FEDERAL FOOD, DRUG, AND COSMETIC ACT

Amendments

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

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]

Bills and resolutions

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

Dept. of HHS: 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]

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

——— 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]

——— 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]

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

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

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

——— 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]

——— 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 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]

——— 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]

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

——— 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 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]

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

Food industry: improve and clarify certain disclosure requirements for restaurants, similar retail food establishments, and vending machines (see S. 3574), S6454 [19SE] (see H.R. 6174), H5200 [24JY]

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

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]

Letters

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]

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]

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]

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]

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

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]

Drugs: improve safety, H3224 [30MY]

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

——— 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]

——— 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]

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

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

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

——— 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]

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

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

——— 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]

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

——— 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]

——— 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]

Food: require labels on food that contains, or is produced with, a genetically engineered material (H.R. 3553), H6073 [19SE]

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

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]

Women: improve prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women, H3865 [20JN]

——— improve prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women (H.R. 3526), H817 [16FE]

Remarks in Senate

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

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

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

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

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

——— 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]

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

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

——— 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]

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

——— 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]

——— 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]

——— 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]

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

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]

Reports filed

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]

Texts of

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

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]