FOOD AND DRUG ADMINISTRATION

Amendments

Agriculture, rural development, FDA, and related agencies programs: making appropriations (H.R. 5973), H3977 [21JN]

——— making appropriations (H.R. 5973), consideration (H. Res. 697), H4025 [26JN]

Appropriations: making for Dept. of Defense and other Federal departments and agencies, rescind unobligated stimulus funds, and reduce discretionary spending (H.R. 1), S8052, S8073, S8084, S8085 [17DE], S8117, S8126, S8128, S8130, S8141, S8142, S8143, S8144, S8147, S8149, S8150, S8151 [18DE], S8164, S8178, S8184, S8195, S8207, S8208, S8212, S8223, S8224 [19DE], S8305, S8306, S8307 [20DE], S8366, S8368, S8369, S8372 [21DE], S8429, S8430, S8431, S8432, S8433, S8434, S8442 [27DE], S8462, S8463, S8469, S8472, S8476, S8496, S8508 [28DE]

Dept. of HHS: reauthorize certain programs to protect against pandemics and attacks from chemical, biological, radiological, and nuclear weapons (S. 1855), S1475, S1484 [7MR]

Drugs: 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]

Taxation: repeal excise tax on medical devices (H.R. 436), H3601 [7JN]

——— repeal excise tax on medical devices (H.R. 436), consideration (H. Res. 679), H3598 [7JN]

Articles and editorials

Bizarre Outcome on Generic Drugs, S2499 [18AP]

Bills and resolutions

Advertising: prohibit use of Federal money for any media advertisement, campaign, or form of publicity against the use of a food or beverage that is lawfully marketed under the Federal Food, Drug, and Cosmetic Act (see H.R. 3848), H218 [31JA]

Agriculture, rural development, FDA, and related agencies programs: making appropriations (see S. 2375), S2821 [26AP] (see H.R. 5973), H3914 [20JN]

——— making appropriations (H.R. 5973), consideration (see H. Res. 697), H3974 [21JN]

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

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

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

Cosmetics: establish procedures and requirements for registration of cosmetic product manufacturing entities, submission of cosmetic product and ingredient statements, and reporting of adverse events (see H.R. 4395), H1977 [18AP]

——— improve safety (see H.R. 4262), H1570 [26MR]

Dept. of HHS: 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]

——— foster further innovation and entrepreneurship in the health information technology sector (see H.R. 6626), H6586 [3DE]

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

——— reauthorize certain programs to protect against pandemics and attacks from chemical, biological, radiological, and nuclear weapons (see H.R. 6672), H6828 [17DE]

Diseases: help prevent occurrence of cancer resulting from the use of ultraviolet tanning lamps by imposing more stringent controls on the use of such devices (see S. 2301), S2545 [19AP]

——— strengthen ability to seek advice from external experts on rare diseases, their burdens, and unmet medical needs of individuals with rare diseases (see S. 2281), S2243 [29MR] (see H.R. 4156), H1272 [7MR]

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

——— 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 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]

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

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

——— 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]

——— 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]

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

——— make corrections relative to user fees (see H.R. 6433), H6150 [19SE]

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

——— reduce regulatory burdens that unnecessarily delay new medical devices from reaching the market (see S. 2067), S323 [2FE]

Health: ensure that a medical device is not marketed based on a determination that it is substantially equivalent to a device that has been recalled due to a flaw in technology or design that adversely affects safety (see H.R. 3847), H218 [31JA]

Labeling: 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]

NIH: enhance the clinical trial registry data bank reporting requirements and enforcement measures (see H.R. 5283), H2273 [27AP] (see H.R. 6272), H5704 [2AU]

Pandemic and All-Hazards Preparedness Act: extend limited antitrust exemption (see S. 3715), S8548 [30DE]

Pediatric Medical Device Safety and Improvement Act: extend (see H.R. 3975), H639 [8FE]

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

Pharmaceuticals: 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]

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

Product safety: enhance oversight of medical device recalls and provide for conditional clearance of certain medical devices (see H.R. 5866), H3266 [30MY]

Safety: improve postmarket risk identification and analysis for medical devices (see H.R. 5341), H2317 [7MY]

——— include devices in the postmarket risk identification and analysis system and expedite implementation of the unique device identification system for medical devices (see S. 2193), S1733 [15MR]

——— limit the quantity of arsenic and lead in beverages containing fruit juice pursuant to certain tolerances (see H.R. 3984), H640 [8FE]

——— limit the quantity of arsenic in rice and rice products (see H.R. 6509), H6274 [21SE]

States: prevent 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]

Taxation: disapprove rule relative to taxable medical devices (see S.J. Res. 51), S8364 [21DE]

——— repeal excise tax on medical devices (see H.R. 5906), H3660 [7JN]

——— repeal excise tax on medical devices (H.R. 436), consideration (see H. Res. 679), H3577 [6JN]

Cloture motions

Appropriations: making for Dept. of Defense and other Federal departments and agencies, rescind unobligated stimulus funds, and reduce discretionary spending (H.R. 1), S8195 [19DE], S8340 [21DE]

Drugs: 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]

Letters

Agriculture, rural development, FDA, and related agencies appropriations: Stephen E. Blaire and Richard E. Pates, U.S. Conference of Catholic Bishops, H4021 [26JN]

Dept. of HHS programs to protect against pandemics and attacks from chemical, biological, radiological, and nuclear weapons reauthorization: James C. Greenwood, Biotechnology Industry Organization, H7294 [19DE]

——— Maureen Donahue Hardwick, Alliance for Biosecurity, H7294 [19DE]

——— several public health organizations, H7295 [19DE]

——— Stephanie Silverman, Roundtable on Critical Care Policy (organization), H7295 [19DE]

——— Thomas K. McInerny, American Academy of Pediatrics, H7294 [19DE]

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]

FDA medical device user-fee program: Dept. of HHS, S8277–S8295 [20DE]

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]

Health Care Cost Reduction Act: Charles M. Loveless, American Federation of State, County and Municipal Employees, H3605 [7JN]

——— Christopher W. Hansen, American Cancer Society Cancer Action Network, Inc., Shereen Arent, American Diabetes Association, and Mark A. Schoeberl, American Heart Association, H3605 [7JN]

——— DeAnn Friedholm, Consumers Union, H3603 [7JN]

——— Ethan Rome, Health Care for America Now (organization), H3604 [7JN]

——— Judy Waxman and Joan Entmacher, National Women’s Law Center, H3603 [7JN]

——— Ronald F. Pollack, Families USA (organization), H3605 [7JN]

——— Walter J. Humann, OsteoMed Inc., H3592 [7JN]

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

——— Dawn Gibbs, S3503 [23MY]

Improve safety of dietary supplements by requiring manufacturers to register supplement products with the FDA and amending labeling requirements: Chuck Bell and Ioana Rusu, Consumers Union, S3552 [24MY]

——— Michael F. Jacobson, Center for Science in the Public Interest, S3552 [24MY]

Limit the quantity of arsenic in rice and rice products: Ellen Bloom and Ami V. Gadhia, Consumers Union, E1619 [21SE]

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]

Prevent FDA approval of genetically-engineered fish unless NOAA concurs with such approval: Ioana Rusu, Consumers Union, S3496 [23MY]

——— Keith Curley, Trout Unlimited (organization), S3497 [23MY]

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]

Motions

Appropriations: making for Dept. of Defense and other Federal departments and agencies, rescind unobligated stimulus funds, and reduce discretionary spending (H.R. 1), S8016 [13DE], S8195 [19DE], S8341, S8342 [21DE], S8464, S8482 [28DE]

Drugs: 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]

Taxation: repeal excise tax on medical devices (H.R. 436), H3616 [7JN]

Press releases

Consumer Groups Oppose H.R. 436, Health Care Cost Reduction Act, H3604 [7JN]

Remarks in House

Agriculture, rural development, FDA, and related agencies programs: making appropriations (H.R. 5973), H3946 [21JN]

——— making appropriations (H.R. 5973), consideration (H. Res. 697), H4017–H4027 [26JN]

Appropriations: making for Dept. of Defense and other Federal departments and agencies, rescind unobligated stimulus funds, and reduce discretionary spending (H.R. 1), H5945 [13SE], H7478 [31DE], H7567–H7578 [2JA]

Dept. of HHS: reauthorize certain programs to protect against pandemics and attacks from chemical, biological, radiological, and nuclear weapons (H.R. 6672), H7282–H7296 [19DE]

Diseases: establish a comprehensive interagency response to reduce lung cancer mortality in a timely manner (H.R. 1394), E1735 [6NO]

——— 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]

——— strengthen ability to seek advice from external experts on rare diseases, their burdens, and unmet medical needs of individuals with rare diseases, H3225 [30MY], H3864 [20JN]

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]

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

——— 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 safety, H3224 [30MY]

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

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

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

——— 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]

EPA: waive ban on over-the-counter asthma inhalers enacted as part of international agreement to stop using products containing chlorofluorocarbons (CFCs) and allow existing stock to be sold until FDA approves replacement, H4872 [17JY]

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’’ (H.R. 6191), H5212 [25JY], E1320 [25JY]

——— 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]

Government regulations: create a pathway for premarket notification and review of laboratory-developed tests (H.R. 3207), H952 [27FE]

——— expedite process for requesting de novo classification of a device, H3228 [30MY]

——— improve humanitarian device regulation, H3867 [20JN], E917 [31MY]

——— make clarifications relative to persons accredited to review reports and make recommendations for initial classification of devices, H3230 [30MY]

——— make corrections relative to user fees (H.R. 6433), H6137 [19SE]

——— regulations concerning safe dietary ingredients in dietary supplements, E342 [8MR]

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

——— ensure that a medical device is not marketed based on a determination that it is substantially equivalent to a device that has been recalled due to a flaw in technology or design that adversely affects safety, H3225 [30MY]

——— importance of disease and vaccine research, E2021–E2023 [31DE]

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

OraSure Technologies, Inc.: FDA approval of OraQuick In-Home HIV test, E854 [18MY], E1227 [11JY]

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

Pharmaceuticals: 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]

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

Safety: improve postmarket risk identification and analysis for medical devices, H3224 [30MY], H3865 [20JN]

——— limit the quantity of arsenic in rice and rice products (H.R. 6509), E1619 [21SE]

Taxation: exempt certain emergency medical devices from the excise tax on medical devices (H.R. 1310), H4764 [10JY]

——— repeal excise tax on medical devices, H5915 [12SE]

——— repeal excise tax on medical devices (H.R. 436), H3366 [1JN], H3584, H3587, H3588, H3601–H3618 [7JN], H3797, H3798 [19JN], H6810 [17DE], E1025, E1031, E1035 [8JN], E1041 [12JN], E1052 [18JN], E1124 [21JN]

——— repeal excise tax on medical devices (H.R. 436), consideration (H. Res. 679), H3589–H3601 [7JN]

——— repeal excise tax on medical devices (H.R. 436), motion to recommit, H3616 [7JN]

——— repeal excise tax on medical devices (H.R. 5906), H3591 [7JN]

Remarks in Senate

Appropriations: making for Dept. of Defense and other Federal departments and agencies, rescind unobligated stimulus funds, and reduce discretionary spending (H.R. 1), S8050–S8060, S8062 [17DE], S8112, S8116–S8118, S8124–S8131, S8133–S8135 [18DE], S8161, S8163, S8164, S8177, S8178, S8184–S8197 [19DE], S8236, S8243–S8245, S8261 [20DE], S8341, S8342 [21DE], S8425–S8427, S8429–S8445 [27DE], S8462–S8474, S8476–S8497, S8519 [28DE], S8544 [30DE], S8639, S8640 [2JA]

——— making for Dept. of Defense and other Federal departments and agencies, rescind unobligated stimulus funds, and reduce discretionary spending (H.R. 1), unanimous-consent agreement, S8340 [21DE], S8445 [27DE]

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

Children and youth: 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]

China: accelerate investigation into imported pet food, S380 [7FE]

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]

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

Crime: require proof of intent for certain prohibited acts, S3501 [23MY], S3561 [24MY]

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

——— reauthorize certain programs to protect against pandemics and attacks from chemical, biological, radiological, and nuclear weapons (S. 1855), S1476, S1484 [7MR]

Dietary supplements: improve safety by requiring manufacturers to register supplement products with the FDA and amending labeling requirements, S3413 [22MY], S3466, S3467, S3482–S3485 [23MY], S3552, S3563 [24MY]

Diseases: help prevent occurrence of cancer resulting from the use of ultraviolet tanning lamps by imposing more stringent controls on the use of such devices (S. 2301), S2547 [19AP]

——— strengthen ability to seek advice from external experts on rare diseases, their burdens, and unmet medical needs of individuals with rare diseases, S3507 [23MY]

Drugs: 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]

——— 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]

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

——— 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]

——— 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]

——— 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]

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

——— 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]

——— 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]

Energy drinks: institute regulation and oversight of energy drinks as beverages to ensure safe caffeine levels, S6843–S6845 [15NO]

Fish and fishing: prevent approval of genetically-engineered fish unless NOAA concurs with such approval, S3495 [23MY], S3554 [24MY]

——— repeal duplicate programs relating to the inspection and grading of catfish, S4275 [19JN]

——— require imported catfish be subject to same inspection standards as domestic catfish, S4264 [19JN]

Food: allow States to require labels on food that contains, or is produced with, a genetically engineered material, S4169 [14JN], S4384 [21JN]

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

Government regulations: 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 regulations do not limit access to dietary supplements, S3501 [23MY], S3561 [24MY]

——— improve medical device approval process, S4615, S4618 [26JN]

——— make corrections relative to user fees (H.R. 6433), S6671 [21SE]

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

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

——— promote development of medical devices for patients with rare diseases, improve medical device approval process, and lift profit cap on humanitarian use devices, S3494 [23MY]

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

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

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

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

Law enforcement: prohibit FDA employees from carrying firearms and making arrests without warrants, S3501 [23MY], S3561 [24MY]

Medical gases: provide for regulation, S3414 [22MY]

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

Pandemic and All-Hazards Preparedness Act: extend limited antitrust exemption (S. 3715), S8552 [30DE]

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]

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

——— 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]

Product safety: ensure no future delays on implementation of new sunscreen labeling and testing standards, S3564 [24MY]

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

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

Taxation: repeal excise tax on medical devices, S3412 [22MY], S4924 [12JY], S6508 [20SE]

——— repeal excise tax on medical devices (H.R. 436), S3829 [7JN], S3929 [11JN], S3931 [12JN]

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

Reports filed

Agriculture, Rural Development, FDA, and Related Agencies Programs Appropriations: Committee on Appropriations (House) (H.R. 5973) (H. Rept. 112–542), H3914 [20JN]

——— Committee on Appropriations (Senate) (S. 2375) (S. Rept. 112–163), S2819 [26AP]

Consideration of H.R. 436, Health Care Cost Reduction Act and H.R. 5882, Legislative Branch of the Government Appropriations: Committee on Rules (House) (H. Res. 679) (H. Rept. 112–518), H3577 [6JN]

Consideration of H.R. 5973, Agriculture, Rural Development, FDA, and Related Agencies Programs Appropriations: Committee on Rules (House) (H. Res. 697) (H. Rept. 112–545), H3974 [21JN]

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]

Protect Medical Innovation Act: Committee on Ways and Means (House) (H.R. 436) (H. Rept. 112–514), H3479 [5JN]

Rulings of the Chair

Appropriations: making for Dept. of Defense and other Federal departments and agencies, rescind unobligated stimulus funds, and reduce discretionary spending (H.R. 1), S8464, S8482 [28DE]

Statements

Health Care Cost Reduction Act: Executive Office of the President, H3604 [7JN]

Summaries

Medical Device Industry Overstates Tax Impact: Bloomberg Finance L.P., H3595 [7JN]

Texts of

H. Res. 679, consideration of H.R. 436, Protect Medical Innovation Act and H.R. 5882, legislative branch of the Government appropriations, H3589 [7JN]

H. Res. 697, consideration of H.R. 5972, Depts. of Transportation and HUD and related agencies appropriations and H.R. 5973, agriculture, rural development, FDA, and related agencies programs appropriations, H4017 [26JN]

H.R. 436, Health Care Cost Reduction Act, H3601 [7JN]

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

H.R. 6433, FDA User Fee Corrections Act, H6137 [19SE]

H.R. 6672, Dept. of HHS programs to protect against pandemics and attacks from chemical, biological, radiological, and nuclear weapons reauthorization, H7282–H7292 [19DE]

S. 1855, Dept. of HHS programs to protect against pandemics and attacks from chemical, biological, radiological, and nuclear weapons reauthorization, S1476, S1484–S1493 [7MR]

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. 3715, Pandemic and All-Hazards Preparedness Act limited antitrust exemption extension, S8552 [30DE]

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