FEDERAL FOOD, DRUG, AND COSMETIC ACT

Amendments

FDA: provide greater access to affordable pharmaceuticals (S. 812), S6909, S6930, S6960, S6961, S6963 [17JY], S6978, S7048, S7049, S7050, S7060 [18JY], S7232, S7233 [23JY], S7284, S7316, S7317, S7318 [24JY], S7382 [25JY], S7435 [26JY], S7589, S7590, S7591, S7592, S7593, S7594, S7598, S7601, S7611 [30JY]

Analyses

Preservation of Antibiotics for Human Treatment Act (S. 2508), S4283 [13MY]

Bills and resolutions

Animals: ensure use of certain antibiotic drugs in agriculture does not compromise human health by contributing to the development of antibiotic resistance (see S. 2508), S4281 [13MY] (see H.R. 3804), H633 [27FE]

———establish a program of fees relative to animal drugs (see S. 2665), S5851 [20JN] (see H.R. 4955), H3668 [18JN]

Diseases: amend relative to the development of products for rare diseases (see H.R. 4014), H1087 [20MR]

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. 5534), H6982 [2OC]

———ensure competition in pharmaceutical industry and increased access to affordable drugs (see S. 2818), S7469 [29JY]

———establish requirements relative to the sale of, or the offer to sell, prescription drugs through the Internet (see H.R. 4990), H3824 [21JN]

FDA: establish authority for the imposition of civil penalties for certain direct-to-consumer advertisements (see H.R. 4833), H3036 [23MY]

———grant authority to regulate tobacco (see S. 2626), S5584 [14JN]

———include a notification period before discontinuing a biological product (see S. 2049), S2260 [21MR]

———protect the health and safety of American consumers from seafood contaminated by certain substances (see S. 2759), S7033 [18JY]

———provide authority to recall food when there is a reasonable basis for believing that the food is adulterated and presents health risks (see H.R. 5488), H6776 [26SE]

———provide greater access to affordable pharmaceuticals (see H.R. 5272), H5994 (see H.R. 5311), H5996 [26JY] (see H.R. 5350), H6129 [9SE]

———provide greater access to affordable pharmaceuticals (H.R. 1862), consideration (see H. Res. 517), H6085 [5SE]

Food: ensure safety of genetically engineered foods (see H.R. 4813), H2944 [22MY]

———require foods containing known allergens to bear labeling that states that fact and the names of the allergens (see S. 2499), S4145 [9MY] (see S. 3001), S9229 [25SE] (see H.R. 4704), H2355 [9MY] (see H.R. 5747), H9023 [14NO]

———require labels on food that contains, or is produced with, a genetically engineered material (see H.R. 4814), H2944 [22MY]

Food industry: require FDA premarket review and oversight of all genetically engineered foods (see S. 3095), S10359 [10OC]

Health: establish a system independent of the FDA for the review of health claims and to define health claims (see H.R. 3811), H633 [27FE]

Medical devices: add requirements relative to reprocessing and reuse (see S. 3130), S10676 [17OC]

———improve regulation (see H.R. 5651), H8021 [16OC]

Medicine Equity and Drug Safety Act: implementation (see H. Res. 478), H4497 [10JY]

Pharmaceuticals: eligibility of certain applicants for approval of a generic drug for a competition-free period (see H.R. 4998), H3825 [21JN]

———importation of certain prescription drugs (see H.R. 5186), H5194 [23JY]

Women: ensure safe pregnancies by increasing research and data collection on treatments and cures for pregnancy complications and providing information to women, practitioners, and the public (see S. 2328), S3435 [25AP] (see H.R. 4602), H1673 [25AP]

Cloture motions

FDA: provide greater access to affordable pharmaceuticals (S. 812), S7299 [24JY], S7462 [29JY], S7633 [31JY]

———provide greater access to affordable pharmaceuticals (S. 812), motion to proceed, S6798 [15JY], S6883 [17JY]

Descriptions

Public Health Security and Bioterrorism Preparedness and Response Act (H.R. 3448): Amendments Relative to Food Enforcement Authorities Provided Under the Federal Food, Drug, and Cosmetic Act, H2857 [22MY]

Letters

Greater Access to Affordable Pharmaceuticals Act: Abbey S. Meyers, National Organization for Rare Disorders, Inc., S7641 [31JY]

———Carl B. Feldbaum, Biotechnology Industry Organization, S6994 [18JY], S7570 [30JY]

———Coalition for a Competitive Pharmaceutical Market, S6845 [16JY], S7641, S7648 [31JY]

———D. Michael Fisher, Attorney General of Pennsylvania, S7636 [31JY]

———Dick Wagoner, Jr., General Motors Corp., S7641 [31JY]

———Eliot Spitzer, Attorney General of New York, S7636 [31JY]

———James E. Rogan, Patent and Trademark Office, S7571 [30JY]

———Janell Mayo Duncan, Consumers Union, S7642 [31JY]

———Jody Hunter, Business for Affordable Medicine (organization), S6845 [16JY], S7648 [31JY]

———Kathleen D. Jaeger, Generic Pharmaceutical Association, S7641 [31JY]

———Michael K. Kirk, American Intellectual Property Law Association, S7346 [25JY]

———Senator Kennedy, S7026-S7028 [18JY]

———Stephen Mulloney, Massachusetts Biotechnology Council, S6995 [18JY]

Labeling and advertising requirements for dietary supplements containing ephedrine alkaloids and prohibit sales of such supplements to minors: Charles W. Fricke, and Kevin and Debra Riggins, S11675 [20NO]

Medical Device User Fee and Modernization Act: Tommy G. Thompson, Sec. of HHS, S11551 [19NO]

Preservation of Antibiotics for Human Treatment Act: Mohammad N. Akhter, American Public Health Association, S4283 [13MY]

Lists

Opponents and supporters of S. 812, Greater Access to Affordable Pharmaceuticals Act, S7638 [31JY]

Motions

Drugs: consideration of legislation to provide greater access to affordable pharmaceuticals, H6957 [2OC]

FDA: provide greater access to affordable pharmaceuticals (S. 812), S7206 [23JY], S7283 [24JY], S7534 [30JY], S7633 [31JY]

Proposals

Consideration of legislation to provide greater access to affordable pharmaceuticals, H6856 [1OC], H6955 [2OC]

Remarks in House

Animals: ensure use of certain antibiotic drugs in agriculture does not compromise human health by contributing to the development of antibiotic resistance (H.R. 3804), H2114 [7MY], E1147 [25JN]

Diseases: amend relative to the development of products for rare diseases (H.R. 4014), H6814-H6818, H6883 [1OC]

Drugs: consideration of legislation to provide greater access to affordable pharmaceuticals, H6955-H6958 [2OC]

FDA: provide greater access to affordable pharmaceuticals (H.R. 1862), H2110 [7MY], H6268 [17SE], H6377, H6387, H6390, H6393, H6394, H6398 [19SE]

———provide greater access to affordable pharmaceuticals (H.R. 5272), H6261, H6268, H6297 [17SE]

Health: establish a system independent of the FDA for the review of health claims and to define health claims (H.R. 3811), E218 [27FE]

Medical devices: improve regulation (H.R. 3580), H7153-H7164 [7OC], E1798 [8OC], E1844 [11OC]

———improve regulation (H.R. 5651), H7965 [16OC]

Remarks in Senate

Animals: ensure use of certain antibiotic drugs in agriculture does not compromise human health by contributing to the development of antibiotic resistance (S. 2508), S4283, S4284 [13MY]

———establish a program of fees relative to animal drugs (S. 2665), S5862-S5866 [20JN]

Children and youth: amend certain laws relative to pediatric studies of drugs, S5192 [6JN]

Diseases: amend relative to the development of products for rare diseases (H.R. 4014), S10769 [17OC]

Drugs: correct impediments to allowing importation of prescription drugs into the U.S. by pharmacists and wholesalers for resale, S2637-S2639 [15AP]

FDA: grant authority to regulate tobacco (S. 2626), S5598-S5601 [14JN]

———protect the health and safety of American consumers from seafood contaminated by certain substances (S. 2759), S7043 [18JY]

———provide greater access to affordable pharmaceuticals (S. 812), S6802, S6811 [15JY], S6873 [16JY], S6883-S6931 [17JY], S6968-S6972, S6976-S7016, S7019-S7028 [18JY], S7093-S7100 [19JY], S7127, S7134-S7158 [22JY], S7180-S7189, S7194-S7218 [23JY], S7244-S7246, S7249-S7263, S7282-S7299 [24JY], S7327-S7336, S7340, S7342-S7350, S7366 [25JY], S7398-S7413, S7423, S7424 [26JY], S7457, S7460, S7464 [29JY], S7505, S7514-S7551, S7565-S7571, S7614-S7616 [30JY], S7618-S7651 [31JY], S7849-S7851, S7853-S7858, S7875-S7878 [1AU], S8630, S8631 [17SE], S9182 [25SE], S10407 [15OC]

———provide greater access to affordable pharmaceuticals (S. 812), motion to proceed, S6797-S6801 [15JY], S6818-S6829, S6831-S6858 [16JY], S6878-S6883 [17JY]

———provide greater access to affordable pharmaceuticals (S. 812), unanimous-consent agreement, S7545 [30JY]

Food: require foods containing known allergens to bear labeling that states that fact and the names of the allergens (S. 2499), S4163 [9MY]

———require foods containing known allergens to bear labeling that states that fact and the names of the allergens (S. 3001), S9231 [25SE]

Food industry: require FDA premarket review and oversight of all genetically engineered foods (S. 3095), S10371 [10OC]

Government regulations: establish labeling and advertising requirements for dietary supplements containing ephedrine alkaloids and prohibit sales of such supplements to minors, S11672-S11675 [20NO]

Medical devices: improve regulation (H.R. 5651), S10619, S10752-S10754 [17OC], S11549-S11551 [19NO]

Pharmaceuticals: bioequivalence standards for generic drugs, S6993-S6996 [18JY]

———require companies to disclose any gifts or incentives given to doctors or health care providers and require manufacturers to disclose any rebates given to pharmaceutical benefits managers, S7007 [18JY]

States: clarify authority to enter into drug rebate agreements with manufacturers in order to provide prescription drug coverage to individuals not covered by Medicaid, S6978-S6982, S7010-S7016 [18JY]

Women: ensure safe pregnancies by increasing research and data collection on treatments and cures for pregnancy complications and providing information to women, practitioners, and the public (S. 2328), S3440 [25AP]

Reports filed

Food Allergen Consumer Protection Act: Committee on Health, Education, Labor, and Pensions (Senate) (S. 2499) (S. Rept. 107-322), S10674 [17OC]

Greater Access to Affordable Pharmaceuticals Act: Committee on Health, Education, Labor, and Pensions (Senate) (S. 812), S6649 [11JY]

Medical Device Regulation Improvement: Committee on Energy and Commerce (House) (H.R. 3580) (H. Rept. 107-728), H7171 [7OC]

Medical Device User Fee and Modernization Act: Committee on Energy and Commerce (House) (H.R. 3580) (H. Rept. 107-728), H7928 [15OC]

Rare Diseases Orphan Product Development Act: Committee on Energy and Commerce (House) (H.R. 4014) (H. Rept. 107-702), H6925 [1OC]

Requirements Relative to the Sale of, or the Offer To Sell, Prescription Drugs Through the Internet: Committee on Energy and Commerce (House) (H.R. 4990) (H. Rept. 107-546), H4064, H4067 [26JN]

Safe Motherhood Act for Research and Treatment (SMART Mom Act): Committee on Health, Education, Labor, and Pensions (Senate) (S. 2328), S8671 [17SE]

Rulings of the Chair

Drugs: consideration of legislation to provide greater access to affordable pharmaceuticals, H6957 [2OC]

Statements

Greater Access to Affordable Pharmaceuticals Act: David Beier, S7346 [25JY]

———Eliot Spitzer, Attorney General of New York, S7637 [31JY]

Summaries

Medical Device User Fee and Modernization Act (H.R. 5651), S11549-S11551 [19NO]

Texts of

H.R. 3580, Medical Device User Fee and Modernization Act, H7153-H7160 [7OC]

H.R. 4014, Rare Diseases Orphan Product Development Act, H6815 [1OC]

H.R. 5651, Medical Device User Fee and Modernization Act, H7965-H7974 [16OC]

S. 812, Greater Access to Affordable Pharmaceuticals Act, S6884-S6887 [17JY], S8007-S8012 [1AU]

S. 2499, Food Allergen Consumer Protection Act, S4164 [9MY]

S. 2626, Youth Smoking Prevention and Public Health Protection Act, S5601-S5613 [14JN]

S. 2665, Animal Drug User Fee Act, S5863-S5865 [20JN]

S. 2759, Seafood Safety Enforcement Act, S7044 [18JY]

S. 3001, Food Allergen Labeling and Consumer Protection Act, S9231-S9233 [25SE]

S. 3095, Genetically Engineered Foods Act, S10372-S10375 [10OC]