FEDERAL FOOD, DRUG, AND COSMETIC ACT

Bills and resolutions

Cosmetics: provide grants to identify ingredients in salon products harmful to salon workers and women of color, promote green chemistry solutions, and require disclosure of ingredients on labels and company websites (see H.R. 3620), H2594 [24MY]

——— substantially restrict use of animal testing for cosmetics (see H.R. 5399), H4262 [12SE]

DEA: define currently accepted medical use with severe restrictions for controlled substances (see S. 689), S669 [7MR] (see H.R. 1393), H1148 [7MR]

Dept. of HHS: allow expedited approval of generic prescription drugs and temporary importation of prescription drugs during noncompetitive drug markets and drug shortages (see S. 845), S825 [16MR]

——— issue final ruling deeming foods containing xylitol as misbranded unless label or labeling of such foods contains warning specifying toxic effects of xylitol for dogs if ingested (see H.R. 617), H509 [30JA]

——— prohibit use or declaration of public health emergency with respect to abortion (see H.R. 384), H242 [17JA]

——— provide for Pediatric Brain Tumor Real-World Data Registry Program (see H.R. 6288), H5650 [8NO]

——— reauthorize certain programs relative to public health security and all-hazards preparedness and response (see S. 2333), S2984 [18JY] (see H.R. 4697), H3698 [18JY]

——— require drug manufacturers to include printed inserts containing drug information when they ship their products to pharmacies (see H.R. 1173), H873 [24FE]

Diseases and disorders: prohibit vaccination mandates for coronavirus (see S. 167), S172 [31JA] (see H.R. 403), H248 [20JA]

——— regulate human cadaveric islets for transplantation as organs (see S. 2205), S2225 [22JN] (see H.R. 4304), H3109 [22JN]

Drugs: mitigate effects of coronavirus pandemic on incentives for development of orphan drugs (see H.R. 1805), H1464 [27MR]

——— prohibit certain uses of xylazine (see S. 993), S999 [28MR] (see H.R. 1839), H1527 [28MR]

EPA: provide grants to reduce amount of food waste (see S. 177), S172 [31JA] (see H.R. 652), H574 [31JA]

FDA: address regulation of zootechnical animal food substances (see S. 1842), S2005 [7JN] (see H.R. 6687), H6740 [7DE]

——— allow digital communication of prescribing information for drugs, including biological products (see S. 2916), S4678 [26SE] (see H.R. 1503), H1248 [9MR]

——— allow for hemp-derived cannabidiol and hemp-derived cannabidiol containing substances in dietary supplements and food (see S. 2451), S3459 [20JY] (see H.R. 4849), H3948 [25JY]

——— allow rejection of citizen petition if it is believed primary purpose of petition is to delay approval of pending drug application and refer such petitioners to FTC (see S. 1067), S1053 [29MR]

——— allow women greater access to wider range of self-administered contraceptives (see H.R. 1512), H1248 [9MR]

——— amend device shortage notifications (see H.R. 3807), H2740 [5JN]

——— amend laws relative to 180-day exclusivity period (see S. 1114), S1089 [30MR]

——— ban certain substances in cosmetic products (see H.R. 3619), H2594 [24MY]

——— ban use of intentionally added per- and polyfluoroalkyl substances in cosmetics (see H.R. 6519), H6048 [30NO]

——— clarify process for denying certain petitions whose primary purpose is to delay approval of application submitted relative to certain drugs (see H.R. 3030), H2118 [28AP]

——— codify definition of beef for labeling purposes, reinforce existing misbranding provisions to eliminate consumer confusion, and enhance Dept. of Agriculture labeling enforcement measures (see S. 3281), S5458 [9NO]

——— deem certain substances to be unsafe for use as food contact substances (see H.R. 6105), H5174 [26OC]

——— define term natural cheese (see S. 981), S954 [27MR] (see H.R. 1803), H1464 [27MR]

——— enhance drug manufacturing amount information reporting (see H.R. 3810), H2740 [5JN]

——— enhance safeguards relative to infant formula (see H.R. 5316), H4211 [29AU]

——— ensure patients have access to certain urgent-use compounded medications (see H.R. 167), H104 [9JA]

——— ensure safety of imported seafood (see H.R. 1057), H851 [17FE]

——— establish additional authorities regarding conduct of pediatric investigations of molecularly targeted drugs to treat cancer (see S. 2897), S4654 [21SE] (see H.R. 3433), H2425 [17MY]

——— establish electronic format for medical device recall notifications (see S. 2907), S4654 [21SE] (see H.R. 5662), H4456 [21SE]

——— establish nonvisual accessibility standards for certain devices with digital interfaces (see H.R. 1328), H1049 [1MR]

——— establish Office of Food Safety Reassessment (see H.R. 3927), H2778 [7JN]

——— establish process to allow holders of abbreviated new generic drug applications to make labeling changes to include new or updated safety-related information (see H.R. 4134), H2932 [14JN]

——— establish special rules allowing generic manufacturers to sue brand-name manufacturers who overstate applications concerning method of use patents (see S. 1128), S1090 [30MR]

——— establish time-limited conditional approval pathway, subject to specific obligations, for certain drugs and biological products (see S. 1906), S2029 [8JN] (see H.R. 4408), H3157 [30JN]

——— exempt non-invasive diagnostic devices from regulation as devices (see H.R. 71), H100 [9JA]

——— expand certain authorities relative to recall of controlled substances to apply with respect to all drugs (see H.R. 2500), H1707 [6AP]

——— expand types of devices for which required labeling may be made available solely by electronic means (see H.R. 3723), H2638 [25MY]

——— improve priority review process of human drug applications to encourage treatment for agents that present national security threats (see S. 1122), S1090 [30MR] (see H.R. 5708), H4497 [26SE]

——— 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. 95), S120 [26JA] (see H.R. 427), H249 [20JA]

——— limit presence of toxic elements in, and otherwise regulate, infant and toddler food (see H.R. 6756, 6770), H6941 [13DE]

——— make certain changes relative to approval of abbreviated applications for approval of new animal drugs (see H.R. 1683), H1300 [21MR]

——— make hemp, cannabidiol derived from hemp, and any other ingredient derived from hemp lawful for use as dietary ingredients in dietary supplements (see H.R. 1629), H1292 [17MR]

——— modernize methods of authenticating controlled substances in pharmaceutical distribution supply chain (see H.R. 4988), H4138 [27JY]

——— prohibit sale of poppy seeds, or food that contains poppy seeds, with unsafe levels of certain opiates (see S. 3354), S5674 [29NO] (see H.R. 6512), H5983 [29NO]

——— provide authority to prohibit water buffalo products from being marketed as buffalo and clarify that buffalo is common name for bison (see S. 258), S230 [2FE] (see H.R. 3866), H2762 [6JN]

——— provide for establishment and maintenance of Pediatric Research Site Network (see H.R. 5269), H4203 [25AU]

——— provide for greater transparency relative to fragrance and flavor ingredients in cosmetics (see H.R. 3621), H2595 [24MY]

——— provide for notification by manufacturers of critical essential medicines of increased demand of such drugs (see S. 2362), S2985 [18JY] (see H.R. 3008), H2117 [28AP]

——— provide for regulation of in-vitro clinical tests (see H.R. 2369), H1640 [29MR]

——— provide increased transparency in generic drug applications (see H.R. 3839), H2761 [6JN]

——— provide marketing reciprocity to certain drugs, biological products, and medical devices authorized to be lawfully marketed abroad (see S. 1712), S1744 [18MY] (see H.R. 3532), H2455 [18MY]

——— reaffirm authority to approve drugs for abortion care (see H. Res. 309), H1887 [19AP]

——— reauthorize user fee programs relating to new animal drugs and generic new animal drugs (see S. 1844), S2005 [7JN] (see H.R. 1418), H1149 [7MR]

——— require cosmetic supply chains disclose ingredients, toxicity, and safety data to cosmetic companies needed to make safe cosmetics (see H.R. 3622), H2595 [24MY]

——— require label of drug intended for human use to identify each ingredient that is, or is derived directly or indirectly from, major food allergen or gluten-containing grain (see S. 2079), S2185 [21JN] (see H.R. 4263), H3071 [21JN]

——— require manufacturers of life-saving drugs to submit data and information to assess stability of such drugs and determine their longest supported expiration date (see H.R. 3793), H2740 [5JN]

——— require medical device manufacturers to provide notification of design or cleaning instruction changes and safety warnings issued in foreign countries about design and cleaning (see H.R. 1090), H853 [17FE]

——— set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions (see S. 1214), S1256 [19AP]

——— strengthen requirements related to nutrient information on food labels (see S. 1289), S1381 [26AP] (see S. 3512), S5961 [13DE] (see H.R. 2901), H2048 [26AP] (see H.R. 6766), H6941 [13DE]

FTC: deter filing of sham citizen petitions to cover attempt to interfere with approval of competing generic drug or biosimilar and foster competition and facilitate review of drug petitions filed in good faith (see S. 148), S147 [30JA]

Insurance: require out-of-network coverage for qualified individuals diagnosed with rare pediatric disease participating in approved clinical trials (see H.R. 5647), H4455 [21SE]

Interstate commerce: authorize regulation relative to food containing cannabidiol derived from hemp (see H.R. 1628), H1292 [17MR]

Marijuana: provide for new rules on regulation of marijuana (see H.R. 6673), H6740 [7DE]

Pharmaceuticals: clarify that artificial intelligence and machine learning technologies can qualify as practitioner eligible to prescribe drugs if State authorized and FDA approved, cleared, or authorized (see H.R. 206), H105 [9JA]

——— prohibit use of patents, trade secrets, or other intellectual property to inhibit competition (see S. 574), S567 [1MR] (see H.R. 4692), H3640 [17JY]

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. 107), S120 [26JA] (see H.R. 1486), H1247 [9MR]

——— exempt premium cigar industry from certain regulations (see H.J. Res. 99), H5669 [9NO]

Letters

Animal Drug User Fee Act reauthorization performance goals and procedures fiscal year 2024 through 2028: FDA, S5038–S5042 [17OC]

Animal Generic User Fee Act reauthorization performance goals and procedures fiscal year 2024 through 2028: FDA, S5042 [17OC]

Remarks in House

FDA: allow for hemp-derived cannabidiol and hemp-derived cannabidiol containing substances in dietary supplements and food (S. 2451), E705 [24JY]

——— allow women greater access to wider range of self-administered contraceptives (H.R. 1512), H1263 [10MR]

——— impose additional restrictions on tobacco flavors for use in e-cigarettes, H769 [8FE], H805 [9FE]

——— modernize methods of authenticating controlled substances in pharmaceutical distribution supply chain (H.R. 4988), H5973 [29NO]

——— prohibit use and distribution of abortion drugs, H3901 [25JY]

——— reauthorize user fee programs relating to new animal drugs and generic new animal drugs (H.R. 1418), H3620–H3624 [17JY]

Remarks in Senate

Diseases and disorders: prohibit vaccination mandates for coronavirus (S. 167), S248 [7FE]

FDA: establish time-limited conditional approval pathway, subject to specific obligations, for certain drugs and biological products, S412 [15FE]

——— 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, S68, S69 [24JA]

——— reauthorize user fee programs relating to new animal drugs and generic new animal drugs (S. 1844), S5038 [17OC]

Reports filed

Ensuring Timely Access to Generics Act: Committee on Health, Education, Labor, and Pensions (Senate) (S. 1067), S2221 [22JN]

Expanding Access to Low-Cost Generics Act: Committee on Health, Education, Labor, and Pensions (Senate) (S. 1114), S2221 [22JN]

FDA User Fee Programs Relating to New Animal Drugs and Generic New Animal Drugs Reauthorization: Committee on Energy and Commerce (House) (H.R. 1418) (H. Rept. 118–104), H2785 [9JN]

——— Committee on Health, Education, Labor, and Pensions (Senate) (S. 1844), S3618 [26JY]

Pandemic and All-Hazards Preparedness and Response Act: Committee on Health, Education, Labor, and Pensions (Senate) (S. 2333), S4227 [6SE]

Retaining Access and Restoring Exclusivity (RARE) Act: Committee on Health, Education, Labor, and Pensions (Senate) (S. 1214), S2221 [22JN]

Stop Significant and Time-Wasting Abuse Limiting Legitimate Innovation of New Generics (Stop STALLING) Act: Committee on the Judiciary (Senate) (S. 148), S567 [1MR]

Texts of

H.R. 1418, FDA user fee programs relating to new animal drugs and generic new animal drugs reauthorization, H3620–H3623 [17JY]

S. 2907, Medical Device Recall Improvement Act, S4658 [21SE]