FEDERAL FOOD, DRUG, AND COSMETIC ACT

Amendments

Drugs: improve DEA scheduling process for new FDA-approved drugs under the Controlled Substances Act and registration process for use of controlled substances in clinical trials (H.R. 639), S7494 [26OC], H8212 [16NO]

FDA: establish Federal labeling standards for food with genetically modified ingredients and natural foods (H.R. 1599), H5426, H5430, H5431, H5432, H5433 [23JY]

——— establish Federal labeling standards for food with genetically modified ingredients and natural foods (H.R. 1599), consideration (H. Res. 369), H5355 [22JY]

Articles and editorials

Let Americans Decide for Themselves on GMOs, H5425 [23JY]

Mandatory GMO Labeling—It’s Your Right To Know, H5423 [23JY]

Bills and resolutions

Agriculture: authorize the interstate traffic of unpasteurized milk and milk products in final package form for human consumption between States that allow the sale of such products (see H.R. 3563), H6178 [18SE]

——— prohibit Federal interference in interstate traffic of unpasteurized milk and milk products in final package form for human consumption between States that allow the sale of such products (see H.R. 3564), H6178 [18SE]

Chemicals: allow marketing, distribution, or sale of solid antimicrobial copper alloys with certain claims and exclude certain solid antimicrobial copper alloys from regulation as drugs or devices (see H.R. 1424), H1768 [18MR]

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 H.R. 4061), H8359 [18NO]

——— grant provisional approval to fast-tracked drugs used in therapies and treatments for life-threatening diseases (see H.R. 1376), H1661 [16MR]

——— prevent abuse of dextromethorphan by restricting over-the-counter sales and bulk distribution of cough medicines by teenagers (see H.R. 3250), H5588 [28JY]

——— promulgate regulations on patient medication information to ensure patients receive consistent and high-quality information about prescription drugs (see S. 2214), S7594 [28OC]

——— publish revised Clinical Laboratory Improvement Amendments (CLIA) waiver study design guidance for manufacturers of in vitro diagnostic devices (see H.R. 2443), H3387 [19MY]

——— reauthorize certain programs relative to national health security (see S. 2055), S6809 [17SE]

——— require a safety assessment of food containers composed of bisphenol A and require food packaging containing bisphenol A to be labeled as such (see S. 821), S1660 [19MR]

——— require NIH to consider sex differences in medical research and direct FDA to guarantee clinical drug trials are sufficient to determine safety and effectiveness for both men and women (see H.R. 2101), H2653 [29AP]

Drugs: improve DEA scheduling process for new FDA-approved drugs under the Controlled Substances Act and registration process for use of controlled substances in clinical trials (see S. 481), S982 [12FE] (see H.R. 639), H702 [2FE]

——— provide for legitimate use of medicinal marijuana in accordance with State laws (see H.R. 2373), H3252 [15MY]

——— reschedule marijuana under the Controlled Substances Act, allow for medicinal use of marijuana in accordance with State laws, and exclude cannabidiol from the definition of marijuana (see H.R. 1774), H2209 [14AP]

FDA: amend policies relative to approval of certain antibacterial and antifungal drugs (see H.R. 2629), H3877 [3JN]

——— amend process for incorporation of medical device performance standards established by a nationally or internationally recognized standard organization (see H.R. 2425), H3387 [19MY]

——— amend the advisory committee process relative to regulatory approval of medical devices (see H.R. 2427), H3387 [19MY]

——— 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. 931), H1033 [12FE]

——— authorize priority review for breakthrough devices (see H.R. 2337), H3212 [14MY]

——— clarify definition and regulation of combination products (see S. 1767), S5129 [15JY]

——— create a limited population pathway for approval of certain antibacterial drugs (see S. 185), S238 [16JA]

——— define types of valid scientific evidence appropriate for determining effectiveness of medical devices (see H.R. 2423), H3387 [19MY]

——— develop and use patient experience data to enhance structured risk-benefit framework in drug regulatory decisionmaking (see H.R. 2338), H3212 [14MY]

——— ease regulatory burden relative to certain class I and class II medical devices (see H.R. 2426), H3387 [19MY]

——— ease regulatory burden relative to certain medical devices (see S. 1622), S4298 [18JN]

——— enhance reporting requirements pertaining to use of antimicrobial drugs in food animals (see H.R. 2459), H3388 [19MY]

——— enhance the process for reviewing combination products (see H.R. 2433), H3387 [19MY]

——— ensure efficiency of clinical trials through broader application of Bayesian statistics and adaptive trial designs (see H.R. 2438), H3387 [19MY]

——— ensure eligible product developers have competitive access to approved drugs and licensed biological products to enable development and testing of new products (see H.R. 2841), H4541 [18JN]

——— ensure safety of cosmetics (see S. 1014), S2272 [20AP]

——— ensure the safety of imported seafood (see S. 190), S283 [20JA]

——— ensure valid generic drugs may enter the market (see S. 131), S100 [8JA]

——— establish a third-party quality system assessment program for medical devices (see S. 2187), S7413 [21OC] (see H.R. 2422), H3387 [19MY]

——— establish certain requirements relative to labeling of pollock and golden king crab as being from Alaska (see S. 2095), S7005 [29SE] (see H.R. 3806), H7137 [22OC]

——— establish Federal labeling standards for food with genetically modified ingredients and natural foods (see H.R. 1599), H2031 [25MR]

——— establish Federal labeling standards for food with genetically modified ingredients and natural foods (H.R. 1599), consideration (see H. Res. 369), H5329 [21JY]

——— establish new procedures and requirements for registration of cosmetic manufacturing establishments, submission of cosmetic and ingredient statements, and reporting of serious cosmetic adverse events (see H.R. 4075), H8360 [18NO]

——— 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. 2301), S8079 [18NO]

——— establish streamlined data review program relative to approval of licensure of certain drugs (see H.R. 2415), H3387 [19MY]

——— evaluate potential use of evidence from clinical experience to help support approval of new indications for approved drugs (see H.R. 2416), H3387 [19MY]

——— extend market exclusivity periods for certain new drug applications and abbreviated new drug applications (see H.R. 1353), H1635 [13MR]

——— extend market exclusivity periods for drugs approved to prevent, diagnose, or treat a rare disease or condition (see S. 1421), S3237 [21MY] (see H.R. 971), H1067 [13FE]

——— facilitate dissemination of health care economic information (see H.R. 2452), H3388 [19MY]

——— grant authority to modify predicate/grandfather date for regulation of certain newly deemed tobacco products (see H.R. 2058), H2496 [28AP]

——— improve and clarify certain disclosure requirements for restaurants and similar retail food establishments and amend authority to bring certain proceedings (see S. 2217), S7655 [29OC] (see H.R. 2017), H2464 [23AP]

——— improve training and oversight of employees involved in implementing the least burdensome appropriate means concept relative to regulatory approval of medical devices (see H.R. 2424), H3387 [19MY]

——— incentivize the development of abuse-deterrent drugs (see H.R. 2335), H3212 [14MY]

——— increase number of individuals allowed to use certain medical devices under the humanitarian device exemption (see S. 2188), S7413 [21OC] (see H.R. 2428), H3387 [19MY]

——— issue guidance on precision medicine (see H.R. 2455), H3388 [19MY]

——— modify composition and size of Reagan-Udall Foundation Board of Directors (see H.R. 2435), H3387 [19MY]

——— permit the sale of, and access to, ‘‘research use only’’ products in diagnostic tests (see H.R. 298), H357 [13JA]

——— preserve effectiveness of medically important antimicrobials used in treatment of animal diseases in order to minimize development of antibiotic-resistant bacteria (see S. 621), S1217 [2MR]

——— promote use of innovative statistical methods in clinical protocols for drugs, biological products and devices, and postapproval studies and clinical trials (see H.R. 1066), H1163 [25FE]

——— provide for development of accelerated approval development plans for investigational drugs and biological products (see H.R. 2547), H3560 [21MY]

——— provide for issuance of up-to-date regulations and guidance applying to dissemination by means of Internet of information about medical products (see H.R. 2479), H3506 [20MY]

——— provide for the regulation of health software (see H.R. 2396), H3308 [18MY]

——— provide for the regulation of patient records and certain decision support medical software (see S. 1101), S2431 [27AP]

——— provide incentives for the development of new combination drugs (see H.R. 406), H429 [20JA]

——— reauthorize a program of priority review to encourage treatments for rare pediatric diseases (see H.R. 1537), H1847 [23MR]

——— reform program allowing for expanded access to certain experimental treatments or breakthrough drugs for seriously ill patients (see H.R. 909), H1032 [12FE]

——— require labeling of genetically-engineered fish (see H.R. 393), H406 [14JA]

——— require that genetically engineered food and foods that contain genetically engineered ingredients be labeled accordingly (see S. 511), S983 [12FE] (see H.R. 913), H1032 [12FE]

——— 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. 3648), H6705 [29SE]

——— strengthen regulation of compounding drugs by pharmacies (see S. 1406), S3183 [20MY]

Food: amend inspection laws to notify consumers of products produced from crops, livestock, or poultry raised on sewage sludge-treated land (see H.R. 737), H811 [4FE]

——— decrease incidence of food waste (see H.R. 4184), H9025 [7DE]

Health: prevent human health threats posed by the consumption of equines raised in the U.S. (see S. 1214), S2688 [6MY]

——— provide for reciprocal marketing approval of certain drugs, biological products, and devices that are authorized to be lawfully marketed abroad (see S. 2388), S8602 [10DE]

Pharmaceuticals: allow manufacture, importation, distribution, and sale of investigational drugs and devices intended for use by terminally ill patients (see H.R. 790), H854 [5FE]

——— allow personal importation and reimportation of prescription drugs (see H.R. 2623), H3877 [3JN]

——— allow personal importation of safe and affordable drugs from approved pharmacies in Canada (see S. 122), S99 [8JA] (see H.R. 2228), H2792 [1MY]

——— allow personal importation of safe and affordable drugs from certain countries (see S. 1790), S5170 [16JY]

——— ensure greater affordability of prescription drugs (see S. 2023), S6604 [10SE] (see H.R. 3513), H6074 [16SE]

——— preserve effectiveness of medically important antimicrobials used in treatment of human and animal diseases (see H.R. 1552), H1848 [23MR]

Product safety: prohibit the sale of infant formula after the expiration date on the product (see H.R. 2936), H4770 [25JN]

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. 441), S900 [10FE] (see H.R. 662), H703 [2FE]

Cost Estimates

Improving Regulatory Transparency for New Medical Therapies Act (H.R. 639): CBO, H1641 [16MR]

Letters

Improving Regulatory Transparency for New Medical Therapies Act: Representative Goodlatte, Committee on the Judiciary (House), H1640 [16MR]

——— Representative Upton, Committee on Energy and Commerce (House), H1640 [16MR]

Safe and Accurate Food Labeling Act: Ben Burkett, National Family Farm Coalition, H5352 [22JY]

——— Chris Waldrop, Consumer Federation of America, H5353 [22JY]

——— Jean Halloran and Urvashi Rangan, Consumers Union, H5352 [22JY]

——— John W. Boyd, Jr., National Black Farmers Association, H5351 [22JY]

——— Jostein Solheim, Ben & Jerry’s Homemade, Inc., H5352 [22JY]

——— Representative Conaway, Committee on Agriculture (House), H5416 [23JY]

——— Representative Upton, Committee on Energy and Commerce (House), H5416 [23JY]

——— Robynn Shrader, National Co+Op Grocers (organization), H5353 [22JY]

——— Scott Faber, Environmental Working Group, H5353 [22JY]

——— several organizations, H5353 [22JY]

——— Tom Colicchio, Food Policy Action (organization), H5353 [22JY]

Press releases

NFU Reiterates Support for Mandatory GMO Labeling, Opposes Pompeo Bill but Notes Progress: National Farmers Union, H5351 [22JY], H5423 [23JY]

Remarks in House

Creating Hope Act: reauthorize, H4980 [9JY]

Drugs: improve DEA scheduling process for new FDA-approved drugs under the Controlled Substances Act and registration process for use of controlled substances in clinical trials (H.R. 639), H1638–H1641 [16MR]

——— improve DEA scheduling process for new FDA-approved drugs under the Controlled Substances Act and registration process for use of controlled substances in clinical trials (H.R. 639), Senate amendment, H8212, H8213 [16NO]

FDA: ensure tribal sovereignty to prohibit or restrict the cultivation of genetically engineered plants on tribal lands, H5431, H5432 [23JY]

——— establish Federal labeling standards for food with genetically modified ingredients and natural foods (H.R. 1599), H5284 [16JY], H5300, H5308 [21JY], H5338 [22JY], H5408, H5416–H5439 [23JY], E1135 [28JY], E1298 [16SE]

——— establish Federal labeling standards for food with genetically modified ingredients and natural foods (H.R. 1599), consideration (H. Res. 369), H5345–H5357 [22JY]

——— establish streamlined data review program relative to approval of licensure of certain drugs, H4977 [9JY]

——— extend market exclusivity periods for drugs approved to prevent, diagnose, or treat a rare disease or condition, H5012 [9JY], E1037 [10JY]

——— extend market exclusivity periods for drugs approved to prevent, diagnose, or treat a rare disease or condition (H.R. 971), H2970 [14MY]

——— grant authority to modify predicate/grandfather date for regulation of certain newly deemed tobacco products (H.R. 2058), E596 [28AP]

——— improve priority review voucher incentive program for expedited review of treatments for tropical and rare pediatric diseases, E1307 [17SE]

——— provide for the regulation of health software, H5010 [9JY], E1061 [14JY]

——— reform program allowing for expanded access to certain experimental treatments or breakthrough drugs for seriously ill patients, H4980 [9JY]

——— require that genetically engineered food and foods that contain genetically engineered ingredients be labeled accordingly (H.R. 913), H5424, H5430 [23JY]

——— require U.S. companies labeling their products in foreign countries as containing genetically modified organisms to label the equivalent product the same way in the U.S., H5430, H5431 [23JY]

Food: decrease incidence of food waste (H.R. 4184), H9089 [9DE]

Pharmaceuticals: preserve effectiveness of medically important antimicrobials used in treatment of human and animal diseases (H.R. 1552), E394, E400 [24MR]

Remarks in Senate

Dept. of HHS: require a safety assessment of food containers composed of bisphenol A and require food packaging containing bisphenol A to be labeled as such (S. 821), S1667 [19MR]

Drugs: improve DEA scheduling process for new FDA-approved drugs under the Controlled Substances Act and registration process for use of controlled substances in clinical trials (H.R. 639), S7495 [26OC]

FDA: approval of genetically-engineered salmon for food, S8137 [19NO]

——— ensure safety of cosmetics (S. 1014), S2274 [20AP]

——— establish Federal labeling standards for food with genetically modified ingredients and natural foods (H.R. 1599), S8290 [2DE], S8339 [3DE], S8475 [8DE]

——— grant authority to modify predicate/grandfather date for regulation of certain newly deemed tobacco products, S2509–S2511 [29AP], S7580–S7583 [28OC]

——— preserve effectiveness of medically important antimicrobials used in treatment of animal diseases in order to minimize development of antibiotic-resistant bacteria (S. 621), S1218 [2MR]

——— require labeling of genetically-engineered salmon, S8137 [19NO]

Pharmaceuticals: allow personal importation of safe and affordable drugs from approved pharmacies in Canada, S8351 [3DE]

——— ensure greater affordability of prescription drugs (S. 2023), S6997, S6998 [29SE]

Reports filed

Consideration of H.R. 1599, Safe and Accurate Food Labeling Act and H.R. 1734, Improving Coal Combustion Residuals Regulation Act: Committee on Rules (House) (H. Res. 369) (H. Rept. 114–216), H5329 [21JY]

Improving Regulatory Transparency for New Medical Therapies Act: Committee on Energy and Commerce (House) (H.R. 639) (H. Rept. 114–41), H1660 [16MR]

——— Committee on Health, Education, Labor, and Pensions (Senate) (S. 481), S7101 [1OC]

Safe and Accurate Food Labeling Act: Committee on Agriculture (House) (H.R. 1599) (H. Rept. 114–208), H5289 [16JY], H5329 [21JY]

Texts of

H. Res. 369, consideration of H.R. 1599, Safe and Accurate Food Labeling Act and H.R. 1734, Improving Coal Combustion Residuals Regulation Act, H5345 [22JY]

H.R. 639, Improving Regulatory Transparency for New Medical Therapies Act, H1638 [16MR], H8212 [16NO]

H.R. 1599, Safe and Accurate Food Labeling Act, H5426–H5430 [23JY]