POLICY BRIEFINGS

FDA Commissioner Nomination Expected in Coming Weeks

President Joe Biden is closing in on a nominee to head the Food and Drug Administration (FDA) and is expected to announce his decision prior to November 15. Current names reportedly under consideration include Laurie Glimcher, president and CEO of the Dana-Farber Cancer Institute; Joshua Sharfstein, a former FDA deputy commissioner; and Michelle McMurry-Heath, head of the Biotechnology Innovation Organization. The White House faces a legal deadline to pick a nominee. Janet Woodcock, who is currently serving as acting FDA commissioner, can only remain in charge of the agency until mid-November unless she or another individual has been officially nominated for the position.

Senate Confirms DHS General Counsel

The Senate confirmed Jonathan Meyer as general counsel of the Department of Homeland Security (DHS) last week. Meyer’s nomination was advanced by a 51-47 vote. As DHS’ chief legal official, Meyer will play a role in shaping the department’s immigration, cybersecurity, and counterterrorism policies. He previously worked as DHS deputy general counsel and senior counselor during the Obama administration.

DoD Sets Deadline for Civilian Vaccination

Department of Defense civilian employees will be required to be fully vaccinated against COVID-19 by November 22, 2021, according to an announcement from the department last week. Those with previous COVID-19 infections or previous serology will not be considered fully vaccinated for the purposes of this mandate. Additional guidance, including procedures for processing vaccination exemption requests, will be published by the Under Secretary of Defense for Personnel and Readiness in the future.

Upcoming Congressional Hearings and Markups

House Veterans’ Affairs Subcommittee on Health legislative hearing; 2:00 p.m.; October 13

House Energy and Commerce Subcommittee on Consumer Protection and Commerce legislative hearing “Investing in American Jobs: Legislation to Strengthen Manufacturing and Competitiveness;” 12:00 p.m.; October 14

Recently Introduced Health Legislation

H.R.5474 — To make exclusive the authority of the Federal Government to regulate the labeling of products made in the United States and introduced in interstate or foreign commerce, and for other purposes. Sponsor: Rep. Trahan, Lori [D- MA-3]; Committees: House - Energy and Commerce

H.R.5471 —To amend the Occupational Safety and Health Act of 1970 to prohibit the Secretary of Labor from issuing a temporary standard with respect to COVID-19 vaccination or testing, and for other purposes. Sponsor: Rep. Tenney, Claudia [R-NY-22]; Committees: House - Education and Labor

H.R.5469 — To amend the 21st Century Cures Act to support State and local agencies with responsibility for children services in their response to the opioid abuse crisis, and for other purposes. Sponsor: Rep. Strickland, Marilyn [D-WA-10]; Committees: House - Energy and Commerce

H.R.5467 — To amend the Federal Food, Drug, and Cosmetic Act to clarify that artificial intelligence and machine learning technologies can qualify as a practitioner eligible to prescribe drugs if authorized by the State involved and approved, cleared, or authorized by the Food and Drug Administration, and for other purposes. Sponsor: Rep. Schweikert, David [R-AZ-6]; Committees: House - Energy and Commerce

H.R.5465 — To amend title 18, United States Code, to require federally licensed firearms importers, manufacturers, and dealers to meet certain requirements with respect to securing their firearms inventory, business records, and business premises. Sponsor: Rep. Schneider, Bradley Scott [D-IL-10]; Committees: House – Judiciary

H.R.5464 —To prohibit the imposition of a fine, fee, or taxation on any person for violation of a COVID-19 vaccine mandate issued by the Occupational Safety and Health Administration or any other executive agency, and for other purposes. Sponsor: Rep. Roy, Chip [R-TX-21]; Committees: House - Energy and Commerce; Education and Labor; Oversight and Reform; Ways and Means

H.R.5463 — To increase reporting requirements and transparency requirements in the 340B Drug Pricing Program, and for other purposes. Sponsor: Rep. Rosendale Sr., Matthew M. [R-MT-At Large]; Committees: House - Energy and Commerce; Ways and Means

H.R.5462 — To amend the Internal Revenue Code of 1986 to repeal the excise tax on indoor tanning services. Sponsor: Rep. Reed, Tom [R-NY-23]; Committees: House - Ways and Means

H.R.5461 — To rescind 1.3 percent of total defense spending and authorize the same amount for international COVID vaccine production and distribution. Sponsor: Rep. Pocan, Mark [D-WI-2]; Committees: House - Foreign Affairs; Appropriations

H.R.5452 — To amend title XVIII of the Social Security Act to include physical therapists as practitioners able to furnish telehealth services under the Medicare program. Sponsor: Rep. Hinson, Ashley [R-IA-1]; Committees: House - Energy and Commerce; Ways and Means

H.R.5450 — To prohibit the use of Federal funds to implement or enforce a COVID-19 vaccine mandate, and for other purposes. Sponsor: Rep. Harshbarger, Diana [R-TN-1]; Committees: House - Energy and Commerce; Education and Labor; Oversight and Reform; Ways and Means

H.R.5442 — To direct the Secretary of Health and Human Services to submit to Congress a report on actions taken by the Secretary to ensure compliance with disclosure requirements relating to foreign influence. Sponsor: Rep. Curtis, John R. [R-UT-3]; Committees: House - Energy and Commerce

H.R.5440 — To amend the Homeland Security Act of 2002 to establish the Cyber Incident Review Office in the Cybersecurity and Infrastructure Security Agency of the Department of Homeland Security, and for other purposes. Sponsor: Rep. Clarke, Yvette D. [D-NY-9]; Committees: House - Homeland Security

H.R.5436 —To prohibit the sale of a firearm unless the firearm or packaging carries a label that provides the number of the National Suicide Prevention Lifeline. Sponsor: Rep. Brownley, Julia [D-CA-26]; Committees: House - Energy and Commerce

H.R.5435 — To amend the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to establish a Neuroscience Center of Excellence and a Neuroscience Translation Working Group, and for other purposes. Sponsor: Rep. Blumenauer, Earl [D-OR-3]; Committees: House - Energy and Commerce

H.R.5432 — To amend the Families First Coronavirus Response Act to require group health plans and health insurance issuers to cover T cell immune response testing without the imposition of cost sharing. Sponsor: Rep. Miller-Meeks, Mariannette [R-IA-2]; Committees: House - Energy and Commerce; Ways and Means; Education and Labor

H.R.5430 —To amend title XVIII of the Social Security Act to provide coverage for wigs as durable medical equipment under the Medicare program, and for other purposes. Sponsor: Rep. McGovern, James P. [D-MA-2]; Committees: House - Energy and Commerce; Ways and Means

H.Res.698 — Supporting the designation of October 2, 2021, as World Ostomy Day and National Ostomy Awareness Day. Sponsor: Rep. Payne, Donald M., Jr. [D-NJ-10]; Committees: House - Oversight and Reform

S.2925 — A bill to provide for a strategic plan for the domestic manufacture of necessary medical supplies or supplies needed to facilitate emergency or medical response, and for other purposes; Sponsor: Sen. Rosen, Jacklyn [D-NV]; Committees: Senate - Health, Education, Labor, and Pensions

H.R.5478 — To direct the Secretary of Health and Human Services to require disclosure of participation in foreign talent programs as a condition of receipt of Federal extramural biomedical research; Sponsor: Rep. Bilirakis, Gus M. [R-FL-12]; Committees: House - Energy and Commerce

H.R.5479 — To establish the Supply Chain Resiliency and Crisis Response Office in the Department of Commerce, and for other purposes; Sponsor: Rep. Bourdeaux, Carolyn [D-GA-7]; Committees: House - Energy and Commerce

H.R.5480 — To clarify the applicability of the Religious Freedom Restoration Act of 1993 to rules issued under the Occupational Safety and Health Act of 1970 and to amend such Act to prohibit emergency temporary standards with respect to vaccines, and for other purposes; Sponsor: Rep. Estes, Ron [R-KS-4]; Committees: House - Education and Labor

H.R.5487 — To improve research and data collection on stillbirths, and for other purposes; Sponsor: Rep. Herrera Beutler, Jaime [R-WA-3]; Committees: House - Energy and Commerce

H.R.5488 — To amend the Public Health Service Act to clarify that the Secretary of Health and Human Services shall lead all Federal public health and medical response to emergencies and disasters declared by the President pursuant to the National Emergencies Act or the Robert T. Stafford Disaster Relief and Emergency Assistance Act, and for other purposes; Sponsor: Rep. Hudson, Richard [R-NC-8]; Committees: House - Energy and Commerce; Transportation and Infrastructure; Homeland Security

H.R.5491 — To authorize the Director of the Cybersecurity and Infrastructure Security Agency to designate certain elements of critical infrastructure as systemically important, and for other purposes; Sponsor: Rep. Katko, John [R-NY-24]; Committees: House - Homeland Security

H.R.5492 — To establish an Office of Manufacturing Security and Resilience in the Department of Commerce, and for other purposes; Sponsor: Rep. Kinzinger, Adam [R-IL-16]; Committees: House - Energy and Commerce

H.R.5495 — To establish the Supply Chain Resiliency and Crisis Response Office in the Department of Commerce, and for other purposes; Sponsor: Rep. Malinowski, Tom [D-NJ-7]; Committees: House - Energy and Commerce

H.R.5503 — To amend title XVIII of the Social Security Act to preserve access to rehabilitation innovation centers under the Medicare program; Sponsor: Rep. Schakowsky, Janice D. [D-IL-9]; Committees: House - Ways and Means; Energy and Commerce

H.R.5505 — To establish a National Resilience Center of Excellence in the Department of Commerce, and for other purposes; Sponsor: Rep. Wild, Susan [D-PA-7]; Committees: House - Energy and Commerce

S.2941 — A bill to amend the Public Health Service Act to limit the liability of health care professionals who volunteer to provide health care services in response to a disaster; Sponsor: Sen. Cassidy, Bill [R-LA]; Committees: Senate - Health, Education, Labor, and Pensions

S.2952 — A bill to amend the Federal Food, Drug, and Cosmetic Act to allow manufacturers and sponsors of a drug to use alternative testing methods to animal testing to investigate the safety and effectiveness of a drug, and for other purposes; Sponsor: Sen. Paul, Rand [R-KY]; Committees: Senate - Health, Education, Labor, and Pensions

S.2971 — A bill to require the Secretary of Labor to revise the Standard Occupational Classification System to accurately count the number of emergency medical services practitioners in the United States; Sponsor: Sen. Casey, Bob [D-PA]; Committees: Senate - Health, Education, Labor, and Pensions

S.2973 — A bill to establish an Inspector General of the National Institutes of Health; Sponsor: Sen. Blackburn, Marsha [R- TN]; Committees: Senate - Health, Education, Labor, and Pensions

S.2974 — A bill to amend the Public Health Service Act to provide for a Reducing Youth Use of E-Cigarettes Initiative; Sponsor: Sen. Blumenthal, Richard [D-CT]; Committees: Senate - Health, Education, Labor, and Pensions

S.2982 — A bill to authorize the Secretary of Health and Human Services to award grants to establish or expand programs to implement evidence-aligned practices in health care settings for the purpose of reducing the suicide rates of covered individuals, and for other purposes; Sponsor: Sen. Schatz, Brian [D-HI]; Committees: Senate - Health, Education, Labor, and Pensions

S.2983 — A bill to provide for an accelerated approval pathway for certain drugs that are authorized to be lawfully marketed in other countries; Sponsor: Sen. Braun, Mike [R-IN]; Committees: Senate - Health, Education, Labor, and Pensions

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