FEDERAL FOOD, DRUG, AND COSMETIC ACT

Amendments

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]

FDA: 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

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]

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

——— prevent abuse of dextromethorphan by restricting over-the-counter sales and bulk distribution (see S. 644), S2146 [21MR]

——— 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]

——— submit annual reports on assessment and collection of certain tobacco user fees (see H.R. 389), H280 [23JA]

Drugs: reschedule marijuana under the Controlled Substances Act and allow for medicinal use of marijuana in accordance with State laws (see H.R. 689), H545 [14FE]

FDA: 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]

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

——— ensure safe use of cosmetics (see H.R. 1385), H1824 [21MR]

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

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

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

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

——— 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]

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

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

——— 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]

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

——— 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]

——— 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]

——— 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]

——— 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]

——— 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]

Food: amend inspection laws to notify consumers of products produced from crops, livestock, or poultry raised on sewage sludge-treated land (see H.R. 213), H52 [4JA]

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]

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

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

——— 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]

Product safety: ban use of bisphenol A in food and beverage containers (see H.R. 2248), H3095 [4JN]

——— ban use of bisphenol A in food and beverage containers for children, baby food, and infant formula and regulate its use in other food containers (see S. 1124), S4058 [10JN]

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

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

FDA: strengthen regulation of human drug compounding and drug supply chain security (H.R. 3204), motion to proceed, S7923 [7NO], 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]

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

FDA: 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

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]

Drugs: reschedule marijuana under the Controlled Substances Act and allow for medicinal use of marijuana in accordance with State laws (H.R. 689), E150 [14FE]

FDA: 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]

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

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

——— 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]

——— 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]

Orphan Drug Act: anniversary, E13 [4JA]

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

Product safety: ban use of bisphenol A in food and beverage containers (H.R. 2248), H6660 [22OC]

Remarks in Senate

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]

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

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

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

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

——— require labeling of genetically-engineered fish, S2279 [22MR]

——— 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], 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]

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

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

Product safety: ban use of bisphenol A in food and beverage containers for children, baby food, and infant formula and regulate its use in other food containers (S. 1124), S4059 [10JN]

Reports filed

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]

Statements

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

Texts of

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]