FOOD AND DRUG ADMINISTRATION

Amendments

Drugs: streamline, coordinate and expand research and foster increased communication between doctors and patients relative to cannabidiol and other marijuana components and their medical benefits (S. 253), S1781 [24MR]

Bills and resolutions

Abortion: preserve access to abortion medications (see S. 4467), S3159 [23JN] (see H.R. 8405), H6706 [18JY]

——— require more accurate reporting of abortion drug prescribing and related adverse events (see H.R. 6702), H1114 [9FE]

Advertising: promulgate rule relative to disclosure of side effects, contraindications, and effectiveness in prescription drug ads while also prohibiting distracting representations that detract from such disclosures (see H.R. 8289), H5935 [5JY]

Agriculture, rural development, FDA, and related agencies programs: making appropriations (see S. 4661), S3782 [28JY] (see H.R. 8239), H5923 [28JN]

Animals: allow for alternatives to animal testing for purposes of drug and biological product applications (see S. 5002), S5540 [29SE]

Business and industry: improve infant formula supply chain (see H.R. 7802), H5097 [17MY] (see H.R. 7830), H5174 [18MY]

Children and youth: direct President to provide documents to House of Representatives relative to recall of infant formula manufactured by Abbott Laboratories and potential impacts on supply chain (see H. Res. 1287), H7170 [26JY]

Conflict of interest: address potential conflicts among contractors (see H.R. 8828), H7841 [14SE]

Consumers: deem certain regulated products as drugs (see S. 4333), S2752 [26MY]

Contraceptives: preempt State bans on prescription, provision, or use of drug, biological product, or device for contraception if approved, licensed, cleared, or otherwise authorized for human use by FDA for contraception (see H.R. 8421), H6882 [19JY]

Critical Path Public-Private Partnerships: reauthorize (see S. 4152), S2358 [5MY] (see H.R. 7658), H4713 [3MY]

DEA: modify registration requirements relative to research with controlled substances (see S. 5123), S6779 [17NO]

——— require removal of drug from scheduling within certain period pursuant to recommendation of Dept. of HHS (see H.R. 8931), H8064 [21SE]

Defense Production Act: designate baby formula as scarce and critical material (see S. 4226), S2519 [16MY] (see H.R. 7781), H5009 [16MY]

Dept. of HHS: clarify conditions to approve generic drug applications with labeling temporarily different than brand name drug (see S. 4351), S2785 [6JN] (see H.R. 6973), H1372 [8MR]

——— collect and disseminate information on pharmaceutical affordability assistance programs to consumers and health facilities (see S. 4481), S3159 [23JN]

——— contract with third-party organizations to carry out independent value assessments for approved drugs (see H.R. 9321), H8541 [16NO]

——— direct President to provide documents to House of Representatives relative to Dept. of HHS actions taken relative to coronavirus pandemic response (see H. Res. 1268), H7170 [26JY]

——— evaluate process by which interchangeable biological products are approved to be used in pharmaceuticals (see H.R. 8877), H7964 [19SE]

——— grant eligible researchers access to drugs or biologic products at discounted price for qualified research (see S. 4026), S2091 (see S. 4053), S2092 [7AP] (see H.R. 7472), H4432 [7AP]

——— improve domestic manufacturing surge capacity and capabilities for biodefense and pandemic preparedness (see S. 3588), S546 [7FE]

——— improve inspections of foreign drug manufacturing establishments (see H.R. 7006), H1421 [9MR]

——— increase unannounced inspections of foreign human drug establishments and evaluate differences between domestic and foreign establishments, including impact of advanced notice to establishment owners (see H.R. 6980), H1373 [8MR]

——— maintain list of country of origin of all drugs marketed in U.S. and ban use of Federal funds for purchase of drugs manufactured in China (see H.R. 7121), H3826 [17MR]

——— publish on FDA website guidelines for do-it-yourself instructions for preparing baby formula at home and resource material on how to find baby formula alternatives (see S. 4212), S2493 [12MY]

——— report on interoperability of medical devices (see H.R. 9067), H8315 [29SE]

——— require Inspector General investigation and report on Vaccine Adverse Event Reporting System (see H.R. 7308), H4071 [31MR]

——— review and update guidance annually on medical device cybersecurity in consultation with Cybersecurity and Infrastructure Security Agency for industry and FDA staff (see S. 4336), S2752 [26MY]

——— support endemic fungal disease research, incentivize valley fever vaccine development, and discover new antifungal therapies and diagnostics to fight infections such as Valley Fever (see S. 3498), S220 [13JA]

——— update and clarify rule on substances generally recognized as safe and establish Office of Food Chemical Safety Reassessment within FDA Center for Food Safety and Applied Nutrition (see S. 4316), S2751 [26MY]

Diseases and disorders: accelerate approval of products for serious or life-threatening diseases or conditions (see H.R. 6996), H1373 [8MR]

——— establish additional authorities regarding conduct of pediatric investigations of molecularly targeted drugs to treat cancer (see S. 4215), S2493 [12MY] (see H.R. 6972), H1372 [8MR]

——— prohibit Federal Government from limiting State access to key therapies and from prioritizing Federal contracts over State contracts relative to purchasing supplies to combat coronavirus pandemic (see S. 3440), S23 [4JA] (see H.R. 6832), H1145 [25FE]

——— prohibit vaccination mandates for coronavirus (see H.R. 6395), H193 [13JA]

——— strengthen review and approval of drugs to treat rare diseases and conditions (see S. 4071), S2092 [7AP] (see H.R. 6888), H1207 [1MR]

Drugs: allow manufacturers and sponsors of drugs to use alternative testing methods to animal testing to investigate safety and effectiveness of biological products (see S. 4288), S2620 [19MY]

——— amend process informing persons submitting abbreviated application for new drug whether new drug is qualitatively or quantitatively same as listed drug (see H.R. 7032), H1422 [9MR]

——— deny approval of new drug application for opioid analgesic drug on basis of such drug not being clincally superior to other commercially available drugs (see S. 4340), S2752 [26MY] (see H.R. 8586), H7405 [28JY]

——— 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. 9011), H8220 [28SE]

——— expand certain authorities relative to recall of controlled substances to apply with respect to all drugs (see H.R. 6545), H330 [1FE]

——— improve patient access to emerging medication therapies by clarifying scope of permitted communications between biopharmaceutical manufacturers and population health decision makers (see H.R. 7008), H1421 [9MR] (see H.R. 9297), H8507 [15NO]

——— improve requirements for making determination of interchangeability of biological product and its reference product (see S. 6), S6778 [17NO]

——— make certain changes relative to approval of abbreviated applications for approval of new animal drugs (see H.R. 8857), H7881 [15SE]

——— modernize process of accelerated approval of drugs for serious or life-threatening diseases or conditions (see S. 4446), S3075 [22JN]

——— modernize therapeutic equivalence rating determinations (see H.R. 7377), H4152 [4AP]

——— prohibit alteration, falsification, fabrication, destruction, omission, or removal of records or certain information required to be produced or maintained for drugs (see H.R. 6431), H252 [19JA]

——— provide for mandatory recall authority over regulated drugs and homeopathic products (see H.R. 6834), H1146 [25FE]

——— provide for period of exclusivity for first interchangeable biological products (see S. 4303), S2708 [25MY]

——— provide increased transparency in generic drug applications (see S. 4338), S2752 [26MY]

——— publicly release summary of reasoning for approving drugs, biological products, and other therapies via accelerated approval process (see S. 4390), S2939 [14JN]

——— reauthorize program of grants and contracts for development of drugs for rare diseases and conditions (commonly known as ‘‘orphan drugs’’) (see H.R. 7640), H4712 [3MY]

——— require foreign establishments engaged in production of drug or device to register whether or not drug or device undergoes further processing at separate location outside U.S. prior to being imported (see S. 3449), S117 [10JA]

——— require guidance on extending expiration dates for certain scarce drugs (see S. 3493), S189 [12JA] (see H.R. 7669), H4721 [6MY]

——— require prompt reports on marketing status by holders of approved applications for biological products (see S. 4302), S2708 [25MY] (see H.R. 7035), H1422 [9MR]

——— revise and extend user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products (see H.R. 7667), H4721 [6MY]

——— set forth limitations on exclusivity for orphan drugs (see S. 4185), S2449 [11MY]

——— shorten exclusivity period for brand name biological products (see H.R. 7828), H5174 [18MY]

——— streamline, coordinate, and expand research and foster increased communication between doctors and patients relative to cannabidiol and other marijuana components and their medical benefits (see H.R. 8454), H7065 [21JY]

——— strengthen authority relative to foreign drug facility inspections (see S. 3509), S220 [13JA]

——— strengthen requirements for postapproval studies for drugs approved using accelerated approval (see H.R. 6963), H1329 [7MR]

Families and domestic relations: increase Federal support for nonprofit milk banks and access to donor milk for medically-vulnerable infants (see S. 5292), S7252 [15DE] (see H.R. 9196), H8402 [18OC]

Federal Food, Drug, and Cosmetic Act: reauthorize provision relative to drugs containing single enantinomers (see S. 4378), S2910 [13JN]

Food: act upon pending submissions for new infant formula and increase regulatory flexibility in event of infant formula shortage (see H.R. 8010), H5445 [9JN]

——— ensure safety of imported seafood (see H.R. 8732), H7716 [19AU]

——— improve safety and supply of infant formula (see H.R. 7933), H5232 [3JN]

——— make food and food additives that are sterilized using ethylene oxide or propylene oxide misbranded unless that process is disclosed on labeling (see H.R. 7167), H3853 [18MR]

——— prevent food shortages, including shortages of infant formula and certain medical foods (see S. 4256), S2586 [18MY] (see H.R. 7989), H5409 [8JN]

Food Safety Administration: establish (see S. 4520), S3270 [13JY] (see H.R. 8358), H6334 [13JY]

Foreign countries: clarify reporting requirements for establishments within foreign country engaged in manufacture, preparation, propagation, compounding, or processing of active pharmaceutical ingredients (see H.R. 6483), H300 [25JA]

Government regulations: classify human donor milk that undergoes pasteurization as exempt infant formula (see H.R. 7358), H4126 [1AP]

——— repeal authority to require that drugs be dispensed only upon prescription (see H.R. 6512), H307 [28JA]

——— require manufacturers of infant formula to warn about discontinuance or interruption in production of infant formula (see H.R. 8038), H5486 [13JN]

Health: provide for national uniformity for reproductive health products (see S. 4748), S3862 [2AU]

——— reaffirm preemptive authority relative to State laws that inhibit access to or use of any reproductive health product (see H. Res. 1434), H8395 [14OC]

——— reaffirm preemptive authority relative to State laws that inhibit access to or use of any reproductive health product (H. Res. 1434), adopt (see H. Res. 1529), H9982 [21DE]

——— report on barriers, including regulatory inefficiencies, to domestic manufacturing of active pharmaceutical ingredients, finished drug products, and devices (see H.R. 6710), H1119 [11FE]

——— require certain drug manufacturers entering into settlement agreements for violations of law to make supplemental payments to increase medical research funding (see S. 5322), S9625 [20DE] (see H.R. 9687), H10055 [22DE]

——— require manufacturers of dietary supplements to list dietary supplements (see S. 4090), S2154 [26AP]

——— require manufacturers to report medical device shortages, expedite review of essential medical devices, and grant authority to request information relative to security of U.S. medical product supply chain (see H.R. 7208), H3862 [24MR]

Insurance: require group health plans and group or individual health insurance coverage to provide coverage for over-the-counter contraceptives (see S. 4347), S2752 [26MY] (see H.R. 7894), H5219 [27MY]

Internet: provide process to lock and suspend domain names used to facilitate online sale of drugs illegally (see S. 3984), S1910 [31MR]

Kratom: protect access (see S. 5316), S9625 [20DE] (see H.R. 9634), H9909 [20DE]

Medical devices: allow for devices with predetermined change control plan to be marketed without submitting supplemental application or premarket notification if changes are consistent with such plans (see S. 4386), S2910 [13JN] (see H.R. 8299), H5939 [7JY]

——— allow waivers of annual establishment registration fees for small businesses (see S. 4385), S2910 [13JN] (see H.R. 9329), H8587 [17NO]

——— clarify requirements for remanufacturing (see H.R. 7253), H3895 [28MR]

——— exempt non-invasive diagnostic devices from regulation as devices (see H.R. 6513), H307 [28JA]

——— notify public about new information relative to medical device in order to reduce or limit number of patients exposed to potential risk identified based on such emerging signal (see S. 4349), S2785 [6JN] (see H.R. 7646), H4713 [3MY]

——— reauthorize Pediatric Device Consortia (PDC) grant program and allow profits for certain Humanitarian Device Exemption (HDE) devices (see H.R. 7679), H4721 [6MY]

Minorities: enhance data reporting on clinical trial demographics and provide resources to improve access to clinical trials in underrepresented communities (see H.R. 6584), H946 [3FE]

Operation Warp Speed: express that process should be integrated within operations (see H. Res. 876), H252 [19JA]

Patents: establish interagency task force between Patent and Trademark Office and FDA for sharing information and providing technical assistance relative to patents (see S. 4430), S3003 [16JN]

Pharmaceuticals: allow digital communication of prescribing information for drugs, including biological products (see H.R. 7559), H4453 [21AP]

——— authorize program to support adoption of, and improve development of, innovative approaches to pharmaceutical product design and manufacturing (see H.R. 6988), H1373 [8MR]

——— modernize methods of authenticating controlled substances in pharmaceutical distribution supply chain (see H.R. 7653), H4713 [3MY]

——— prohibit manufacturers from interfering with therapeutically equivalent or interchangeable substitutions by health care providers to limit competition from generic drug or biosimilar biological products (see H.R. 7473), H4432 [7AP]

——— revise and extend user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products (see S. 4348), S2752 [26MY] (see S. 4535), S3308 [14JY]

Product safety: require premarket submission of cyber devices to include information demonstrating reasonable assurance of safety and effectiveness throughout life cycle of cyber device (see S. 3983), S1910 [31MR] (see H.R. 7084), H3742 [15MR]

——— work through Codex process to review and update internationally recognized standards for infant formula to ensure standards are consistent with requirements for import to U.S. (see H.R. 7718), H4860 [11MY]

Science: promulgate rules to update certain regulations relative to human cells, tissues, and cellular and tissue-based products (see H.R. 6948), H1328 [7MR]

Tariff: terminate duties and other restrictions on importation of infant formula (see S. 4252), S2586 [18MY]

Tobacco products: require recall of electronic nicotine delivery systems that have not been subject to premarket review (see H.R. 8202), H5877 [23JN]

Women: treat certain menstrual products as misbranded if labels do not list each ingredient or component (see H.R. 8829), H7841 [14SE]

Cloture motions

Califf, Robert M.: nomination to be FDA Commissioner, S621 [10FE], S666 [14FE]

Letters

Revise and extend FDA user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products: Xavier Becerra, Sec. of HHS, S5171, S5172, S5173, S5174, S5175, S5176, S5177 [28SE]

Lists

Votes recorded by proxy on H. Res. 1529, adopt H. Res. 1434, reaffirm FDA preemptive authority relative to State laws that inhibit access to or use of any reproductive health product, H9972 [21DE]

Votes recorded by proxy on H.R. 7667, revise and extend FDA user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, H5403 [8JN]

Votes recorded by proxy on H.R. 8454, Medical Marijuana and Cannabidiol Research Expansion Act, H7146 [26JY]

Notices

Estimated budget effects of H.R. 7667, revise and extend FDA user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, H5330 [7JN]

Estimated budget effects of H.R. 8454, Medical Marijuana and Cannabidiol Research Expansion Act, H7163 [26JY]

Remarks in House

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 (H.R. 554), H281 [20JA]

Agriculture, rural development, FDA, and related agencies programs: making appropriations, H1411 [9MR], H6733, H6734, H6737, H6738, H6740, H6841, H6842, H6843, H6844, H6846 [19JY], H6896 [20JY]

All American Pharmaceutical (company): development of new baby formula in response to infant formula shortage, E731 [14JY]

Biden, President: evaluation of administration, H5492 [14JN]

——— evaluation of administration relative to infant formula shortage, H5470 [13JN], H5600 [15JN], H5812 [22JN], H5836 [23JN]

——— direct unused pandemic appropriations to address infant formula shortage, require FDA submit report on shortage, and assess amount of infant formula stockpiled by Government, H5161 [18MY]

Dept. of HHS: improve inspections of foreign drug manufacturing establishments, E594 [8JN]

——— require Inspector General investigation and report on Vaccine Adverse Event Reporting System (H.R. 7308), H4158 [5AP]

Diseases and disorders: prohibit vaccination mandates for coronavirus, H343 [2FE]

Drug abuse: designate methamphetamine as emerging threat (S. 854), H1156–H1158 [28FE]

Drugs: lower out of pocket spending, protect access to new cures and medications, strengthen transparency, and encourage competition (H.R. 19), H4035–H4038, H4043 [31MR], H7681, H7686 [12AU], E362 [6AP]

——— revise and extend user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products (H.R. 7667), H5298–H5321 [7JN], E594, E599 [8JN], E629 [15JN]

Food: improve safety and supply of infant formula, H5344 [8JN]

Food Safety Administration: establish (H.R. 8358), H5982 [13JY], E723 [13JY]

Health: provide for regulation of in-vitro clinical tests, H5320 [7JN]

——— provide for regulation of in-vitro clinical tests (H.R. 4128), H3785 [17MR]

——— reaffirm preemptive authority relative to State laws that inhibit access to or use of any reproductive health product (H. Res. 1434), H9973 [21DE]

——— reaffirm preemptive authority relative to State laws that inhibit access to or use of any reproductive health product (H. Res. 1434), adopt (H. Res. 1529), H9968, H9969 [21DE]

——— recognize benefits of vitamin D intake for preventing respiratory infection and coronavirus complications and encourage CDC and FDA to issue guidance on vitamin D intake for elderly and immunocompromised individuals, H250 [19JA], H3847 [18MR], H4124 [1AP], H4429 [7AP], H4855 [11MY], H5172 [18MY], H5324 [7JN], H5483 [13JN], H6878 [19JY]

Minorities: enhance data reporting on clinical trial demographics and provide resources to improve access to clinical trials in underrepresented communities, E594 [8JN]

Reagan-Udall Foundation for the Food and Drug Administration: increase funding (S. 1662), H1159 [28FE]

Safety: provide consumers the right to know if food has been treated by known carcinogenic substances through accurate labeling, H3763 [16MR]

Remarks in Senate

Animals: allow for alternatives to animal testing for purposes of drug and biological product applications (S. 5002), S5514 [29SE]

Biden, President: evaluation of administration relative to coronavirus pandemic, S44 [5JA], S469 [2FE], S532 [7FE]

Califf, Robert M.: nomination to be FDA Commissioner, S621 [10FE], S657, S665, S666 [14FE], S685–S688 [15FE]

——— nomination to be FDA Commissioner, unanimous-consent agreement, S671 [14FE]

Children and youth: address baby formula shortage, S2637 [24MY]

Drugs: decriminalize marijuana at Federal level and provide for taxation and regulation of marijuana products, S620 [10FE]

——— modernize process of accelerated approval of drugs for serious or life-threatening diseases or conditions (S. 4446), S3077 [22JN]

——— provide for period of exclusivity for first interchangeable biological products (S. 4303), S2709 [25MY]

——— reform procedures relative to approval of opioid drugs, S685 [15FE]

——— require guidance on extending expiration dates for certain scarce drugs (S. 3493), S191 [12JA]

——— require prompt reports on marketing status by holders of approved applications for biological products (S. 4302), S2709 [25MY]

——— revise and extend user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products (H.R. 7667), S4630 [15SE]

——— streamline, coordinate and expand research and foster increased communication between doctors and patients relative to cannabidiol and other marijuana components and their medical benefits (S. 253), S1784 [24MR]

Food Safety Administration: establish, S3323 [18JY]

——— establish (S. 4520), S9715 [21DE]

Health: require manufacturers of dietary supplements to list dietary supplements (S. 4090), S2137 [26AP], S4630 [15SE], S7013 [7DE]

Pharmaceuticals: revise and extend user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, S5171 [28SE]

Reagan-Udall Foundation for the Food and Drug Administration: release of ‘‘Operational Evaluation of the FDA Human Foods Program’’ report, S9715 [21DE]

Tobacco products: address rise in use of e-cigarettes, S466 [2FE], S1161 [15MR], S2556 [18MY], S3103 [23JN], S3252 [13JY], S4630 [15SE]

——— decision to suspend ban on sale of Juul vaping products, S3252 [13JY]

Reports filed

Adopt H. Res. 1434, Reaffirm FDA Preemptive Authority Relative to State Laws That Inhibit Access to or Use of Any Reproductive Health Product: Committee on Rules (House) (H. Res. 1529) (H. Rept. 117–660), H9982 [21DE]

Agriculture, Rural Development, FDA, and Related Agencies Programs Appropriations: Committee on Appropriations (House) (H.R. 8239) (H. Rept. 117–392), H5923 [28JN]

Direct President To Provide Documents Relative to Recall of Infant Formula Manufactured by Abbott Laboratories and Potential Impacts on Supply Chain: Committee on Energy and Commerce (House) (H. Res. 1287) (H. Rept. 117–538), H8370 [30SE]

Direct President To Provide Documents to House of Representatives Relative to Dept. of HHS Actions Taken Relative to Coronavirus Pandemic Response: Committee on Energy and Commerce (House) (H. Res. 1268) (H. Rept. 117–531), H8313 [29SE]

FDA Safety and Landmark Advancements (FDASLA) Act: Committee on Health, Education, Labor, and Pensions (Senate) (S. 4348), S3269 [13JY]

Interagency Patent Coordination and Improvement Act: Committee on the Judiciary (Senate) (S. 4430), S3860 [2AU]

Nomination of Robert M. Califf To Be FDA Commissioner: Committee on Health, Education, Labor, and Pensions (Senate), S219 [13JA]

Revise and Extend FDA User-Fee Programs for Prescription Drugs, Medical Devices, Generic Drugs, and Biosimilar Biological Products: Committee on Energy and Commerce (House) (H.R. 7667) (H. Rept. 117–348), H5331 [7JN]

Statements

FDA User-Fee Programs for Prescription Drugs, Medical Devices, Generic Drugs, and Biosimilar Biological Products Goals and Procedures: Xavier Becerra, Sec. of HHS, S5177–S5220 [28SE]

Tables

Estimated pay-as-you-go effects of H.R. 7667, revise and extend FDA user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, H5330 [7JN]

Texts of

H. Res. 1434, reaffirm FDA preemptive authority relative to State laws that inhibit access to or use of any reproductive health product, H9973 [21DE]

H. Res. 1529, adopt H. Res. 1434, reaffirm FFA preemptive authority relative to State laws that inhibit access to or use of any reproductive health product, H9968 [21DE]

H.R. 2617, agriculture, rural development, FDA, and related agencies programs appropriations, H9790–H9803 [14DE]

H.R. 7667, revise and extend FDA user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, H5298–H5319 [7JN]

H.R. 8454, Medical Marijuana and Cannabidiol Research Expansion Act, H7120–H7122 [26JY]

S. 854, Methamphetamine Response Act, H1156 [28FE]

S. 1662, Supporting the Foundation for the National Institutes of Health and the Reagan-Udall Foundation for the Food and Drug Administration Act, H1159 [28FE]

S. 4090, Dietary Supplement Listing Act, S2156 [26AP]

S. 4430, Interagency Patent Coordination and Improvement Act, S3005 [16JN]

S. 4520, Food Safety Administration Act, S3273 [13JY]

S. 5002, FDA Modernization Act 2.0, S5514 [29SE]