FOOD AND DRUG ADMINISTRATION

Amendments

Agriculture, rural development, FDA, and related agencies programs: making appropriations (H.R. 2410), consideration (H. Res. 274), H4055 [26JN]

Appropriations: making continuing (H.J. Res. 77), consideration (H. Res. 371), H6251, H6253 [4OC]

Dept. of HHS: reauthorize certain programs to protect against pandemics and attacks from chemical, biological, radiological, and nuclear weapons (H.R. 307), S948 [27FE], H823 [4MR]

Drugs: strengthen regulation of compounding drugs by pharmacies (S. 959), S6080, S6081 [30JY]

——— strengthen regulation of human drug compounding and drug supply chain security (H.R. 3204), S7683, S7684 [30OC], S8008 [13NO], S8026, S8057 [14NO]

Bills and resolutions

Advertising: prohibit use of Federal money for any media advertisement, campaign, or publicity against the use of a food or beverage lawfully marketed under the Federal Food, Drug, and Cosmetic Act (see H.R. 1572), H2026 [15AP]

Agriculture, rural development, FDA, and related agencies programs: making appropriations (see S. 1244), S5498 [27JN] (see H.R. 2410), H3758 [18JN]

——— making appropriations (H.R. 2410), consideration (see H. Res. 274), H4037 [25JN]

Animals: reauthorize user fee programs relating to generic new animal drugs (see H.R. 1408), H1856 [9AP]

——— reauthorize user fee programs relating to new animal drugs (see H.R. 1407), H1856 [9AP]

——— reauthorize user fee programs relating to new animal drugs and generic new animal drugs (see S. 622), S2026 [20MR]

Appropriations: making continuing (see H.J. Res. 77), H6223 [3OC]

——— making continuing (H.J. Res. 77), consideration (see H. Res. 371), H6223 [3OC]

Budget: exempt certain user fees from budget sequestration (see S. 1413), S6126 [31JY] (see H.R. 2725), H4724 [18JY]

Contraceptives: establish certain duties for pharmacies to ensure provision of FDA-approved contraception (see S. 333), S772 [14FE] (see H.R. 728), H546 [14FE]

Cosmetics: ensure safe use (see H.R. 1385), H1824 [21MR]

Dept. of HHS: establish single, front-of-package labeling system for all foods required to bear nutrition labeling and eliminate deceptive claims and update existing nutrition labels (see S. 1653), S7829 [5NO] (see H.R. 3147), H5766 [19SE]

——— foster further innovation and entrepreneurship in the health information technology sector (see H.R. 2363), H3591 [13JN]

——— grant provisional approval to fast-tracked drugs used in therapies and treatments for life-threatening diseases (see H.R. 2090), H2910 [22MY]

——— reauthorize certain programs to protect against pandemics and attacks from chemical, biological, radiological, and nuclear weapons (see S. 242), S519 [7FE] (see H.R. 307), H176 [18JA]

Dietary supplements: improve safety by requiring manufacturers to register supplement products with the FDA and amending labeling requirements (see S. 1425), S6206 [1AU]

Diseases: reduce disparities and improve access to diagnosis and treatment of prostate cancer for underserved populations and men with a family history of prostate cancer (see S. 516), S1592 [11MR]

Drugs: encourage use of abuse-deterrent formulations of drugs (see S. Res. 97), S2649 [15AP] (see H. Res. 161), H2026 [15AP]

——— enhance reporting requirements pertaining to use of antimicrobial drugs in food animals (see H.R. 820), H658 [26FE]

——— improve ability to study use of antimicrobial drugs in food-producing animals (see S. 895), S3256 [8MY]

——— increase Federal oversight of prescription opioid treatment and assistance to States in reducing opioid abuse, diversion, and deaths (see S. 348), S772 [14FE] (see H.R. 672), H501 [13FE]

——— modify approval of any drug containing controlled-release oxycodone hydrochloride to limit such approval to use for relief of severe-only pain (see H.R. 1366), H1823 [21MR]

——— prohibit wholesalers from purchasing prescription drugs from pharmacies and enhance information and transparency of drug wholesalers engaged in interstate commerce (see H.R. 1958), H2602 [14MY]

——— provide incentives for the development of new combination drugs (see H.R. 2985), H5396 [2AU]

——— strengthen regulation of compounding drugs by pharmacies (see S. 959), S3531 [15MY] (see H.R. 2186), H2954 [23MY] (see H.R. 3019), H5397 [2AU] (see H.R. 3089), H5546 [12SE]

——— strengthen regulation of human drug compounding and drug supply chain security (see H.R. 3204), H5921 [27SE]

Fish and fishing: require labeling of genetically-engineered fish (see S. 248), S519 [7FE] (see H.R. 584), H413 [6FE]

Food: require that genetically engineered food and foods that contain genetically engineered ingredients be labeled accordingly (see S. 809), S2960 [24AP] (see H.R. 1699), H2297 [24AP]

Food industry: improve and clarify certain disclosure requirements for restaurants, similar retail food establishments, and vending machines (see S. 1756), S8457 [21NO] (see H.R. 1249), H1629 [19MR]

Government regulations: prohibit use of Federal funds to finalize, implement, or enforce the proposed rule entitled ‘‘Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption’’ (see H.R. 2071), H2838 [21MY]

——— provide for the regulation of medical software (see H.R. 3303), H6675 [22OC]

——— revise regulations applicable to the declaration of the trans fat content of a food on the label and in the labeling of the food when such content is below a certain level (see H.R. 3624), H7364 [22NO]

Health: incentivize the development of abuse-deterrent drugs (see H.R. 486), H342 [4FE]

Labeling: require the label of drugs to contain a parenthetical statement identifying the source of any ingredient constituting or derived from a grain or starch-containing ingredient (see H.R. 2003), H2654 [15MY]

NIH: enhance the clinical trial registry data bank reporting requirements and enforcement measures (see H.R. 2031), H2717 [16MY] (see H.R. 2301), H3251 [6JN]

Pharmaceuticals: allow personal importation and reimportation of prescription drugs (see H.R. 3715), H8107 [12DE]

——— clarify the orphan drug exception to the annual fee on branded prescription pharmaceutical manufacturers and importers (see S. 1128), S4212 [11JN] (see H.R. 2315), H3287 [11JN]

——— ensure valid generic drugs may enter the market (see S. 504), S1269 [7MR]

——— preserve effectiveness of medically important antimicrobials used in treatment of human and animal diseases (see S. 1256), S5498 [27JN] (see H.R. 1150), H1425 [14MR]

——— prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market (see S. 214), S469 [4FE] (see H.R. 3709), H7687 [11DE]

——— strengthen and secure the pharmaceutical distribution supply chain to protect consumers from counterfeit pharmaceuticals (see S. 957), S3531 [15MY] (see H.R. 1919), H2567 [9MY]

Product safety: prohibit the sale of infant formula after the expiration date on the product (see H.R. 2306), H3256 [10JN]

Research: approve certain drugs and biological products for use in a limited population of patients to address increases in bacterial and fungal resistance to drugs and biological products (see H.R. 3742), H8108 [12DE]

——— permit the sale of, and access to, ‘‘research use only’’ products in diagnostic tests (see H.R. 3005), H5397 [2AU]

Small business: waive or reduce certain fees applicable to generic drug facilities if such fees present a significant barrier to market entry due to limited resources or other circumstances (see H.R. 3631), H7394 [2DE]

Taxation: disapprove rule relative to taxable medical devices (see S.J. Res. 8), S944 [27FE]

——— exempt certain emergency medical devices from the excise tax on medical devices (see H.R. 581), H413 [6FE]

——— repeal excise tax on medical devices (see S. 232), S519 [7FE] (see H.R. 523), H410 [6FE] (see H.R. 1295), H1718 [20MR]

Tobacco products: clarify FDA jurisdiction over certain tobacco products and protect jobs and small businesses involved in the sale, manufacturing, and distribution of cigars (see S. 772), S2798 [18AP] (see H.R. 792), H595 [15FE]

Cloture motions

Drugs: strengthen regulation of human drug compounding and drug supply chain security (H.R. 3204), motion to proceed, S7949 [12NO], S8027 [14NO]

Letters

Dept. of HHS programs to protect against pandemics and attacks from chemical, biological, radiological, and nuclear weapons reauthorization: Alliance for Biosecurity, H833 [4MR]

——— James C. Greenwood, Biotechnology Industry Organization, H833 [4MR]

——— several health organizations, H199 [22JA]

——— several public health organizations, H834 [4MR]

——— Stephanie Silverman, Roundtable on Critical Care Policy (organization), H834 [4MR]

——— Thomas K. McInerny, American Academy of Pediatrics, H833 [4MR]

FDA continuing appropriations: several organizations, H6330 [7OC]

Repeal excise tax on medical devices: several organizations, H5993–H5996 [28SE]

——— Walter J. Humann, OsteoMed (business), H5976 [28SE]

Safeguarding America’s Pharmaceuticals Act: several organizations, H2982, H2983 [3JN]

——— Stanley C. Weisser, California State Board of Pharmacy, H2981 [3JN]

Lists

Organizations supporting H.R. 3204, Drug Quality and Security Act, S8028 [14NO]

Staff and Senators who worked on H.R. 3204, Drug Quality and Security Act, S8025 [14NO]

Motions

Appropriations: making continuing (H.J. Res. 77), H6332, H6333 [7OC]

Drugs: strengthen regulation of human drug compounding and drug supply chain security (H.R. 3204), S7841 [6NO], S7891 [7NO], S7937 [12NO], S7973 [13NO], S8026 [14NO]

Remarks in House

Agriculture, rural development, FDA, and related agencies programs: making appropriations, H5779 [20SE]

——— making appropriations (H.R. 2410), H3968 [20JN], H6263 [4OC]

——— making appropriations (H.R. 2410), consideration (H. Res. 274), H4049–H4057 [26JN]

Animals: reauthorize user fee programs relating to new animal drugs and generic new animal drugs (S. 622), H2984–H2993 [3JN], E829 [10JN]

Appropriations: making continuing (H.J. Res. 77), H6326–H6334 [7OC], E1467 [9OC]

——— making continuing (H.J. Res. 77), consideration (H. Res. 371), H6244–H6254 [4OC]

——— making continuing (H.J. Res. 77), motion to recommit, H6333 [7OC]

Contraceptives: decision to allow over-the-counter access to emergency-contraceptive drug Plan B One Step without age restriction, H3639 [14JN]

——— establish certain duties for pharmacies to ensure provision of FDA-approved contraception (H.R. 728), E148 [14FE]

Crime: decriminalization of marijuana, H345 [5FE]

Dept. of HHS: reauthorize certain programs to protect against pandemics and attacks from chemical, biological, radiological, and nuclear weapons (H.R. 307), H187–H201 [22JA]

——— reauthorize certain programs to protect against pandemics and attacks from chemical, biological, radiological, and nuclear weapons (H.R. 307), Senate amendment, H823–H836 [4MR], E255 [7MR]

——— require a scientific and economic analysis of the FDA Food Safety Modernization Act before final regulations are enforced, H3921, H3922 [19JN]

Diseases: urge approval of drug to treat Duchenne Muscular Dystrophy, H5078 [25JY], E1223 [2AU]

Drugs: address prescription drug abuse, H1873 [10AP]

——— encourage use of abuse-deterrent formulations of drugs (H. Res. 161), H2030 [16AP]

——— enhance reporting requirements pertaining to use of antimicrobial drugs in food animals (H.R. 820), H2991 [3JN]

——— prohibit wholesalers from purchasing prescription drugs from pharmacies and enhance information and transparency of drug wholesalers engaged in interstate commerce, E784 [4JN]

——— strengthen regulation of compounding drugs by pharmacies, H5961, H5962, H5965 [28SE]

——— strengthen regulation of compounding drugs by pharmacies (H.R. 3019), E1223 [2AU]

——— strengthen regulation of human drug compounding and drug supply chain security (H.R. 3204), H5946–H5965 [28SE]

Economy: impact of budget sequestration, H1863 [10AP], H4084 [27JN]

EPA: waive ban on over-the-counter asthma inhalers enacted as part of international agreement to stop using products containing chlorofluorocarbons (CFCs) and allow existing stock to be sold until FDA approves replacement, H2778 [20MY]

Food: require that genetically engineered food and foods that contain genetically engineered ingredients be labeled accordingly (H.R. 1699), H2258 [24AP]

Government regulations: reevaluate proposed rule entitled ‘‘Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption’’, H3727 [18JN]

Pharmaceuticals: clarify the orphan drug exception to the annual fee on branded prescription pharmaceutical manufacturers and importers (H.R. 2315), unanimous-consent agreement, H5055 [25JY]

——— preserve effectiveness of medically important antimicrobials used in treatment of human and animal diseases (H.R. 1150), H2991, H2992 [3JN], H6623 [16OC], E299 [14MR]

——— strengthen and secure the pharmaceutical distribution supply chain to protect consumers from counterfeit pharmaceuticals, H5961, H5962, H5965 [28SE]

——— strengthen and secure the pharmaceutical distribution supply chain to protect consumers from counterfeit pharmaceuticals (H.R. 1919), H2968–H2984 [3JN], E784, E796 [4JN], E883 [17JN]

——— strengthen and secure the pharmaceutical distribution supply chain to protect consumers from counterfeit pharmaceuticals (S. 957), H2979 [3JN]

Taxation: repeal excise tax on medical devices, H534, H535 [14FE], H2691 [16MY], H5975, H5980, H5990, H5993, H5996, H5998, H6001 [28SE], H6014 [30SE], H6064 [1OC], H6595 [15OC], H6609 [16OC], H7107 [14NO]

——— repeal excise tax on medical devices (H.R. 523), H2590, H2595, H2597 [14MY], H5186 [31JY], H5758–H5764 [19SE], H6001 [28SE]

Tobacco products: release of report on effects of menthol cigarettes, E1143 [25JY]

Remarks in Senate

Agriculture, rural development, FDA, and related agencies programs: making appropriations (S. 1244), S6910–S6912 [26SE]

Animals: reauthorize user fee programs relating to new animal drugs and generic new animal drugs (S. 622), S3275 [8MY]

Appropriations: making continuing (H.J. Res. 77), S7200 [4OC], S7263 [7OC], S7309 [8OC], S7311 [9OC]

Dept. of HHS: reauthorize certain programs to protect against pandemics and attacks from chemical, biological, radiological, and nuclear weapons (H.R. 307), S948–S957 [27FE], S1123 [5MR]

Dietary supplements: improve safety by requiring manufacturers to register supplement products with the FDA and amending labeling requirements, S1920 [19MR], S6041 [30JY]

Drugs: clarify regulation of animal drug compounding, S8071, S8072 [18NO]

——— increase Federal oversight of prescription opioid treatment and assistance to States in reducing opioid abuse, diversion, and deaths (S. 348), S779 [14FE]

——— strengthen regulation of compounding drugs by pharmacies (H.R. 2186), S7967 [13NO]

——— strengthen regulation of human drug compounding and drug supply chain security (H.R. 3204), S7800 [4NO], S7802 [5NO], S7864 [6NO], S8026–S8030 [14NO], S8071–S8076, S8079, S8080 [18NO]

——— strengthen regulation of human drug compounding and drug supply chain security (H.R. 3204), motion to proceed, S7846 [6NO], S7923 [7NO], S7938, S7940–S7944 [12NO], S7965, S7967–S7970, S7974, S7981, S7985 [13NO], S8013, S8024 [14NO]

——— strengthen regulation of human drug compounding and drug supply chain security (H.R. 3204), unanimous-consent agreement, S8071 [18NO]

——— strengthen regulation of human drug compounding and drug supply chain security (H.R. 3204), unanimous-consent request, S7984, S7985 [13NO], S8029, S8030 [14NO]

Fish and fishing: require labeling of genetically-engineered fish, S2279 [22MR]

Food industry: preserve safety and meat inspections at meatpacking plants, S1970 [20MR]

GAO: report on FDA Adverse Event Reporting System for dietary supplements, S1920 [19MR]

Pharmaceuticals: allow fast track approval of certain orphan drugs, S3002 [25AP]

——— preserve effectiveness of medically important antimicrobials used in treatment of human and animal diseases (S. 1256), S5503 [27JN]

Taxation: repeal excise tax on medical devices, S2108, S2109, S2127, S2133 [21MR], S6813 [24SE], S6926–S6928 [26SE], S7235 [5OC], S7290, S7299 [8OC], S7316, S7342 [9OC]

Reports filed

Agriculture, Rural Development, FDA, and Related Agencies Programs Appropriations: Committee on Appropriations (House) (H.R. 2410) (H. Rept. 113–116), H3758 [18JN]

——— Committee on Appropriations (Senate) (S. 1244) (S. Rept. 113–46), S5497 [27JN]

Consideration of H.J. Res. 75–80 and 82–85, Various Federal Agencies and Programs Continuing Appropriations and H.R. 3223, Federal Employee Retroactive Pay Fairness Act: Committee on Rules (House) (H. Res. 371) (H. Rept. 113–242), H6223 [3OC]

Consideration of H.R. 2410, Agriculture, Rural Development, FDA, and Related Agencies Appropriations: Committee on Rules (House) (H. Res. 274) (H. Rept. 113–131), H4037 [25JN]

Dept. of HHS Programs To Protect Against Pandemics and Attacks From Chemical, Biological, Radiological, and Nuclear Weapons Reauthorization: Committee on Health, Education, Labor, and Pensions (Senate) (H.R. 307), S771 [14FE]

FDA User Fee Programs Relating to New Animal Drugs and Generic New Animal Drugs Reauthorization: Committee on Health, Education, Labor, and Pensions (Senate) (S. 622), S2025 [20MR]

FDA User Fee Programs Relating to New Animal Drugs Reauthorization: Committee on Energy and Commerce (House) (H.R. 1407) (H. Rept. 113–188), H5395 [2AU]

Pharmaceutical Compounding Quality and Accountability Act: Committee on Health, Education, Labor, and Pensions (Senate) (S. 959), S4673 [19JN]

Safeguarding America’s Pharmaceuticals Act: Committee on Energy and Commerce (House) (H.R. 1919) (H. Rept. 113–93), H3014 [3JN]

Rulings of the Chair

Appropriations: making continuing (H.J. Res. 77), H6333 [7OC]

Statements

Safeguarding America’s Pharmaceuticals Act: Pew Charitable Trust, H2981 [3JN]

Texts of

H. Res. 274, consideration of H.R. 2410, agriculture, rural development, FDA, and related agencies programs appropriations, H4049 [26JN]

H. Res. 371, consideration of H.J. Res. 75–80 and 82–85, various Federal agencies and programs continuing appropriations and H.R. 3223, Federal Employee Retroactive Pay Fairness Act, H6244 [4OC]

H.J. Res. 77, continuing appropriations, H6326 [7OC]

H.R. 307, Dept. of HHS programs to protect against pandemics and attacks from chemical, biological, radiological, and nuclear weapons reauthorization, S948–S957 [27FE], H187–H197 [22JA]

H.R. 1911, Safeguarding America’s Pharmaceuticals Act, H2969–H2978 [3JN]

H.R. 3204, Drug Quality and Security Act, H5946–H5960 [28SE]

S. 622, FDA reauthorization of user fee programs relating to new animal drugs and generic new animal drugs, S3275–S3282 [8MY]

S. 622, FDA user fee programs relating to new animal drugs and generic new animal drugs reauthorization, H2984–H2991 [3JN]

S. 1425, Dietary Supplement Labeling Act, S6216 [1AU]

S. Res. 97, FDA encouragement of use of abuse-deterrent formulations of drugs, S2654 [15AP]