FEDERAL FOOD, DRUG, AND COSMETIC ACT

Amendments

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]

——— 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), consideration (H. Res. 377), H3811 [15MY]

Bills and resolutions

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]

Cosmetics: substantially restrict use of animal testing for cosmetics (see H.R. 5141), H8958 [18NO]

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]

——— 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]

——— 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]

——— require drug manufacturers to include printed inserts containing drug information when they ship their products to pharmacies (see H.R. 5198), H9120 [20NO]

Drugs: provide for legitimate use of medicinal marijuana in accordance with State laws (see H.R. 171), H207 [3JA]

——— require National Academy of Medicine study on determining reasonable drug prices and establish Drug Affordability and Access Committee to issue reasonable pricing determination for each drug (see S. 2387), S5248 [31JY]

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]

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

——— 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 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]

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

——— 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 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]

——— 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 S. 1617), S3059 [22MY] (see H.R. 1503), H2366 [5MR]

——— 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]

——— 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]

——— 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]

——— 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]

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

——— 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 (see H.R. 2339), H3274 [18AP]

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

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

——— 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]

——— 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]

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

——— 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]

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

——— 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]

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

——— 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]

——— 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]

——— 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]

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

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

——— 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 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]

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

——— 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]

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

——— 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]

——— require medical device 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]

——— 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]

——— 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]

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

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

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

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

Food: 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]

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]

——— 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), consideration (see H. Res. 377), H3787 [14MY]

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]

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

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]

Motions

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), H3904 [16MY]

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

Dept. of HHS: 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]

FDA: 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]

——— 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]

——— 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, H3800 [15MY], H3857, H3860 [16MY]

——— 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 (H.R. 938), H3429 [2MY], H10118 [11DE]

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

——— 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]

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

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

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

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 (H.R. 2374), H3455 [7MY]

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), 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]

——— 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), consideration (H. Res. 377), H3801–H3813 [15MY]

——— 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), corrections in engrossment, H3911 [16MY]

——— 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), motion to recommit, H3908, H3909 [16MY]

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

Remarks in Senate

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

——— 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 (S. 2723), S6245 [29OC]

——— 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]

Drugs: 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]

FDA: 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]

——— ensure safety of cosmetics (S. 726), S1742 [7MR]

——— 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]

——— 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 and educate public about health risks, S5431 [11SE], S5549–S5551 [18SE]

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

——— 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]

——— 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]

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

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]

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 (S. 1895), S4710 [9JY], S4752, S4755 [10JY], S4834 [16JY], S5158, S5165–S5167 [30JY], S5436 [11SE], S6527 [13NO]

——— 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), S6934 [10DE]

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

Reports filed

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

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]

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]

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]

Tables

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

Top opioid distributors and manufacturers 2006 through 2012, S4884 [17JY]

Texts of

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.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]

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