PHARMACEUTICALS

Amendments

Safety: provide for take-back disposal of controlled substances in certain instances (H.R. 5809), S10364, S10413, S10415 [16DE], H8792 [21DE]

———provide for take-back disposal of controlled substances in certain instances (S. 3397), S6666 [3AU], H7316 [29SE]

Articles and editorials

Dems Tap Drug Maker Millions for PhRMA-Friendly Bill, H1606 [18MR]

Walgreens—No New Medicaid Patients as of April 16, S1727 [18MR]

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. 5578), H4779 [23JN]

Centers for Disease Control and Prevention: establish and implement a birth defects prevention, risk reduction, and public awareness program (see S. 3479), S4849 [10JN] (see H.R. 5462), H4214 [28MY]

Charities: encourage pharmaceutical manufacturers and health care providers to donate prescription medications to nonprofit organizations that fill prescriptions for low-income individuals (see H. Res. 1311), H3078 [29AP]

Consumers: require mail-order pharmacies to notify customers when generic drugs become available and prevent such pharmacies from substituting drugs without prescriber authorization (see H.R. 6255), H7389 [29SE]

Contraceptives: establish certain duties for pharmacies to ensure provision of FDA-approved contraception (see S. 3357), S3716 [13MY] (see H.R. 5309), H3483 [13MY]

Controlled Substances Act: address use of intrathecal pumps (see S. 3274), S2758 [28AP]

Dept. of HHS: amend and reauthorize the Controlled Substance Monitoring Program (see S. 3575), S5786 [13JY] (see H.R. 5710), H5502 [1JY]

———design, construct, and operate facilities to develop and produce biological products used to respond to potential bioterrorist attacks or naturally occurring pathogens (see S. 3140), S1750 [18MR]

———establish an America Rx drug discount program for individuals without access to prescription drugs at discounted prices (see H.R. 5888), H6163 [27JY]

Dept. of Justice: make grants to States, units of local government, Indian tribes, and other entities for prescription drug disposal units and for prescription drug abuse education (see H.R. 5925), H6402 (see H.R. 5925), H6454 [29JY]

Dept. of Veterans Affairs: provide for certain requirements relative to immunization of veterans (see H.R. 5516), H4386 [10JN]

———share information about use of controlled substances by veterans with State prescription monitoring programs to prevent misuse and diversion of prescription medicines (see S. 3575), S5786 [13JY]

Diseases: ensure U.S. global HIV/AIDS assistance prioritizes saving lives by focusing on access to treatment (see S. 3627), S6078 [21JY]

———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 H.R. 6389), H7394 [29SE]

Drugs: improve safety (see H.R. 6543), H8785 [17DE]

———more effectively regulate anabolic steroids (see S. 4032), S10304 [15DE]

———provide for the mandatory recall of adulterated or misbranded drugs (see H.R. 5740), H5617 [14JY]

———restore application of the 340B drug discount program to orphan drugs for children's hospitals (see S. 11), S7618 [28SE]

FDA: ensure autonomy and eliminate conflicts-of-interest relative to drug company fees and advisory panels, improve postmarket drug safety, regulate off-label uses, and clarify liability for approved drugs (see H.R. 4816), H1323 [10MR]

———improve priority review voucher incentive program for expedited review of treatments for tropical and rare pediatric diseases (see S. 3697), S6736 [4AU]

———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. 4956), H2457 [25MR]

———provide additional quality control of drugs (see S. 3690), S6651 [3AU]

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. 4489), H325 [21JA]

Federal Food, Drug, and Cosmetic Act: distribution and citation of scientific research in connection with foods and dietary supplements (see H.R. 4913), H2260 [23MR]

Government regulations: importation of prescription drugs (see S. 3415), S4211 [25MY]

Health: allow the resell or transfer of covered outpatient drugs to individuals with HIV/AIDS in connection with medication regimen adherence services being provided by a licensed health care professional (see H.R. 6176), H6879 [22SE]

———expand and accelerate genomics research and initiatives to improve the accuracy of disease diagnosis, increase drug safety, and identify novel treatments (see H.R. 5440), H4022 (see H.R. 5440), H4083 [27MY]

———provide for insurance and Medicare Advantage reform, reduce disparities in Medicare, and regulate importation of prescription drugs (see H.R. 4813), H1323 [10MR]

———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 (see H.R. 6173), H6879 [22SE]

Health care professionals: support establishment of Doctor of Nursing Practice and Doctor of Pharmacy dual degree programs (see S. 3859), S7618 [28SE]

Insurance: ensure transparency and proper operation of pharmacy benefit managers (see H.R. 5234), H3272 [6MY]

Medicare: exempt blood glucose self-testing equipment and supplies furnished by small retail community pharmacies from competitive acquisition programs (see H.R. 5235), H3272 [6MY]

———expand access to medication therapy management services (see S. 3543), S5538 [29JN]

———improve access of beneficiaries to intravenous immune globulins (IVIG) (see H.R. 5597), H4871 [24JN]

———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. 5732), H5616 [14JY]

———prohibit mid-year changes in the formularies of Part D plans (see H.R. 4917), H2261 [23MR]

———provide coverage of clinical pharmacist practitioner services under part B (see H.R. 5389), H3822 [25MY]

———reduce costs of prescription drugs for beneficiaries and guarantee access to comprehensive prescription drug coverage (see S. 4024), S8786 [10DE]

———require the Dept. of HHS to negotiate lower covered part D prescription drug prices for beneficiaries (see S. 3413, 3415), S4211 [25MY] (see H.R. 4752), H1103 [3MR]

National Influenza Vaccination Week: designate (see H. Res. 1003), H40 [12JA]

National Lock Your Meds Day: designate (see H. Res. 1580), H6405 (see H. Res. 1580), H6457 [29JY]

Patient Protection and Affordable Care Act: repeal limits on health-related tax benefits and treat high deductible plans as qualified health plans (see H.R. 5936), H6403 (see H.R. 5936), H6455 [29JY]

Prescription Drug Disposal Awareness Day: designate (see S. Res. 539), S4143 [24MY]

Research: ensure that rules for approval of pharmaceutical and biological products do not require medical ethics violations in human and vertebrate animal testing (see S. 3921), S7788 [29SE]

Safety: provide for take-back disposal of controlled substances in certain instances (see S. 3397), S4143 [24MY] (see H.R. 5809), H5920 [21JY]

Small business: express importance of biotechnology firms meeting small business standards to the U.S., its people, and its economy (see H. Res. 1179), H1396 [12MR]

Sports: clarify relationship between the policies of leagues or associations and State or local law regarding the use of performance-enhancing drugs (see S. 3851), S7618 [28SE]

Descriptions

DEA Authorization of Certain Health Care Professionals in Nursing Homes To Transmit DEA-licensed Practitioners' Orders To Deliver Pain Medications, S11026 [22DE]

Letters

Birth Defects Prevention, Risk Reduction, and Awareness Act: Cindy Brownstein, Spina Bifida Association, E1011 [28MY]

———Judith S. Palfrey, American Academy of Pediatrics, E1010 [28MY]

———Marina L. Weiss, March of Dimes Foundation, E1010 [28MY]

———Mark Ballow, American Academy of Allergy, Asthma & Immunology, E1011 [28MY]

———Sharon Voyer Lavigne, University of Connecticut Health Center, E1010 [28MY]

HIV vaccine development: Senator Coburn, S3904 [18MY]

Patient Protection and Affordable Care Act: Pharmakon Long Term Care Pharmacy, Inc., and Pharmakon Pharmaceuticals, Inc., E1300-E1302 [13JY]

Restore application of the 340B drug discount program to orphan drugs for children's hospitals: James Mandell and Robert K. Coughlin, S7621 [28SE]

———several Senators, S7621 [28SE]

Lists

Health organizations supporting H. Res. 1003, National Influenza Vaccination Week, H347 [26JA]

Remarks in House

AIDS Drug Assistance Programs: funding, H6883 [23SE]

Business and industry: prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, H5386 [1JY]

Centers for Disease Control and Prevention: establish and implement a birth defects prevention, risk reduction, and public awareness program (H.R. 5462), H7195, H7196 [28SE], H7380 [29SE], E1010 [28MY], E1827 [29SE]

Contraceptives: establish certain duties for pharmacies to ensure provision of FDA-approved contraception (H.R. 5309), E847 [13MY]

Dept. of HHS: amend and reauthorize the Controlled Substance Monitoring Program (H.R. 5710), H6850-H6852 [22SE]

Dept. of Veterans Affairs: implement program to re-label prescription drugs used in VA hospitals to be sent home with discharged patients for outpatient use, H6245 [28JY]

———provide for certain requirements relative to immunization of veterans (H.R. 5516), E1072 [10JN]

Diseases: 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 (H.R. 2366), E926 [25MY]

Federal employees: ensure Federal Employees Health Benefit Program integrity, transparency, and cost savings in the pricing and contracting of prescription drug benefits (H.R. 4489), E70 [21JA]

Government regulations: importation of prescription drugs, H1365 [12MR]

Health: provide discounts on covered inpatient drugs when patients do not have prescription drug insurance coverage, H4170 [28MY]

Medicare: eliminate gap in coverage of prescription drug benefit, H1365 [12MR], H1575 [17MR], H2255 [23MR], H2264 [24MR], H4250 [9JN]

———release of part D prescription drug benefit rebate checks, H4334, H4335, H4336 [10JN], H4438, H4439, H4442 [15JN]

National Association of Chain Drug Stores: observance of RxIMPACT Day, E340 [10MR]

National Influenza Vaccination Week: designate (H. Res. 1003), H345-H348 [26JA]

Safety: provide for take-back disposal of controlled substances in certain instances (H.R. 5809), H6855-H6857 [22SE]

———provide for take-back disposal of controlled substances in certain instances (H.R. 5809), Senate amendments, H8792-H8798 [21DE]

———provide for take-back disposal of controlled substances in certain instances (S. 3397), H7316-H7318 [29SE]

Senior citizens: address needs to improve quality of life, H5550 [14JY]

Targacept, Inc.: tribute to Alzheimer's disease research, E2107 [9DE]

Remarks in Senate

Centers for Disease Control and Prevention: establish and implement a birth defects prevention, risk reduction, and public awareness program (S. 3479), S4851 [10JN]

DEA: authorize certain health care professionals in nursing homes to transmit DEA-licensed practitioners' orders to deliver pain medications, S10925 [21DE], S11026 [22DE]

Dept. of HHS: amend and reauthorize the Controlled Substance Monitoring Program (S. 3575), S5791, S5792 [13JY]

———design, construct, and operate facilities to develop and produce biological products used to respond to potential bioterrorist attacks or naturally occurring pathogens (S. 3140), S1751 [18MR]

Dept. of Veterans Affairs: named J.D. Power and Associates top mail order pharmacy program, S11027 [22DE]

———share information about use of controlled substances by veterans with State prescription monitoring programs to prevent misuse and diversion of prescription medicines (S. 3575), S5791, S5792 [13JY]

Depts. of Defense and Veterans Affairs: address prescription drug abuse among the Armed Forces and veterans, S7023 [13SE]

Diseases: development of an HIV vaccine, S3904 [18MY]

———ensure U.S. global HIV/AIDS assistance prioritizes saving lives by focusing on access to treatment (S. 3627), S6085 [21JY]

Drugs: more effectively regulate anabolic steroids (S. 4032), S10305 [15DE]

———restore application of the 340B drug discount program to orphan drugs for children's hospitals (S. 11), S7620 [28SE], S8343 [1DE]

Government regulations: importation of prescription drugs (S. 3415), S4218 [25MY]

Health care professionals: recognize contribution of pharmacies to U.S. health system, S1515 [15MR]

———support establishment of Doctor of Nursing Practice and Doctor of Pharmacy dual degree programs (S. 3859), S7634 [28SE]

HIV Vaccine Awareness Day: observance, S3904 [18MY]

Medicaid: maintain rebates on certain pharmaceuticals, S6766 [5AU]

Medicare: eliminate gap in coverage of prescription drug benefit, S4572 [28MY], S7932 [17NO]

———expand access to medication therapy management services (S. 3543), S5539 [29JN]

———part D prescription drug benefit funding, S784-S787 [25FE]

———reduce costs of prescription drugs for beneficiaries and guarantee access to comprehensive prescription drug coverage (S. 4024), S8787, S8788 [10DE]

———require the Dept. of HHS to negotiate lower covered part D prescription drug prices for beneficiaries (S. 3415), S4218 [25MY]

Medicare/Medicaid: eliminate fraudulent payments for prescription drugs and prohibit Federal coverage of erectile dysfunction drugs for child molesters and rapists and of drugs to induce abortion, S1942, S1998 [24MR]

Older Americans Act: reauthorize, S7261 [21SE]

Prescription Drug Disposal Awareness Day: designate (S. Res. 539), S4162 [24MY]

Safety: provide for take-back disposal of controlled substances in certain instances (H.R. 5809), S10364 [16DE], S11022 [22DE]

———provide for take-back disposal of controlled substances in certain instances (S. 3397), S4162 [24MY], S6666, S6667 [3AU], S6860, S6861 [5AU], S7770 [29SE]

Reports filed

Birth Defects Prevention, Risk Reduction, and Awareness Act: Committee on Energy and Commerce (House) (H.R. 5462) (H. Rept. 111-642), H7153, H7210 [28SE]

Controlled Substance Monitoring Program Amendment and Reauthorization: Committee on Energy and Commerce (House) (H.R. 5710) (H. Rept. 111-616), H6878 [22SE]

Preserve Access to Affordable Generics Act: Committee on the Judiciary (Senate) (S. 369) (S. Rept. 111-123), S438 [2FE]

Safe Drug Disposal Act: Committee on Energy and Commerce (House) (H.R. 5809) (H. Rept. 111-618), H6878 [22SE]

Secure and Responsible Drug Disposal Act: Committee on the Judiciary (Senate) (S. 3397), S6519 [29JY]

Texts of

H. Res. 1003, National Influenza Vaccination Week, H345 [26JA]

H.R. 5462, Birth Defects Prevention, Risk Reduction, and Awareness Act, H7195 [28SE]

H.R. 5710, Controlled Substance Monitoring Program amendment and reauthorization, H6850 [22SE]

H.R. 5809, Safe Drug Disposal Act, H6855 [22SE]

S. 11, restore application of the 340B drug discount program to orphan drugs for children's hospitals, S7621 [28SE]

S. 3397, Secure and Responsible Drug Disposal Act, S6666 [3AU]

S. 3575, National All Schedules Prescription Electronic Reporting Reauthorization Act, S5791 [13JY]

S. 3859, Doctor of Nursing Practice and Doctor of Pharmacy Dual Degree Program Act, S7634 [28SE]

S. Res. 539, Prescription Drug Disposal Awareness Day, S4148, S4162 [24MY]