POLICY BRIEFINGS


Energy and Commerce Requests Briefing on Generic Marketing


Bipartisan leadership of the House Energy and Commerce Committee have requested a briefing from Commissioner of Food and Drugs Stephen Hahn about marketing status reporting requirements for generic drugs. The Food and Drug Administration Reauthorization Act of 2017 (FDARA) requires certain drug applicants to notify the agency about marketing status, withdrawals from the market, and when a drug will not be for sale within 180 days of FDA approval. The lawmakers express concerns about actions possibly taken by manufacturers to manipulate the market, pointing to “instances where generic manufacturers allegedly exited the market temporarily to suppress competition and fix prices.” They ask for details about temporary market withdrawals reported to FDA, how FDA is monitoring and tracking marketing status information, and whether FDA is addressing gaps or overlaps in information manufacturers must report when withdrawing from the market.


Meadows to Replace Mulvaney as White House Chief of Staff


President Trump announced that Rep. Mark Meadows (R-N.C.) will replace Mick Mulvaney as his chief of staff. Rep. Meadows is the former chairman of the House Freedom Caucus and the current ranking member of the House Oversight and Reform Committee. He planned to retire from Congress at the end of the year. Mulvaney will be appointed as U.S. special envoy for Northern Ireland.


Upcoming Congressional Hearings and Markups


House Appropriations Subcommittee on Labor, Health and Humans Services, Education and Related Agencies hearing titled “Centers for Disease Control and Prevention Budget Request for FY 2021;” 10:00 a.m., 2358-C Rayburn Bldg.; March 10

House Oversight and Reform Subcommittee on National Security hearing “U.S. Biodefense and Response to the Novel Coronavirus Outbreak;” 2:00 p.m., 2154 Rayburn Bldg.; March 10

House Homeland Security Subcommittee on Emergency Preparedness, Response, and Recovery hearing “Community Perspectives on Coronavirus Preparedness and Response;” 2:00 p.m., 310 Cannon Bldg.; March 10

House Oversight and Reform Committee hearing “Coronavirus Preparedness and Response;” 10:00 a.m., 2154 Rayburn Bldg. March 11

House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies hearing “Food and Drug Administration Budget Request for FY2021;” 11:00 a.m., 2362-A Rayburn Bldg.; March 11

House Homeland Security Committee hearing “Confronting the Coronavirus: The Federal Response;” 2:00 p.m., 310 Cannon Bldg.; March 11

House Veterans Affairs Subcommittee on Health hearing “Resilience and Coping: Mental Health of Women Veterans;” 2:00 p.m., 210 Capitol Bldg.; March 11

House Appropriations Subcommittee on State, Foreign Operations, and Related Programs Public Witness Day; 8:30 a.m., 2358-C Rayburn Bldg.; March 12

House Appropriations Subcommittee on Defense Member Day; 9:00 a.m., H-140 Capitol Bldg.; March 12

House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies Public Witness Day; time and location TBA; March 24


Recently Introduced Health Legislation


H.Res.873 — Recognizing the impact and importance of improving prevention, detection, and treatment modalities for African-American women with cardiovascular disease and diabetes; Sponsor: Rep. Beatty, Joyce [D-OH-3]; Committees: House - Energy and Commerce

H.Res.874 — Expressing support for the annual Heart Valve Disease Awareness Day on February 22, 2020, coinciding with American Heart Month; Sponsor: Rep. Beatty, Joyce [D-OH-3]; Committees: House - Energy and Commerce

H.R.5991 — To extend protections to part-time workers in the areas of family and medical leave and pension plans, and to ensure equitable treatment in the workplace; Sponsor: Rep. Schakowsky, Janice D. [D-IL-9]; Committees: House - Education and Labor; House Administration; Oversight and Reform; Ways and Means; Judiciary

H.R.5997 — To direct the Secretary of Health and Human Services to designate an official within the Department of Health and Human Services to coordinate the efforts of Federal departments and agencies with respect to COVID-19; Sponsor: Rep. Engel, Eliot L. [D-NY-16]; Committees: House - Energy and Commerce

H.R.6003 — To exempt certain Federal first responder grants from matching fund requirements to address the Nation’s rising rate of first responder suicides and other mental health issues, and for other purposes; Sponsor: Rep. Kelly, Robin L. [D-IL-2]; Committees: House - Judiciary; Science, Space, and Technology

H.R.6004 — To amend title XXVII of the Public Health Service Act to require the Secretary of Health and Human Services to establish a grant program for purposes of facilitating State efforts to establish or maintain all-payer claims databases, and for other purposes; Sponsor: Rep. Lipinski, Daniel [D-IL-3]; Committees: House - Energy and Commerce; Education and Labor

H.R.6005 — To amend title XXVII of the Public Health Service Act to increase transparency of group health plans and health insurance issuers offering group or individual health insurance coverage by removing gag clauses on price and quality information, and for other purposes; Sponsor: Rep. Malinowski, Tom [D-NJ-7]; Committees: House - Energy and Commerce

H.R.6008 — To direct the Attorney General to develop crisis intervention training tools for use by first responders related to interacting with persons who have a traumatic brain injury, another form of acquired brain injury, or post-traumatic stress disorder, and for other purposes; Sponsor: Rep. Pascrell, Bill, Jr. [D-NJ-9]; Committees: House - Judiciary; Energy and Commerce

H.R.6019 — To expand the tropical disease product priority review voucher program to encourage treatments for coronavirus; Sponsor: Rep. Jeffries, Hakeem S. [D-NY-8]; Committees: House - Energy and Commerce

S.Res.511 — A resolution supporting the role of the United States in helping save the lives of children and protecting the health of people in developing countries with vaccines and immunization through GAVI, the Vaccine Alliance; Sponsor: Sen. Rubio, Marco [R-FL]; Committees: Senate - Foreign Relations

S.Res.513 — A resolution designating February 2020 as “American Heart Month” and February 7, 2020, as “National Wear Red Day”; Sponsor: Sen. Sinema, Kyrsten [D-AZ]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Voice Vote.

S.3342 — A bill to amend the Controlled Substances Act to prohibit the deceptive sale of fentanyl, and for other purposes; Sponsor: Sen. Cotton, Tom [R-AR]; Committees: Senate – Judiciary

S.3343 — A bill to amend the Federal Food, Drug, and Cosmetic Act to provide enhanced security for the medical supply chain; Sponsor: Sen. Hawley, Josh [R-MO]; Committees: Senate - Health, Education, Labor, and Pensions

S.3346 — A bill to amend the Homeland Security Act of 2002 to authorize the use of Homeland Security Grant Program funds for anti-blood loss purposes, and for other purposes; Sponsor: Sen. Menendez, Robert [D-NJ]; Committees: Senate - Homeland Security and Governmental Affairs

S.3350 — A bill to amend title XVIII of the Social Security Act to deem certain State Veterans homes meeting certain health and safety standards as meeting conditions and requirements for skilled nursing facilities under the Medicare and Medicaid programs; Sponsor: Sen. Crapo, Mike [R-ID]; Committees: Senate – Finance

S.3351 — A bill to direct the Director of the National Science Foundation to support multidisciplinary research on the science of suicide, and to advance the knowledge and understanding of issues that may be associated with several aspects of suicide including intrinsic and extrinsic factors related to areas such as wellbeing, resilience, and vulnerability; Sponsor: Sen. Cornyn, John [R-TX]; Committees: Senate - Commerce, Science, and Transportation

S.3353 — A bill to amend title XVIII of the Social Security Act to provide for extended months of Medicare coverage of immunosuppressive drugs for kidney transplant patients, and for other purposes; Sponsor: Sen. Cassidy, Bill [R-LA]; Committees: Senate – Finance

S.3354 — A bill to amend the Child Nutrition Act of 1966 to establish a community health partnership grant program; Sponsor: Sen. Brown, Sherrod [D-OH]; Committees: Senate - Agriculture, Nutrition, and Forestry

S.3358 — A bill to extend protections to part-time workers in the areas of family and medical leave and pension plans, and to ensure equitable treatment in the workplace; Sponsor: Sen. Warren, Elizabeth [D-MA]; Committees: Senate - Health, Education, Labor, and Pensions

H.Res.880 — Supporting the designation of March 2020 as National Colorectal Cancer Awareness Month; Sponsor: Rep. Payne, Donald M., Jr. [D-NJ-10]; Committees: House - Oversight and Reform

H.R.6049 — To amend the Federal Food, Drug, and Cosmetic Act to provide enhanced security for the medical supply chain; Sponsor: Rep. Gallagher, Mike [R-WI-8]; Committees: House - Energy and Commerce

S.3370 — A bill to conduct or support further comprehensive research for the creation of a universal coronavirus vaccine; Sponsor: Sen. Markey, Edward J. [D-MA]; Committees: Senate - Health, Education, Labor, and Pensions

S.3372 — A bill to amend the Public Health Service Act to provide for treatment of certain respiratory protective devices as covered countermeasures for purposes of targeted liability protections for pandemic and epidemic products and security countermeasures, and for other purposes; Sponsor: Sen. Fischer, Deb [R-NE]; Committees: Senate - Health, Education, Labor, and Pensions

H.Res.883 — Expressing support for designation of March 3, 2020, as National Triple-Negative Breast Cancer Day; Sponsor: Rep. Morelle, Joseph D. [D-NY-25]; Committees: House - Oversight and Reform

H.R.6062 — To amend certain provisions in the Federal Food, Drug, and Cosmetic Act relating to the discontinuance or interruption in the production of life-saving drugs so as to apply such provisions with respect to life-saving devices, and for other purposes; Sponsor: Rep. Schneider, Bradley Scott [D-IL-10]; Committees: House - Energy and Commerce



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SERVICES




BRIEFING ARCHIVE


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