FOOD AND DRUG ADMINISTRATION

Amendments

Drugs: authorize use of eligible investigational drugs by patients diagnosed with a disease or condition in which death will occur within a matter of months, or with another eligible illness (H.R. 5247), consideration (H. Res. 787), H1709 [20MR]

——— provide for opioid use disorder prevention, recovery, and treatment (H.R. 6), S6063 [6SE], S6193 [17SE], H5522, H5560, H5561, H5562, H5564, H5565, H5566 [22JN]

——— provide for opioid use disorder prevention, recovery, and treatment (H.R. 6), consideration (H. Res. 949), H5302 [20JN]

Food: define the term natural cheese (S. 2322), S7617, S7623 [13DE]

Food industry: improve and clarify certain nutrition disclosure requirements for restaurants and similar retail food establishments and amend authority to bring certain proceedings (H.R. 772), consideration (H. Res. 725), H794 [6FE]

Health: authorize use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law (S. 204), consideration (H. Res. 905), H4300 [22MY]

Taxation: repeal excise tax on medical devices (H.R. 184), consideration (H. Res. 1011), H7099 [24JY]

Appointments

Conferees: H.R. 6147, Dept. of the Interior, environment, and related agencies and financial services and general Government appropriations, S6101 [6SE], H7900 [6SE]

Articles and editorials

Pelosi Pulled Strings To Let Dying Dallas Lawyer Baron Try Experimental Cancer Drug, H1708 [20MR]

Bills and resolutions

Agriculture, rural development, FDA, and related agencies programs: making appropriations (see S. 2976), S2924 [24MY] (see H.R. 5961), H4728 [24MY]

Animals: expand conditional approval pathway for more animal drugs (see H.R. 5599), H3505 [24AP]

——— reauthorize user fee programs relative to new animal drugs and generic new animal drugs (see S. 2434), S1164 [15FE] (see H.R. 5554), H3441 [18AP]

Business and industry: encourage development of priority antimicrobial products through award of a transferable exclusivity extension period (see H.R. 6294), H5975 [28JN]

——— hold pharmaceutical companies accountable for illegal marketing and distribution of opioid products and for their role in creating and exacerbating the opioid epidemic (see S. 2691), S2218 [17AP] (see H.R. 5782), H3935 [11MY]

——— require manufacturers of drugs to post names of countries in which their drugs are manufactured on their Internet websites (see S. 3105), S4343 [21JN]

Cosmetics: ensure safety (see H.R. 6903), H9089 [26SE]

——— require that children’s cosmetics containing talc include an appropriate warning unless the cosmetics are demonstrated to be asbestos-free (see H.R. 4964), H1074 [8FE]

DEA: regulate selective androgen receptor modulators in the same manner as anabolic steroids (see S. 2742), S2391 [24AP]

Dept. of Agriculture: repeal forfeiture rule for peanuts under the nonrecourse marketing assistance loan program and prohibit funding for development of insect-based foods for human consumption (see S. 3716), S7356 [6DE]

——— submit a report to the FDA on use of a Federal standard of identity for olive oil (see H.R. 5249), H1542 [13MR]

Dept. of HHS: develop a joint action plan to reduce single use drug waste and better manage costs relative to drug vial sizes and drug delivery systems (see H.R. 5867), H4209 [17MY] (see H.R. 6142), H5284 [19JN]

——— ensure medications are affordable through increasing transparency, spurring innovation, and protecting competition (see S. 3411), S6038 [5SE]

——— establish a grant program to create comprehensive opioid recovery centers (see S. 2589), S1947 [22MR] (see H.R. 5327), H1697 [19MR]

——— establish Prescription Safety Alert System to combat prescription drug abuse by collecting, maintaining, and providing to dispensers patients’ prescription and dispensing history (see H.R. 6688), H7776 [28AU]

——— establish single, front-of-package labeling system for all foods required to bear nutrition labeling, eliminate deceptive claims, and update existing nutrition labels (see S. 2647), S2075 [11AP] (see H.R. 5425), H3055 [2AP]

——— issue guidance relative to expedited approval of certain drugs (see H.R. 5806), H3976 [15MY]

——— provide for a national strategy to address and overcome Lyme disease and other tick-borne diseases (see H.R. 5878), H4242 [18MY] (see H.R. 5900), H4284 [21MY]

——— reauthorize certain programs to protect against pandemics and attacks from chemical, biological, radiological, and nuclear weapons (see S. 2852), S2679 [15MY] (see H.R. 6378), H6262 [16JY] (see H.R. 7328), H10335 [19DE]

——— support endemic orphan fungal disease research, incentivize valley fever vaccine development, and discover new antifungal therapies and diagnostics (see H.R. 6562), H7721 [26JY]

Diseases and disorders: facilitate effective research on, and treatment of, neglected tropical diseases through coordinated domestic and international efforts (see S. 3212), S4951 [12JY]

Drugs: allow for detention, refusal, and destruction of certain drugs offered for importation (see H.R. 5752), H3928 [10MY]

——— amend policies relative to postapproval study requirements for certain controlled substances (see H.R. 5811), H3976 [15MY]

——— authorize use of eligible investigational drugs by patients diagnosed with a disease or condition in which death will occur within a matter of months, or with another eligible illness (see H.R. 5247), H1541 [13MR]

——— authorize use of eligible investigational drugs by patients diagnosed with a disease or condition in which death will occur within a matter of months, or with another eligible illness (H.R. 5247), consideration (see H. Res. 787), H1697 [19MR]

——— consider potential for misuse and abuse when determining whether to approve certain drugs (see H.R. 5803), H3976 [15MY]

——— decriminalize marijuana, use tax revenues to assist certain small businesses, research effects on driving and health, restrict advertising to protect children, and expunge certain marijuana-related convictions (see S. 3174), S4734 [28JN]

——— deter opioid abuse and addiction through development of high-quality, evidence-based opioid analgesic prescribing guidelines (see H.R. 6133), H5283 [19JN]

——— encourage development and use of new antimicrobial drugs in order to treat antibiotic-resistant infections (see S. 3787), S7926 [19DE]

——— ensure valid generic drugs may enter the market by removing generic drug exclusivity period from any generic company that enters into pay-for-delay settlements with brand-name drug manufacturers (see S. 2476), S1286 [28FE]

——— improve medical research on marijuana (see H.R. 4825), H552 [18JA]

——— improve oversight of new opioids and education of prescribers, limit availability of addictive painkillers, strengthen prescription drug monitoring, and establish drug disposal programs (see S. 2729), S2342 [23AP] (see H.R. 5865), H4209 [17MY]

——— increase authority to restrict entrance of illicit drugs into the U.S. through international mail facilities (see S. 2739), S2391 [24AP]

——— modify outdated drug labels to reflect new evidence relevant to the drug and its use (see S. 3519), S6355 [27SE]

——— provide for accelerated approval of non-opioid or non-addictive pain medications and treatments for substance use disorders (see S. 2669), S2141 [16AP]

——— provide for delivery of a controlled substance by a pharmacy to an administering practitioner (see H.R. 5202), H1476 [7MR]

——— provide for opioid use disorder prevention, recovery, and treatment (see H.R. 6), H5151 [13JN]

——— provide for opioid use disorder prevention, recovery, and treatment (H.R. 6), concur in Senate amendment (see H. Res. 1099), H9406 [28SE]

——— provide for opioid use disorder prevention, recovery, and treatment (H.R. 6), consideration (see H. Res. 949), H5283 [19JN]

——— provide greater oversight over advertising and other promotion materials for opioid drugs to ensure that such materials do not mislead consumers and exacerbate existing crisis (see S. 3420), S6059 [6SE]

——— require drug manufacturers to disclose prices of prescription drugs in any direct-to-consumer advertising and marketing to practitioners of a drug (see H.R. 6576), H7722 [26JY]

——— require guidance on consideration of claims of opioid sparing and on conditions under which to consider misuse and abuse of drugs in making certain determinations for safety (see S. 2665), S2120 [12AP]

——— require improved packaging and disposal methods with respect to certain drugs (see H.R. 5687), H3781 [7MY]

——— require label of drugs with an increased risk of suicide or depression to prominently detail those side effects (see H.R. 6717), H7919 [6SE]

——— require review of durations of use of approved indications of medically-important antibiotics labeled for use in animals (see S. 3099), S4281 [20JN]

——— require risk evaluation and mitigation strategy communication plans provide information on State and Federal regulation of controlled substances including the option to partially fill a prescription (see S. 2608), S1947 [22MR]

——— require warning labels to be affixed to prescription opioid containers or packaging stating such drugs can cause dependence, addiction, and overdose (see S. 3428), S6142 [12SE]

——— shorten exclusivity period for brand name biological products (see H.R. 6577), H7722 [26JY]

——— strengthen authorities to address counterfeit drugs, illegal and synthetic opioids, and opioid-like substances (see H.R. 5228), H1501 [8MR]

——— strengthen penalties on drug companies that fail to monitor and report suspicious opioid distribution practices and increase transparency of Federal oversight of opioid manufacturing and advertising (see S. 2440), S1164 [15FE]

Fish and fishing: exclude species known as bullet tuna and frigate tuna from the standard of identity established for canned tuna (see H.R. 5024), H1177 [14FE]

Food: define the term natural cheese (see S. 2322), S300 [18JA] (see H.R. 4828), H552 [18JA]

——— define the term natural cheese (S. 2322), consideration (see H. Res. 1185), H10586 [21DE]

——— ensure the safety of imported seafood (see H.R. 6212), H5648 [25JN]

Food industry: improve and clarify certain nutrition disclosure requirements for restaurants and similar retail food establishments and amend authority to bring certain proceedings (H.R. 772), consideration (see H. Res. 725), H782 [5FE]

Government regulations: clarify regulatory framework relative to certain nonprescription drugs that are marketed without an approved new drug application (see S. 2315), S253 [17JA] (see H.R. 5333), H1698 [19MR] (see H.R. 7328), H10335 [19DE]

Health: authorize use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law (S. 204), consideration (see H. Res. 905), H4283 [21MY]

Labeling: provide that labeling of certain single ingredient foods is not required to include the term ‘‘added sugar’’ (see H.R. 6634), H7724 [26JY]

Medicare: encourage use of non-opioid analgesics for management of post-surgical pain (see H.R. 5809), H3976 [15MY]

——— provide coverage of FDA-approved qualifying colorectal cancer screening blood-based tests (see S. 2523), S1578 [8MR] (see S. 2928), S2877 [23MY] (see H.R. 6062), H5021 [8JN]

One Health Program: establish an interagency program to collaborate on the concept that human, animal, and ecosystem health intertwine to make ‘‘one health’’ (see S. 2615), S1947 [22MR]

Orphan Drug Act: affirm importance, commend life-saving accomplishments, and recognize need and continued support for research in development of therapies, treatments, and cures for rare diseases (see S. Res. 690), S7051 [15NO] (see H. Res. 1154), H9568 [16NO]

Patents: prevent inter partes review process for challenging patents from diminishing competition in the pharmaceutical industry and provide incentives for drug innovation (see S. 3738), S7431 [11DE] (see H.R. 7251), H10102 [11DE]

Pharmaceuticals: clarify the orphan drug exception to the annual fee on branded prescription pharmaceutical manufacturers and importers (see H.R. 7324), H10269 [17DE]

——— prohibit biological product manufacurers from compensating biosimilar and interchangeable product companies to delay entry of biosimilar and interchangeable products into the market (see S. 3792), S7926 [19DE]

——— prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market (see S. 3792), S7926 [19DE]

Prescription Drug and Medical Device Price Review Board: establish (see H.R. 5739), H3885 [9MY]

Product safety: ban use of ortho-phthalate chemicals as food contact substances (see S. 3155), S4733 [28JN]

——— require Federal and State mandated information declarations and labeling requirements applicable to chemical composition of, and radiation emitted by, consumer products meet minimum scientific standards (see S. 3019), S3035 [6JN] (see H.R. 6022), H4848 [6JN]

Taxation: repeal excise tax on medical devices (see S. 2287), S138 [10JA]

——— repeal excise tax on medical devices (H.R. 184), consideration (see H. Res. 1011), H6648 [23JY]

Tobacco products: impose additional restrictions on tobacco flavors for use in e-cigarettes (see S. 3319), S5582 [1AU]

——— include e-cigarettes in smoking bans in schools, clarify that educational assistance can be used for e-cigarette prevention by schools, and authorize studies in e-cigarette use prevention (see S. 3701), S7275 [4DE]

E-Mails

Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act: Advocates for Opioid Recovery (organization), H9252 [28SE]

Factsheets

Busting the Myths of Menu Labeling, H818 [6FE]

Letters

Codifying Useful Regulatory Definitions (CURD) Act: Jean Halloran, Charlotte Vallaeys, and William Wallace, Consumer Reports (organization), H10426 [20DE]

——— Jessica Almy and Kenneth Forsberg, Good Food Institute, H10427 [20DE]

——— Sarah Sorscher, Center for Science in the Public Interest, H10426 [20DE]

FDA user fee programs relative to new animal drugs and generic new animal drugs reauthorization: Scott Gottlieb and Steve Solomon, FDA, S5472 [31JY]

Importance of food labeling: Jacob Tannenbaum, S4276 [20JN]

——— Senator Rubio, S4276 [20JN]

Opioid drug abuse prevention legislation: Representative Kevin Brady, Committee on Ways and Means (House), H5033, H5062, H5065 [12JN], H5238, H5241, H5248, H5257, H5260, H5262, H5264 [19JN]

——— Representative Walden, Committee on Energy and Commerce (House), H5033, H5062, H5065 [12JN], H5237, H5241, H5248, H5258, H5260, H5262, H5264 [19JN]

Pandemic and All-Hazards Preparedness and Advancing Innovation Act: Chris Frech, Emergent Biosolutions, Inc., H8787 [25SE]

——— Christopher Healey, Grifols USA, LLC, H8787 [25SE]

——— Cletis Earle, College of Healthcare Information Management Executives (CHIME) and Erik Decker, Association for Executives in Healthcare Information Security (AEHIS), H8787 [25SE]

——— David B. Hoyt, American College of Surgeons (organization), H8778 [25SE]

——— David Burt, Genentech, Inc., H8787 [25SE]

——— Eileen Whalen and Jennifer Ward, Trauma Center Association of America, H8788 [25SE]

——— Jack Kingston, Alliance for Biosecurity and Neil L. Bradley, U.S. Chamber of Commerce, H8777 [25SE]

——— James C. Greenwood, Biotechnology Innovation Organization, H8785 [25SE]

——— Jennifer Nieto Carey, California Life Sciences Association, H8785 [25SE]

——— John Wiesman, Association of State and Territorial Health Officials, H8784 [25SE]

——— Kathy Talkington, Pew Charitable Trusts (organization), H8783 [25SE]

——— Kelly Hoover Thompson, Strategic Health Information Exchange Collaborative, H8788 [25SE]

——— Laurence Corash, Cerus Corp., H8786 [25SE]

——— Linda Rouse O’Neill, Health Industry Distributors Association, H8781 [25SE]

——— Lisa Foster and Abby Bownas, Adult Vaccine Access Coalition, H8777 [25SE]

——— Lori Tremmel Freeman, National Association of County and City Health Officials, H8782 [25SE]

——— Mary Beth Bassett, American Association of Blood Banks, Kate Fry, America’s Blood Centers (organization), and James C. Hrouda, American Red Cross, H8777 [25SE]

——— Michael Fitzpatrick, Cellphire, Inc., H8785 [25SE]

——— Mike Ruley, Allied BioScience, Inc., H8777 [25SE]

——— Paul D. Kivela, American College of Emergency Physicians (organization), H8778 [25SE]

——— Paul G. Auwaerter, Infectious Disease Society of America, H8782 [25SE]

——— Rajeev Venkayya, Takeda Vaccines, Inc., H8788 [25SE]

——— Representative McCaul, Committee on Homeland Security (House), H8779 [25SE]

——— Representative Walden, Committee on Energy and Commerce (House), H8779 [25SE]

——— Richard Hatchett, Coalition for Epidemic Preparedness Innovations, H8786 [25SE]

——— Russell C. Ring, Roche Diagnostics Corp., H8788 [25SE]

——— Stefano Bertuzzi and Allen D. Segal, American Society for Microbiology, H8784 [25SE]

——— William Banner, Jr., and Stephen Kaminski, American Association of Poison Control Centers, H8783 [25SE]

Right To Try Act: Andrew McFadyen, Isaac Foundation, H1740 [21MR]

——— several organizations, H4358 [22MY]

Securing Opioids and Unused Narcotics With Deliberate (SOUND) Disposal and Packaging Act: William Simpson, DisposeRX, Inc., H5236 [19JN]

Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act: Carol Keehan, Catholic Health Association of the U.S., H9252 [28SE]

——— Corporate Health Care Coalition, H9250 [28SE]

——— James A. Klein, American Benefits Council, H9251 [28SE]

——— Peter Morris, Alex Dodd, David White, Jay Higham, and John Steinbrun, Opioid Treatment Program Consortium, H5561 [22JN]

——— several organizations, H9253 [28SE]

——— Suzanne P. Clark, U.S. Chamber of Commerce, H9252 [28SE]

——— Tom Van Coverden, National Association of Community Health Centers, H9251 [28SE]

Lists

Organizations opposed to H.R. 5247, Right To Try Act, H1525 [13MR], H1742 [21MR]

Organizations supporting H.R. 6, Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, H9243 [28SE]

Motions

Drugs: authorize use of eligible investigational drugs by patients diagnosed with a disease or condition in which death will occur within a matter of months, or with another eligible illness (H.R. 5247), H1746 [21MR]

——— provide for opioid use disorder prevention, recovery, and treatment (H.R. 6), H5567 [22JN]

Health: authorize use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law (S. 204), H4363 [22MY]

Remarks in House

Agriculture: prohibit Federal interference in interstate traffic of unpasteurized milk and milk products in final package form for human consumption between States that allow the sale of such products, H4218, H4219 [18MY]

Agriculture, rural development, FDA, and related agencies programs: making appropriations, H7894–H7896 [6SE]

Animals: reauthorize user fee programs relative to new animal drugs and generic new animal drugs (H.R. 5554), H6237–H6242 [16JY]

Barton, Representative: appreciation of opportunity to serve, H10098–H10101 [11DE]

Business and industry: hold pharmaceutical companies accountable for illegal marketing and distribution of opioid products and for their role in creating and exacerbating the opioid epidemic (S. 2691), H3588 [26AP]

DEA: develop training materials covering circumstances when a pharmacist may decline to fill a prescription due to suspicion the prescription is fraudulent, forged, or indicative of abuse (H.R. 4275), H5066, H5067 [12JN]

Dept. of HHS: establish a grant program to create comprehensive opioid recovery centers (H.R. 5327), H3434 [18AP], H5026, H5055–H5057 [12JN]

——— issue guidance relative to expedited approval of certain drugs, H5297 [20JN], H5512, H5516–H5518 [22JN]

——— provide greater transparency of discounts provided by drug manufacturers by requiring Pharmacy Benefit Managers to reimburse community pharamacists at the same rate as high volume box stores, H9541 [16NO]

——— reauthorize certain programs to protect against pandemics and attacks from chemical, biological, radiological, and nuclear weapons (H.R. 6378), H8759–H8789 [25SE]

——— reauthorize certain programs to protect against pandemics and attacks from chemical, biological, radiological, and nuclear weapons (H.R. 7328), H10366–H10393 [20DE]

Drugs: allow for detention, refusal, and destruction of certain drugs offered for importation (H.R. 5752), H5117–H5119 [13JN]

——— amend policies relative to postapproval study requirements for certain controlled substances (H.R. 5811), H5243, H5244 [19JN]

——— authorize evidence based report analyzing current marijuana policies and their effects on communities, H6637 [23JY]

——— authorize use of eligible investigational drugs by patients diagnosed with a disease or condition in which death will occur within a matter of months, or with another eligible illness (H.R. 5247), H1521–H1529, H1530 [13MR], H1738–H1750 [21MR]

——— authorize use of eligible investigational drugs by patients diagnosed with a disease or condition in which death will occur within a matter of months, or with another eligible illness (H.R. 5247), consideration (H. Res. 787), H1704–H1712 [20MR]

——— authorize use of eligible investigational drugs by patients diagnosed with a disease or condition in which death will occur within a matter of months, or with another eligible illness (H.R. 5247), motion to recommit, H1747, H1748 [21MR]

——— deter opioid abuse and addiction through development of high-quality, evidence-based opioid analgesic prescribing guidelines, H5563, H5564 [22JN]

——— improve expanded access program to allow patients access to experimental life-saving drugs, H4364, H4365 [22MY]

——— preserve effectiveness of medically important antimicrobials used in treatment of animal diseases in order to minimize development of antibiotic-resistant bacteria (H.R. 1587), H3825 [8MY]

——— prevent entrance of illicit drugs in the U.S. by international airmail, H3435 [18AP]

——— provide for additional residency positions to help combat opioid crisis, increase funding for opioid abuse crisis, and prohibit delays of generic drugs and biosimilar biological products, H5570 [22JN], E905 [25JN]

——— provide for opioid use disorder prevention, recovery, and treatment (H.R. 6), H5380 [21JN], H5511–H5572 [22JN], H5755 [27JN], H9553 [16NO], E902 [22JN], E950 [28JN]

——— provide for opioid use disorder prevention, recovery, and treatment (H.R. 6), concur in Senate amendment (H. Res. 1099), H9156, H9174–H9255 [28SE]

——— provide for opioid use disorder prevention, recovery, and treatment (H.R. 6), consideration (H. Res. 949), H5294–H5304 [20JN], E901 [22JN]

——— provide for opioid use disorder prevention, recovery, and treatment (H.R. 6), motion to recommit, H5570 [22JN], E905 [25JN]

——— require FDA guidance relative to investigational drug use by eligible patients, provide liability protection for facilitators of investigational treatments and increase transparency of number of such treatments, H1747, H1748 [21MR]

——— require improved packaging and disposal methods with respect to certain drugs (H.R. 5687), H5234–H5237 [19JN], E904 [22JN]

——— strengthen authorities to address counterfeit drugs, illegal and synthetic opioids, and opioid-like substances (H.R. 5228), H5049–H5052 [12JN], H5118 [13JN], E972 [6JY]

Food: define the term natural cheese (S. 2322), H10425–H10427 [20DE]

Food industry: improve and clarify certain nutrition disclosure requirements for restaurants and similar retail food establishments and amend authority to bring certain proceedings (H.R. 772), H815–H821 [6FE], E150 [7FE]

——— improve and clarify certain nutrition disclosure requirements for restaurants and similar retail food establishments and amend authority to bring certain proceedings (H.R. 772), consideration (H. Res. 725), H790–H797 [6FE]

Government regulations: clarify regulatory framework relative to certain nonprescription drugs that are marketed without an approved new drug application (H.R. 5333), H6227–H6237 [16JY]

——— clarify regulatory framework relative to certain nonprescription drugs that are marketed without an approved new drug application (H.R. 7328), H10366–H10393 [20DE]

Health: authorize use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law (H.R. 878), H685 [30JA], H1647 [15MR]

——— authorize use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law (S. 204), H485 [18JA], H4355–H4366 [22MY], H4682 [23MY], E751 [29MY]

——— authorize use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law (S. 204), consideration (H. Res. 905), H4292–H4301 [22MY]

——— authorize use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law (S. 204), motion to recommit, H4364, H4365 [22MY]

Medicare: encourage use of non-opioid analgesics for management of post-surgical pain, H5512, H5513, H5514 [22JN]

National Prescription Drug Take Back Day: observance, H3765 [7MY]

NorthStar Medical Radioisotopes, LLC: approval of domestic production of Moly99, E327 [15MR]

Taxation: repeal excise tax on medical devices, H419 [17JA], H505 [18JA], H10474 [20DE]

——— repeal excise tax on medical devices (H.R. 184), H6572 [19JY], H6636 [23JY], H7119–H7124 [24JY], H7655 [25JY], E1090, E1093 [26JY]

——— repeal excise tax on medical devices (H.R. 184), consideration (H. Res. 1011), H7095–H7100 [24JY]

Remarks in Senate

Agriculture, rural development, FDA, and related agencies programs: making appropriations, S5227, S5230–S5237, S5240, S5241, S5258 [24JY], S5315–S5317, S5327, S5337, S5339 [25JY], S5394, S5398, S5406–S5411 [26JY], S5468 [31JY], S5527–S5531, S5533–S5539 [1AU], S6045 [6SE]

——— making appropriations (S. 2976), S6203 [18SE]

Animals: reauthorize user fee programs relative to new animal drugs and generic new animal drugs (H.R. 5554), S5472–S5474, S5508 [31JY], S5576 [1AU]

Dept. of HHS: allow personal importation of safe and affordable drugs from approved pharmacies in Canada (S. 92), S7221 [29NO]

——— establish a grant program to create comprehensive opioid recovery centers, S6164 [17SE], S6471 [3OC]

Drugs: authorize use of eligible investigational drugs by patients diagnosed with a disease or condition in which death will occur within a matter of months, or with another eligible illness (H.R. 5247), S1981, S1982 [22MR], S1994 [9AP]

——— authorize use of eligible investigational drugs by patients diagnosed with a disease or condition in which death will occur, or with another eligible illness (H.R. 5247), unanimous-consent request, S1981 [22MR]

——— prohibit abusive delay tactics by pharmaceutical companies to block entry of generic drugs and biosimilar biological products from the market (S. 974), S807 [8FE], S5881 [23AU], S7221 [29NO]

——— provide for accelerated approval of non-opioid or non-addictive pain medications and treatments for substance use disorders, S6470 [3OC]

——— provide for opioid use disorder prevention, recovery, and treatment (H.R. 6), S4376 [25JN], S4380 [26JN], S6048–S6050 [6SE], S6116–S6121, S6126, S6149 [12SE], S6159–S6170, S6172–S6178 [17SE], S6198, S6210, S6215–S6217, S6218 [18SE], S7177 [28NO]

——— provide for opioid use disorder prevention, recovery, and treatment (H.R. 6), House amendment, S6432–S6436 [2OC], S6456, S6459, S6463, S6467, S6468–S6474, S6477–S6484, S6489, S6491 [3OC], S6796–S6798 [11OC]

——— provide for opioid use disorder prevention, recovery, and treatment (H.R. 6), unanimous-consent agreement, S6105 [6SE], S6457 [3OC]

——— require drug manufacturers to disclose prices of prescription drugs in any direct-to-consumer advertising and marketing to practitioners of a drug, S5406–S5409 [26JY], S5736 [21AU], S5809–S5811 [22AU], S5882–S5884 [23AU], S7221 [29NO]

——— require warning labels to be affixed to prescription opioid containers or packaging stating such drugs can cause dependence, addiction, and overdose (S. 3428), S6162 [17SE], S6463 [3OC]

——— strengthen penalties on drug companies that fail to monitor and report suspicious opioid distribution practices and increase transparency of Federal oversight of opioid manufacturing and advertising, S3596 [11JN], S6173 [17SE]

Food: define the term natural cheese (S. 2322), S7623 [13DE]

Food industry: improve and clarify certain nutrition disclosure requirements for restaurants and similar retail food establishments and amend authority to bring certain proceedings (H.R. 772), S5340–S5342 [25JY]

——— improve and clarify certain nutrition disclosure requirements for restaurants and similar retail food establishments and amend authority to bring certain proceedings (H.R. 772), unanimous-consent request, S5340 [25JY]

——— inspection of foreign seafood manufacturers and field examinations of imported seafood funding, S5258 [24JY]

Labeling: prohibit funding for regulations to require the term ‘‘added sugar’’ be included on food labels for honey and maple syrup, S5533 [1AU]

——— prohibit funding to enforce identity standards relative to certain foods, S5534, S5535 [1AU]

——— proposed regulations to require the term ‘‘added sugar’’ be included on food labels for honey and maple syrup, S3883 [13JN]

Pharmaceuticals: improve access to affordable prescription drugs, S7220 [29NO]

——— prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market (S. 124), S7220 [29NO], S7889 [19DE]

Product safety: ban use of ortho-phthalate chemicals as food contact substances (S. 3155), S4737 [28JN]

Taxation: repeal excise tax on medical devices, S92 [9JA]

——— repeal excise tax on medical devices (H.R. 184), S5390 [25JY], S5394 [26JY]

Tobacco products: clarify FDA jurisdiction over certain tobacco products and protect jobs and small businesses involved in the sale, manufacturing, and distribution of cigars, S5409–S5411 [26JY]

Reports filed

Agriculture, Rural Development, FDA, and Related Agencies Programs Appropriations: Committee on Appropriations (House) (H.R. 5961) (H. Rept. 115–706), H4728 [24MY]

——— Committee on Appropriations (Senate) (S. 2976) (S. Rept. 115–259), S2923 [24MY]

Common Sense Nutrition Disclosure Act: Committee on Energy and Commerce (House) (H.R. 772) (H. Rept. 115–86), H17 [8JA]

Consideration of H.R. 6, Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act: Committee on Rules (House) (H. Res. 949) (H. Rept. 115–766), H5283 [19JN]

Consideration of H.R. 184, Protect Medical Innovation Act and H.R. 6311, Increasing Access to Lower Premium Plans and Expanding Health Savings Accounts Act: Committee on Rules (House) (H. Res. 1011) (H. Rept. 115–860), H6648 [23JY]

Consideration of H.R. 772, Common Sense Nutrition Disclosure Act, H.R. 1153, Mortgage Choice Act, and H.R. 4771, Small Bank Holding Company Relief Act: Committee on Rules (House) (H. Res. 725) (H. Rept. 115–546), H782 [5FE]

Consideration of H.R. 4456, Alleviating Stress Test Burdens To Help Investors Act and H.R. 5247, Right To Try Act: Committee on Rules (House) (H. Res. 787) (H. Rept. 115–613), H1697 [19MR]

Consideration of S. 204, Right To Try Act: Committee on Rules (House) (H. Res. 905) (H. Rept. 115–698), H4283 [21MY]

Consideration of S. 2322, Codifying Useful Regulatory Definitions (CURD) Act: Committee on Rules (House) (H. Res. 1185) (H. Rept. 115–1103), H10586 [21DE]

Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act: Committee on the Judicary (Senate) (S. 974), S4343 [21JN]

FDA User Fee Programs Relative to New Animal Drugs and Generic New Animal Drugs Reauthorization: Committee on Health, Education, Labor and Pensions (Senate) (S. 2434), S1452 [7MR]

Over-the-Counter Drug Safety, Innovation, and Reform Act: Committee on Health, Education, Labor, and Pensions (Senate) (S. 2315), S2642 [14MY]

Over-the-Counter Monograph Safety, Innovation, and Reform Act: Committee on Energy and Commerce (House) (H.R. 5333) (H. Rept. 115–827), H6262 [16JY]

Pandemic and All-Hazards Preparedness and Advancing Innovation Act: Committee on Health, Education, Labor, and Pensions (Senate) (S. 2852), S3982 [18JN]

Postoperative Opioid Prevention Act: Committee on Energy and Commerce (House) (H.R. 5809) (H. Rept. 115–753), H5151 [13JN]

Statements

Right To Try Act: Senator Johnson, H4360 [22MY]

Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act: American Society of Addiction Medicine, H9252 [28SE]

——— National Association for Behavorial Healthcare, H9251 [28SE]

——— Simona Combi, First Focus Campaign for Children (organization), H9250 [28SE]

Summaries

Animal Drug User Fee Amendments Goals and Procedures, S5509–S5511 [31JY]

Animal Generic Drug User Fee Amendments Goals and Procedures, S5576 [1AU]

Texts of

H. Res. 725, consideration of H.R. 772, Common Sense Nutrition Disclosure Act, H.R. 1153, Mortgage Choice Act, and H.R. 4771, Small Bank Holding Company Relief Act, H790 [6FE]

H. Res. 787, consideration of H.R. 5247, Right To Try Act, H1704 [20MR]

H. Res. 905, consideration of S. 204, Right To Try Act, H4292 [22MY]

H. Res. 949, consideration of H.R. 6, Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, H5294 [20JN]

H. Res. 1011, consideration of H.R. 184, Protect Medical Innovation Act and H.R. 6311, Increasing Access to Lower Premium Plans and Expanding Health Savings Accounts Act, H7095 [24JY]

H. Res. 1099, concur in Senate amendment to H.R. 6, Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, H9174–H9242 [28SE]

H.R. 6, Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, H5522–H5560 [22JN]

H.R. 184, Protect Medical Innovation Act, H7119 [24JY]

H.R. 772, Common Sense Nutrition Disclosure Act, H815 [6FE]

H.R. 4275, Empowering Pharmacists in the Fight Against Opioid Abuse Act, H5066 [12JN]

H.R. 5228, Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now (SCREEN) Act, H5049–H5051 [12JN]

H.R. 5247, Right To Try Act, H1521 [13MR], H1738 [21MR]

H.R. 5327, Comprehensive Opioid Recovery Centers Act, H5055 [12JN]

H.R. 5333, Over-the-Counter Monograph Safety, Innovation, and Reform Act, H6227–H6235 [16JY]

H.R. 5554, FDA user fee programs relative to new animal drugs and generic new animal drugs reauthorization, H6237–H6241 [16JY]

H.R. 5687, Securing Opioids and Unused Narcotics With Deliberate (SOUND) Disposal and Packaging Act, H5234 [19JN]

H.R. 5752, Stop Illicit Drug Importation Act, H5117 [13JN]

H.R. 5811, amend FDA policies relative to postapproval study requirements for certain controlled substances, H5243 [19JN]

H.R. 6378, Pandemic and All-Hazards Preparedness and Advancing Innovation Act, H8759–H8775 [25SE]

H.R. 7328, Pandemic and All-Hazards Preparedness and Advancing Innovation Act, H10366–H10391 [20DE]

S. 204, Right To Try Act, H4355 [22MY]

S. 2322, Codifying Useful Regulatory Definitions (CURD) Act, H10425 [20DE]

S. 2729, Addiction Prevention and Responsible Opioid Practices Act, S2343–S2346 [23AP]

S. 3174, Marijuana Freedom and Opportunity Act, S4740 [28JN]

S. 3319, Stopping Appealing Flavors in E-Cigarettes for Kids (SAFE Kids) Act, S5585 [1AU]

S. Res. 690, affirm importance and commend life-saving accomplishments of Orphan Drug Act, and recognize need and continued support for research in development of therapies, treatments, and cures for rare diseases, S7055 [15NO]