PHARMACEUTICALS

Bills and resolutions

Agriculture: prohibit open-air cultivation or use of human food or animal feed as host plant and establish tracking system to regulate genetically engineered pharmaceutical and industrial crops (see H.R. 3554), H8124 [2DE]

Animals: provide pet owners the ability to receive copies of veterinary prescriptions (see H.R. 1406), H2410 [6AP]

Business and industry: clarify the orphan drug exception to the annual fee on branded prescription pharmaceutical manufacturers and importers (see S. 1423), S4960 [27JY] (see H.R. 2672), H5660 [27JY]

———prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market (see S. 27), S122 [25JA]

———prohibit marketing of authorized generic drugs (see S. 373), S792 [16FE] (see H.R. 741), H1039 (see H.R. 741), H1070 [16FE]

Centers for Disease Control and Prevention: establish and implement a birth defects prevention, risk reduction, and public awareness program (see S. 1131), S3427 [26MY] (see H.R. 2029), H3755 [26MY]

Consumers: provide tax credit to retirement age individuals, remove barriers to importation, and prohibit certain regulation of Internet sites relative to prescription drugs (see H.R. 147), H39 [5JA]

Contraceptives: establish certain duties for pharmacies to ensure provision of FDA-approved contraception (see S. 1415), S4911 [26JY] (see H.R. 2659), H5579 [26JY]

Controlled Substances Act: authorize practitioners other than physicians to dispense certain narcotic drugs for maintenance or detoxification treatment without obtaining separate registration (see H.R. 1729), H3060 [4MY]

Crime: increase penalties for counterfeit drug trafficking (see S. 1886), S7702 [17NO] (see H.R. 3468), H7829 [17NO] (see H.R. 3668), H8966 [14DE]

———increase penalties for stealing, transporting, and storing stolen prescription drugs (see S. 1002), S2992 [16MY]

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. 1888), H3279 [12MY]

DEA: authorize certain health care professionals in nursing homes to transmit DEA-licensed practitioners' orders to deliver pain medications (see S. 1560), S5624 [14SE]

Dept. of HHS: amend and reauthorize the controlled substance monitoring program (see H.R. 866), H1455 [1MR]

———establish an America Rx drug discount program for individuals without access to prescription drugs at discounted prices (see H.R. 2296), H4456 [22JN]

———provide for the participation of pharmacists in National Health Service Corps programs (see S. 48), S123 [25JA]

———provide States with incentives to require elementary and secondary schools to maintain, and permit school personnel to administer, epinephrine (see S. 1884), S7702 [17NO] (see H.R. 3627), H8318 [8DE]

———revise and expand the 340B Drug Pricing Program to improve provision of discounts on drug purchases for certain safety net providers (see H.R. 2674), H5660 [27JY]

Dept. of Veterans Affairs: provide for certain requirements relative to immunization of veterans (see S. 1799), S7127 [3NO] (see H.R. 1930), H3302 [13MY]

Diseases: de-link research and development incentives from drug prices for new medicines to treat HIV/AIDS and stimulate greater sharing of scientific knowledge (see S. 1138), S3428 [26MY]

———preserve effectiveness of medically important antibiotics used in treatment of human and animal diseases (see S. 1211), S3813 [15JN] (see H.R. 965), H1664 [9MR]

———reduce disparities and improve access to diagnosis and treatment of prostate cancer for underserved populations and men with a family history of prostate cancer (see S. 1190), S3773 [14JN] (see H.R. 2159), H4185 [14JN]

———require group and individual health insurance coverage and group health plans to cover oral cancer drugs on terms no less favorable than coverage provided for intravenously administered anticancer medications (see H.R. 2746), H5883 [1AU]

Drugs: ban the sale of certain synthetic drugs (see S. 409), S871 [17FE] (see S. 839), S2506 [14AP] (see H.R. 1571), H2909 [15AP]

———improve detection of the fraudulent abuse of prescriptions to obtain controlled substances in schedule II or III (see H.R. 1266), H2106 [30MR]

———improve safety (see H.R. 1483), H2603 [12AP] (see H.R. 3026), H6413 [22SE]

———increase Federal oversight of prescription opioid treatment and assistance to States in reducing opioid abuse, diversion, and deaths (see S. 507), S1406 [8MR] (see H.R. 1925), H3302 [13MY]

———increase penalties for operators of pill mills (see S. 1760), S6872 [20OC] (see H.R. 1065), H1796 [14MR]

———provide for the disposal of drugs pursuant to national pharmaceutical stewardship programs (see H.R. 2939), H6230 [15SE]

EPA: convene a task force to develop recommendations on the proper disposal of unused pharmaceuticals (see H.R. 1677), H2933 [2MY]

FDA: allow fast track approval of certain orphan drugs (see H.R. 3737), H10013 [20DE]

———allow manufacturers to distribute and cite scientific research on health benefits of foods and dietary supplements without affecting regulatory category of the product (see H.R. 1364), H2326 [5AP]

———ensure valid generic drugs may enter the market (see S. 1882), S7612 [16NO]

———improve capacity to prevent drug shortages (see S. 296), S614 [7FE] (see H.R. 2245), H4363 [21JN]

———improve priority review voucher incentive program for expedited review of treatments for tropical and rare pediatric diseases (see S. 606), S1826 [17MR] (see H.R. 3059), H6456 [23SE]

———improve the safety of Internet pharmacies (see S. 2002), S8679 [15DE]

———modify approval of any drug containing controlled-release oxycodone hydrochloride to limit such approval to use for relief of severe-only pain (see H.R. 1316), H2265 [1AP]

———provide additional quality control of drugs (see S. 1584), S5773 [20SE]

———provide for regulation of medical gases (see H.R. 2227), H4326 [16JN]

———provide incentives for the development of qualified infectious disease products (see S. 1734), S6764 [19OC] (see H.R. 2182), H4276 [15JN]

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. 979), H1664 [9MR]

Government regulations: allow importation of prescription drugs (see S. 319), S642 [10FE]

Health: permit an individual to be treated by a health care practitioner with any method of medical treatment such individual requests (see H.R. 2736), H5883 [1AU]

———provide coverage of hormone replacement therapy and alternative therapies for treatment of menopausal symptoms (see H.R. 383), H395 [20JA]

———raise awareness of the risk of internal bleeding for patients taking anti-coagulant drugs (see H. Res. 279), H3645 (see H. Res. 279), H3683 [25MY]

———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. 1862), H3278 [12MY]

Health care professionals: authorize physicians to transport controlled substances from a practice setting to another practice setting or to a disaster area (see H.R. 3724), H9926 [16DE]

———require practitioners to obtain particular training or special certification on addiction and substance abuse, and appropriate and safe use of certain controlled substances (see H.R. 2119), H4034 [3JN]

———support establishment of Doctor of Nursing Practice and Doctor of Pharmacy dual degree programs (see S. 53), S123 [25JA]

Insurance: ensure transparency and proper operation of pharmacy benefit managers (see S. 1058), S3275 [24MY] (see H.R. 1971), H3409 [24MY]

Medicaid: encourage States to increase generic drug utilization (see S. 1356), S4554 [13JY] (see H.R. 3342), H7330 [3NO]

———remove exclusion from medical assistance of items and services for patients in mental institutions (see H.R. 340), H354 [19JA]

———require drug manufacturers to pay rebates to State prescription drug discount programs as a condition of participation in a rebate agreement for outpatient prescription drugs (see H.R. 989), H1665 [9MR]

Medicare: apply exceptions process fairly for tiered formulary drugs in prescription drug plans (see H.R. 3613), H8318 [8DE]

———authorize the Dept. of HHS to negotiate lower covered part D prescription drug prices for beneficiaries (see S. 31), S122 [25JA]

———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. 725), S2130 [5AP] (see H.R. 3150), H6781 [11OC]

———deliver a meaningful drug benefit and lower prescription drug prices (see S. 560), S1547 [10MR] (see H.R. 999), H1723 [10MR]

———exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals (see S. 733), S2130 [5AP] (see H.R. 905), H1573 [3MR]

———exempt blood glucose self-testing equipment and supplies furnished by small retail community pharmacies from competitive acquisition programs (see H.R. 1936), H3342 [23MY]

———expand access to medication therapy management services (see S. 274), S543 [3FE]

———extended coverage of immunosuppressive drugs for kidney transplant patients and other renal dialysis provisions (see S. 1454), S5071 [29JY] (see H.R. 2969), H6271 [20SE]

———improve access to physical medicine and rehabilitation services (see H.R. 2785), H5885 [1AU]

———permit coverage of certain covered part D drugs for uses that are determined to be for medically accepted indications based upon clinical evidence in peer reviewed medical literature (see H.R. 1055), H1769 [11MR]

———prevent fraud and abuse and require National Provider Identifiers for reimbursement of prescriptions under part D (see H.R. 3474), H7889 [18NO]

———prevent payment adjustments for professionals who are not successful electronic prescribers and remove electronic prescribing as element for use of certified electronic health record (EHR) technology (see H.R. 2128), H4035 [3JN]

———promote medication therapy management under the part D prescription drug program (see H.R. 891), H1573 [3MR]

———provide coverage for the shingles vaccine (see H.R. 859), H1454 [1MR]

———provide for coverage of home infusion drug therapy (see S. 1203), S3813 [15JN] (see H.R. 2195), H4277 [15JN]

———reduce the costs of prescription drugs (see S. 1699), S6461 [12OC]

———require drug manufacturers to provide rebates for drugs dispensed to low-income individuals under the prescription drug benefit program (see S. 1206), S3813 [15JN] (see H.R. 2190), H4277 [15JN]

———require the Dept. of HHS to negotiate lower covered part D prescription drug prices for beneficiaries (see S. 44), S123 [25JA] (see H.R. 2248), H4363 [21JN]

———study issues on access to intravenous immune globulin (IVIG) for beneficiaries in all care settings and establish demonstration project on benefits of coverage to administer IVIG in the home (see S. 960), S2928 [12MY] (see H.R. 1845), H3218 [11MY]

Medicare/Medicaid: prevent misuse, overutilization, and trafficking of prescription drugs by limiting access to such drugs by high-risk beneficiaries (see S. 882), S2686 [4MY]

National Medicine Abuse Awareness Month: designate (see S. Res. 261), S5536 [13SE]

National security: recognize importance of biosecurity and agrodefense (see S. Res. 47), S642 [10FE]

Patient Protection and Affordable Care Act: repeal limits on distributions from tax-preferred accounts for certain medicines and tax increase on certain distributions from health and medical savings accounts (see H.R. 524), H549 [8FE]

———repeal limits on health-related tax benefits and treat high deductible plans as qualified health plans (see H.R. 450), H506 [26JA]

———repeal prohibition on using medical savings account funds to purchase over-the-counter medications (see S. 1368), S4608 [14JY] (see H.R. 2529), H5085 [14JY]

Pharmacies: ensure and foster safety and quality of care and competitive marketplace by exempting independent pharmacies from antitrust laws in negotiations with health and health insurance providers (see H.R. 1946), H3342 [23MY]

Research: provide incentives for investment in research and development for new medicines and enhance access to new medicines (see S. 1137), S3428 [26MY]

Sports: prohibit the use of performance-enhancing drugs in horseracing (see S. 886), S2687 [4MY] (see H.R. 1733), H3061 [4MY]

Supreme Court: disapprove Sorrell v. IMS Health Inc., decision on disclosure and use of individual physician prescribing practices (see H. Res. 343), H4793 [8JY]

Taxation: allow a deduction for amounts paid for health insurance and prescription drug costs of individuals (see H.R. 171), H39 [5JA]

———deny any deduction for direct-to-consumer advertisements of prescription drugs (see H.R. 722), H922 [15FE]

Letters

Birth Defects Prevention, Risk Reduction, and Awareness Act: Cindy Brownstein, Spina Bifida Association, E979 [27MY]

———Dennis K. Ledford, American Academy of Allergy, Asthma, & Immunology, E979 [27MY]

———Lori Wolf, Organization of Teratology Information Specialists, E980 [27MY]

———Marina L. Weiss, March of Dimes Foundation, E980 [27MY]

———Matthew E. Melmed, ZERO TO THREE—National Center for Infants, Toddlers, and Families, E980 [27MY]

———O. Marion Burton, American Academy of Pediatrics, E980 [27MY]

———Richard N. Waldman, American Congress of Obstetricians and Gynecologists, E980 [27MY]

Generating Antibiotic Incentives Now (GAIN) Act: B. Keith English, University of Tennessee Health Science Center and Le Bonheur Children's Hospital, S7029 [2NO]

———Meri Armour, Le Bonheur Children's Hospital, S7029 [2NO]

———several East Tennessee State University administrators and faculty, S7029 [2NO]

———William E. Evans, St. Jude Children's Research Hospital, S7028 [2NO]

Remarks in House

Baron, Mel: American Pharmacists Association Foundation Pinnacle Award recipient, E1175 [23JN]

Centers for Disease Control and Prevention: establish and implement a birth defects prevention, risk reduction, and public awareness program (H.R. 2029), E979 [27MY]

Chaudhuri, Bodhisattwa: Pharmaceutical Research and Manufacturers of America Foundation award recipient, E1445 [29JY]

Consumers: provide tax credit to retirement age individuals, remove barriers to importation, and prohibit certain regulation of Internet sites relative to prescription drugs (H.R. 147), E7 [5JA]

Contraceptives: establish certain duties for pharmacies to ensure provision of FDA-approved contraception (H.R. 2659), E1411 [26JY]

Dept. of HHS: AIDS Drug Assistance Program funding, H1185, H1186 [17FE]

———amend and reauthorize the controlled substance monitoring program (H.R. 866), E385 [1MR]

Dept. of Veterans Affairs: provide for certain requirements relative to immunization of veterans (H.R. 1930), E896 [13MY]

Diseases: preserve effectiveness of medically important antibiotics used in treatment of human and animal diseases (H.R. 965), E437 [9MR]

———reduce disparities and improve access to diagnosis and treatment of prostate cancer for underserved populations and men with a family history of prostate cancer (H.R. 2159), E1082 [14JN]

Drug Take-Back Day: observance, H7988 [30NO]

Drugs: increase penalties for operators of pill mills (H.R. 1065), H2298 [5AP]

———provide for the disposal of drugs pursuant to national pharmaceutical stewardship programs (H.R. 2939), E1639 [15SE]

FDA: clarification of order approving the drug Makena for women at risk for preterm birth but denying Makena market exclusivity, H2050 [30MR]

———funding, H824 [15FE], E1123 [16JN]

———prohibit funding for distribution of mifepristone (RU-486) through telemedicine, H4268, H4269 [15JN], H4319 [16JN]

———require use of hard science in developing regulations, H4236-H4238 [15JN]

Federal agencies and departments: ensure agency rule reform does not create regulatory burdens for providing low-cost prescription drugs for seniors, veterans, servicemen, and their families, H8103 [2DE]

Health: increase awareness relative to potential risks associated with the use of anti-coagulant drugs to treat blood clots and deep vein thrombosis (DVT), E530 [17MR]

———support regenerative medicine through research funding and commercial development of regenerative products and develop a regulatory environment that enables rapid approval of safe and effective products, H638 [10FE]

Health care professionals: recognize importance and value of pharmacists, E428 [8MR]

Medicaid: require drug manufacturers to pay rebates to State prescription drug discount programs as a condition of participation in a rebate agreement for outpatient prescription drugs (H.R. 989), E441 [9MR]

Medicare: authorize the Dept. of HHS to negotiate lower covered part D prescription drug prices for beneficiaries, H5289 [21JY]

———eliminate gap in coverage of prescription drug benefit, H100 [6JA], H2509 [7AP], H2827 [14AP], H3272 [12MY]

———improve access to physical medicine and rehabilitation services (H.R. 2785), E1470 [1AU]

———provide coverage for the shingles vaccine (H.R. 859), E387 [1MR]

———provide for coverage of home infusion drug therapy (H.R. 2195), H4200 [15JN]

NIH: funding, H1013 [16FE]

Patient Protection and Affordable Care Act: impact of repeal on senior citizen prescription drug rebates, H270, H271 [19JA], H8201 [7DE]

Remarks in Senate

Business and industry: prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market (S. 27), S143 [25JA]

———prohibit marketing of authorized generic drugs, S1098 [2MR]

———prohibit marketing of authorized generic drugs (S. 373), S797 [16FE]

Crime: increase penalties for counterfeit drug trafficking (S. 1886), S7705 [17NO]

———increase penalties for stealing, transporting, and storing stolen prescription drugs (S. 1002), S6592 [17OC]

DEA: authorize certain health care professionals in nursing homes to transmit DEA-licensed practitioners' orders to deliver pain medications (S. 1560), S5627 [14SE]

Dept. of HHS: provide for the participation of pharmacists in National Health Service Corps programs (S. 48), S160 [25JA]

Diseases: preserve effectiveness of medically important antibiotics used in treatment of human and animal diseases (S. 1211), S3837-S3839 [15JN]

Drugs: address issues relative to prescription drug abuse, S6591 [17OC]

———ban the sale of certain synthetic drugs (S. 839), S2520 [14AP]

———increase Federal oversight of prescription opioid treatment and assistance to States in reducing opioid abuse, diversion, and deaths (S. 507), S1408 [8MR]

Economy: national objectives priority assignments, S7988 [29NO]

FDA: ensure valid generic drugs may enter the market (S. 1882), S7616 [16NO]

———improve capacity to prevent drug shortages (S. 296), S6901 [31OC]

———improve the safety of Internet pharmacies (S. 2002), S8684 [15DE]

———prohibit funding to prevent individuals from importing prescription drugs from Canada for personal use, S6650 [18OC], S6730, S6749 [19OC], S6794, S6797, S6801 [20OC]

———provide incentives for the development of qualified infectious disease products (H.R. 2182), S7028-S7030 [2NO]

Government regulations: allow importation of prescription drugs (S. 319), S644 [10FE]

———cost regulation of drug hormone, progesterone, to prevent premature births, S2800 [9MY]

Health: prohibit funding to implement regulations regarding the removal of essential-use designation for epinephrine used in oral pressurized metered-dose inhalers, S6934 [1NO]

Medicare: deliver a meaningful drug benefit and lower prescription drug prices (S. 560), S1561 [10MR]

———exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals (S. 733), S2139 [5AP]

———expand access to medication therapy management services (S. 274), S546 [3FE]

———extended coverage of immunosuppressive drugs for kidney transplant patients and other renal dialysis provisions (S. 1454), S5076 [29JY]

———provide for coverage of home infusion drug therapy (S. 1203), S3831 [15JN]

———require drug manufacturers to provide rebates for drugs dispensed to low-income individuals under the prescription drug benefit program (S. 1206), S3836 [15JN]

———require the Dept. of HHS to negotiate lower covered part D prescription drug prices for beneficiaries (S. 44), S2369 [12AP]

———study issues on access to intravenous immune globulin (IVIG) for beneficiaries in all care settings and establish demonstration project on benefits of coverage to administer IVIG in the home (S. 960), S2933 [12MY]

Medicare/Medicaid: prevent misuse, overutilization, and trafficking of prescription drugs by limiting access to such drugs by high-risk beneficiaries (S. 882), S6592 [17OC]

National Association of Chain Drug Stores: observance of RxIMPACT Day, S1399 [8MR]

National Medicine Abuse Awareness Month: designate (S. Res. 261), S5581 [13SE], S5933 [23SE]

Patient Protection and Affordable Care Act: repeal prohibition on using medical savings account funds to purchase over-the-counter medications (S. 1368), S4609 [14JY]

Research: science, medical, and pharmaceutical innovation, research, and development funding, S1614 [15MR]

Sports: prohibit the use of performance-enhancing drugs in horseracing (S. 886), S2689 [4MY]

Reports filed

Combating Dangerous Synthetic Stimulants Act: Committee on the Judiciary (Senate) (S. 409), S5017 [28JY]

Combating Designer Drugs Act: Committee on the Judiciary (Senate) (S. 839), S5017 [28JY]

Counterfeit Drug Penalty Enhancement Act: Committee on the Judiciary (Senate) (S. 1886), S8460 [8DE]

Preserve Access to Affordable Generics Act: Committee on the Judiciary (Senate) (S. 27), S4845 [22JY]

Texts of

S. 27, Preserve Access to Affordable Generics Act, S144-S146 [25JA]

S. 31, Prescription Drug and Health Improvement Act, S151 [25JA]

S. 48, Pharmacist Student Loan Repayment Eligibility Act, S160 [25JA]

S. 560, Medicare Prescription Drug Savings and Choice Act, S1561-S1563 [10MR]

S. 733, exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals, S2140 [5AP]

S. 886, Interstate Horseracing Improvement Act, S2690 [4MY]

S. 1211, Preservation of Antibiotics for Medical Treatment Act, S3839-S3841 [15JN]

S. 1454, extended Medicare coverage of immunosuppressive drugs for kidney transplant patients and other renal dialysis provisions, S5076 [29JY]

S. 1882, Fair and Immediate Release of Generic Drugs (FAIR Generics) Act, S7616 [16NO]

S. 1884, School Access to Emergency Epinephrine Act, S7704 [17NO]

S. 1886, Counterfeit Drug Penalty Enhancement Act, S7705 [17NO]

S. 2002, Online Pharmacy Safety Act, S8685-S8687 [15DE]

S. Res. 47, recognize importance of biosecurity and agrodefense, S646 [10FE]

S. Res. 261, National Medicine Abuse Awareness Month, S5581 [13SE], S5933 [23SE]