals Act, S55-S58 [7JA]

S. 313, Animal Drug User Fee Act, S7168-S7171 [23MY], S14279-S14282 [7NO], H10293-H10296 [4NO]

S. 650, Pediatric Research Equity Act, S3898-S3900 [18MR], S9811-S9813, S9816-S9818 [23JY], H11567-H11569 [19NO]

S. 948, Drug Company Gift Disclosure Act, S5494 [29AP]

S. 1747, regulate noncorrective contact lenses as medical devices, S12745 [16OC]

S. 1881, Medical Devices Technical Corrections Act, S16058-S16060 [25NO]