FOOD AND DRUG ADMINISTRATION REFORM ACT

Letters

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]

Remarks in House

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]

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

——— improve safety, H3224 [30MY]

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

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

Enact (H.R. 5651), H3192–H3230 [30MY], H3281 [31MY], E917, E925, E927, E929, E930, E932, E933 [31MY], E948, E950 [1JN], E974 [5JN], E1018 [7JN], E1162 [27JN]

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

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

——— 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], 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 humanitarian device regulation, E917 [31MY]

——— improve postmarket risk identification and analysis for medical devices, H3224 [30MY]

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

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

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

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

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

Reports filed

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

Texts of

H.R. 5651, provisions, H3192–H3223 [30MY]