PHARMACEUTICALS related term(s) Drugs

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]

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]

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]

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

Business and industry: 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]

Controlled Substances Act: 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]

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

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]

——— 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]

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]

Diseases: 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]

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

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

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

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

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]

——— 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]

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]

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]

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

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]

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

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]

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]

——— chlorophyllin (see H.R. 5581), H2442 [8MY]

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

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

——— magnesium hydroxide (see H.R. 4794), H2126 [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]

——— preparations intended to assist smokers to stop smoking (see S. 3144), S3086 [10MY]

——— 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]

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]

——— 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, S3252 [17MY]

E-mails

Repeal of Obamacare Act: Bill Cea, H4797 [11JY]

——— Christine Haight Farley, H4798 [11JY]

Letters

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

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]

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]

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]

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]

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), S3243 [17MY], S3295 [21MY], S3389 [22MY], S3561, S3563 [24MY], S4409, S4410 [21JN]

Remarks in House

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

Arena Pharmaceuticals, Inc.: tribute to FDA approval of Belviq for treatment of obesity, E1232 [11JY]

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]

Citizen’s Commission on Human Rights: tribute to initiatives to protect parental rights, E1299 [23JY]

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

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

Critical Path Institute: tribute, E1404 [3AU]

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

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]

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]

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

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

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

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

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

——— improve safety, H3224 [30MY]

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

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

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

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

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]

Evans, William: American Pharmacists Association Remington Honor Medal recipient, E389 [20MR]

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]

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. 5997), H6439, H6440 [27NO], E1836 [29NO]

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

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

Government regulations: 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]

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

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]

House of Representatives: 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]

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]

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

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

Patient Protection and Affordable Care Act: impact, H1378–H1384 [19MR], H1395, H1396, H1398, H1399, H1400 [20MR], H1436, H1439, H1441, H1442, H1475, H1490–H1495 [21MR], H1524 [22MR], H1584 [27MR], H1647, H1650, H1651 [28MR], H1744 [29MR], H1924 [18AP], H3797–H3804 [19JN], H3961–H3966 [21JN], H4664 [9JY], H4689, H4695 [10JY], H4782, H4784, H4813–H4816 [11JY], H4897–H4900 [17JY], H5139, H5188–H5191 [24JY], H5209 [25JY], E404 [21MR], E418 [22MR], E464 [28MR], E1383 [1AU]

——— 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]

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

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

World Immunization Week: observance, E661 [26AP]

Remarks in Senate

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

——— limit increase of copayments for the TRICARE pharmacy benefits program, S7382 [4DE]

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

Business and industry: 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]

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]

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 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 Justice: establish uniform standards for the exchange of controlled substance and prescription information to prevent diversion, fraud, and abuse of such substances and drugs, S3555 [24MY], S4630 [26JN]

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

Drugs: address increase in synthetic drug use, S679–S682 [15FE]

——— 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]

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

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

——— modify certain exemptions to the Freedom of Information Act relating to drug inspection information obtained from foreign government agencies, S3547 [24MY], S4625 [26JN]

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

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]

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

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

Iran: exempt from sanctions humanitarian trade licensed by Dept. of the Treasury Office of Foreign Assets Control, S3324 [21MY]

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]

——— 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), S8380 [21DE]

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, S1821 [20MR], S1873–S1875, S1879–S1883 [21MR], S1956–S1963, S1988–S1991 [22MR], S2014, S2020–S2023 [26MR], S2160–S2163 [28MR], S2200, S2214 [29MR], S4731–S4733 [29JN], S4808–S4810 [10JY], S4879 [11JY], S5202 [19JY], S5445–S5447 [26JY], S5692–S5699, S5713 [31JY], S6042–S6044 [10SE], S6586–S6589 [21SE]

——— impact on tax burden, S4856–S4858 [11JY]

——— 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]

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

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]

Reports filed

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

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]

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]

Texts of

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

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