FOOD AND DRUG ADMINISTRATION

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]

Food: 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]

Health: accelerate discovery, development, and delivery of 21st century lifesaving cures and devices (H.R. 6), H5035, H5069, H5071, H5072, H5074, H5076, H5077, H5078 [10JY]

——— accelerate discovery, development, and delivery of 21st century lifesaving cures and devices (H.R. 6), consideration (H. Res. 350), H4984 [9JY]

Taxation: repeal excise tax on medical devices (H.R. 160), consideration (H. Res. 319), H4455 [17JN]

Articles and editorials

Device Tax Thwarts Expansion in Winston-Salem, H4453 [17JN]

Excuse for Crushing Kratom—FDA’s Undue Scrutiny Is Unscientific, E1164 [29JY]

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]

Agriculture, rural development, FDA, and related agencies programs: making appropriations (see S. 1800), S5170 [16JY] (see S. 2129), S7123 [5OC] (see H.R. 3049), H5171 [14JY]

Birth control: withdraw approval for the Essure permanent birth control system (see H.R. 3920), H7741 [4NO]

Breakthrough devices: authorize priority review (see H.R. 2337), H3212 [14MY]

——— provide for expedited development and priority review (see S. 1077), S2400 [23AP]

Budget: exempt certain user fees from budget sequestration (see H.R. 1078), H1163 [25FE]

Business and industry: 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]

Consumers: allow for regulation of electronic nicotine delivery systems and e-liquids like tobacco cigarettes and establish labeling, packaging, and dosage limits for such products (see H.R. 1517), H1803 [19MR]

Contraceptives: ensure employers cannot prohibit access, call for an FDA study on whether prescriptions are necessary for contraceptives, and allow use of certain health accounts to purchase over-the-counter drugs (see S. 1438), S3238 [21MY]

Cosmetics: ensure safety (see S. 1014), S2272 [20AP]

Dept. of Agriculture: disapprove rule on inspection of fish of the order Siluriformes, including catfish (see S.J. Res. 27), S8438 [7DE] (see S.J. Res. 28), S8602 [10DE]

Dept. of HHS: establish a National Diabetes Clinical Care Commission (see S. 586), S1161 [26FE] (see H.R. 1192), H1524 [2MR]

——— 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]

——— provide for enhanced Federal efforts on prevention, education, treatment, and research relative to Lyme disease and other tick-borne diseases (see S. 1503), S3775 [4JN]

——— provide for research relative to Lyme disease and other tick-borne diseases (see H.R. 789), H854 [5FE]

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

——— 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]

Dept. of Justice: improve enforcement efforts relative to prescription drug diversion and abuse (see S. 483), S982 [12FE] (see H.R. 471), H530 [22JA]

Dept. of Veterans Affairs: adopt and implement a standard identification protocol for use in tracking and procurement of biological implants and tissue or bone grafts (see S. 2334), S8191 [30NO] (see H.R. 1016), H1084 [20FE]

Diseases: facilitate effective research on, and treatment of, neglected tropical diseases, including ebola, through coordinated domestic and international efforts (see H.R. 1797), H2268 [15AP]

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

Drugs: allow the sponsor of an application for the approval of a targeted drug to rely upon data and information with respect to such sponsor’s previously approved targeted drugs (see S. 2030), S6651 [15SE]

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

——— award grants for studying the process of continuous drug manufacturing (see H.R. 2444), H3388 [19MY]

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

——— decriminalize marijuana at the Federal level and leave States the power to regulate marijuana similar to the power to regulate alcohol (see H.R. 1013), H1084 [20FE]

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

——— encourage development and use of new antimicrobial drugs in order to treat antibiotic-resistant infections (see H.R. 512), H532 [22JA]

——— 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 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]

——— establish procedures regarding approval of opioid drugs (see S. 954), S2220 [15AP]

——— 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 the rare pediatric disease priority review voucher program (see S. 1878), S6073 [28JY]

——— 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]

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

——— increase Federal oversight of prescription opioid treatment and assistance to States in reducing opioid abuse, diversion, and deaths (see S. 1431), S3237 [21MY]

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

——— 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 development of safe drugs for neonates (see S. 2041), S6699 [16SE]

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

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

——— reduce opioid misuse and abuse (see H.R. 3677), H6787 [1OC]

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

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

Fish and fishing: 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]

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

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]

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

——— 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]

——— limit quantity of inorganic arsenic in rice and rice products (see H.R. 2529), H3559 [21MY]

——— 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]

Food industry: 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]

FTC: prohibit the marketing of electronic cigarettes to children (see S. 430), S900 [10FE] (see H.R. 478), H530 [22JA]

GAO: assess the FDA’s current regulatory pathway for reviewing generic versions of nonbiologic complex drug products (see H.R. 1576), H1899 [24MR]

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 S. 496), S982 [12FE]

——— provide for the regulation of medical 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]

Health: accelerate discovery, development, and delivery of 21st century lifesaving cures and devices (see H.R. 6), H3386 [19MY]

——— accelerate discovery, development, and delivery of 21st century lifesaving cures and devices (H.R. 6), consideration (see H. Res. 350), H4954 [8JY]

——— authorize use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law (see H.R. 3012), H5029 [9JY]

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

——— 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]

——— require certain drug manufacturers entering into settlement agreements for violations of law to make supplemental payments to be used to increase medical research funding (see S. 320), S653 [29JA] (see H.R. 744), H812 [4FE]

Labeling: 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]

——— 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]

National Prostate Cancer Council on Screening, Early Detection, Assessment, and Monitoring of Prostate Cancer: establish (see S. 216, 222), S347 [21JA] (see H.R. 2730), H4241 [11JN]

NIH: encourage a global pediatric clinical trial network (see H. Con. Res. 46), H3212 [14MY]

——— enhance the clinical trial registry data bank reporting requirements and enforcement measures (see H.R. 617), H662 [28JA]

——— research risks posed by dioxin, synthetic fibers, and other additives in feminine hygiene products and urge the FDA to monitor and disclose contaminants in all menstrual hygiene products (see H.R. 1708), H2110 [26MR]

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]

——— clarify the orphan drug exception to the annual fee on branded prescription pharmaceutical manufacturers and importers (see S. 1906), S6186 [30JY] (see H.R. 3618), H6260 [25SE] (see H.R. 3678), H6787 [1OC]

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

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

——— expedite review of pharmaceuticals approved for marketing in the European Union (see H.R. 1455), H1769 [18MR]

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

——— prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market (see S. 2019), S6533 [9SE]

Product safety: 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]

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

——— 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]

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

——— 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]

——— 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]

——— 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]

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

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

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. 931), H1033 [12FE]

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

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

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

——— 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]

Science: express sense of Congress relative to enabling scientific engagement (see H.R. 2445), H3388 [19MY]

——— recognize importance of breakthroughs in biomedicine, biotechnology, and life sciences in diagnosis and treatment of illness and address funding gap between basic research and clinical development (see H. Res. 95), H856 [5FE]

Silvio O. Conte Senior Biomedical Research Service: modify hiring and retention authority (see H.R. 2439), H3387 [19MY]

Taxation: exempt certain emergency medical devices from the excise tax on medical devices (see H.R. 518), H532 [22JA]

——— repeal excise tax on medical devices (see S. 149), S200 (see S. 157), S201 [13JA] (see S. 844), S1780 [24MR] (see H.R. 160), H41 [6JA] (see H.R. 1533), H1847 [23MR]

——— repeal excise tax on medical devices (H.R. 160), consideration (see H. Res. 319), H4430 [16JN]

Technology: 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]

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]

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

Women: ensure timely access to affordable birth control (see S. 1532), S3925 [9JN] (see H.R. 3163), H5402 [22JY]

Cost Estimates

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

Letters

Ensuring Patient Access and Effective Drug Enforcement Act: Representative Goodlatte, Committee on the Judiciary (House), H2330 [21AP]

——— Representative Upton, Committee on Energy and Commerce (House), H2330 [21AP]

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]

21st Century Cures Act: Representative Lamar Smith, Committee on Science, Space, and Technology (House), H5009 [9JY]

——— Representative Paul Ryan, Committee on Ways and Means (House), H5009 [9JY]

——— Representative Upton, Committee on Energy and Commerce (House), H5009 [9JY]

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

Abortion: prohibit taxpayer funded abortions, H4982, H5013, H5014 [9JY], H5072, H5073 [10JY], E1046 [13JY], E1069 [15JY]

Birth control: withdraw approval for the Essure permanent birth control system (H.R. 3920), H7378 [2NO], H9087 [9DE], H9210 [10DE], H9677 [17DE]

Budget: exempt certain user fees from budget sequestration, H5012 [9JY]

Business and industry: 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]

Dept. of HHS: provide for research relative to Lyme disease and other tick-borne diseases, H5014 [9JY]

Dept. of Justice: improve enforcement efforts relative to prescription drug diversion and abuse (H.R. 471), H2329–H2332 [21AP]

Dept. of Veterans Affairs: adopt and implement a standard identification protocol for use in tracking and procurement of biological implants and tissue or bone grafts, H5308 [21JY]

Diseases: address multistate measles outbreak, H686 [2FE]

——— facilitate effective research on, and treatment of, neglected tropical diseases, including ebola, through coordinated domestic and international efforts (H.R. 1797), E514 [16AP]

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

Drugs: decriminalize marijuana at the Federal level and leave States the power to regulate marijuana, H7031 [21OC], H8284 [18NO]

——— decriminalize marijuana at the Federal level and leave States the power to regulate marijuana similar to the power to regulate alcohol, H985 [12FE]

——— encourage development and use of new antimicrobial drugs in order to treat antibiotic-resistant infections, H5075 [10JY]

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

——— 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]

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

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

——— 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]

——— impact of genetically engineered salmon on wild salmon stocks and the fishing industry, H5425 [23JY]

——— prohibit use of term ‘‘natural’’ on food consisting of a genetically engineered plant, H5432, H5433 [23JY]

——— 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]

——— standard to limit level of non-toxigenic E. coli found in raw milk cheeses, H9186 [9DE]

Government regulations: exempt from complete analysis of potential impacts of rules on small entities any FDA regulation relating to consumer safety, H828–H830 [5FE]

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

Health: accelerate discovery, development, and delivery of 21st century lifesaving cures and devices (H.R. 6), H3399 [20MY], H3650 [2JN], H4476 [17JN], H4656 [25JN], H4972, H5008–H5016 [9JY], H5034, H5035–H5082, H5083, H5084 [10JY], H5094 [13JY], H5179, H5219 [15JY], H6219 [24SE], H7266 [28OC], H7399 [3NO], E1031, E1032, E1036–E1038 [10JY], E1045, E1046, E1047 [13JY], E1060, E1061 [14JY], E1069 [15JY]

——— accelerate discovery, development, and delivery of 21st century lifesaving cures and devices (H.R. 6), consideration (H. Res. 350), H4976–H4985 [9JY]

——— address regulatory issues relative to discovery that use of laparoscopic power morcellator to remove fibroids increases risk of spreading unsuspected cancerous tissue, H4487 [17JN]

——— importance of immunizations, H709 [3FE], H765 [4FE]

——— support the recording of Unique Device Identifiers at the point-of-care in electronic health record systems to enhance the availability of medical device data for post-market surveillance purposes, H5076, H5077 [10JY]

National Prostate Cancer Council on Screening, Early Detection, Assessment, and Monitoring of Prostate Cancer: establish (H.R. 2730), H4388 [16JN], H6292 [28SE]

NIH: research risks posed by dioxin, synthetic fibers, and other additives in feminine hygiene products and urge the FDA to monitor and disclose contaminants in all menstrual hygiene products (H.R. 1708), E441 [26MR]

Pharmaceuticals: address rising cost of generic drugs, H6232 [25SE]

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

Safety: issue a report on the risks and benefits associated with a two-tiered approval process that would permit certain medical devices to provisionally come to market if they have demonstrated safety but not efficacy, H5077, H5078 [10JY]

Taxation: repeal excise tax on medical devices, H7149, H7153, H7158 [23OC], H8871 [2DE], H9426 [17DE]

——— repeal excise tax on medical devices (H.R. 160), H110, H113 [8JA], H4387 [16JN], H4445, H4447, H4472–H4478, H4487 [17JN], H4496, H4527, H4528, H4535 [18JN], H4607 [24JN], E922, E930, E931, E932 [18JN], E988 [25JN], E1004 [7JY]

——— repeal excise tax on medical devices (H.R. 160), consideration (H. Res. 319), H4449–H4455 [17JN]

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

Remarks in Senate

Agriculture, rural development, FDA, and related agencies programs: making appropriations (S. 2129), S7127 [5OC], S7130 [6OC]

Committee on Health, Education, Labor, and Pensions (Senate): priorities, S174 [13JA]

——— release of Innovation for Healthier Americans Report to improve innovation in cutting-edge treatments, drugs, and devices, S626–S629 [29JA]

Consumers: allow for regulation of electronic nicotine delivery systems and e-liquids like tobacco cigarettes and establish labeling, packaging, and dosage limits for such products, S2541 [29AP], S2551, S2557–S2559 [30AP]

Cosmetics: ensure safety (S. 1014), S2274 [20AP]

Drugs: decriminalize marijuana at the Federal level and leave States the power to regulate marijuana similar to the power to regulate alcohol, S7620 [29OC]

——— 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]

——— 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]

Fish and fishing: approval of genetically-engineered salmon for food, S8137 [19NO]

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

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

FTC: prohibit the marketing of electronic cigarettes to children, S4929 [9JY], S7580–S7583, S7587 [28OC]

Health: require certain drug manufacturers entering into settlement agreements for violations of law to make supplemental payments to be used to increase medical research funding (S. 320), S657 [29JA]

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

——— condemn and call for investigation of pharmaceutical companies purchasing rights of existing drugs and drastically increasing the price of such drugs, S7118 [5OC]

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

Safety: impact of sequestration on enforcement of food safety regulations, S4172 [16JN]

Taxation: repeal excise tax on medical devices, S8270, S8285 [2DE]

——— repeal excise tax on medical devices (H.R. 160), S4522 [22JN], S4523 [23JN]

——— repeal excise tax on medical devices (S. 149), S450 [26JA]

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

Reports filed

Agriculture, Rural Development, FDA, and Related Agencies Programs Appropriations: Committee on Appropriations (House) (H.R. 3049) (H. Rept. 114–205), H5171 [14JY]

——— Committee on Appropriations (Senate) (S. 1800) (S. Rept. 114–82), S5169 [16JY]

Consideration of H.R. 6, 21st Century Cures Act: Committee on Rules (House) (H. Res. 350) (H. Rept. 114–193), H4954 [8JY]

Consideration of H.R. 160, Protect Medical Innovation Act and H.R. 1190, Protecting Seniors’ Access to Medicare Act: Committee on Rules (House) (H. Res. 319) (H. Rept. 114–157), H4430 [16JN]

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]

Ensuring Patient Access and Effective Drug Enforcement Act: Committee on Energy and Commerce (House) (H.R. 471) (H. Rept. 114–85), H2318 [20AP]

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]

Protect Medical Innovation Act: Committee on Ways and Means (House) (H.R. 160) (H. Rept. 114–147), H4241 [11JN]

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

21st Century Cures Act: Committee on Energy and Commerce (House) (H.R. 6) (H. Rept. 114–190), H4860 [7JY]

Statements

Continuing America’s Leadership in Medical Innovation for Patients: Senator Alexander, Committee on Health, Education, Labor, and Pensions (Senate), S1490 [12MR]

Nomination of Robert M. Califf To Be FDA Commissioner: Senator Alexander, S8153 [19NO]

Summaries

Innovation for Healthier Americans Report: Committee on Health, Education, Labor, and Pensions (Senate), S627 [29JA]

Texts of

H. Res. 319, consideration of H.R. 160, Protect Medical Innovation Act and H.R. 1190, Protecting Seniors’ Access to Medicare Act, H4449 [17JN]

H. Res. 350, consideration of H.R. 6, 21st Century Cures Act, H4976 [9JY]

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. 6, 21st Century Cures Act, H5035–H5069 [10JY]

H.R. 160, Protect Medical Innovation Act, H4472 [17JN]

H.R. 471, Ensuring Patient Access and Effective Drug Enforcement Act, H2329 [21AP]

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]