POLICY BRIEFINGS

Egorin Confirmed as HHS Assistant Secretary


The Senate confirmed Melanie Anne Egorin to serve as assistant secretary of Health and Human Services last week. Egorin has previously worked as deputy staff health director for the House Ways and Means Committee. Her nomination was approved by voice vote.


House Judiciary Advances Health, Marijuana Legislation


The House Judiciary Committee advanced four bills last week aimed at curbing anticompetitive practices that result in higher pharmaceutical prices. The Stop Stalling Access to Affordable Medications Act (H.R. 2883) would prohibit the use of citizen petitions by branded-drug companies to keep lower-cost generic competitors off the market. The Preserve Access to Affordable Generics and Biosimilars Act (H.R. 2891) would prohibit manufacturers from compensating other drug companies to delay the entry of a generic or biosimilar product to the market. The Affordable Prescriptions for Patients Through Promoting Competition Act (H.R. 2873) would enable the Federal Trade Commission (FTC) to crack down on product hopping. The Affordable Prescriptions for Patients Through Improvements to Patient Litigation Act (H.R. 2884) would limit the number of patents a biologic drug manufacturer can assert in litigation against a biosimilar competitor. The panel also advanced the Marijuana Opportunity, Reinvestment, and Expungement (MORE) Act (H.R. 3617), which aims to reform federal cannabis regulations by removing marijuana from the list of federally controlled substances and providing for the expungement of Federal marijuana convictions and arrests.


Lawmakers Release Agenda on Mental Health, Addiction


The Bipartisan Addiction and Mental Health Task Force released its 2021 legislative agenda last week. The agenda contains measures that aim to increase access to recovery resources, end the stigma around addiction and mental health, support the public health infrastructure, and create safeguards against the flow of illicit drugs. The lawmakers are asking leadership of the House of Representatives to dedicate at least a week to the consideration of up to 60 addiction and mental health-related measures. The Task Force, announced earlier this year, merged the 116th Congress’ Bipartisan Opioid Task Force and Freshmen Working Group on Addiction.


Burr Releases Latest Brief on Pandemic Response


Ranking Member of the Senate Health, Education, Labor, Pensions (HELP) Committee Richard Burr (R-N.C.) has released the latest in a series of reports on the federal government’s continued pandemic response. The policy brief, “Strengthening FDA’s Regulatory Readiness: Implementing Lessons Learned from the COVID-19 Pandemic,” focuses on the Food and Drug Administration’s (FDA) role throughout the pandemic and the challenges that arose during the agency’s pandemic response. The report contains the following key recommendations:

  • FDA should build on the steps it took to expedite the development and review of tests, therapeutics, and vaccines by encouraging the use of technologies, leveraging cross-agency scientific resources, and providing a clear and predictable pathway for test developers.
  • FDA should prioritize the sustainability of medical product supply chains to prevent future disruptions by simplifying regulatory processes, incentivizing new ways to manufacture medical products, and modernizing the agency’s use of remote tools to conduct inspections.
  • FDA should leverage the regulatory authorities and flexibilities that were used throughout the pandemic to inform long-term improvements at the agency, strengthening overall FDA readiness and operations and enhancing real-time communication with American innovators.


Doc Caucus Urge CDC to Recognize Natural Immunity


Members of the GOP Doctors Caucus have sent a letter to the U.S. Centers for Disease Control and Prevention (CDC) urging the agency to acknowledge natural immunity from COVID-19. “Natural immunity, to date, has been dismissed without adequate scientific acknowledgment and the CDC continues to ignore scientific evidence when making policies to achieve herd immunity,” the letter asserts. The lawmakers asked the CDC to work with other federal agencies to ensure all future policies and federally funded research consider natural immunity. The letter to CDC Director Rochelle Walensky was led by Sen. Roger Marshall, MD (R-Kan.) and signed by Sens. Bill Cassidy, MD (R-La.) and Rand Paul, MD (R-Ky.) and Reps. Andy Harris, MD (R-Md.), Mariannette Miller-Meeks, MD (R-Iowa), Larry Bucshon, MD (R-Ind.), Scott DesJarlais, MD (R-Tenn.), Gregory Murphy, MD (R-N.C.), Neal Dunn, MD (R-Fla.), Diana Harshbarger, PharmD (R-Tenn.), Buddy Carter, R.Ph. (R-Ga.), Jeff Van Drew, DMD (R-N.J.), Ronny Jackson, MD (R-Texas), Mark Green, MD (R-Tenn.), and Brian Babin, DDS (R-Texas).


Three VRBPAC Meetings Announced to Discuss Vaccine Boosters


The Food and Drug Administration (FDA) has announced three forthcoming meetings of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss Janssen and Moderna COVID-19 vaccine boosters, as well as Pfizer data on its COVID-19 vaccine for children aged 5-11. The meetings on vaccine booster doses will be held on October 14 (Moderna) and October 15 (Janssen). The meeting on Pfizer’s latest data will be held on October 26. In related news, President Joe Biden received his booster of the Pfizer-BioNTech COVID-19 vaccine last week. During the event, the President stated that boosters “are important, but that the most important thing we need to do is get more people vaccinated.” Senate Minority Leader Mitch McConnell (R-Ky.) also received his booster dose last week.


Justice Kavanaugh Tests Positive for COVID-19


Supreme Court Justice Brett Kavanaugh announced that he has tested positive for COVID-19. He has been fully vaccinated since January and is not experiencing symptoms. The Supreme Court will open their nine-month term with arguments in five cases this week; Kavanaugh plans to participate virtually from home.


Summary of ARPA-H Listening Sessions Released


The National Institutes of Health (NIH) and the White House have released a report summarizing the listening sessions held to date on the President’s proposed Advanced Research Projects Agency for Health (ARPA-H). Of the fifteen listening sessions, ten sessions, led by NIH, focused on specific research areas. These sessions were open to the public. The remaining five sessions, led by the Office of Science and Technology Policy (OSTP), were invite-only and attended by various stakeholder organizations representing patient advocacy groups, biomedical professional groups, venture capital firms, private industry, and other non-biomedical STEM professional organizations. The report summarizes the major themes that arose across the fifteen listening sessions ranging from specific project or program proposals, potential collaboration avenues, and operational considerations. An additional listening session is planned for October 20 for participants to respond to the summary and offer additional recommendations.


New GAO Report on MIPS Provider Experience, Performance


The Government Accountability Office (GAO) has released a new report on the experience and performance of providers under the Merit-Based Incentive Payment System (MIPS). The report found that from 2017-2019, over 90% of providers earned a small increase (less than 2%) to their Medicare payments. Providers questioned whether MIPS helps to meaningfully improve quality of care or patient outcomes. Some providers interviewed also raised concerns that the program’s design incentivizing reporting over quality improvement.


Upcoming Congressional Hearings and Markup


Senate Commerce, Science, and Transportation Committee hearing “Enhancing Data Security;” 10:00 a.m.; October 6

House Energy and Commerce Subcommittee on Communications and Technology legislative hearing “Strengthening Our Communications Networks to Meet the Needs of Consumers;” 12:00 p.m., 2123 Rayburn Bldg.; October 6

House Veterans’ Affairs Subcommittee on Technology Modernization hearing on the VA Electronic Health Record Transparency Act of 2021 and IT Reform and Data Collection Bills; 10:00 a.m.; October 7

Senate Commerce, Science, and Transportation Subcommittee on Communication, Media, and Broadband hearing to examine the state of telehealth, focusing on removing barriers to access and improving patient outcomes; 10:00 a.m.; October 7



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