PHARMACEUTICALS see also Drugs

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]

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]

Medicare: treatment of patient encounters in ambulatory surgical centers in determining meaningful electronic health records use (S. 1347), S6425 [5AU]

Mental health: reauthorize and improve programs related to mental health and substance use disorders (S. 1893), S8906, S8908, S8910 [18DE]

Articles and editorials

Leaked Trade Deal Terms Prompt Fears for Pharmaceutical Benefits Scheme, H4658 [25JN]

Bills and resolutions

Aviation: require air carriers to modify certain policies relative to use of epinephrine for in-flight emergencies (see S. 1972), S6380 [5AU]

Business and industry: 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]

——— 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]

Consumers: ensure greater affordability of prescription drugs (see S. 2023), S6604 [10SE]

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

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]

Cuba: facilitate export of U.S. agricultural products, remove impediments to export of medical devices and medicines, allow travel by U.S. citizens, and establish an agricultural export promotion program (see H.R. 635), H702 [2FE]

Dept. of HHS: amend and reauthorize National All Schedules Prescription Electronic Reporting (NASPER) Grant Program (see S. 480), S982 [12FE] (see H.R. 1725), H2111 [26MR]

——— conduct a pilot project to investigate how to improve medication adherence for individuals with chronic diseases (see H.R. 4292), H10710 [18DE]

——— conduct or support a comprehensive study comparing total health outcomes, including risk of autism, in vaccinated populations and unvaccinated populations (see H.R. 1636), H2033 [25MR]

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

——— limit copayment, coinsurance, or other cost-sharing requirements applicable to prescription drugs in a specialty drug tier to the amount applicable to drugs in a non-preferred brand drug tier (see H.R. 1600), H2031 [25MR]

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

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

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

——— require children enrolled in Head Start and Early Head Start programs be vaccinated (see S. 486), S982 [12FE] (see H.R. 933), H1034 [12FE]

——— 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 Homeland Security: make anthrax vaccines and antimicrobials available to emergency response providers (see S. 1915), S6239 [3AU] (see H.R. 1300), H1612 [4MR]

Dept. of Justice: award grants to address prescription opioid abuse and heroin use (see S. 524), S983 [12FE] (see H.R. 953), H1035 [12FE]

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

——— provide grants for drug disposal sites (see H.R. 2463), H3505 [20MY]

Dept. of Veterans Affairs: furnish non-formulary drugs and medicines to veterans diagnosed with mental health disorders (see H.R. 2123), H2766 [30AP]

——— provide for certain requirements relative to immunization of veterans (see S. 172), S201 [13JA]

Depts. of Defense and Veterans Affairs: establish a joint uniform formulary for systemic pain and psychotropic drugs critical to transitioning treatment of an individual between Depts. (see S. 1721), S4841 [8JY]

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]

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

——— 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 (see S. 1566), S4103 [11JN] (see H.R. 2739), H4241 [11JN]

Drugs: address prescription opioid and heroin abuse (see S. 1134), S2530 [29AP] (see H.R. 2805), H4491 [17JN]

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

——— establish programs for health care provider training in Federal health care and medical facilities, establish Federal co-prescribing guidelines, and establish a grant program relative to naloxone (see S. 2256), S7814 [5NO]

——— exempt real property from civil forfeiture due to medical-marijuana-related conduct authorized by State law (see H.R. 262), H188 [9JA]

——— 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]

——— increase access to opioid addiction treatment by expanding ability of medical professionals to provide medication-assisted therapies (see S. 1455), S3309 [22MY] (see H.R. 2536), H3560 [21MY]

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

——— making appropriations to address heroin and opioid drug abuse epidemic (see S. 2423), S8883 [18DE]

——— modernize treatment of opioid addiction (see H.R. 2872), H4650 [24JN]

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

——— provide certain protections from civil liability for individuals prescribing or administering opioid overdose drugs (see H.R. 1821), H2269 [15AP]

——— provide grants to improve treatment of substance use disorders (see S. 1410), S3237 [21MY]

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

——— reduce prescription drug misuse and abuse (see S. 636), S1246 [3MR]

——— remove regulatory barriers to re-exportation of controlled substances among European Economic Area countries (see H.R. 2340), H3212 [14MY]

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

FAA: initiate a rulemaking relative to upgrading aircraft medical kits for children on airplanes (see H.R. 3379), H5766 [29JY]

FDA: 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]

——— 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]

——— 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]

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

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

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

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

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

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

——— 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]

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

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

——— 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]

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

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

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

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

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

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

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

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

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

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

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

——— require the label of drugs to contain a parenthetical statement identifying the source of any ingredient constituting or derived from a grain or starch-containing ingredient (see H.R. 3648), H6705 [29SE]

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

Federal employees: ensure Federal Employees Health Benefit Program integrity, transparency, and cost savings in the pricing and contracting of prescription drug benefits (see H.R. 2175), H2769 [30AP]

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 (see H.R. 361), H404 [14JA]

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. 1200), S2687 [6MY] (see H.R. 3174), H5465 [23JY]

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: 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]

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]

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

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

——— improve access, certainty, and innovation relative to vaccines (see H.R. 786), H854 [5FE]

——— 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]

——— recognize importance of vaccinations and immunizations (see H. Res. 117), H1069 [13FE]

——— recognize right of individuals to have personal control over medical assistance and treatment necessary to alleviate intolerable physical suffering (see S. 2204), S7470 [22OC]

——— 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]

Health care professionals: authorize physicians to transport controlled substances from a practice setting to another practice setting or disaster area (see H.R. 3014), H5029 [9JY]

——— require certain practitioners authorized to prescribe controlled substances to complete continuing education (see S. 1392), S3183 [20MY] (see H.R. 3889), H7623 [3NO]

Insurance: expand eligibility for reimbursement for smoking cessation services to include copayments for such services by covered beneficiaries under TRICARE who are eligible for Medicare (see S. 1313), S2849 [13MY]

Medicaid: encourage States to adopt administrative procedures relative to nonmedical exemptions from immunization requirements (see S. 1921), S6296 [4AU]

——— require payment of an additional rebate to State plans in the case of increase in the price of a generic drug at a rate that is greater than the rate of inflation (see S. 1364), S2971 [18MY] (see H.R. 2391), H3308 [18MY]

Medicare: apply exceptions process fairly for tiered formulary drugs in prescription drug plans (see S. 1488), S3678 [3JN] (see H.R. 2624), H3877 [3JN]

——— cover supplies associated with insulin injection, home needle removal, decontamination, and disposal devices, and disposal of needles and syringes through a sharps-by-mail or similar program (see S. 1066), S2400 [23AP] (see H.R. 1727), H2111 [26MR]

——— deliver a meaningful drug benefit and lower prescription drug prices (see S. 1884), S6136 [29JY] (see H.R. 3261), H5589 [28JY]

——— ensure equal access of beneficiaries to community pharmacies in underserved areas as network pharmacies under Medicare prescription drug coverage (see S. 1190), S2650 [5MY] (see H.R. 793), H855 [5FE]

——— establish Value-Based Insurance Design demonstration program for use under Medicare Advantage plans, preserve beneficiary choice, and revise treatment of infusion drugs furnished through durable medical equipment (see H.R. 2581), H3581 [29MY]

——— 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. 1396), S3183 [20MY] (see H.R. 2570), H3573 [22MY]

——— exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals (see S. 506), S983 [12FE] (see H.R. 696), H756 [3FE]

——— improve access to medication therapy management (see S. 776), S1628 [18MR]

——— improve formulary requirements for prescription drug plans and Medicare Advantage prescription drug plans relative to certain categories or classes of drugs (see S. 648), S1302 [4MR]

——— improve integrity (see H.R. 1021), H1112 [24FE]

——— make premium and cost-sharing subsidies available to low-income beneficiaries in Puerto Rico or other territories (see S. 2342), S8306 [2DE] (see H.R. 4163), H8970 [2DE]

——— modify payment for outpatient department procedures that utilize drugs as supplies (see S. 1466), S3310 [22MY] (see H.R. 1178), H1499 [27FE]

——— provide coverage of pharmacist services in medically underserved areas (see S. 314), S653 [29JA] (see H.R. 592), H660 [28JA]

——— provide for a pharmaceutical and technology ombudsman (see H.R. 2325), H3211 [14MY]

——— provide for coverage of home as a site of care for infusion therapy (see S. 275), S589 [28JA] (see H.R. 605), H661 [28JA]

——— provide for pharmacy benefits manager standards under the prescription drug program and transparency of payment methodology of pharmacies (see H.R. 244), H187 [9JA]

——— provide for the coordination of programs to prevent and treat obesity (see S. 1509), S3776 [4JN] (see H.R. 2404), H3309 [18MY]

——— provide programs to prevent prescription drug abuse (see S. 1913), S6187 [30JY] (see H.R. 2298), H2957 [13MY]

——— remove enrollment restriction on certain physicians and practitioners prescribing covered outpatient drugs under the prescription drug program (see H.R. 4062), H8359 [18NO]

——— require drug manufacturers to provide rebates for drugs dispensed to low-income individuals under the prescription drug benefit program (see S. 1083), S2400 [23AP] (see H.R. 2005), H2464 [23AP]

——— require the Dept. of HHS to determine covered part D prescription drug prices for beneficiaries (see H.R. 4207), H9205 [9DE]

——— require the Dept. of HHS to negotiate lower covered part D prescription drug prices for beneficiaries (see S. 31), S11 [6JA] (see H.R. 3061), H5172 [14JY]

——— strengthen rules applied in case of competition for diabetic testing strips (see H.R. 771), H853 [5FE]

——— treatment of patient encounters in ambulatory surgical centers in determining meaningful electronic health records use (see S. 1347), S2933 [14MY] (see H.R. 887), H981 [11FE]

Mental health: reauthorize and improve programs related to mental health and substance use disorders (see S. 1893), S6136 [29JY]

Minorities: improve inclusion in clinical trials (see H.R. 2468), H3505 [20MY]

Patient Protection and Affordable Care Act: repeal amendments which disqualify expenses for over-the-counter drugs under health savings accounts and health flexible spending arrangements (see S. 709), S1438 [11MR] (see H.R. 1270), H1610 [4MR]

——— repeal amendments which disqualify expenses for over-the-counter drugs under health savings accounts and health flexible spending arrangements and impose contribution caps (see S. 836), S1708 [23MR] (see H.R. 1547), H1848 [23MR]

Social Security: reform (see H.R. 1756), H2152 [13AP]

Sports: improve integrity and safety of interstate horseracing (see H.R. 2641), H3877 [3JN]

——— improve integrity and safety of interstate horseracing by requiring a uniform anti-doping program to be enforced by an independent Thoroughbred Horseracing Anti-Doping Authority (see H.R. 3084), H5289 [16JY]

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. 3676), H6787 [1OC]

Taxation: allow a credit against tax for clinical testing expenses for qualified infectious disease drugs and rapid diagnostic tests to address the rising public health challenge of antibiotic resistance (see H.R. 3539), H6136 [17SE]

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]

First Responder Anthrax Preparedness Act: Representative McCaul, Committee on Homeland Security (House), H5505 [27JY]

——— Representative Upton, Committee on Energy and Commerce (House), H5505 [27JY]

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]

Protecting the Integrity of Medicare Act: Representative Paul Ryan, Committee on Ways and Means (House), H2081 [26MR]

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]

Remarks in House

American Pharmacists Month: observance, H6846 [7OC], H7016, H7017 [20OC]

Centers for Disease Control and Prevention: conduct study to determine how efforts to incentivize development of new antibiotics may impact antibiotic resistance, H5074, H5075 [10JY]

——— whistleblower allegations relative to intentional omission of findings from study examining possible relationship between certain vaccines and autism, H5602 [29JY]

Council Bluffs, IA: anniversary of Oard-Ross Drug (business), E1002 [7JY]

Creating Hope Act: reauthorize, H4980 [9JY]

Dept. of HHS: amend and reauthorize National All Schedules Prescription Electronic Reporting (NASPER) Grant Program (H.R. 1725), H4778 [7JY], H5796–H5798 [8SE]

——— establish a Biodefense Injury Compensation Program, E1835 [18DE]

Dept. of Homeland Security: make anthrax vaccines and antimicrobials available to emergency response providers (H.R. 1300), H5504–H5506 [27JY]

Dept. of Justice: award grants to address prescription opioid abuse and heroin use, H3671 [2JN]

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

——— Prescription Drug Monitoring Program funding, H3706 [2JN]

Dept. of Veterans Affairs: furnish non-formulary drugs and medicines to veterans diagnosed with mental health disorders, H3177 [14MY]

——— furnish non-formulary drugs and medicines to veterans diagnosed with mental health disorders (H.R. 2123), H2670 [30AP]

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

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

——— 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. 2739), H4970 [9JY]

Drugs: address prescription drug and heroin abuse, H7031 [21OC]

——— address prescription opioid and heroin abuse (H.R. 2805), H4778 [7JY]

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

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

——— 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]

——— increase access to opioid addiction treatment by expanding ability of medical professionals to provide medication-assisted therapies (H.R. 2536), H6845 [7OC]

——— provide certain protections from civil liability for individuals prescribing or administering opioid overdose drugs (H.R. 1821), E501 [15AP]

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

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

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

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

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

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

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. 361), H675–H677 [2FE], E145 [2FE]

Graziano, Michael: tribute to ‘‘Resistance’’ documentary on antibiotic resistance, E394 [24MR]

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]

——— importance of immunizations, H903 [10FE]

——— recognize importance of vaccinations and immunizations, H2368 [22AP]

Health care professionals: tribute to pharmacists, H7016–H7023 [20OC]

Medicaid: require payment of an additional rebate to State plans in the case of increase in the price of a generic drug at a rate that is greater than the rate of inflation, H7304 [28OC]

Medicare: ensure equal access of beneficiaries to community pharmacies in underserved areas as network pharmacies under Medicare prescription drug coverage (H.R. 793), H7019, H7020 [20OC]

——— establish drug management program under part D to protect at-risk beneficiaries from controlled substance abuse, H4980 [9JY]

——— 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, H739 [3FE]

——— 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 (H.R. 2570), H4447, H4479–H4483 [17JN]

——— include information on the coverage of intensive behavioral therapy for obesity in the ‘‘Medicare and You Handbook’’ and coordinate programs to prevent and treat obesity, H2889 [13MY]

——— provide coverage of pharmacist services in medically underserved areas (H.R. 592), H7017, H7019, H7021 [20OC]

——— provide for coverage of home as a site of care for infusion therapy (H.R. 605), H4483 [17JN], E133 [28JA]

——— provide for pharmacy benefits manager standards under the prescription drug program and transparency of payment methodology of pharmacies (H.R. 244), H7017–H7019, H7021–H7023 [20OC], H9029 [8DE]

——— provide for the coordination of programs to prevent and treat obesity (H.R. 2404), H7399 [3NO]

——— provide programs to prevent prescription drug abuse, E1037 [10JY]

——— treatment of patient encounters in ambulatory surgical centers in determining meaningful electronic health records use, H4480, H4481 [17JN]

Minorities: improve inclusion in clinical trials, H5012 [9JY]

National Association of Chain Drug Stores: observance of RxIMPACT Day, E378 [23MR]

Pain Awareness Month: observance, E1381 [29SE]

Patient Protection and Affordable Care Act: repeal amendments which disqualify expenses for over-the-counter drugs under health savings accounts and health flexible spending arrangements and impose contribution caps (H.R. 1547), H1835 [23MR]

Social Security: support policies to protect, expand, and secure long-term future, H7262 [28OC]

South St. Paul, MN: tribute to PRO Pharmacy (business), E1008 [7JY]

West Virginia: address prescription opioid and heroin abuse, H7036 [21OC]

Remarks in Senate

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

Children and youth: impact of budget cuts on Federal aid programs for children, S1775–S1777 [24MR]

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

Dept. of Defense: prevent abuse and provide accountability in approval process for compound pharmaceuticals, S6366 [5AU]

Dept. of Justice: award grants to address prescription opioid abuse and heroin use, S1071 [24FE]

——— award grants to address prescription opioid abuse and heroin use (S. 524), S6275, S6276 [4AU]

Drugs: address prescription drug and heroin abuse, S7368 [21OC]

——— address prescription opioid and heroin abuse (S. 1134), S6276 [4AU]

——— establish programs for health care provider training in Federal health care and medical facilities, establish Federal co-prescribing guidelines, and establish a grant program relative to naloxone (S. 2256), S7819 [5NO]

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

FDA: 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]

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

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]

Medicare: deliver a meaningful drug benefit and lower prescription drug prices (S. 1884), S7119 [5OC]

——— treatment of patient encounters in ambulatory surgical centers in determining meaningful electronic health records use (S. 1347), S6425 [5AU]

Medicare/Medicaid: deliver a meaningful drug benefit and lower prescription drug prices, S6171 [30JY]

Mental health: reauthorize and improve programs related to mental health and substance use disorders, S8330, S8345 [3DE]

——— reauthorize and improve programs related to mental health and substance use disorders (S. 1893), S8908, S8910 [18DE]

National Association of Chain Drug Stores: observance of RxIMPACT Day, S1707 [23MR]

Patient Protection and Affordable Care Act: establish a deficit-neutral reserve fund to repeal amendments which disqualify expenses for over-the-counter drugs under health savings accounts and health flexible spending arrangements, S1857 [25MR]

Social Security: reform, S1482 [12MR], S4821 [8JY]

Reports filed

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

Dept. of HHS National All Schedules Prescription Electronic Reporting (NASPER) Grant Program Amendment and Reauthorization: Committee on Energy and Commerce (House) (H.R. 1725) (H. Rept. 114–245), H5846 [8SE]

Electronic Health Fairness Act: Committee on Finance (Senate) (S. 1347) (S. Rept. 114–106), S6186 [30JY]

——— Committee on Ways and Means (House) (H.R. 887) (H. Rept. 114–40), H1635 [13MR]

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

First Responder Anthrax Preparedness Act: Committee on Homeland Security (House) (H.R. 1300) (H. Rept. 114–222), H5401 [22JY]

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]

Mental Health Awareness and Improvement Act: Committee on Health, Education, Labor, and Pensions (Senate) (S. 1893), S7101 [1OC]

Preservation of Access for Seniors in Medicare Advantage Act: Committee on Ways and Means (House) (H.R. 2581) (H. Rept. 114–161), H4430 [16JN]

Protecting the Integrity of Medicare Act: Committee on Ways and Means (House) (H.R. 1021) (H. Rept. 114–46), H1767 [18MR]

Restoring Access to Medication Act: Committee on Ways and Means (House) (H.R. 1270) (H. Rept. 114–308), H7173 [23OC]

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

Statements

Centers for Disease Control and Prevention Whistleblower Allegations Relative to Intentional Omission of Findings From Study Examining Possible Relationship Between Certain Vaccines and Autism: William Thompson, H5602 [29JY]

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

Reemergence of Vaccine-Preventable Diseases—Exploring the Public Health Successes and Challenges: Senator Alexander, Committee on Health, Education, Labor and Pensions (Senate), S979 [12FE]

Tables

Price comparison of prescription drugs offered in the U.S. and Canada, S6997 [29SE]

Texts of

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

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

H.R. 361, Medical Preparedness Allowable Use Act, H675 [2FE]

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. 1300, First Responder Anthrax Preparedness Act, H5504 [27JY]

H.R. 1725, Dept. of HHS National All Schedules Prescription Electronic Reporting (NASPER) Grant Program amendment and reauthorization, H5796 [8SE]

H.R. 2570, Strengthening Medicare Advantage Through Innovation and Transparency for Seniors Act, H4479 [17JN]

S. 1347, Electronic Health Fairness Act, S6425 [5AU]

S. 1884, Medicare Prescription Drug Savings and Choice Act, S6139 [29JY]

S. 1893, Mental Health Awareness and Improvement Act, S8908–S8910, S8911–S8913 [18DE]