DRUGS related term(s) Crime; Pharmaceuticals

Amendments

Crime: increase penalties for counterfeit drug trafficking (S. 1886), S1430, S1431 [6MR]

FDA: revise and extend the user-fee programs for prescription drugs and medical devices and establish user-fee programs for generic drugs and biosimilars (S. 3187), S3288, S3289, S3290 [17MY], S3332, S3333, S3335, S3384, S3385 [21MY], S3430, S3431, S3432, S3433, S3434, S3450, S3451, S3452, S3453, S3454, S3455, S3456 [22MY], S3482, S3485, S3488, S3489, S3490, S3491, S3492, S3495, S3497, S3506, S3520, S3533 [23MY], S3536, S3545, S3546 [24MY], S4410, S4423, S4424 [21JN], H3825 [20JN]

Hereditary Angioedema Awareness Day: observance (S. Res. 286), S221, S222 [31JA]

Law enforcement: coordinate efforts to protect U.S. border cities from drug trafficking, gunrunning, illegal alien smuggling, violence, and kidnapping along and across U.S. borders (H.R. 915), S6664 [21SE], H6437 [27NO]

Articles and editorials

Bizarre Outcome on Generic Drugs, S2499 [18AP]

Lobby E-Mails Show Depth of Obama Ties to Drug Industry, S4445 [25JN]

ObamaCare’s Secret History—How a Pfizer CEO and Big Pharma Colluded With the White House at the Public’s Expense, S4444 [25JN]

Strassel—Axelrod’s Obamacare Dollars, S4442, S4446 [25JN]

U.S. Should Legalize Industrial Hemp, S4138 [13JN]

Why Ryancare and Obamacare Looks So Similar, S2161 [28MR]

Bills and resolutions

Animals: condemn practice of gassing stray cats and dogs (see H. Res. 761), H5707 [2AU]

——— disapprove use of gas chambers to euthanize shelter animals and support State laws requiring the use of drugs for euthanasia by animal shelters (see H. Res. 736), H5078 [19JY]

Aviation: include ultralight aircraft under the definition of aircraft relative to aviation smuggling and identify equipment and technology to track illegal use of such aircraft near the Mexican border (see H.R. 3801), H113 [23JA]

Best Pharmaceuticals for Children Act: permanently extend and strengthen (see H.R. 4274), H1739 [28MR]

Committee on Oversight and Government Reform (House): disapprove of Chairman Issa’s actions relative to certain ongoing criminal investigations and statements relative to Attorney General Holder (see H. Res. 718), H4614 [29JN] (see H. Res. 718), H4684 [9JY]

——— initiate or intervene in judicial proceedings to enforce certain subpoenas issued to Attorney General Holder (see H. Res. 706), H4064 [26JN]

——— initiate or intervene in judicial proceedings to enforce certain subpoenas issued to Attorney General Holder (H. Res. 706), consideration (see H. Res. 708), H4155 [27JN]

Controlled Substances Act: exclude industrial hemp from the definition of marijuana (see S. 3501), S5977 [2AU]

——— make any substance containing hydrocodone a schedule II drug (see S. 2297), S2496 [18AP]

——— place synthetic drugs in Schedule I indicating high potential for abuse, no current accepted medical use, and lack of accepted safety for use under medical supervision (see S. 3189, 3190), S3234 [16MY] (see H.R. 6312), H5705 [2AU]

——— prevent abuse of dextromethorphan (see S. 3376), S4893 [11JY]

Crime: increase penalties for stealing, transporting, and storing stolen prescription drugs (see H.R. 4223), H1427 [20MR]

Death and dying: reduce deaths occurring from overdoses (see H.R. 6311), H5705 [2AU]

Dept. of Agriculture: prohibit income deductions for controlled substances, including medical marijuana, when determining Supplemental Nutrition Assistance Program benefits (see S. 3368), S4821 [10JY]

Dept. of HHS: establish a working group to develop and disseminate best practices to ensure accessibility in prescription drug labeling for visually-impaired and blind individuals (see H.R. 4087), H950 [24FE]

——— exempt Substance Abuse and Mental Health Services Administration from sequestration (see H.R. 6692), H7424 [20DE]

——— expedite research and drug development to combat the most deadly and costly chronic diseases (see S. 2069), S323 [2FE] (see H.R. 3891), H440 [2FE]

——— grant provisional approval to fast-tracked drugs used in therapies and treatments for life-threatening diseases (see H.R. 6288), H5704 [2AU]

——— 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 tree (see H.R. 4209), H1390 [19MR]

——— promulgate regulations on patient medication information to ensure patients receive consistent and high-quality information about prescription drugs (see S. 3212), S3422 [22MY] (see H.R. 6514), H6275 [21SE]

——— protect and preserve access of Medicare beneficiaries in rural areas to health care providers and extend discounts under the 340B Drug Pricing Program (see H.R. 5194), H2271 [27AP] (see H.R. 5624), H2443 [8MY]

——— provide for public disclosure of charges for certain hospital and ambulatory surgical center treatment episodes (see H.R. 5709), H2644 [10MY]

——— provide grants for treatment of heroin, cocaine, methamphetamine, ecstasy, and PCP abuse (see H.R. 5711), H2644 [10MY]

Dept. of Homeland Security: provide for annual reports on the status of operational control of international land and maritime borders of the U.S. and unlawful entries (see H.R. 6025), H4064 [26JN]

——— reduce trafficking of drugs and prevent human smuggling across the Southwest border by deterring construction and use of border tunnels (see H.R. 4119), H1133 [1MR]

Dept. of Justice: establish uniform standards for the exchange of controlled substance and prescription information to prevent diversion, fraud, and abuse of such substances and drugs (see S. 2254), S2242 [29MR] (see H.R. 4292), H1740 [28MR]

——— provide grants for juvenile mentoring (see S. 3328), S4417 [21JN]

——— provide with additional tools to target extraterritorial drug trafficking activity (see H.R. 3909), H512 [6FE]

Dept. of State: designate as foreign terrorist organizations certain Mexican drug cartels and submit a report on activities assisting Mexico with drug cartel violence (see H.R. 4303), H1803 [29MR]

Dept. of Transportation: establish a pilot program to study the benefits of using hair specimens for preemployment controlled substances tests of commercial motor vehicle operators (see H.R. 6641), H6675 [5DE]

Diseases: commend progress made by anti-tuberculosis programs (see H. Res. 594), H1542 [22MR]

——— increase immunization rates (see S. 3344), S4674 [27JN]

——— recognize potential for virtual elimination of pediatric HIV and AIDS and keeping HIV positive mothers alive (see H. Con. Res. 123), H2645 [10MY]

Drug-Free Communities Support Program: extend authorization (see S. 2159), S1422 [6MR]

Ecuador: condemn repression of democracy and human rights, express concern on lack of counternarcotics cooperation and relationship with Iran, and discourage renewal of trade preference systems (see H. Res. 745), H5525 [31JY]

EPA: allow for the distribution, sale, and consumption of remaining inventories of over-the-counter chlorofluorocarbon (CFC) epinephrine inhalers (see H.R. 6190), H5290 [25JY]

FDA: ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve public health (see S. 2113), S699 [15FE]

——— ensure continued research and development of drugs and medical devices for use in children (see S. 2289), S2392 [17AP]

——— establish recall authority for drugs and increase criminal penalties for sale or trade of knowingly adulterated or misbranded prescription drugs (see H.R. 6679), H7264 [18DE]

——— establish user-fee programs for generic drugs and biosimilars (see H.R. 3988), H640 [8FE]

——— expedite approval of drugs for serious or life-threatening diseases or conditions (see H.R. 4132), H1152 [5MR]

——— expedite development, evaluation, and approval of breakthrough drugs (see S. 2236), S2030 [26MR] (see H.R. 5334), H2316 [7MY]

——— extend market exclusivity periods for drugs in certain combinations of drugs (see H.R. 6502), H6274 [21SE]

——— extend period for a first applicant relative to a generic drug and to obtain tentative approval without forfeiting the exclusivity period (see H.R. 4332), H1804 [29MR]

——— improve the safety of Internet pharmacies (see H.R. 4095), H1016 [28FE]

——— incentivize development of tamper-resistant drugs (see H.R. 6160), H5077 [19JY]

——— permit manufacturers of generic drugs to provide additional warnings relative to such drugs in the same manner as brand name drugs (see S. 2295), S2496 [18AP] (see H.R. 4384), H1976 [18AP]

——— prevent States from conducting duplicative inspections of establishments in which a drug or device is manufactured, processed, packed, or held by a manufacturer or wholesale distributor (see H.R. 4056), H901 [16FE]

——— prohibit wholesalers from purchasing prescription drugs from pharmacies and enhance information and transparency of drug wholesalers engaged in interstate commerce (see H.R. 5853), H3166 [22MY]

——— promote accountability, transparency, innovation, efficiency, and timeliness (see S. 2292), S2392 [17AP]

——— 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. 4972), H2267 [27AP]

——— revise and extend the user-fee programs for prescription drugs and medical devices and establish user-fee programs for generic drugs and biosimilars (see S. 2516), S2922 [7MY] (see S. 3187), S3174 [15MY] (see H.R. 5651), H2565 [9MY]

——— strengthen regulation of compounding drugs by pharmacies (see H.R. 6584), H6323 [2NO] (see H.R. 6638), H6675 [5DE]

Federal agencies and departments: establish programs in regulatory agencies to permit the labeling of certain products that do not contain any carcinogens as ‘‘cancer free’’ (see H.R. 6191), H5291 [25JY]

——— establish programs in regulatory agencies to permit the labeling of certain products that do not contain any carcinogens as ‘‘carcinogen free’’ (see H.R. 6601), H6428 [16NO]

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. 5997), H3974 [21JN]

Firearms: enhance criminal penalties for straw purchasers of firearms (see H.R. 4190), H1304 [8MR]

Government regulations: eliminate requirements for duplicative clinical testing of new drugs, vaccines, biological products, or medical devices if inconsistent with relevant ethical norms (see S. 3506), S5977 [2AU]

——— more effectively regulate anabolic steroids (see S. 3431), S5381 [25JY]

Health: address critical drug shortages (see H.R. 3839), H218 [31JA]

——— extend health information technology assistance eligibility to behavioral health, mental health, and substance abuse professionals and facilities (see H.R. 6043), H4156 [27JN]

——— find Attorney General Holder in contempt of Congress for refusal to comply with subpoenas issued by the Committee on Oversight and Government Reform (House) (H. Res. 711), consideration (see H. Res. 708), H4155 [27JN]

——— recommend against finding Attorney General Holder in contempt of Congress for refusal to comply with subpoenas issued by the Committee on Oversight and Government Reform (House) (see H. Res. 712), H4604 [28JN]

Marijuana: exempt real property from civil forfeiture due to medical-marijuana-related conduct authorized by State law (see H.R. 6335), H5706 [2AU]

——— provide an affirmative defense for medical use in accordance with the laws of the States (see H.R. 6134), H4907 [17JY]

——— provide that Federal law shall not preempt State law (see H.R. 6606), H6469 [27NO]

Medicare: permit direct payment to pharmacies for certain compounded drugs for a specific beneficiary for use through an implanted infusion pump (see S. 3496), S5977 [2AU] (see H.R. 6326), H5706 [2AU]

——— permit the Dept. of HHS to negotiate lower covered part D prescription drug prices for beneficiaries (see H.R. 6392), H5999 [13SE]

——— promote public notification and provide incentives to reduce drug shortages (see H.R. 6611), H6535 [29NO]

——— provide for pharmacy benefits manager standards under the prescription drug program to further fair audits of and payments to pharmacies (see H.R. 4215), H1426 [20MR]

Medicare/Medicaid: implement prescriber education programs and establish requirements for administration of antipsychotics to residents of skilled nursing facilities (see S. 3604), S6546 [20SE]

Mexico: apply whole-of-government plan, in coordination with Mexican Government, to combat Mexican-based transnational criminal organizations (see H.R. 6280), H5704 [2AU]

National Medicine Abuse Awareness Month: designate (see S. Res. 564), S6454 [19SE]

Obama, President: appoint special counsel to investigate operations transferring firearms to drug cartels where U.S. law enforcement personnel do not monitor such firearms (see H. Res. 532), H374 [1FE]

Office of National Drug Control Policy: increase public awareness about the dangers of synthetic drugs through the National Youth Anti-Drug Media Campaign (see H.R. 4205), H1390 [19MR]

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 H.R. 5842), H3162 [18MY]

Pediatric Research Equity Act: permanently extend and strengthen (see H.R. 4274), H1739 [28MR]

Pharmaceuticals: allow importation, distribution, and sale of investigational drugs and devices intended for use by terminally ill patients (see H.R. 6342), H5706 [2AU]

——— prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market (see H.R. 3995), H692 [9FE]

——— prohibit prescription drug price-gouging during states of market shortage (see S. 3622), S6625 [21SE]

Red Ribbon Week: support goals and ideals (see S. Res. 578), S6626 [21SE] (see H. Res. 795), H6232 [20SE]

Rotary International: commend efforts to prevent and eradicate polio (see S. Res. 473), S3631 [24MY] (see H. Res. 704), H4064 [26JN]

Schools: prohibit Federal education funding for elementary or secondary schools that provide access to emergency postcoital contraception (see H.R. 4046), H801 [15FE]

Tariff: canagliflozin (see S. 2921), S2966 [8MY]

——— Cetalox (see H.R. 4727), H2125 [25AP]

——— cyanamide (see S. 2349), S2731 [25AP]

——— diethylaminoethyl-dextran (see S. 2350), S2731 [25AP]

——— o-acetylsalicylic acid (aspirin) (see S. 2758), S2926 [7MY] (see S. 2948), S2967 [8MY] (see H.R. 5276), H2273 [27AP]

——— placebos to be used in clinical trials for the drug ASKP1240 (see H.R. 5364), H2317 [7MY]

——— placebos to be used in clinical trials for the drug ASP0777 (see H.R. 5358), H2317 [7MY]

——— placebos to be used in clinical trials for the drug ASP2408 (see H.R. 5357), H2317 [7MY]

——— 3-phthalimidopropionaldehyde (see S. 2351), S2731 [25AP]

Taxation: include vaccines against seasonal influenza within the definition of taxable vaccines (see S. 3716), S8665 [2JA] (see H.R. 6687), H7359 [19DE]

——— repeal certain tax increases (see H.R. 4064), H901 [16FE]

——— repeal certain tax increases enacted as part of health care reform (see H.R. 6088), H4684 [9JY]

U.S. Anti-Doping Agency: increase congressional oversight (see H.R. 6546), H6276 [21SE]

Veterans: establish veterans’ treatment courts (see S. 3702), S8302 [20DE]

Cloture motions

FDA: revise and extend the user-fee programs for prescription drugs and medical devices and establish user-fee programs for generic drugs and biosimilars (S. 3187), House amendment, S4410 [21JN], S4449 [25JN]

E-mails

U.S.-Mexico border security: Bill Bagi, H1217 [7MR]

Letters

Asthma Inhalers Relief Act: Maureen Donahue Hardwick, International Pharmaceutical Aerosol Consortium (excerpt), H6727 [12DE]

Border Tunnel Prevention Act: Representative Camp, Committee on Ways and Means (House), H2671 [15MY]

——— Representative Lamar Smith, Committee on the Judiciary (House), H2672 [15MY]

——— Representative Peter T. King, Committee on Homeland Security (House), H2672 [15MY]

Designer Anabolic Steroid Control Act: Gretchen DuBeau, Alliance for Natural Health USA, S5384 [25JY]

——— John Shaw, Natural Products Association, S5383 [25JY]

——— Loren Israelsen, United Natural Products Alliance, S5384 [25JY]

——— Michael McGuffin, American Herbal Products Association, S5383 [25JY]

——— Scott M. Melville, Consumers Healthcare Products Association, S5384 [25JY]

——— Steve Mister, Council for Responsible Nutrition, S5384 [25JY]

——— Travis T. Tygart, U.S. Anti-Doping Agency, S5384 [25JY]

Ecuadorian human rights violations, democracy efforts, and drug trafficking situation: Carlos R. Lange, Sociedad Ecuatoriana del Exterior (organization), E1652 [21SE]

Expedite approval of drugs for serious or life-threatening diseases or conditions: several health advocacy organizations, H3225 [30MY]

Faster Access to Specialized Treatments (FAST) Act: several health organizations, E975 [5JN]

Food and Drug Administration Safety and Innovation Act: Emil Kakkis, EveryLife Foundation for Rare Diseases, H3864 [20JN]

——— Pat Furlong, Parent Project Muscular Dystrophy (organization), H3864 [20JN]

Impact of drug approval process on drug prices: Alfred E. Mann, H3585 [7JN]

Improve FDA capacity to prevent drug shortages: Carol Gill, S3503 [23MY]

——— Dawn Gibbs, S3503 [23MY]

Investigation of Dept. of Justice operations transferring firearms to drug cartels where U.S. law enforcement personnel do not monitor such firearms: Representative Cummings, H4171, H4172 [28JN]

——— Representative Issa, Committee on Oversight and Government Reform (House), H4409–H4411 [28JN], E1188, E1189 [29JN]

Medical Preparedness Allowable Use Act: Tim Stephens, Emergency Services Coalition for Medical Preparedness, H6440 [27NO]

Medicare IVIG Access and Strengthening Medicare and Repaying Taxpayers Act: Representative Camp, Committee on Ways and Means (House), H7304 [19DE]

——— Representative Upton, Committee on Energy and Commerce (House), H7303 [19DE]

Patient Safety and Generic Labeling Improvement Act: Allison M. Zieve, Public Citizen (organization), S2499 [18AP]

——— Joyce A. Rogers, AARP, S2498 [18AP]

——— several consumer organizations, S2499 [18AP]

Secure Border Act: Representative Camp, Committee on Ways and Means (House), E972 [5JN]

——— Representative Peter T. King, Committee on Homeland Security (House), E972 [5JN]

Spending Reductions Through Innovations in Therapies Agenda (SPRINT) Act: Robert Egge, Alzheimer’s Association, S325 [2FE]

Lists

Committee on Health, Education, Labor, and Pensions (Senate) staff who worked on S. 3187, FDA Safety and Innovation Act, S3608 [24MY]

Organizations supporting S. 3187, FDA Safety and Innovation Act, S3305 [21MY]

Persons denied access to compassionate drug use by the FDA, E1408 [3AU]

Memorandums

Investigation of Alleged Agreements Between the White House and Health Care Industry Stakeholders Prior to Passage of the Patient Protection and Affordable Care Act: Committee on Energy and Commerce (House), S4443, S4444 [25JN]

Messages

National Drug Control Strategy: President Obama, S2543 [19AP], H2028 [19AP]

Motions

——— initiate or intervene in judicial proceedings to enforce certain subpoenas issued to Attorney General Holder (H. Res. 706), consideration (H. Res. 708), H4174 [28JN]

FDA: revise and extend the user-fee programs for prescription drugs and medical devices and establish user-fee programs for generic drugs and biosimilars (S. 3187), S3243 [17MY], S3295 [21MY], S3389 [22MY], S3561, S3563 [24MY], S4409, S4410 [21JN]

Press releases

NBPC Calls for the Resignation of Attorney General Eric Holder: National Border Patrol Council, H4171 [28JN]

Remarks in House

American Herbal Products Association: anniversary, E187 [14FE]

Armed Forces: address prescription drug abuse among military personnel and veterans, H3005 [17MY]

Callender, Kathleen: Mayor of Golden, CO, Award for Excellence recipient, E1832, E1840 [29NO]

Callender-Potters, Heather: Mayor of Golden, CO, Award for Excellence recipient, E1832, E1840 [29NO]

China: allegations of exporting pharmaceuticals containing human flesh, H2335 [8MY]

Coast Guard: tribute to interception of cocaine shipments, E1040 [12JN]

——— hold bipartisan public hearings with testimony from persons having knowledge relative to operations transferring firearms to drug cartels, H4412, H4413 [28JN]

——— initiate or intervene in judicial proceedings to enforce certain subpoenas issued to Attorney General Holder (H. Res. 706), H4418–H4421 [28JN], E1196 [29JN], E1405 [3AU]

——— initiate or intervene in judicial proceedings to enforce certain subpoenas issued to Attorney General Holder (H. Res. 706), consideration (H. Res. 708), H4164–H4175 [28JN]

——— vote by Republican members to hold Attorney General Holder in contempt of Congress relative to operations transferring firearms to drug cartels, H3959 [21JN]

Controlled Substances Act: make any substance containing hydrocodone a schedule II drug, H3224 [30MY]

——— place synthetic drugs in Schedule I indicating high potential for abuse, no current accepted medical use, and lack of accepted safety for use under medical supervision, H3868 [20JN]

Crime: address issues relative to prescription drug abuse, H5529–H5532 [1AU]

——— increase penalties for counterfeit drug trafficking (H.R. 3668), H3719–H3721 [18JN], E1101 [21JN]

——— increase penalties for operators of pill mills, H3224 [30MY]

——— increase penalties for operators of pill mills (H.R. 1065), H5529 [1AU]

——— increase penalties for stealing, transporting, and storing stolen prescription drugs (H.R. 4223), H3991–H3994 [26JN], E1173 [28JN]

DEA: tribute to National Drug Take Back Day, E672 [26AP]

Dept. of Defense: authorize a pilot program on enhancements of efforts on mental health in the National Guard and Reserves through community partnerships, E1993 [21DE]

——— prohibit military promotion boards from considering any information regarding mental health or addiction issues, except in cases where individuals are determined to be a danger to themselves or others, H3054–H3056 [17MY]

Dept. of HHS: allow to cause destruction of any drug refused admission due to reasonable probability of causing serious adverse health consequences or death or valued below a certain amount, H3228 [30MY]

Dept. of Homeland Security: establish Border Enforcement Security Task Force, H3244, H3245 [30MY]

——— provide for annual reports on the status of operational control of international land and maritime borders of the U.S. and unlawful entries (H.R. 6025), H6432–H6434 [27NO], E1843 [29NO]

——— reduce trafficking of drugs and prevent human smuggling across the Southwest border by deterring construction and use of border tunnels (H.R. 4119), H2669–H2673 [15MY]

Dept. of Justice: Drug Courts Program funding, H2371 [8MY]

——— prohibit funding to prevent States from implementing laws that authorize the use, distribution, possession, or cultivation of medical marijuana, H2524–H2529 [9MY]

——— whistleblower allegations relative to operations transferring firearms to drug cartels where U.S. law enforcement personnel do not monitor such firearms, H2493–H2496 [9MY], H3813 [20JN], H3918, H3947 [21JN], H6794 [13DE]

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. 2746), H4076 [27JN]

Ecuador: human rights violations, democracy efforts, and drug trafficking situation, E1651 [21SE]

Ed Keating Center, Inc.: tribute, E1575 [20SE]

EPA: allow for the distribution, sale, and consumption of remaining inventories of over-the-counter chlorofluorocarbon (CFC) epinephrine inhalers (H.R. 6190), H6724–H6728 [12DE], E1780 [16NO], E1937 [17DE]

FDA: accelerate patient access to new medical treatments, E933 [31MY]

——— allow fast track approval of certain orphan drugs (H.R. 3737), H580 [8FE], H3864 [20JN]

——— develop uniform Federal standards for third party logistics providers to ensure safety and security in the delivery of pharmaceuticals, H3227, H3230 [30MY]

——— expedite approval of drugs for serious or life-threatening diseases or conditions, H3225 [30MY], H3864 [20JN], E974 [5JN]

——— expedite development, evaluation, and approval of breakthrough drugs, H3228 [30MY]

——— improve capacity to prevent drug shortages (H.R. 2245), H3863 [20JN]

——— improve priority review voucher incentive program for expedited review of treatments for rare pediatric diseases, H3226 [30MY]

——— improve priority review voucher incentive program for expedited review of treatments for tropical and rare pediatric diseases, H3865 [20JN]

——— incentivize development of tamper-resistant drugs, H6836 [18DE]

——— incentivize development of tamper-resistant drugs (H.R. 6160), H5531 [1AU]

——— permit manufacturers of generic drugs to provide additional warnings relative to such drugs in the same manner as brand name drugs (H.R. 4384), E580 [18AP]

——— provide incentives for the development of qualified infectious disease products, H3227, H3228 [30MY], E927 [31MY]

——— review classification of painkiller OxyContin for treatment of moderate pain and deny approval for generic versions, H5530 [1AU]

——— revise and extend the user-fee programs for prescription drugs and medical devices and establish user-fee programs for generic drugs and biosimilars (H.R. 5651), H2457 [9MY], H3192–H3230 [30MY], H3281 [31MY], E917, E925, E927, E929, E930, E932, E933 [31MY], E948, E950 [1JN], E974 [5JN], E1018 [7JN], E1162 [27JN]

——— revise and extend the user-fee programs for prescription drugs and medical devices and establish user-fee programs for generic drugs and biosimilars (S. 3187), H3825–H3868 [20JN], E1147 [27JN]

——— establish programs in regulatory agencies to permit the labeling of certain products that do not contain any carcinogens as ‘‘carcinogen free’’ (H.R. 6601), E1788 [16NO]

FTC: approval of merger between Express Scripts, Inc., and Medco, E704 [7MY]

——— potential merger between Express Scripts, Inc., and Medco, E673 [26AP]

Government regulations: encourage development of prescription drug monitoring programs to track the dispensing of controlled drugs to patients, H2335 [8MY]

——— exempt regulations on offshore bank account disclosure, middle income tax relief, invasive species, prescription drug safety, and foreclosure relief and predatory lending from regulatory freeze, H5318 [26JY]

——— increase Federal oversight of prescription opioid treatment and assistance to States in reducing opioid abuse, diversion, and deaths (H.R. 1925), H5529 [1AU]

Health: address critical drug shortages, H3281 [31MY]

——— address critical drug shortages (H.R. 3839), H387 [2FE]

——— health care programs funding, H1715 [28MR]

Health care professionals: require practitioners to obtain particular training or special certification on addiction and substance abuse, and appropriate and safe use of certain controlled substances (H.R. 2119), H5529 [1AU]

Hitchcock Center for Women Inc.: anniversary, E1375 [1AU]

House of Representatives: find Attorney General Holder in contempt of Congress for refusal to comply with subpoenas issued by the Committee on Oversight and Government Reform (House) (H. Res. 711), H4069, H4072, H4073, H4074, H4076, H4077 [27JN], H4161, H4162, H4163, H4402–H4418, H4425 [28JN], E1157 [27JN], E1180 [28JN], E1184, E1191, E1193, E1196, E1199 [29JN], E1247 [12JY], E1405 [3AU]

——— find Attorney General Holder in contempt of Congress for refusal to comply with subpoenas issued by the Committee on Oversight and Government Reform (House) (H. Res. 711), motion to refer, H4412, H4413 [28JN]

——— tribute to staff who worked on S. 3187, Food and Drug Administration Safety and Innovation Act, H3861 [20JN]

Insurance: ensure transparency and proper operation of pharmacy benefit managers (H.R. 1971), E673 [26AP]

——— coordinate efforts to protect U.S. border cities from drug trafficking, gunrunning, illegal alien smuggling, violence, and kidnapping along and across U.S. borders (H.R. 915), Senate amendment, H6437–H6439 [27NO], E1839 [29NO]

Medicare: impact of withdrawal of least costly alternative policies relative to certain prostate cancer drugs covered by Medicare Part B, E1929 [13DE]

——— provide for pharmacy benefits manager standards under the prescription drug program to further fair audits of and payments to pharmacies (H.R. 4215), H2144 [26AP], E673 [26AP], E713 [7MY]

——— 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 (H.R. 1845), H7301–H7308 [19DE], E1998 [21DE], E2005 [27DE]

Mexico: U.S. policy, H4825 [11JY]

National Association of Chain Drug Stores: observance of RxIMPACT Day, E381 [19MR], E407 [21MR]

National Community Pharmacists Association: tribute to Protect Your Pharmacy Now! week, E550 [17AP]

National objectives: priority assignments, H6362–H6367 [14NO]

National Prescription Drug Awareness Month: observance, E449 [27MR]

National security: improve border security, H1008–H1013 [28FE], H1144 [5MR], H1217 [7MR]

——— improve border security (H.R. 1299), H3236–H3239 [30MY]

New York: tribute to passage of law combating prescription drug abuse, H4830 [12JY]

Obama, President: appoint special counsel to investigate operations transferring firearms to drug cartels where U.S. law enforcement personnel do not monitor such firearms, H380 [2FE]

——— appoint special counsel to investigate operations transferring firearms to drug cartels where U.S. law enforcement personnel do not monitor such firearms (H. Res. 532), H382 [2FE]

Office of the Director of National Intelligence: authorize participation in information sharing with Canada and Mexico for the purposes of border security and combating drug trafficking, H3300 [31MY]

Operation UNITE (organization): tribute, E592 [19AP]

OxyContin: address issues relative to composition, marketing, and regulatory approval, H5532 [1AU]

Patient Protection and Affordable Care Act: impact, H4830 [12JY]

——— repeal amendments which disqualify expenses for over-the-counter drugs under health savings accounts and health flexible spending arrangements, H3584, H3591, H3593, H3594, H3601, H3605, H3606, H3609, H3611, H3613, H3614, H3616 [7JN], E1031 [8JN]

——— repeal amendments which disqualify expenses for over-the-counter drugs under health savings accounts and health flexible spending arrangements (H.R. 5842), H3366 [1JN]

Pediatric Research Equity Act: permanently extend and strengthen, E1162 [27JN]

Pharmaceuticals: allow importation, distribution, and sale of investigational drugs and devices intended for use by terminally ill patients (H.R. 6342), E1407 [3AU]

——— Pharmaceutical Traceability Enhancement Code (RxTEC) proposal to establish national standard to address drug traceability and pedigree, H3226, H3229 [30MY], E917 [31MY]

Rosary Hall (organization): anniversary, E1067 [19JN]

Rotary International: commend efforts to prevent and eradicate polio, E1141 [26JN]

Safety: improve, H3224 [30MY]

Smithfield, RI: tribute to Alexion Inc., biopharmaceutical manufacturing facility, E1636 [21SE]

Transportation Security Administration: call for investigation of allegations of airport screeners involved in a drug smuggling ring, H2138 [26AP]

Tyler’s Light (organization): tribute, E533 [16AP]

Unemployment: require drug testing as a condition for application and receipt of unemployment compensation, H357, H360, H361 [1FE]

Veterans: authorize veterans’ treatment courts and encourage services for veterans through drug courts, H2389 [8MY]

Vicini, Tom: Major League Baseball and Partnership at Drugfree.org (organization) Commissioner’s Play Healthy Award recipient, E1873 [4DE]

Warren Coalition: tribute to Youth Hero medal recipients, E683 [27AP]

World Immunization Week: observance, E661 [26AP]

Remarks in Senate

Armed Forces: address prescription drug abuse among military personnel and veterans, S6096 [11SE]

Best Pharmaceuticals for Children Act: permanently extend and strengthen, S3400–S3402 [22MY], S3477 [23MY]

Breuer, Lanny: call for resignation for allegations relative to operations transferring firearms to drug cartels where U.S. law enforcement personnel do not monitor such firearms, S411 [9FE]

Committee on Health, Education, Labor, and Pensions (Senate): investigation of fungal meningitis outbreak resulting from tainted medication, S6846 [15NO]

——— tribute to staff who worked on S. 3187, FDA Safety and Innovation Act, S3608 [24MY]

Controlled Substances Act: exclude industrial hemp from the definition of marijuana, S4138, S4139 [13JN], S4399 [21JN]

——— make any substance containing hydrocodone a schedule II drug, S3506 [23MY], S3560, S3564 [24MY], S4183 [14JN], S4408 [21JN], S4605 [26JN]

——— place synthetic drugs in Schedule I indicating high potential for abuse, no current accepted medical use, and lack of accepted safety for use under medical supervision, S3491, S3503 [23MY], S3546, S3548, S3556 [24MY], S4449 [25JN], S4625, S4630 [26JN]

——— place synthetic drugs in Schedule I indicating high potential for abuse, no current accepted medical use, and lack of accepted safety for use under medical supervision (S. 605), S680, S681 [15FE]

Crime: increase penalties for counterfeit drug trafficking, S3507 [23MY], S3566, S3567 [24MY], S4625 [26JN]

——— increase penalties for counterfeit drug trafficking (S. 1886), S1431 [6MR]

——— increase penalties for stealing, transporting, and storing stolen prescription drugs (H.R. 4223), S6671 [21SE]

Dept. of Defense: establish drug take-back program, S7205 [29NO]

Dept. of HHS: expedite research and drug development to combat the most deadly and costly chronic diseases (S. 2069), S324, S325 [2FE]

——— promulgate regulations on patient medication information to ensure patients receive consistent and high-quality information about prescription drugs, S3564 [24MY]

Dept. of Homeland Security: reduce trafficking of drugs and prevent human smuggling across the Southwest border by deterring construction and use of border tunnels (H.R. 4119), S3292 [17MY]

——— reduce trafficking of drugs and prevent human smuggling across the Southwest border by deterring construction and use of border tunnels (S. 1236), S172 [30JA]

——— release of report relative to operations transferring firearms to drug cartels where U.S. law enforcement personnel do not monitor such firearms, S6585 [21SE]

——— whistleblower allegations relative to operations transferring firearms to drug cartels where U.S. law enforcement personnel do not monitor such firearms, S410–S412 [9FE], S1706 [15MR], S3954–S3956 [12JN]

Diseases: increase immunization rates (S. 3344), S4675 [27JN]

Drug-Free Communities Support Program: extend authorization (S. 2159), S1423, S1424 [6MR]

FDA: accelerate patient access to new medical treatments, S3564 [24MY]

——— create standards for information provided to patients when receiving prescription medications, S3464 [23MY]

——— develop standardized protocols for obtaining authorization for administering an antipsychotic for non-FDA approved use, S3418 [22MY]

——— develop uniform Federal standards for third party logistics providers to ensure safety and security in the delivery of pharmaceuticals, S3414 [22MY]

——— ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve public health, S3556 [24MY]

——— ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve public health (S. 2113), S702 [15FE]

——— ensure continued research and development of drugs and medical devices for use in children, S3477 [23MY], S3565 [24MY]

——— ensure continued research and development of drugs and medical devices for use in children (S. 2289), S2395 [17AP]

——— ensure safety and quality of medical products and enhance authorities, S3468 [23MY], S3551 [24MY]

——— ensure that adequate information is disseminated to health care providers about potential benefits and risks of medical products on all patient populations, S3498–S3500 [23MY]

——— ensure transparency in drug and medical device user fee agreement negotiations by allowing Members of Congress or designated staff to attend negotiation meetings, S3492–S3494 [23MY]

——— expedite development, evaluation, and approval of breakthrough drugs, S3417 [22MY], S4615, S4618 [26JN]

——— improve capacity to prevent drug shortages, S3301–S3304 [21MY], S3389, S3396, S3418 [22MY], S3460, S3469, S3488, S3498, S3502 [23MY], S3551, S3567 [24MY]

——— improve capacity to prevent drug shortages (S. 296), S106–S108 [26JA]

——— investigation into allegations of monitoring of protected communications of Federal employees suspected to be whistleblowers, S5074–S5076 [17JY]

——— permit manufacturers of generic drugs to provide additional warnings relative to such drugs in the same manner as brand name drugs (S. 2295), S2497–S2500 [18AP]

——— promote accountability, transparency, innovation, efficiency, and timeliness, S3494 [23MY]

——— promote accountability, transparency, innovation, efficiency, and timeliness (S. 2292), S4616, S4625 [26JN]

——— provide additional quality control of drugs, S3417 [22MY]

——— provide for regulation of medical gases, S3414 [22MY]

——— provide incentives for the development of qualified infectious disease products, S3396 [22MY], S3477 [23MY], S3555 [24MY], S4624 [26JN], S5299 [24JY]

——— regulation and oversight of compounding pharmacies to prevent manufacturing and tainting of medications, S6846 [15NO]

——— require a portion of employee performance awards be connected to employee’s ability to review drugs and medical devices in a timely manner, S3490 [23MY]

——— require an independent assessment of review of the drug application process, S3489 [23MY]

——— require report on issues with respect to small business, S3500 [23MY]

——— revise and extend the user-fee programs for prescription drugs and medical devices and establish user-fee programs for generic drugs and biosimilars (S. 3187), S3178 [15MY], S3181 [16MY], S3479–S3504, S3506–S3509 [23MY], S3535–S3538, S3540–S3548, S3550–S3609 [24MY], S4668 [27JN], S5299 [24JY]

——— revise and extend the user-fee programs for prescription drugs and medical devices and establish user-fee programs for generic drugs and biosimilars (S. 3187), House amendment, S4408, S4409, S4410 [21JN], S4435–S4438, S4441–S4446, S4449 [25JN], S4601, S4602, S4605, S4610–S4619, S4624–S4627, S4630 [26JN]

——— revise and extend the user-fee programs for prescription drugs and medical devices and establish user-fee programs for generic drugs and biosimilars (S. 3187), motion to proceed, S3243, S3252, S3265 [17MY], S3295–S3298, S3301–S3307, S3313 [21MY], S3389, S3394–S3397, S3400–S3402, S3409–S3415, S3417–S3419 [22MY], S3459, S3460, S3464–S3470, S3477, S3479 [23MY]

——— revise and extend the user-fee programs for prescription drugs and medical devices and establish user-fee programs for generic drugs and biosimilars (S. 3187), unanimous-consent agreement, S3316 [21MY], S3479 [23MY], S4388 [21JN]

——— revoke drug exclusivity from certain entities for violations of Federal and State laws regulating pharmaceuticals, S3486–S3488 [23MY], S3540, S3543, S3562 [24MY]

Government regulations: ban the sale of certain synthetic drugs, S4449 [25JN], S4625 [26JN]

——— ban the sale of certain synthetic drugs (S. 409), S680, S681 [15FE]

——— ban the sale of certain synthetic drugs (S. 839), S680, S681 [15FE]

——— more effectively regulate anabolic steroids (S. 3431), S5383–S5385 [25JY]

Health: fine prescription drug manufacturers for failure to notify the FDA of a known discontinuance of a lifesaving drug, S3396 [22MY]

——— release of ‘‘Health Care Delivery System Reform and the Patient Protection and Affordable Care Act’’ report, S2200 [29MR]

Hereditary Angioedema Awareness Day: observance (S. Res. 286), S222 [31JA]

Insurance: ensure transparency and proper operation of pharmacy benefit managers (S. 1058), S3080 [10MY]

Medicare: permit direct payment to pharmacies for certain compounded drugs for a specific beneficiary for use through an implanted infusion pump (S. 3496), S5986 [2AU]

National Association of Chain Drug Stores: observance of RxIMPACT Day, S1844 [20MR]

National Medicine Abuse Awareness Month: designate (S. Res. 564), S6469 [19SE]

NIH: medical research and development funding, S5924 [2AU]

——— provide a deadline for issuance of regulations regarding clinical trial registration and report requirements, S3491 [23MY]

Patient Protection and Affordable Care Act: impact of implementation on health care, coverage, costs, and accessibility, S1843 [20MR]

——— repeal amendments which disqualify expenses for over-the-counter drugs under health savings accounts and health flexible spending arrangements, S3829 [7JN]

Pediatric Research Equity Act: permanently extend and strengthen, S3400–S3402 [22MY], S3477 [23MY]

Pharmaceuticals: allow importation of prescription drugs from Canada, S3467 [23MY], S3537, S3540–S3545, S3557, S3559, S3562 [24MY], S4441–S4446 [25JN], S4849 [11JY]

——— prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, S3411 [22MY], S3542, S3547, S3553, S3557 [24MY]

Postal Service: require maintenance of expected delivery time for protected mail items, S2466 [18AP]

Rotary International: commend efforts to prevent and eradicate polio (S. Res. 473), S4641 [26JN]

Synthetic drugs: address increase in use, S679–S682 [15FE]

Taxation: include vaccines against seasonal influenza within the definition of taxable vaccines (S. 3716), S8667 [2JA]

Reports

Least Costly Alternative Policies—Impact on Prostate Cancer Drugs Covered Under Medicare Part B: Dept. of HHS (excerpt), E1929 [13DE]

Patient Protection and Affordable Care Act Impact on Medicare Prescription Drug Coverage: Federal Hospital Insurance and Federal Supplementary Medical Insurance Trust Funds Boards of Trustees, H4715 [10JY]

Recommend Finding of Attorney General Holder in Contempt of Congress for Refusal To Comply With Subpoenas: Committee on Oversight and Government Reform (House), H4177–H4401 [28JN]

Reports filed

Asthma Inhalers Relief Act: Committee on Energy and Commerce (House) (H.R. 6190) (H. Rept. 112–673), H6059 [14SE]

Border Enforcement Security Task Force Act: Committee on Homeland Security and Governmental Affairs (Senate) (H.R. 915) (S. Rept. 112–206), S6062 [10SE]

Commend Rotary International Efforts To Prevent and Eradicate Polio: Committee on Foreign Relations (Senate) (S. Res. 473), S4366 [20JN]

Consideration of H. Res. 706, Committee on Oversight and Government Reform Initiation or Intervention in Proceedings To Enforce Subpoenas Issued to Attorney General Holder: Committee on Rules (House) (H. Res. 708) (H. Rept. 112–553), H4155 [27JN]

Consideration of H. Res. 711, House of Representatives Finding of Attorney General Holder in Contempt of Congress for Refusal To Comply With Certain Subpoenas: Committee on Rules (House) (H. Res. 708) (H. Rept. 112–553), H4155 [27JN]

Counterfeit Drug Penalty Enhancement Act: Committee on the Judiciary (House) (H.R. 3668) (H. Rept. 112–537), H3732 [18JN]

Drug-Free Communities Support Program Authorization Extension: Committee on the Judiciary (Senate) (S. 2159), S2242 [29MR]

FDA Reform Act: Committee on Energy and Commerce (House) (H.R. 5651) (H. Rept. 112–495), H3171 [25MY]

FDA Safety and Innovation Act: Committee on Health, Education, Labor, and Pensions (Senate) (S. 2516), S2922 [7MY]

Private Property Rights Protection Act: Committee on the Judiciary (House) (H.R. 4119) (H. Rept. 112–418), H1496 [21MR]

Recommend Finding of Attorney General Holder in Contempt of Congress for Refusal To Comply With Subpoenas: Committee on Oversight and Government Reform (House) (H. Rept. 112–546), H3981 [25JN]

Restoring Access to Medication Act: Committee on Ways and Means (House) (H.R. 5842) (H. Rept. 112–516), H3479 [5JN]

Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety (Safe Doses) Act: Committee on the Judiciary (House) (H.R. 4223) (H. Rept. 112–549), H3981 [25JN]

Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety (SAFE DOSES) Act: Committee on the Judiciary (Senate) (S. 1002) (S. Rept. 112–204), S6062 [10SE]

Statements

Representative Dingell’s Criticism of Attorney General Holder Contempt of Congress Resolutions Vote in the House of Representatives: Brian A. Terry Family, H4166, H4407 [28JN]

Texts of

H. Res. 706, Committee on Oversight and Government Reform (House) initiation or intervention in judicial proceedings to enforce certain subpoenas issued to Attorney General Holder, H4418 [28JN]

H. Res. 708, consideration of H. Res. 706, Committee on Oversight and Government Reform (House) initiation or intervention in judicial proceedings to enforce certain subpoenas issued to Attorney General Holder, H4164 [28JN]

H. Res. 708, consideration of H. Res. 711, House of Representatives finding of Attorney General Holder in contempt of Congress for refusal to comply with subpoenas issued by the Committee on Oversight and Government Reform (House), H4164 [28JN]

H. Res. 711, House of Representatives finding of Attorney General Holder in contempt of Congress for refusal to comply with subpoenas issued by the Committee on Oversight and Government Reform (House), H4402 [28JN]

H. Res. 712, recommend against the House of Representatives finding Attorney General Holder in contempt of Congress for refusal to comply with subpoenas issued by the Committee on Oversight and Government Reform (House), H4177 [28JN]

H. Res. 718, disapprove of Committee on Oversight and Government Reform (House) Chairman Issa’s actions relative to certain ongoing criminal investigations and statements relative to Attorney General Holder, H4614 [29JN]

H.R. 915, Border Enforcement Security Task Force Act, S6664 [21SE], H3243 [30MY]

H.R. 1299, Secure Border Act, H3237 [30MY]

H.R. 1845, Medicare IVIG Access and Strengthening Medicare and Repaying Taxpayers Act, H7301–H7303 [19DE]

H.R. 3668, Counterfeit Drug Penalty Enhancement Act, H3719 [18JN]

H.R. 3801, Ultralight Aircraft Smuggling Prevention Act, H163 [25JA]

H.R. 4119, Border Tunnel Prevention Act, H2669 [15MY]

H.R. 4223, Strengthening and Focusing Enforcement To Deter Organized Stealing and Enhance Safety (Safe Doses) Act, H3991 [26JN]

H.R. 5651, FDA Reform Act, H3192–H3223 [30MY]

H.R. 5997, Medical Preparedness Allowable Use Act, H6439 [27NO]

H.R. 6025, Mandatory Operational Control Reporting and Performance Measures Act, H6432 [27NO]

H.R. 6190, Asthma Inhalers Relief Act, H6724 [12DE]

S. 1236, Border Tunnel Prevention Act, S172 [30JA]

S. 2159, Drug-Free Communities Support Program authorization extension, S1424 [6MR]

S. 2295, Patient Safety and Generic Labeling Improvement Act, S2498 [18AP]

S. 3187, FDA Safety and Innovation Act, S3568–S3608 [24MY], H3825–H3861 [20JN]

S. 3716, include vaccines against seasonal influenza within the definition of taxable vaccines, S8667 [2JA]

S. Res. 286, Hereditary Angioedema Awareness Day, S222 [31JA]

S. Res. 473, commend efforts of Rotary International to prevent and eradicate polio, S3639 [24MY], S4642 [26JN]

S. Res. 564, National Medicine Abuse Awareness Month, S6465, S6470 [19SE]

S. Res. 578, support goals and ideals of Red Ribbon Week, S6631, S6680 [21SE]