FOOD AND DRUG ADMINISTRATION

Amendments

Depts. of Commerce, Justice, Agriculture, Interior, Transportation, HUD, and VA, FDA, EPA, science, and military construction: making appropriations (H.R. 3055), S5951, S5978–S6046 [22OC], S6098–S6133 [23OC], S6165–S6175 [24OC], S6183, S6185, S6186, S6194–S6204 [28OC], S6248–S6254 [29OC], S6306 [30OC], S6311–S6315, S6321 [31OC], S6722, S6723 [20NO], S6734 [21NO], H4780, H4804 [19JN], H4940, H4941, H4943, H4944, H4945, H4960 [20JN], H8972, H9035 [19NO]

——— making appropriations (H.R. 3055), consideration (H. Res. 445), H4787 [19JN]

Health: reduce prescription drug prices, facilitate entry of generic and biosimilar products into the market, strengthen Federal exchanges, and reverse extension of short-term health plans (H.R. 987), H3873, H3874, H3876, H3877, H3878, H3879, H3880, H3882, H3883, H3884, H3885, H3886, H3887, H3888, H3889, H3891, H3892, H3893, H3894, H3896, H3897, H3898, H3900, H3901 [16MY]

Articles and editorials

Clinical Trials Shed Light on Minority Health, H4544 [12JN]

Bills and resolutions

Abortion: improve regulation of abortion drugs by prohibiting approval of new drugs, preventing labeling changes of existing drugs, and preventing providers from dispensing drugs remotely, by mail, or telemedicine (see S. 3072), S7113 [17DE] (see H.R. 4399), H7834 [19SE]

Advertising: restrict direct-to-consumer drug advertising (see H.R. 4106), H7480 [30JY]

Agriculture: 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. 5410), H10257 [12DE]

——— provide authority to investigate animal feeding operations near produce farms where foodborne illness outbreaks occur to better determine the root causes of such outbreaks (see S. 2958), S6756 [21NO] (see H.R. 5415), H10257 [12DE]

Agriculture, rural development, FDA, and related agencies programs: making appropriations (see S. 2522), S5602 [19SE] (see H.R. 265), H280 [8JA] (see H.R. 3164), H4348 [6JN]

——— making appropriations (H.R. 265), consideration (see H. Res. 28), H280 [8JA]

Animals: prevent human health threats posed by consumption of equines raised in the U.S. (see H.R. 875), H1333 [30JA] (see H.R. 961), H1349 [4FE]

Business and industry: address abuse of citizen petition process by brand drug manufacturers (see S. 660), S1659 [5MR]

——— hold pharmaceutical companies accountable for dubious marketing and distribution of opioid products and for their role in creating and exacerbating the opioid epidemic (see S. 1584), S3005 [21MY] (see H.R. 2917), H4118 [22MY]

CDC: develop program to prevent use of electronic nicotine delivery systems among students in middle and high schools and award grants to implement such program (see S. 3096), S7156 [18DE] (see H.R. 5482), H12210 [18DE]

Chemicals: clarify meaning of a new chemical entity (see H.R. 4955), H8717 [31OC]

Colleges and universities: designate institutions of higher education that provide research, data, and leadership on continuous manufacturing as National Centers of Excellence in Continuous Pharmaceutical Manufacturing (see H.R. 4866), H8538 [28OC]

Contraceptives: establish certain duties for pharmacies to ensure provision of FDA-approved contraception (see S. 1086), S2328 [9AP] (see H.R. 2182), H3217 [9AP]

——— provide women greater access by increasing availability of contraceptives over-the-counter and allowing use of health savings accounts to purchase such products (see S. 930), S2087 [28MR]

Cosmetics: define terms ‘‘natural’’ and ‘‘naturally-derived ingredient’’ relative to personal care products and provide authority to remove misbranded products from the marketplace (see H.R. 5017), H8738 [8NO]

——— ensure safety (see S. 726), S1734 [7MR] (see H.R. 4296), H7704 [12SE]

——— improve safety (see H.R. 5279), H9221 [3DE]

——— prohibit cosmetic animal testing and sale of cosmetics tested on animals (see S. 2886), S6625 [18NO]

——— require that children’s cosmetics containing talc include an appropriate warning unless the cosmetics are demonstrated to be asbestos-free (see H.R. 1816), H2754 [18MR]

DEA: regulate selective androgen receptor modulators in the same manner as anabolic steroids (see S. 2895), S6669 [19NO]

Dept. of HHS: allow expedited approval of generic prescription drugs and temporary importation of prescription drugs during noncompetitive drug markets and drug shortages (see S. 844), S1899 [14MR]

——— allow importation by wholesalers, pharmacies, and individuals of safe and affordable drugs from FDA-certified foreign sellers (see S. 97), S142 [10JA] (see H.R. 447), H462 [10JA]

——— allow personal importation of safe and affordable drugs from approved pharmacies in Canada (see S. 61), S103 [9JA] (see H.R. 478), H463 [10JA]

——— educate health care professionals and the public on biosimilar biological products (see S. 1681), S3106 [23MY] (see H.R. 4400), H7834 [19SE]

——— ensure medications are affordable through increasing transparency, allowing Medicare to negotiate lower prices and importation of certain drugs, spurring innovation, and protecting competition (see S. 1801), S3363 [12JN]

——— establish Prescription Safety Alert System to combat prescription drug abuse by collecting, maintaining, and providing to dispensers patients’ prescription and dispensing history (see H.R. 1845), H2761 [21MR]

——— mitigate drug shortages by prioritizing review of new drug applications, inspections, and reasons for shortages and assess national security threats associated with drug and ingredient shortages (see S. 2723), S6242 [29OC]

——— prohibit sale or distribution of tobacco products to individuals under the age of 21 (see S. 1541), S2962 [20MY]

——— provide for a national strategy to address and overcome Lyme disease and other tick-borne diseases (see H.R. 220), H209 [3JA]

——— reauthorize certain programs to protect against pandemics and attacks from chemical, biological, radiological, and nuclear weapons (see S. 1379), S2743 [8MY] (see H.R. 269), H280 [8JA]

——— support endemic fungal disease research, incentivize fungal vaccine development, and discover new antifungal therapies and diagnostics to fight infections such as valley fever (see S. 1567), S3004 [21MY] (see H.R. 2858), H4063 [21MY]

Dept. of the Treasury: establish Biomedical Innovation Fund (see H.R. 5400), H10123 [11DE]

Dept. of Veterans Affairs: adopt and implement a standard identification protocol for use in tracking and procurement of biological implants (see H.R. 547), H600 [15JA]

Depts. of Commerce, Justice, Agriculture, Interior, Transportation, HUD, and VA, FDA, EPA, science, and military construction: making appropriations (H.R. 3055), consideration (see H. Res. 445), H4769 [18JN]

——— making appropriations (H.R. 3055), consideration of Senate amendment (see H. Res. 708), H8957 [18NO]

——— making appropriations (H.R. 3055), correction in enrollment (see H. Con. Res. 75), H9057 [19NO]

Diseases and disorders: expand tropical disease product priority review voucher program to encourage treatments for Middle East respiratory syndrome, Nipah, and Rift Valley fever (see H.R. 4553), H8080 [27SE]

——— facilitate effective research on, and treatment of, neglected tropical diseases through coordinated international efforts (see S. 2481), S5539 [17SE] (see H.R. 3460), H5165 [25JN]

——— facilitate effective research on, and treatment of, neglected tropical diseases, including Ebola, through coordinated domestic and international efforts (see H.R. 826), H1242 [28JA]

Drugs: allow for importation of affordable and safe insulin by wholesale distributors, pharmacies, and individuals (see H.R. 1478), H2314 [28FE]

——— allow rejection of a citizen petition if it is believed the primary purpose of the petition is to delay approval of a pending drug application and refer such petitioners to the FTC (see S. 1169), S2433 [11AP] (see H.R. 2455), H3404 [1MY]

——— amend exclusivity period granted to a first generic drug application (see S. 3092), S7156 [18DE]

——— amend mission statement to require the agency to address the nation’s prescription opioid addiction epidemic (see S. 417), S1133 [7FE]

——— clarify process for denying certain petitions whose primary purpose is to delay approval of an application submitted relative to certain drugs (see H.R. 2387), H3303 [29AP]

——— clarify types of patents on safe and effective drug list, require list of applicable exclusivities for listed drugs, update patent sponsor requirements, and reform patent list guidelines (see H.R. 1503), H2366 [5MR]

——— codify policy of requiring drug products to contain an active moiety that has not been used in a previously approved product in granting new chemical entity exclusivity (see S. 1636), S3104 [23MY]

——— create a mechanism whereby insulin manufacturers may sell directly to consumers at current net prices (see H.R. 5382), H10015 [10DE]

——— decriminalize marijuana, use tax revenues to assist certain small businesses, research effects on driving and health, restrict advertising to protect children, and expunge certain marijuana-related convictions (see S. 1552), S2962 [20MY] (see H.R. 2843), H4009 [20MY]

——— decriminalize marijuana at the Federal level and leave States the power to regulate marijuana similar to the power to regulate alcohol (see H.R. 420), H358 [9JA]

——— encourage development and use of new antimicrobial drugs in order to treat antibiotic-resistant infections (see S. 1712), S3215 [4JN] (see H.R. 4100), H7479 [30JY]

——— 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. 985), H1362 [5FE]

——— ensure valid generic drugs may enter the market by removing generic drug exclusivity period from any generic company that enters into pay-for-delay settlements with brand-name drug manufacturers (see H.R. 1506), H2366 [5MR]

——— establish a time-limited conditional approval pathway, subject to specific obligations, for certain drugs (see S. 3133), S7208 [19DE] (see H.R. 5497), H12289 [19DE]

——— establish procedures relative to approval of opioid drugs (see S. 418), S1133 [7FE]

——— increase competition in generic drug market by removing barriers for a generic drug to come to market by curbing patent manipulation by brand name drug manufacturers (see S. 1209), S2435 [11AP] (see H.R. 3812), H5999 [17JY]

——— increase competition in generic drug market by removing barriers for a second generic drug to come to market created by exclusivity period granted to a first generic drug application (see H.R. 938), H1341 [31JA]

——— invest in qualified clinical testing for high-risk, high-reward drugs that address unmet medical needs to treat rare and life-threatening diseases (see H.R. 5402), H10123 [11DE]

——— limit exclusive approval or licensure of orphan drugs (see H.R. 4712), H8226 [17OC]

——— lower out of pocket spending, protect access to new cures and medications, strengthen transparency, and encourage competition (see S. 3129), S7208 [19DE] (see H.R. 19), H9386 [9DE]

——— make permanent the policy to speed up time for biosimilar products to get approved and made available to consumers (see S. 1140), S2432 [11AP] (see H.R. 2011), H2938 [1AP]

——— prevent abuse of dextromethorphan by restricting over-the-counter sales of cough medicines to teenagers and prohibiting bulk distribution of unfinished dextromethorphan to unauthorized persons (see H.R. 863), H1332 [30JA]

——— prohibit abusive delay tactics by pharmaceutical companies to block entry of generic drugs and biosimilar biological products from the market (see S. 340), S867 [5FE] (see H.R. 965), H1361 [5FE]

——— prohibit opioids from being labeled for intended use to treat long-term chronic pain, except for cancer pain, end-of-life care, or when other pain management treatments are inadequate (see S. 2089), S4806 [11JY]

——— provide for a pathway for chemically synthesized insulin to be approved under an abbreviated new drug application (see H.R. 4244), H7558 [9SE]

——— provide for an accelerated approval pathway for certain drugs that are authorized to be lawfully marketed in other countries (see S. 658), S1659 [5MR]

——— require label of drugs with an increased risk of suicide or depression to prominently detail those side effects (see H.R. 4404), H7834 [19SE]

——— require labeling of country of origin of a drugs active ingredients (see H.R. 5381), H10015 [10DE]

——— require manufacturers of approved biological products to disclose and list patents, biosimilarity, and exclusivity information relative to their products and promote biosimilar competition (see S. 659), S1659 [5MR] (see H.R. 4850), H8457 [23OC]

——— require warning labels to be affixed to prescription opioid containers or packaging stating such drugs can cause dependence, addiction, and overdose (see S. 1449), S2815 [14MY] (see H.R. 2732), H3789 [14MY]

——— revoke approval of one opioid pain medication for each new opioid pain medication approved (see S. 419), S1133 [7FE]

——— shorten exclusivity period for brand name biological products (see H.R. 3379), H5005 [20JN]

——— shorten monopoly periods for prescription drugs that are subjects of sudden price hikes (see S. 366), S919 [6FE]

——— speed up approvals of lower-cost, generic, and ‘‘follow-on’’ insulin products (see S. 2103), S4807 [11JY] (see H.R. 5444), H10608 [17DE]

——— streamline, coordinate and expand research and foster increased communication between doctors and patients relative to cannabidiol and other marijuana components and their medical benefits (see S. 2032), S4628 [27JN]

——— strengthen regulation of compounding drugs by pharmacies (see H.R. 1959), H2915 [28MR]

EPA: ban use of pesticide chlorpyrifos (see S. 921), S2087 [28MR] (see H.R. 230), H209 [3JA]

——— cancel registration for all uses of the pesticide paraquat (see H.R. 3817), H5999 [17JY]

Federal agencies and departments: improve reporting about animal testing and alternative test method use by Federal agencies (see H.R. 249), H228 [4JA]

Fish and fishing: amend market name of genetically altered salmon (see S. 282), S769 [30JA] (see H.R. 1103), H1462 [7FE]

——— require labeling of genetically-engineered fish (see H.R. 1104), H1462 [7FE]

Food: clarify oversight and jurisdiction over regulation, inspection, and labeling of cell-cultured meat and poultry (see S. 1056), S2270 [4AP]

——— define the term natural cheese (see S. 1669), S3105 [23MY] (see H.R. 4487), H7988 [25SE]

——— prohibit sale of poppy seeds, or food that contains poppy seeds, with unsafe levels of certain opiates (see S. 1016), S2240 [3AP] (see H.R. 2078), H3068 [3AP]

——— provide for regulation, inspection, and labeling of food produced using animal cell culture technology (see S. 3053), S7048 [16DE]

FTC: deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar and foster competition and facilitate review of drug petitions filed in good faith (see S. 1224), S2485 [29AP] (see H.R. 2374), H3302 [29AP]

Government regulations: clarify regulatory framework relative to certain nonprescription drugs that are marketed without an approved new drug application (see S. 2740), S6299 [30OC] (see H.R. 269), H280 [8JA] (see H.R. 3443), H5075 [24JN]

——— establish standards for the design of electronic nicotine delivery systems (see S. 2536), S5663 [24SE]

Health: lower health care costs by ending surprise medical bills, reducing drug prices, and improving health care transparency, public health, and exchange of health information (see S. 1895), S3843 [19JN]

——— provide for publication of a list of licensed biological products (see H.R. 1520), H2366 [5MR]

——— recognize importance of vaccinations and immunizations (see S. Res. 165), S2435 [11AP]

——— 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 H.R. 5031), H8739 [8NO]

——— study effects of radiofrequency radiation in 5G networks on human health (see S. 2515), S5602 [19SE]

Hermstad, Jaci: deem application to the FDA for compassionate use of gene therapy antisense oligonucleotides to be approved (see H.R. 2855), H4010 [20MY]

Insurance: require group health plans and group or individual health insurance coverage to provide coverage for over-the-counter contraceptives (see S. 1847), S3476 [13JN] (see H.R. 3296), H4700 [14JN]

Labeling: codify definition of beef for labeling purposes, reinforce existing misbranding provisions to eliminate consumer confusion, and enhance Dept. of Agriculture labeling enforcement measures (see S. 3016), S6992 [11DE] (see H.R. 4881), H8538 [28OC]

——— establish requirements for quality and discard dates that are, at the option of food labelers, included in food packaging (see S. 2337), S5196 [30JY] (see H.R. 3981), H7463 [25JY]

——— provide authority to prohibit water buffalo products from being marketed as buffalo and clarify that buffalo is common name for bison (see S. 2479), S5493 [16SE]

——— require enforcement of labeling regulations against misbranded imitation dairy products such as milk, cheese, or yogurt (see S. 792), S1898 [14MR]

——— require enforcement of labeling regulations against misbranded imitation dairy products such as milk, cheese, or yogurt (H.R. 778) (see H.R. 1769), H2743 [14MR]

——— require labels of drugs that contain an ingredient that is derived directly or indirectly from a gluten-containing grain to identify each such ingredient (see S. 3021), S6992 [11DE] (see H.R. 2074), H3068 [3AP]

——— update labeling of certain drugs with outdated labeling (see S. 1897), S3843 [19JN]

Medical Device Sterilization Challenge: establish (see H.R. 3044), H4180 [30MY]

Medical devices: allow continued processing of medical device applications and associated user fees during a lapse in appropriations (see H.R. 1362), H2232 [26FE]

——— amend liability under State and local requirements relative to certain medical devices by allowing legal recourse by victims of unsafe devices (see H.R. 2669), H3726 [10MY]

——— require manufacturers to provide notification of design or cleaning instruction changes and safety warnings issued in foreign countries about design and cleaning (see H.R. 818), H1242 [28JA]

——— require physicians and physicians’ offices to be treated as covered device users required to report on certain adverse events involving medical devices (see H.R. 2915), H4118 [22MY]

Medicare: provide coverage of FDA-approved qualifying colorectal cancer screening blood-based tests (see H.R. 1765), H2743 [14MR]

——— provide for expedited coding and coverage of novel medical products (see S. 2326), S5195 [30JY]

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 (see H.R. 3865), H7157 [19JY]

Oceans: develop standards for a ‘‘Reef Safe’’ label for sunscreen (see S. 1375), S2743 [8MY] (see H.R. 2587), H3500 [8MY]

One Health Program: establish an interagency program to collaborate on the concept that human, animal, and ecosystem health intertwine to make ‘‘one health’’ to prevent and respond to disease outbreaks (see S. 1903), S3844 [19JN] (see H.R. 3771), H5910 [16JY]

Orphan Drug Act: affirm importance, commend life-saving accomplishments, and recognize need and continued support for research in development of therapies, treatments, and cures for rare diseases (see H. Res. 242), H2755 [18MR]

Patents: prevent inter partes review process for challenging patents from diminishing competition in the pharmaceutical industry and provide incentives for drug innovation (see S. 344), S919 [6FE] (see H.R. 990), H1389 [6FE]

Pesticides: increase scrutiny of glyphosate residues (see H.R. 1783), H2744 [14MR]

Pharmaceuticals: prohibit biological product manufacurers from compensating biosimilar and interchangeable product companies to delay entry of biosimilar and interchangeable products into the market (see H.R. 1499), H2366 [5MR]

——— prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market (see S. 64), S103 [9JA] (see H.R. 1344), H2100 [25FE] (see H.R. 1499), H2366 [5MR]

——— prohibit prescription drug manufacturers from compensating other companies to delay entry of generic drugs, biosimilar biological products, or interchangeable biological products into the market (see H.R. 2375), H3302 [29AP]

——— provide for reciprocal marketing approval of certain drugs, biological products, and devices that are authorized to be lawfully marketed abroad (see S. 2161), S4947 [18JY]

——— shorten monopoly periods for prescription drugs that are the subjects of sudden price hikes (see H.R. 1188), H1582 [13FE]

Product safety: deem per- and polyfluoroalkyl substances used in food containers or cookware as unsafe and implement a ban on use in such products (see H.R. 2827), H3962 [17MY]

——— prohibit sale of infant formula after the expiration date on the product (see H.R. 2267), H3255 [10AP]

Rare Pediatric Disease Designation Program: permanently reauthorize to issue priority review vouchers to encourage treatments for rare pediatric diseases (see H.R. 4439), H7865 [20SE]

Research: reauthorize innovation projects (see H.R. 4633), H8110 [11OC]

Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act: provide funding for programs and activities (see S. 2102), S4807 [11JY] (see H.R. 4460), H7901 [24SE]

Taxation: exempt certain emergency medical devices from the excise tax on medical devices (see H.R. 1290), H2032 [14FE]

——— repeal excise tax on medical devices (see S. 692), S1733 [7MR] (see H.R. 2207), H3252 [10AP]

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. 9), S19 [3JA] (see H.R. 1854), H2795 [25MR]

——— enhance health warnings on cigarette packages, raise minimum age to purchase tobacco products, restrict tobacco flavors, and regulate sale and marketing of all tobacco, including e-cigarettes and accessories (H.R. 2339) (see H.R. 2339), H3274 [18AP]

——— establish a tobacco product standard that imposes certain limits on concentration of nicotine for e-liquids (see H.R. 4624), H8101 [8OC]

——— impose additional restrictions on tobacco flavors for use in e-cigarettes (see S. 655), S1659 [5MR] (see H.R. 1498), H2365 [5MR]

——— prohibit use of e-cigarettes and other electronic nicotine delivery systems in schools (see S. 1832), S3475 [13JN] (see H.R. 4019), H7465 [25JY]

——— raise minimum age restriction relative to sale of tobacco products and require age verification for online sales of vaping products (see H.R. 2084), H3099 [4AP]

——— require a recall of electronic nicotine delivery systems that have not been subject to premarket review (see H.R. 5005), H8738 [8NO]

Women: treat certain menstrual products as misbranded if labels do not list each ingredient or component (see H.R. 2268), H3255 [10AP]

Cloture motions

Depts. of Commerce, Justice, Agriculture, Interior, Transportation, HUD, and VA, FDA, EPA, science, and military construction: making appropriations (H.R. 3055), S6187 [28OC], S6271 [30OC], S6735 [21NO]

——— making appropriations (H.R. 3055), motion to proceed, S5881 [17OC], S5946 [22OC]

Hahn, Stephen: nomination to be FDA Commissioner, S6878 [5DE], S6986 [11DE]

Letters

Impose ban on tobacco flavors for use in e-cigarettes: Senator Durbin, S6635 [19NO]

Over-the-Counter Drug Safety, Innovation, and Reform Act: Senator Braun, S1893 [14MR]

Lists

Senate staff who worked on H.R. 3055, Depts. of Commerce, Justice, Agriculture, Interior, Transportation, HUD, and VA, FDA, EPA, science, and military construction appropriations, S6322 [31OC]

Motions

Agriculture, rural development, FDA, and related agencies programs: making appropriations (H.R. 265), H397 [10JA]

Depts. of Commerce, Justice, Agriculture, Interior, Transportation, HUD, and VA, FDA, EPA, science, and military construction: making appropriations (H.R. 3055), S5880 [17OC], S6734, S6735 [21NO], H9035 [19NO]

Notices

Estimated budget effects of H.R. 987, Strengthening Health Care and Lowering Prescription Drug Costs Act, H3786 [14MY], H3921 [16MY]

Intention to object to H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act: Senator Braun, S1910 [14MR]

Remarks in House

Advertising: restrict direct-to-consumer drug advertising, H8966 [19NO]

Agriculture, rural development, FDA, and related agencies programs: across-the-board funding reduction, H4943 [20JN]

——— making appropriations, H184, H186 [3JA], H1152 [23JA], H10589, H10590, H10592 [17DE]

——— making appropriations (H.R. 265), H375–H398, H451 [10JA], H550 [15JA]

——— making appropriations (H.R. 265), consideration (H. Res. 28), H302–H311 [9JA]

——— making appropriations (H.R. 265), motion to recommit, H397 [10JA]

Animals: prevent human health threats posed by consumption of equines raised in the U.S. (H.R. 961), H10234 [12DE]

Dept. of Defense: clarify contraception coverage parity to ensure all methods of contraception approved by the FDA are covered by TRICARE without copay, including contraceptive counseling, insertion, and removal, H5545 [10JY]

Dept. of HHS: provide for a national strategy to address and overcome Lyme disease and other tick-borne diseases, H10594 [17DE]

——— reauthorize certain programs to protect against pandemics and attacks from chemical, biological, radiological, and nuclear weapons (H.R. 269), H237–H266 [8JA]

——— reauthorize certain programs to protect against pandemics and attacks from chemical, biological, radiological, and nuclear weapons (S. 1379), H4245–H4265 [4JN]

Depts. of Commerce, Justice, Agriculture, Interior, Transportation, HUD, and VA, FDA, EPA, science, and military construction: making appropriations (H.R. 3055), H4670 [13JN], H4797–H4896 [19JN], H4928, H4929–H4997 [20JN], H5011–H5022 [21JN], H5047–H5072 [24JN], H5100–H5104 [25JN], E806 [20JN]

——— making appropriations (H.R. 3055), consideration (H. Res. 445), H4779–H4789 [19JN]

——— making appropriations (H.R. 3055), consideration of Senate amendment (H. Res. 708), H8967–H8971 [19NO]

——— making appropriations (H.R. 3055), correction in enrollment (H. Con. Res. 75), H9041 [19NO]

——— making appropriations (H.R. 3055), Senate amendment, H8966, H8972–H9041 [19NO], H9156 [21NO], E1483 [20NO]

Depts. of HHS and Education: ensure access by students and faculty of pharmacy schools to information on use and availability of generic drugs and biosimilar biological products, H3882 [16MY]

Diseases and disorders: facilitate effective research on, and treatment of, neglected tropical diseases through coordinated international efforts, H10594 [17DE]

——— facilitate effective research on, and treatment of, neglected tropical diseases through coordinated international efforts (H.R. 3460), H9194–H9197 [3DE]

——— prioritize approval of NurOwn stem cell therapy for treatment of amyotrophic lateral sclerosis (ALS), H9126 [21NO]

Drugs: clarify types of patents on safe and effective drug list, require list of applicable exclusivities for listed drugs, update patent sponsor requirements, and reform patent list guidelines (H.R. 1503), H3486–H3488 [8MY], H4401 [11JN]

——— invest in qualified clinical testing for high-risk, high-reward drugs that address unmet medical needs to treat rare and life-threatening diseases, H10210, H10211 [12DE]

——— lower out of pocket spending, protect access to new cures and medications, strengthen transparency, and encourage competition, H10041 [11DE], H10133–H10139, H10201, H10202, H10204, H10209, H10211, H10215, H10216, H10219, H10235 [12DE]

——— lower out of pocket spending, protect access to new cures and medications, strengthen transparency, and encourage competition (H.R. 19), H10022, H10027, H10035, H10098–H10122 [11DE]

——— prohibit abusive delay tactics by pharmaceutical companies to block entry of generic drugs and biosimilar biological products from the market, H3858, H3864, H3865, H3873 [16MY]

——— prohibit abusive delay tactics by pharmaceutical companies to block entry of generic drugs and biosimilar biological products from the market (H.R. 965), H3429 [2MY], H3455 [7MY], H3911 [16MY]

——— provide for opioid use disorder prevention, recovery, and treatment, E1330 [23OC]

Funding, H392 [10JA]

Government regulations: clarify regulatory framework relative to certain nonprescription drugs that are marketed without an approved new drug application (H.R. 269), H237–H266 [8JA]

——— clarify regulatory framework relative to certain nonprescription drugs that are marketed without an approved new drug application (H.R. 3443), E971, E977 [24JY]

——— prohibit funding to finalize, implement, or enforce draft guidance on drug products labeled as homeopathic, H4943, H4944 [20JN]

Health: accelerate discovery, development, and delivery of 21st century lifesaving cures and devices, E41 [14JA]

——— provide for publication of a list of licensed biological products (H.R. 1520), H3485, H3486 [8MY]

——— recognize importance of vaccinations and immunizations, H3287 [29AP]

——— reduce prescription drug prices, facilitate entry of generic and biosimilar products into the market, strengthen Federal exchanges, and reverse extension of short-term health plans (H.R. 987), H3715 [10MY], H3731 [14MY], H3800 [15MY], H3851, H3852, H3853–H3911, H3913 [16MY], H4123 [23MY], H4401 [11JN], H5085 [25JN], H5175 [26JN], H7693 [12SE], H9248 [4DE], E623 [17MY]

Hermstad, Jaci: deem application to the FDA for compassionate use of gene therapy antisense oligonucleotides to be approved (H.R. 2855), H5081 [25JN]

Labeling: require enforcement of labeling regulations against misbranded imitation dairy products such as milk, cheese, or yogurt (H.R. 778) (H.R. 1769), H7998 [26SE]

Pharmaceuticals: prohibit biological product manufacturers from compensating biosimilar and interchangeable product companies to delay entry of biosimilar and interchangeable products into the market, H3800 [15MY], H3856 [16MY]

——— prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, H3800 [15MY], H3856 [16MY]

Product safety: prohibit sale of infant formula after the expiration date on the product (H.R. 2267), E446 [10AP]

Right To Try Act: implementation, H9126 [21NO]

Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act: anniversary, E1350 [28OC]

Taxation: repeal excise tax on medical devices, H5931, H5962, H5964 [17JY], H7253 [24JY], H9125 [21NO]

——— repeal excise tax on medical devices (H.R. 2207), H8842, H8843 [14NO], H9270 [5DE], H10039–H10041 [11DE]

Women: treat certain menstrual products as misbranded if labels do not list each ingredient or component (H.R. 2268), E448 [10AP]

Remarks in Senate

Business and industry: hold pharmaceutical companies accountable for illegal marketing and distribution of opioid products and for their role in creating and exacerbating the opioid epidemic, S4883–S4885 [17JY]

Cosmetics: ensure safety (S. 726), S1742 [7MR]

Dept. of HHS: allow personal importation of safe and affordable drugs from approved pharmacies in Canada (S. 61), S2001 [26MR], S2868 [15MY]

——— prohibit sale or distribution of tobacco products to individuals under the age of 21 (S. 1541), S2964–S2966 [20MY], S3017 [22MY], S3066 [23MY], S4588 [27JN]

——— reauthorize certain programs to protect against pandemics and attacks from chemical, biological, radiological, and nuclear weapons (H.R. 269), S106 [9JA], S111 [10JA]

——— reauthorize certain programs to protect against pandemics and attacks from chemical, biological, radiological, and nuclear weapons (S. 1379), S2929 [16MY]

Depts. of Commerce, Justice, Agriculture, Interior, Transportation, HUD, and VA, FDA, EPA, science, and military construction: across-the-board funding reduction, S6184, S6186 [28OC]

——— making appropriations (H.R. 3055), S4739 [9JY], S4744 [10JY], S5913 [21OC], S5951–S5953, S5959 [22OC], S6057–S6060, S6065 [23OC], S6179, S6180, S6183–S6187 [28OC], S6208–S6216, S6218, S6221–S6223, S6227, S6232, S6233 [29OC], S6263, S6284 [30OC], S6315, S6319–S6323, S6327, S6359 [31OC], S6386 [5NO], S6503, S6504 [12NO]

——— making appropriations (H.R. 3055), correction in enrollment (H. Con. Res. 75), S6736 [21NO]

——— making appropriations (H.R. 3055), House amendment, S6631, S6641 [19NO], S6682, S6696, S6703 [20NO], S6730–S6736 [21NO]

——— making appropriations (H.R. 3055), motion to proceed, S5880 [17OC], S5911 [21OC], S5931, S5933, S5944–S5947, S5949–S5951 [22OC]

——— making appropriations (H.R. 3055), unanimous-consent agreement, S6146 [24OC], S6293, S6294 [30OC]

Drugs: increase competition in generic drug market by removing barriers for a generic drug to come to market by curbing patent manipulation by brand name drug manufacturers (S. 1209), S2854–S2856 [15MY]

——— lower out of pocket spending, protect access to new cures and medications, strengthen transparency, and encourage competition (H.R. 19), S6959 [11DE]

——— prohibit abusive delay tactics by pharmaceutical companies to block entry of generic drugs and biosimilar biological products from the market, S2716 [8MY], S4755 [10JY], S5158 [30JY], S6527 [13NO]

——— prohibit abusive delay tactics by pharmaceutical companies to block entry of generic drugs and biosimilar biological products from the market (S. 340), S868, S873 [5FE], S875 [6FE], S2366 [10AP], S2868, S2872 [15MY], S4753 [10JY], S5177 [30JY]

——— provide for opioid use disorder prevention, recovery, and treatment, S3147 [3JN], S3305 [11JN], S5028, S5033 [24JY], S5437 [11SE]

——— require drug manufacturers to disclose prices of prescription drugs in any direct-to-consumer advertising and marketing to practitioners of a drug, S1865 [14MR], S2733 [8MY], S3177 [4JN], S6418 [6NO], S6459 [7NO], S6498 [12NO], S6521, S6522 [13NO]

——— require manufacturers of approved biological products to disclose and list patents, biosimilarity, and exclusivity information relative to their products and promote biosimilar competition (S. 659), S1752–S1754 [11MR], S2252 [4AP], S2872 [15MY]

——— shorten monopoly periods for prescription drugs that are subjects of sudden price hikes (S. 366), S1501 [27FE]

FDA Modernization Act: implementation, S6945 [10DE]

FTC: deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar and foster competition and facilitate review of drug petitions filed in good faith (S. 1224), S2868 [15MY], S4488 [25JN], S4710 [9JY], S5177 [30JY]

Gottlieb, Scott: assessment of tenure as FDA Commissioner, S2321 [9AP]

Government: impact of shutdown, S117 [10JA]

Government regulations: clarify regulatory framework relative to certain nonprescription drugs that are marketed without an approved new drug application (H.R. 269), S106 [9JA], S111 [10JA]

——— clarify regulatory framework relative to certain nonprescription drugs that are marketed without an approved new drug application (S. 2740), S6915, S6918, S6921, S6944, S6945 [10DE]

——— clarify regulatory framework relative to certain nonprescription drugs that are marketed without an approved new drug application (S. 2740), unanimous-consent agreement, S6900 [9DE]

——— increase reporting transparency and accountability relative to user fees, S6945 [10DE]

Hahn, Stephen: nomination to be FDA Commissioner, S6877 [5DE], S6972, S6986 [11DE]

——— recognize importance of vaccinations and immunizations (S. Res. 165), S2455 [11AP]

Pharmaceuticals: implement strategy to reduce prescription drug prices, S2867–S2872 [15MY]

——— improve access to generic prescription drugs, S5159 [30JY], S6527 [13NO]

——— prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market (S. 64), S2001 [26MR], S6527 [13NO]

Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act: impact, S6135 [24OC], S6274–S6280 [30OC]

——— impact on communities devastated by opioid epidemic, S3147 [3JN]

——— provide funding for programs and activities (S. 2102), S5437 [11SE]

Taxation: repeal excise tax on medical devices, S6913 [10DE]

Tobacco products: impose additional restrictions on tobacco flavors for use in e-cigarettes, S5413 [11SE], S5456 [12SE], S6617 [18NO], S6634 [19NO], S7123 [18DE]

——— impose additional restrictions on tobacco flavors for use in e-cigarettes (S. 655), S5550 [18SE]

——— impose additional restrictions on tobacco flavors for use in e-cigarettes and educate public about health risks, S5431 [11SE], S5549–S5551 [18SE]

——— proposal to ban sale of menthol cigarettes, S257–S259 [16JA], S781–S785 [31JA]

U.S.-Mexico-Canada Agreement (USMCA): impact on prescription drug prices, S6377 [5NO]

Reports filed

Agriculture, Rural Development, FDA, and Related Agencies Programs Appropriations: Committee on Appropriations (House) (H.R. 3164) (H. Rept. 116–107), H4348 [6JN]

——— Committee on Appropriations (Senate) (S. 2522) (S. Rept. 116–110), S5602 [19SE]

Bringing Low-Cost Options and Competition While Keeping Incentives for New Generics (BLOCKING) Act: Committee on Energy and Commerce (House) (H.R. 938) (H. Rept. 116–46), H3438 [2MY]

Consideration of H.R. 265, Agriculture, Rural Development, FDA, and Related Agencies Programs Appropriations: Committee on Rules (House) (H. Res. 28) (H. Rept. 116–1), H280 [8JA]

Consideration of H.R. 987, Strengthening Health Care and Lowering Prescription Drug Costs Act: Committee on Rules (House) (H. Res. 377) (H. Rept. 116–61), H3787 [14MY]

Consideration of H.R. 3055, Depts. of Commerce, Justice, Agriculture, Interior, Transportation, HUD, and VA, FDA, EPA, Science, and Military Construction Appropriations: Committee on Rules (House) (H. Res. 445) (H. Rept. 116–119), H4769 [18JN]

Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act: Committee on Energy and Commerce (House) (H.R. 965) (H. Rept. 116–55), H3726 [10MY]

——— Committee on the Judiciary (House) (H.R. 965) (H. Rept. 116–55), H3726 [10MY], H3922 [16MY]

Lower Health Care Costs Act: Committee on Health, Education, Labor, and Pensions (Senate) (S. 1895), S4698 [8JY]

Nomination of Stephen Hahn To Be FDA Commissioner: Committee on Health, Education, Labor, and Pensions (Senate), S6824 [3DE]

Orange Book Transparency Act: Committee on Energy and Commerce (House) (H.R. 1503) (H. Rept. 116–47), H3438 [2MY]

Over-the-Counter Monograph Safety, Innovation, and Reform Act: Committee on Health, Education, Labor and Pensions (Senate) (S. 2740), S6391 [5NO]

Protecting Consumer Access to Generic Drugs Act: Committee on Energy and Commerce (House) (H.R. 1499) (H. Rept. 116–52), H3725 [10MY]

Purple Book Continuity Act: Committee on Energy and Commerce (House) (H.R. 1520) (H. Rept. 116–48), H3447 [3MY]

Stop Significant and Time-Wasting Abuse Limiting Legitimate Innovation of New Generics (Stop STALLING) Act: Committee on the Judiciary (Senate) (S. 1224), S4676 [28JN]

Statements

Lower Health Care Costs Act: Senator Alexander, Committee on Health, Education, Labor, and Pensions (Senate), S4623 [27JN]

Managing Pain During the Opioid Crisis: Senator Alexander, Committee on Health, Education, Labor, and Pensions (Senate), S2510 [30AP]

Vaccines Saves Lives—What Is Driving Preventable Disease Outbreaks: Senator Alexander, Committee on Health, Education, Labor, and Pensions (Senate), S2509 [30AP]

Tables

Estimated pay-as-you-go effects of H.R. 987, Strengthening Health Care and Lowering Prescription Drug Costs Act, H3786 [14MY], H3921 [16MY]

Texts of

H. Res. 28, consideration of H.R. 265, agriculture, rural development, FDA, and related agencies programs appropriations, H302 [9JA]

H. Res. 377, consideration of H.R. 5, Equality Act, H.R. 312, Mashpee Wampanoag Tribe Reservation Reaffirmation Act, and H.R. 987, Strengthening Health Care and Lowering Prescription Drug Costs Act, H3801 [15MY]

H. Res. 445, consideration of H.R. 3055, Depts. of Commerce, Justice, Agriculture, Interior, Transportation, HUD, and VA, FDA, EPA, science, and military construction appropriations, H4779 [19JN]

H.R. 265, agriculture, rural development, FDA, and related agencies programs appropriations, H376–H388 [10JA]

H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act, H237–H262 [8JA]

H.R. 987, Strengthening Health Care and Lowering Prescription Drug Costs Act, H3868–H3873 [16MY]

H.R. 1503, Orange Book Transparency Act, H3486 [8MY]

H.R. 1520, Purple Book Continuity Act, H3485 [8MY]

H.R. 3055, Depts. of Commerce, Justice, Agriculture, Interior, Transportation, HUD, and VA, FDA, EPA, science, and military construction appropriations, H4804–H4877 [19JN]

H.R. 3460, End Neglected Tropical Diseases Act, H9194 [3DE]

S. 366, Forcing Limits on Abusive and Tumultuous (FLAT) Prices Act, S921 [6FE]

S. 1379, Pandemic and All-Hazards Preparedness and Advancing Innovation Act, S2930–S2946 [16MY], H4245–H4262 [4JN]

S. 1541, Tobacco-Free Youth Act, S2967 [20MY]

S. 1552, Marijuana Freedom and Opportunity Act, S2971 [20MY]

S. 2103, Affordable Insulin Approvals Now Act, S4809 [11JY]

S. 2740, Over-the-Counter Monograph Safety, Innovation, and Reform Act, S6921–S6930 [10DE]

S. 3096, Providing Resources To End the Vaping Epidemic Now for Teenagers (PREVENT) Act, S7159 [18DE]

S. Res. 165, recognize importance of vaccinations and immunizations, S2442 [11AP]