FEDERAL FOOD, DRUG, AND COSMETIC ACT

Amendments

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

——— 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]

Bills and resolutions

Dept. of HHS: 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]

——— 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]

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

FDA: 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]

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

——— 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]

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

——— 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]

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

——— ensure safety of cosmetics (see H.R. 6903), H9089 [26SE]

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

——— 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]

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

——— 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]

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

——— 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]

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

——— 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]

——— 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]

——— 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 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]

——— 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]

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]

Tobacco products: 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]

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]

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: several organizations, H4358 [22MY]

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

Motions

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]

Dept. of HHS: 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: 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 legitimate use of medicinal marijuana in accordance with State laws, H21 [9JA], H471–H475 [17JA]

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

FDA: 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]

——— 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]

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

——— 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]

——— 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]

——— 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]

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

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]

Remarks in Senate

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

Drugs: 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]

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

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

——— 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]

——— 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]

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

——— 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]

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

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

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 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]

Statements

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

Summaries

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

Animal Generic Drug User Fee Amendments Goals and Procedures: FDA, 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. 905, consideration of S. 204, Right To Try Act, H4292 [22MY]

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

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