POLICY BRIEFINGS


WHO Director-General Declares Monkeypox Public Health Emergency


World Health Organization Director-General Tedros Adhanom Ghebreyesus declared the global outbreak of monkeypox a public health emergency of international concern on Saturday, personally intervening after nine members of an expert committee expressed opposition to the declaration. Six members of the committee were in favor of the decision. While the U.S. Department of Health and Human Services (HHS) is considering whether to declare monkeypox a public health emergency, White House COVID-19 response coordinator Ashish Jha stated that monkeypox “can be contained” in the U.S. as testing and vaccinations for the illness begin to ramp up. The Biden administration announced a $140 million research agenda focused on vaccines, testing, and treatment for monkeypox to be overseen by the White House Office of Science and Technology Policy. There have been more than 2,000 cases nationwide, and the U.S. is currently able to test 80,000 people a week and has 300,000 vaccines available. The U.S. is also using a smallpox antiviral medication as treatment. While monkeypox is primarily affecting men who have sex with men, two pediatric patients were identified in the U.S. this week.

House Oversight and Reform Committee Chair Carolyn Maloney (D-N.Y.) has sent a letter to HHS calling on the administration to increase access to monkeypox vaccine, treatment, and testing. Maloney states that many hospitals are not testing for monkeypox and that commercial laboratories still do not have the capacity to test all individuals who have been exposed. She requests a response by August 3 and a committee staff briefing by August 5.


ACIP Recommends Novavax COVID-19 Vaccine


The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) voted unanimously to recommend Novavax Inc.’s COVID-19 vaccine for adults. The company’s vaccine is the first protein- based option against COVID-19, which could make it an appealing choice for individuals hesitant to receive a vaccine that uses mRNA technology. The Biden administration has ordered 3.2 million doses of the vaccine, which can be used as another primary series option for individuals ages 18 and older.


HHS Elevates ASPR to Operating Division


The U.S. Department of Health and Human Services (HHS) announced the elevation of the existing Office of the Assistant Secretary for Preparedness and Response (ASPR) from a staff division to an operating division, taking on the new name of the Administration for Strategic Preparedness and Response (ASPR), in recognition of its growing size and scope. ASPR will now perform as a standalone agency within HHS, which the Department states will allow it to “mobilize a coordinated national response more effectively and efficiently during future disasters and emergencies in close collaboration with its sister agencies.” The name and status change went into immediate effect, but the administrative transition will be phased in over the next two years. Dawn O’Connell, Assistant Secretary for Preparedness and Response, will continue to lead ASPR. The agency will continue to oversee the National Disaster Medical System, the Biomedical Advanced Research and Development Authority, and Medical Reserve Corps, the Strategic National Stockpile, and the HHS Coordination Operations and Response Element.


Harvard Surgeon in Line to Lead NCI


President Joe Biden plans to tap Harvard cancer surgeon Monica M. Bertagnolli, M.D. as the next director of the National Cancer Institute (NCI). Bertagnolli is a professor of surgery at Harvard Medical School and chief of the Brigham and Women’s Hospital and Dana-Farber Cancer Institute’s surgical oncology division. Her appointment would make Bertagnolli the 16th NCI director and the first woman to serve in the position, which does not require Senate confirmation. Doug Lowy, NCI’s principal deputy director, has been serving as acting director since Ned Sharpless stepped down from the leadership position in April.


Fauci Announces Plan to Step Down


Dr. Anthony Fauci, the President’s chief medical adviser, announced that he plans to step down from his current position by the end of President Joe Biden’s term in office. Fauci has served as the Director of the National Institute of Allergy and Infectious Disease since 1984. 'We’re in a pattern now. If somebody says, ‘You’ll leave when we don’t have COVID anymore,’ then I will be 105,” Fauci told Politico. “I think we’re going to be living with this.' Pushing back on reports of retirement, Dr. Fauci further said “I have other things that I want to do in a professional way that I want to have the capability [and] while I still have the energy and the passion to do them.'


Upcoming Congressional Hearings and Markups


Senate HELP Committee hearing “Fighting Fentanyl: The Federal Response to a Growing Crisis;” 10:00 a.m.; July 26

Senate Judiciary Subcommittee on Criminal Justice and Counterterrorism hearing to examine decriminalizing cannabis at the Federal level, focusing on necessary steps to address past harms; 2:30 p.m.; July 26

House Veterans’ Affairs Subcommittee on Technology Modernization hearing “Protecting Our Veterans: Patient Safety and Electronic Health Record Modernization Program;” 10:00 a.m.; July 27

Senate Judiciary Committee executive business meeting to consider S.4430, Interagency Patent Coordination and Improvement Act of 2022; 9:00 a.m.; July 28


Recently Introduced Health Legislation


H.R.8398 — To amend title 38, United States Code, to increase the mileage rate offered by the Department of Veterans Affairs through their Beneficiary Travel program for health related travel, and for other purposes. Sponsor: Rep. Brownley, Julia [D-CA-26]; Committees: House - Veterans’ Affairs

S.4544 — A bill to amend the Public Health Service Act to provide health equity for people with disabilities; Sponsor: Sen. Casey, Robert P. [D-PA]; Committees: Senate - Health, Education, Labor, and Pensions

H.R.8405 — To preserve access to abortion medications; Sponsor: Rep. Bush, Cori [D-MO-1]; Committees: House - Energy and Commerce

S.4557 — A bill to protect a person’s ability to access contraceptives and to engage in contraception, and to protect a health care provider’s ability to provide contraceptives, contraception, and information related to contraception; Sponsor: Sen. Markey, Edward J. [D-MA]; Committees: Senate - Health, Education, Labor, and Pensions

H.R.8421 — To preempt States from establishing, implementing, or enforcing any ban on the prescription, provision, or use of a drug, biological product, or device for contraception if such drug, biological product, or device is approved, licensed, cleared, or otherwise authorized for human use by the Food and Drug Administration for contraception, and for other purposes; Sponsor: Rep. Bice, Stephanie I. [R-OK-5]; Committees: House - Energy and Commerce

H.R.8428 — To allow women greater access to safe and effective oral contraceptive drugs intended for routine use; Sponsor: Rep. Hinson, Ashley [R-IA-1]; Committees: House - Ways and Means; Energy and Commerce

S.4575 — A bill to clarify that the Federal Right to Try law applies to schedule I substances for which a phase I clinical trial has been completed and to provide access for eligible patients to such substances pursuant to the Federal Right to Try law; Sponsor: Sen. Booker, Cory A. [D-NJ]; Committees: Senate – Judiciary

H.R.8440 — To clarify that the Federal Right to Try law applies to schedule I substances for which a phase I clinical trial has been completed and to provide access for eligible patients to such substances pursuant to the Federal Right to Try law; Sponsor: Rep. Blumenauer, Earl [D-OR-3]; Committees: House - Energy and Commerce; Judiciary

H.R.8441 — To amend the Patient Protection and Affordable Care Act to ensure that taxpayer funds for health insurance coverage are available only to authorized individuals, and for other purposes; Sponsor: Rep. Buck, Ken [R-CO-4]; Committees: House - Energy and Commerce; Ways and Means

H.R.8452 — To amend the Public Health Service Act to authorize grants to eligible entities to pay for travel-related expenses and logistical support for individuals with respect to accessing abortion services, and for other purposes; Sponsor: Rep. Strickland, Marilyn [D-WA-10]; Committees: House - Energy and Commerce

S.4591 — A bill to decriminalize and deschedule cannabis, to provide for reinvestment in certain persons adversely impacted by the War on Drugs, to provide expungement of certain cannabis offenses, and for other purposes; Sponsor: Sen. Booker, Cory A. [D-NJ]; Committees: Senate – Finance

S.4593 — A bill to amend title XIX of the Social Security Act to require the Secretary of Health and Human Services to make certain information available on a public website relating to intermediate care facilities for individuals with intellectual disabilities certified for participation under the Medicaid program, and for other purposes; Sponsor: Sen. Kelly, Mark [D-AZ]; Committees: Senate – Finance

H.Res.1244 — Of inquiry requesting the President and directing the Secretary of Health and Human Services to transmit, respectively, certain documents to the House of Representatives relating to any COVID-19 vaccine; Sponsor: Rep. Gosar, Paul A. [R-AZ-4]; Committees: House - Energy and Commerce

H.R.8454 — To expand research on cannabidiol and marijuana, and for other purposes; Sponsor: Rep. Blumenauer, Earl [D-OR-3]; Committees: House - Energy and Commerce; Judiciary

H.R.8468 — To amend title XIX of the Social Security Act to require the Secretary of Health and Human Services to make certain information available on a public website relating to intermediate care facilities for individuals with intellectual disabilities certified for participation under the Medicaid program, and for other purposes; Sponsor: Rep. Gallego, Ruben [D-AZ-7]; Committees: House - Energy and Commerce

H.R.8481 — To amend the Public Health Service Act with respect to public health data accessibility, and for other purposes; Sponsor: Rep. Underwood, Lauren [D-IL-14]; Committees: House - Energy and Commerce



July 25, 2022: | Page 1 Page 2

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