FOOD AND DRUG ADMINISTRATION

Bills and resolutions

Abortion: improve regulation of abortion drugs by prohibiting approval of new drugs, preventing labeling changes of existing drugs, and limiting dispensing of drugs remotely, by mail, or telemedicine (see S. 3697), S290 [27JA]

——— withdraw approval of mifepristone for termination of intrauterine pregnancy (see S. 4066), S1009 [11MR] (see H.R. 7902), H2481 [12MR]

Agriculture: prohibit Federal interference in interstate traffic of unpasteurized milk and milk products in final package form for human consumption between States that allow sale of such products (see H.R. 7880), H2476 [9MR]

Cosmetics: specify that hair straightening or smoothing products containing formaldehyde or formaldehyde releasing substances will be considered adulterated (see H.R. 7685), H2327 [25FE]

Dept. of HHS: ensure that women seeking chemical abortion are made aware of risks involved (see H.R. 7237), H1912 [23JA]

Drugs: amend treatment of homeopathic drug products (see H.R. 7050), H892 [14JA]

——— enhance ability of outsourcing facilities to mitigate drug shortages by allowing short-term period to continue supplying market after drug is in shortage (see H.R. 7528), H2217 [12FE]

——— expand certain authorities relative to recall of controlled substances to apply to all drugs (see H.R. 7980), H2596 [18MR]

——— set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions (see S. 3716), S344 [28JA]

——— strengthen regulation of compounding pharmacies and outsourcing facilities (see S. 3794), S509 [5FE]

Food: establish board to review certain designations that substance used in food is generally recognized as safe relative to intended use of such substance (see H.R. 7291), H1921 [30JA]

Foreign countries: accelerate patient access to innovative medicines and clinical trials for life-threatening diseases by establishing reciprocal approval mechanism with trusted international regulatory authorities (see H.R. 7953), H2550 [17MR]

Government regulations: clarify and affirm preemptive authority over dietary supplement regulation (see H.R. 7366), H2030 [4FE]

——— establish new prohibited acts relative to dietary supplements (see S. 3797), S509 [5FE] (see H.R. 7407), H2041 [5FE]

——— provide for regulation of cannabinoid hemp products (see H.R. 7212), H1349 [22JA]

Health: require manufacturers of dietary supplements to list dietary supplements (see S. 3677), S257 [15JA]

Labeling: specify that food shall be considered misbranded if value of nutrients on its labeling deviates by more than 5 percent of value specified on such labeling (see H.R. 7122), H920 [15JA]

NIH: establish National Institute for Biomedical Research and Development (see H.R. 7854), H2471 [5MR]

Pharmaceuticals: require drug labeling to include original manufacturer and supply chain information (see S. 3788), S509 [5FE]

Product safety: establish standardized pathogen and microorganism testing of infant formula products and manufacturing facilities and mandate notification of specific positive tests and inspection classifications (see H.R. 7867), H2475 [9MR]

Tobacco products: clarify FDA jurisdiction over certain tobacco products and protect jobs and small businesses involved in sale, manufacturing, and distribution of cigars (see S. 3922), S681 [25FE]

Remarks in House

Government regulations: publish final rule relative to nonclinical testing methods (S. 355), H941 [20JA]

Health care facilities: establish expedited process for approval of certain biologics license application supplements for blood centers (H.R. 5791), H1158 [21JA]

NIH: establish National Institute for Biomedical Research and Development (H.R. 7854), H2556 [18MR]

Remarks in Senate

Abortion: improve regulation of abortion drugs by prohibiting approval of new drugs, preventing labeling changes of existing drugs, and limiting dispensing of drugs remotely, by mail, or telemedicine (S. 3697), S292 [27JA]

——— restore in-person dispensing requirements for chemical abortion drugs, S284 [27JA]

Texts of

S. 3677, Dietary Supplement Listing Act, S259 [15JA]

S. 3797, Prohibiting Tianeptine and Other Dangerous Products Act, S512 [5FE]