FOOD AND DRUG ADMINISTRATION SAFETY AND INNOVATION ACT

Amendments

Enact (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]

Bills and resolutions

Enact (see S. 2516), S2922 [7MY] (see S. 3187), S3174 [15MY]

Cloture motions

Enact (S. 3187): House amendment, S4410 [21JN], S4449 [25JN]

——— motion to proceed, S3252 [17MY]

Letters

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]

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]

Provisions: Emil Kakkis, EveryLife Foundation for Rare Diseases, H3864 [20JN]

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

Repeal excise tax on medical devices: Gary R. Herbert, Governor of Utah, S3481 [23MY]

——— Richard R. Nelson, Utah Technology Council, S3480 [23MY]

Lists

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

Organizations supporting S. 3187, provisions, S3305 [21MY]

Motions

Enact (S. 3187), S3243 [17MY], S3295 [21MY], S3389 [22MY], S3561, S3563 [24MY], S4409, S4410 [21JN]

Remarks in House

Controlled Substances Act: 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]

Enact (S. 3187), H3825–H3868 [20JN], E1147 [27JN]

FDA: expedite approval of drugs for serious or life-threatening diseases or conditions, H3864 [20JN]

——— improve humanitarian device regulation, H3867 [20JN]

——— improve postmarket risk identification and analysis for medical devices, H3865 [20JN]

——— 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, H3864 [20JN]

House of Representatives: tribute to staff who worked on S. 3187, provisions, H3861 [20JN]

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

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

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, provisions, S3608 [24MY]

Controlled Substances Act: 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]

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

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

——— provide whistleblower protections for the Commissioned Corps of the Public Health Service Act, S3468, S3491 [23MY]

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]

Drugs: ban the sale of certain synthetic drugs, S4449 [25JN]

——— 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]

Enact (S. 3187), S3178 [15MY], S3181 [16MY], S3479–S3504, S3506–S3509 [23MY], S3535–S3538, S3540–S3548, S3550–S3609 [24MY], S4668 [27JN], S5299 [24JY]

——— House amendment, S4408, S4409, S4410 [21JN], S4435–S4438, S4441–S4446, S4449 [25JN], S4601, S4602, S4605, S4610–S4619, S4624–S4627, S4630 [26JN]

——— motion to proceed, S3243, S3252 [17MY], S3295–S3298, S3301–S3307, S3313 [21MY], S3389, S3394–S3397, S3400–S3402, S3409–S3415, S3417–S3419 [22MY], S3459, S3460, S3464–S3470, S3477, S3479 [23MY]

——— unanimous-consent agreement, S3316 [21MY], S3479 [23MY], S4388 [21JN]

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

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

——— 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 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]

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

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

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

——— 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 proof of intent for certain prohibited acts, S3501 [23MY], S3561 [24MY]

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

——— 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]

Health: repeal excise tax on medical devices, S3479–S3482 [23MY]

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

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]

Taxation: repeal excise tax on medical devices, S3412 [22MY]

Reports filed

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

Texts of

S. 3187, provisions, S3568–S3608 [24MY], H3825–H3861 [20JN]