PHARMACEUTICALS see also Drugs
Articles and editorials
How a Vermont Hospital Fights the American Opioid Epidemic, S3362 [3JN]
Bills and resolutions
Children and youth: provide for identification and dissemination of best practices for medical professionals and other health care providers relative to neonatal abstinence syndrome (see H.R. 4888), H5494 [18JN]
——— provide for identification and dissemination of evidence-informed recommendations for addressing maternal addiction and neonatal abstinence syndrome and study neonatal abstinence syndrome (see S. 2722), S5216 [31JY]
Clinical Research Innovation Month: designate (see H. Res. 733), H7675 [17SE]
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. 2605), S4502 [15JY]
——— establish certain duties for pharmacies to ensure provision of FDA-approved contraception (see S. 2625), S4620 [17JY]
DEA: improve regulation of anabolic steroids (see S. 2012), S890 [11FE] (see H.R. 4771), H5022 [29MY]
Dept. of HHS: amend and reauthorize the Controlled Substance Monitoring Program (see S. 2529), S4003 [25JN]
——— prevent abuse of dextromethorphan by restricting over-the-counter sales and bulk distribution (see H.R. 3969), H1510 [29JA]
——— 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. 4879), H5398 [17JN]
Dept. of Homeland Security: make anthrax vaccines and antimicrobials available to emergency response providers (see H.R. 5620), H7885 [18SE]
Dept. of Justice: award grants to address prescription opioid abuse and heroin use (see S. 2839), S5697 [17SE] (see H.R. 5845), H9044 [10DE]
——— improve enforcement efforts relative to prescription drug diversion and abuse (see H.R. 4069), H1780 [18FE] (see H.R. 4709), H4784 [21MY]
Diseases: facilitate effective research on, and treatment of, neglected tropical diseases through coordinated domestic and international efforts (see H.R. 4847), H5318 [11JN]
Drugs: address prescription opioid and heroin abuse (see S. 2504), S3863 [19JN]
——— encourage development and use of new antimicrobial drugs in order to treat antibiotic-resistant infections (see H.R. 4187), H2300 [11MR]
——— 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. 2862), S5782 [18SE] (see H.R. 4299), H2694 [26MR]
——— increase access to opioid addiction treatment by expanding ability of medical professionals to provide medication-assisted therapies (see S. 2645), S4762 [23JY]
——— increase number of opioid abusing or addicted patients that providers may treat in an outpatient setting and allow qualified nurse practitioners and physician assistants to treat such patients (see S. 2825), S5628 [16SE]
——— reduce opioid misuse and abuse (see H.R. 5587), H7884 [18SE]
FDA: create a limited population pathway for approval of certain antibacterial drugs (see S. 2996), S6540 [10DE]
——— 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. 5657), H7886 [18SE]
——— establish recall authority for drugs and increase criminal penalties for sale or trade of knowingly adulterated or misbranded prescription drugs (see H.R. 5874), H9303 [11DE]
——— expand priority review voucher incentive program to encourage treatments for tropical diseases (see H.R. 5729), H8071 [18NO]
——— expedite review of pharmaceuticals approved for marketing in the European Union (see H.R. 4918), H5557 [19JN]
——— extend market exclusivity periods for drugs approved to prevent, diagnose, or treat a rare disease or condition (see H.R. 5750), H8169 [20NO]
——— incentivize the development of treatments and vaccines for ebola by adding the disease to priority review voucher program (see S. 2917), S5918 [12NO]
——— reform program allowing for expanded access to certain experimental treatments or breakthrough drugs for seriously ill patients (see H.R. 5805), H8867 [8DE]
——— withdraw approval for the drug Zohydro ER and prohibit from approving such drug unless it is reformulated to prevent abuse (see S. 2134), S1652 [13MR] (see H.R. 4241), H2433 [13MR]
FTC: issue rules to promote competition and help consumers save money by giving them the freedom to choose where they buy prescription pet medications (see S. 2756), S5217 [31JY] (see H.R. 4023), H1718 [10FE]
Government regulations: allow personal importation of safe and affordable drugs from approved pharmacies in Canada (see S. 2549), S4153 [26JN]
Health: allow importation, distribution, and sale of investigational drugs and devices intended for use by terminally ill patients (see H.R. 5854), H9302 [11DE]
——— allow manufacture, importation, distribution, and sale of investigational drugs and devices intended for use by terminally ill patients (see H.R. 4475), H3196 [10AP]
——— enhance efforts to address antimicrobial resistance (see S. 2236), S2378 [10AP]
——— support regenerative medicine through research funding and commercial development and develop a regulatory environment that enables rapid approval of safe and effective products (see H.R. 4494), H3240 [28AP]
——— support role of the U.S. in ensuring children in poor countries have access to vaccines and immunization through the GAVI Alliance (organization) (see S. Res. 578), S5993 [13NO] (see H. Res. 688), H6859 [25JY]
International Self-Care Day: designate (see S. Res. 515), S4763 [23JY]
Medicaid: apply requirement that drug manufacturers that increase prices faster than inflation pay an additional rebate to State Medicaid programs to generic drug manufacturers (see S. 2948), S6204 [20NO] (see H.R. 5748), H8169 [20NO]
Medicare: ensure equal access of beneficiaries to community pharmacies in underserved areas as network pharmacies under Medicare prescription drug coverage (see H.R. 4577), H3446 [6MY]
——— establish Value-Based Insurance Design demonstration program to show that reduced copayments or coinsurance can increase utilization, improve clinical outcomes, and lower health care expenditures (see S. 2783), S5507 [10SE] (see H.R. 5183), H6745 [23JY]
——— modify payment for outpatient department procedures that utilize drugs as supplies (see S. 2980), S6350 [4DE] (see H.R. 4857), H5363 [12JN]
——— prohibit further action on the proposed rule on changes to prescription drug benefit programs (see H.R. 4160), H2255 [6MR]
——— provide coverage of pharmacist services in medically underserved areas (see H.R. 4190), H2300 [11MR]
——— provide for coverage of home as a site of care for infusion therapy (see H.R. 5435), H7433 [10SE]
——— provide for pharmacy benefits manager standards under the prescription drug program and transparency of payment methodology of pharmacies (see H.R. 4437), H3143 [9AP] (see H.R. 5815), H8931 [9DE]
——— restore access to diabetic testing supplies for beneficiaries (see S. 1935), S439 [16JA]
——— strengthen rules applied in case of competition for diabetic testing strips (see H.R. 5808), H8868 [8DE]
——— treatment of patient encounters in ambulatory surgical centers in determining meaningful electronic health records use (see H.R. 5556), H7883 [18SE]
Medicare/Medicaid: provide for equitable treatment of residents of territories relative to low-income subsidies under the Medicare prescription drug benefit program (see H.R. 3966), H1510 [29JA]
National Drug Take-Back Week: designate (see S. Res. 466), S3367 [3JN]
National Prescription Opioid and Heroin Abuse Awareness Month: designate (see S. Res. 466), S3367 [3JN]
Patents: advance public health by encouraging independent innovators to pursue drug repurposing research and develop new treatments and cures by providing intellectual property protections for those innovations (see S. 2150), S1691 [24MR] (see H.R. 4287), H2610 [24MR]
——— establish a new class of ‘‘dormant therapy’’ drugs to remove disincentives to the development of certain treatments relative to the length of patent protections (see S. 3004), S6626 [11DE]
Substance Abuse and Mental Health Services Administration: award grants to States to expand access to clinically appropriate services for opioid abuse, dependence or addiction (see H.R. 5339), H7182 [31JY]
U.S. Anti-Doping Agency: reauthorize (see S. 2338), S3029 [14MY] (see H.R. 5614), H7885 [18SE]
Letters
Ensuring Patient Access and Effective Drug Enforcement Act: Representative Goodlatte, Committee on the Judiciary (House), H7005 [29JY]
——— Representative Upton, Committee on Energy and Commerce (House), H7005 [29JY]
Medical Preparedness Allowable Use Act: Hank Clemmensen, International Association of Fire Chiefs, H1518 [3FE]
——— Jeff Walker, International Association of Emergency Managers, H1519 [3FE]
——— Tim Stephens, Emergency Services Coalition for Medical Preparedness, H1518 [3FE]
Veterinary Medicine Mobility Act: Representative Goodlatte, Committee on the Judiciary (House), H5835 [8JY]
——— Representative Upton, Committee on Energy and Commerce (House), H5835 [8JY]
Remarks in House
Budget: allocation of funds, H6756 [24JY]
Children and youth: provide for identification and dissemination of best practices for medical professionals and other health care providers relative to neonatal abstinence syndrome (H.R. 4888), H5882 [9JY]
Clinical Research Innovation Month: designate (H. Res. 733), H7863 [18SE]
CVS Health Corp.: decision to stop selling cigarettes and other tobacco products, H1599 [5FE]
DEA: improve regulation of anabolic steroids (H.R. 4771), H7459–H7461 [15SE]
Dept. of Agriculture: Distance Learning, Telemedicine, and Broadband Program funding through reductions in Grain Inspection, Packers and Stockyards Administration funding, H5296 [11JN]
Dept. of Justice: improve enforcement efforts relative to prescription drug diversion and abuse (H.R. 4709), H7004–H7007 [29JY]
——— Prescription Drug Monitoring Program funding, H4928 [29MY]
Diseases: efforts to contain Ebola outbreak in Africa, E1346 [8SE]
——— facilitate effective research on, and treatment of, neglected tropical diseases through coordinated domestic and international efforts (H.R. 4847), E1346 [8SE]
——— require group and individual health insurance coverage and group health plans to cover oral cancer drugs on terms no less favorable than for cancer medications administered by a health care provider (H.R. 1801), H2699 [27MR]
Drugs: provide an affirmative defense for medical use of marijuana in accordance with the laws of the States (H.R. 710), H2659 [26MR]
——— reschedule marijuana under the Controlled Substances Act and allow for medicinal use of marijuana in accordance with State laws, H2995 [8AP], H4053–H4055 [9MY]
FDA: expedite approval of certain pharmaceuticals and experimental treatments used in cancer treatments, E1424 [16SE]
——— extend market exclusivity periods for drugs approved to prevent, diagnose, or treat a rare disease or condition (H.R. 5750), H8938 [10DE]
——— funding, H5260 [11JN]
——— improve priority review voucher incentive program for expedited review of treatments for tropical and rare pediatric diseases, E1321 [1AU]
——— incentivize the development of treatments and vaccines for ebola by adding the disease to priority review voucher program (S. 2917), H8344 [3DE]
FEMA: codify authority to use Urban Areas Security Initiative and State Homeland Security Grant Program funding for enhancing medical preparedness, medical surge capacity, and mass prophylaxis capabilities (H.R. 1791), H1518–H1520 [3FE], E160 [4FE]
Gainesville, GA: anniversary of Riverside Pharmacy, H8 [7JA]
Hardy, Josh: tribute to support of family and friends relative to appeal to FDA for expedited approval of experimental drug treatment, H2369 [13MR]
Health: promote development of meaningful treatments for patients (H.R. 3091), H2004 [27FE]
——— promote development of meaningful treatments for patients (H.R. 3116), H4480 [20MY]
——— support regenerative medicine through research funding and commercial development and develop a regulatory environment that enables rapid approval of safe and effective products (H.R. 4494), H3252 [29AP]
Howard University Pharmacy Alumni Association: anniversary, E421 [24MR]
Medicare: importance of Part D generic drug pricing, H3138–H3141 [9AP]
——— provide for coverage of home as a site of care for infusion therapy (H.R. 5435), E1378 [10SE]
——— provide for pharmacy benefits manager standards under the prescription drug program and transparency of payment methodology of pharmacies (H.R. 4437), H3138–H3141 [9AP]
National Association of Chain Drug Stores: observance of RxIMPACT Day, E304 [5MR]
U.S. Anti-Doping Agency: reauthorize (S. 2338), H10314 [12DE]
Veterinarians: allow transport and dispensing of controlled substances in the usual course of veterinary practice outside of the registered location (H.R. 1528), H5834–H5836 [8JY]
Remarks in Senate
Children and youth: provide for identification and dissemination of best practices for medical professionals and other health care providers relative to neonatal abstinence syndrome (H.R. 4888), S5161 [31JY]
——— provide for identification and dissemination of evidence-informed recommendations for addressing maternal addiction and neonatal abstinence syndrome and study neonatal abstinence syndrome (S. 2722), S5161 [31JY]
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 (S. 2605), S4475 [15JY], S4514, S4522 [16JY]
——— establish certain duties for pharmacies to ensure provision of FDA-approved contraception (S. 2625), S4622 [17JY]
CVS Health Corp.: decision to stop selling cigarettes and other tobacco products, S847 [10FE]
DEA: improve regulation of anabolic steroids (H.R. 4771), S6696 [11DE]
——— improve regulation of anabolic steroids (S. 2012), S891 [11FE]
——— issuance of final rule implementing the Secure and Responsible Drug Disposal Act, S1905 [1AP]
Dept. of Defense: implement price controls for prescription drug program, S2310 [9AP]
Dept. of Justice: award grants to address prescription opioid abuse and heroin use (S. 2839), S5701 [17SE]
FDA: funding, S3784 [18JN]
——— incentivize the development of treatments and vaccines for ebola by adding the disease to priority review voucher program (S. 2917), S6271 [2DE]
Hardy, Josh: tribute to support of family and friends relative to appeal to FDA for expedited approval of experimental drug treatment, S1646 [13MR]
Health: tribute to global child health programs, S4001 [25JN]
International Self-Care Day: designate (S. Res. 515), S4846 [23JY]
Medicare: release of Committee on Aging (Senate, Special) report, ‘‘Medicare Part D Prescription Drug Benefit—Increasing Use and Access of Affordable Prescription Drugs’’, S6864 [15DE]
National Association of Chain Drug Stores: observance of RxIMPACT Day, S1485 [10MR]
National Drug Take-Back Week: designate (S. Res. 466), S5518 [10SE]
National Prescription Opioid and Heroin Abuse Awareness Month: designate (S. Res. 466), S5518 [10SE]
Taxation: proposed merger of Pfizer Inc., and AstraZeneca PLC relative to treatment of existing inversions by corporations to avoid the U.S. corporate tax by reincorporating in a foreign country, S2932–S2935 [13MY]
U.S. Anti-Doping Agency: reauthorize (S. 2338), S6697 [11DE]
Veterinarians: allow transport and dispensing of controlled substances in the usual course of veterinary practice outside of the registered location (H.R. 1528), S4567, S4568 [16JY]
——— allow transport and dispensing of controlled substances in the usual course of veterinary practice outside of the registered location (S. 1171), S185 [8JA]
World Immunization Week: observance, S2552 [30AP]
Reports filed
Adding Ebola to the FDA Priority Review Voucher Program Act: Committee on Health, Education, Labor, and Pensions (Senate) (S. 2917), S6148 [19NO]
Designer Anabolic Steroid Control Act: Committee on Energy and Commerce (House) (H.R. 4771) (H. Rept. 113–587), H7527 [15SE]
——— Committee on the Judiciary (House) (H.R. 4771) (H. Rept. 113–587), H7527 [15SE]
Ensuring Patient Access and Effective Drug Enforcement Act: Committee on Energy and Commerce (House) (H.R. 4709) (H. Rept. 113–605), H7881 [18SE]
Improving Regulatory Transparency for New Medical Therapies Act: Committee on Energy and Commerce (House) (H.R. 4299) (H. Rept. 113–565), H7038 [29JY]
——— Committee on the Judiciary (House) (H.R. 4299) (H. Rept. 113–565), H7900 [19SE]
Medicare Part D Prescription Drug Benefit—Increasing Use and Access of Affordable Prescription Drugs: Committee on Aging (Senate, Special) (S. Rept. 113–306), S6626 [11DE]
Support Role of the U.S. in Ensuring Children in Poor Countries Have Access to Vaccines and Immunization Through the GAVI Alliance (organization): Committee on Foreign Relations (Senate) (S. Res. 578), S6349 [4DE]
U.S. Anti-Doping Agency Reauthorization: Committee on Commerce, Science, and Transportation (Senate) (S. 2338) (S. Rept. 113–281), S6234 [1DE]
Veterinary Medicine Mobility Act: Committee on Energy and Commerce (House) (H.R. 1528) (H. Rept. 113–457), H4683 [20MY]
Texts of
H.R. 1528, Veterinary Medicine Mobility Act, H5834 [8JY]
H.R. 1791, Medical Preparedness Allowable Use Act, H1518 [3FE]
H.R. 4709, Ensuring Patient Access and Effective Drug Enforcement Act, H7004 [29JY]
H.R. 4771, Designer Anabolic Steroid Control Act, H7459 [15SE]
S. 1171, allow veterinarians to transport and dispense controlled substances in the usual course of veterinary practice outside of the registered location, S185 [8JA]
S. 2338, U.S. Anti-Doping Agency reauthorization, S6697 [11DE], H10314 [12DE]
S. 2722, Protecting Our Infants Act, S5221 [31JY]
S. 2917, Adding Ebola to the FDA Priority Review Voucher Program Act, S6271 [2DE], H8344 [3DE]
S. Res. 466, National Drug Take-Back Week and National Prescription Opioid and Heroin Abuse Awareness Month, S3382 [3JN]
S. Res. 515, International Self-Care Day, S4771 [23JY]
S. Res. 578, support role of the U.S. in ensuring children in poor countries have access to vaccines and immunization through the GAVI Alliance (organization), S5995 [13NO]