FEDERAL FOOD, DRUG, AND COSMETIC ACT

Bills and resolutions

Agriculture: prohibit open-air cultivation or use of human food or animal feed as host plant and establish tracking system to regulate genetically engineered pharmaceutical and industrial crops (see H.R. 6635), H7306 [29JY]

Drugs: allow for medicinal use of marijuana in accordance with State laws (see H.R. 5842), H2486 [17AP]

———improve safety (see H.R. 5839), H2486 [17AP]

———mandate early access by patients to new drugs under clinical investigation for a serious or immediately life-threatening condition for which no comparable or satisfactory drug or other therapy is available (see H.R. 6047), H3884 [14MY]

FDA: amend policies relative to postmarket surveillance of devices (see S. 3020), S4282 [15MY]

———authorize appropriations for seafood inspection regime (see H.R. 5219), H557 [29JA]

———clarify priority review voucher laws (see S. 3151), S5753 [18JN]

———create a three-tiered approval system for drugs, biological products, and devices that is responsive to the needs of seriously ill patients (see S. 3046), S4621 [21MY] (see H.R. 6270), H5407 [12JN]

———establish a program of fees relative to generic new animal drugs (see H.R. 6433), H6229 [8JY]

———implement safeguards in direct-to-consumer advertising following FDA approval of prescription drugs and medical devices (see H.R. 6151), H4830 [22MY]

———revise and extend the animal drug user fee program (see H.R. 6432), H6229 [8JY]

Food: ensure safety (see H.R. 5827), H2442 [16AP]

———ensure the safety of imported seafood and seafood products (see S. 2914), S3401 [24AP]

———extend food labeling requirements to enable customers to make informed choices about nutritional content of standard menu items in large chain restaurants (see S. 2784), S2133 [13MR]

———improve safety by providing for improved information technology to identify high-risk imports and enhanced use of science to identify and address food safety issues (see H.R. 5904), H2759 [24AP]

———require chain restaurants and grocery stores to disclose nutritional information on prepared foods (see S. 3575), S9492 [25SE]

———require disclosure of nutritional information on food offered for sale in food service establishments (see H.R. 7187), H10299 [27SE]

———require labels on food that contains, or is produced with, a genetically engineered material (see H.R. 6636), H7306 [29JY]

Food industry: establish traceability system for food (see S. 3422), S8035 [1AU]

———improve public health and food safety through enhanced enforcement (see S. 3267), S6722 [15JY]

Health: ensure a sufficient supply of vaccines (see H.R. 4991), H294 [16JA]

———ensure safety and quality of medical products and enhance authorities of FDA (see S. 3409), S7905 [31JY]

Pharmaceuticals: require country-of-origin labeling on prescription and over-the-counter drugs (see S. 3633), S9657 [26SE]

Product safety: ban use of bisphenol A in food and beverage containers (see H.R. 6228), H5214 [10JN]

———preserve ability to file State product liability lawsuits relative to defective medical devices (see S. 3398), S7904 [31JY] (see H.R. 6381), H6173 [26JN]

Research: distribution and citation of scientific research in connection with foods and dietary supplements (see H.R. 7120), H10129 [26SE]

Safety: amend relative to the safety of the food supply (see S. 3385), S7904 [31JY]

Water: require manufacturers of bottled water to submit annual reports (see S. 3475), S8383 [11SE]

Letters

Animal Drug User Fee Act Performance Goals and Procedures: Michael O. Leavitt, Sec. of HHS, S8170 [9SE]

Remarks in House

Agriculture: prohibit open-air cultivation or use of human food or animal feed as host plant and establish tracking system to regulate genetically engineered pharmaceutical and industrial crops (H.R. 6635), E1596 [30JY]

FDA: revise and extend the animal drug user fee program (H.R. 6432), H7534-H7541 [30JY], E1683 [1AU]

Food: require disclosure of nutritional information on food offered for sale in food service establishments (H.R. 7187), E2135 [28SE]

———require labels on food that contains, or is produced with, a genetically engineered material (H.R. 6636), E1596 [30JY]

Product safety: preserve ability to file State product liability lawsuits relative to defective medical devices (H.R. 6381), E1387 [26JN], E1402 [8JY], E1523 [22JY]

Women: improve prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women (H.R. 1014), H917 [13FE], H8688-H8691 [23SE], E1980 [25SE], E2135 [28SE]

Remarks in Senate

FDA: clarify priority review voucher laws (S. 3151), S5760 [18JN]

———create a three-tiered approval system for drugs, biological products, and devices that is responsive to the needs of seriously ill patients (S. 3046), S4625 [21MY], S7620 [29JY], S8021 [1AU]

———revise and extend the animal drug user fee program (H.R. 6432), S7983 [1AU], S8115 [8SE], S8170 [9SE]

Food: extend food labeling requirements to enable customers to make informed choices about nutritional content of standard menu items in large chain restaurants (S. 2784), S2159 [13MR]

Food industry: improve public health and food safety through enhanced enforcement (S. 3267), S6817 [16JY]

———improve public health and food safety through enhanced food traceability and inspection systems, S7471 [25JY]

———require that food that contains product from a cloned animal be labeled accordingly, S1580 [5MR]

———require that food that contains product from a cloned animal be labeled accordingly (S. 414), S158 [23JA]

Health: ensure safety and quality of medical products and enhance authorities of FDA (S. 3409), S7968 [31JY]

Pharmaceuticals: importation of prescription drugs, S2087 [13MR]

———require country-of-origin labeling on prescription and over-the-counter drugs (S. 3633), S9715 [26SE]

Product safety: preserve ability to file State product liability lawsuits relative to defective medical devices (S. 3398), S7953 [31JY], S8022 [1AU]

Safety: amend relative to the safety of the food supply (S. 3385), S7933 [31JY]

Women: improve prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women, S5516 [11JN]

Reports filed

Animal Generic Drug User Fee Act: Committee on Energy and Commerce (House) (H.R. 6433) (H. Rept. 110-805), H7627 [30JY]

FDA Animal Drug User Fee Program Revision and Extension: Committee on Energy and Commerce (House) (H.R. 6432) (H. Rept. 110-804), H7627 [30JY]

Heart Disease Education, Analysis Research, and Treatment (HEART) for Women Act: Committee on Energy and Commerce (House) (H.R. 1014) (H. Rept. 110-874), H9083 [23SE]

Statements

Animal Drug User Fee Act Performance Goals and Procedures: Dept. of HHS, S8170-S8171 [9SE]

Animal Generic Drug User Fee Act Performance Goals and Procedures: Dept. of HHS, S8172 [9SE]

Texts of

H.R. 1014, Heart Disease Education, Analysis Research, and Treatment (HEART) for Women Act, H8689 [23SE]

H.R. 6432, FDA animal drug user fee program revision and extension, H7534-H7539 [30JY]

S. 3385, FDA Food Safety Modernization Act, S7934-S7946 [31JY]