POLICY BRIEFINGS

Lawmakers Warn Against Administration’s New LDT Policy


Democratic leadership of the House Energy and Commerce Committee have written to U.S. Department of Health and Human Services (HHS) Secretary Alex Azar raising significant concerns about the decision to allow laboratorydeveloped tests (LDTs) to come to market without review by the Food and Drug Administration (FDA), characterizing the move as a “grave mistake.” The FDA announced last week via an update to its General FAQs that it will no longer be reviewing LDTs, even if requested by the lab sponsor, in line with Secretary Azar’s decision. “This new policy,” the lawmakers argue, “could lead to numerous faulty tests on the market, raising serious concerns about the reliability of tests used to detect COVID-19…This decision will increase the chances of false negative results, endangering countless lives, and weakening our understanding of COVID-19 as we head into fall and winter.”


Oversight Panel Investigates Political Interference at FDA, CDC


House Oversight and Reform Subcommittee on Economic and Consumer Policy Chairman Raja Krishnamoorthi (D-Ill.) is adding to a growing number of probes investigating political influence into scientific decisions being made by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) related to the coronavirus pandemic. The letter addressed to FDA Commissioner Stephen Hahn and CDC Director Robert Redfield Krishnamoorthi requests information detailing changes made by the White House during its review process of the agencies’ communications. The subcommittee asks the agencies to respond by October 19.


E&C Asks for Probe of HHS Cybersecurity Abilities


Bipartisan leadership of the House Energy and Commerce Committee are asking the Government Accountability Office (GAO) to evaluate the U.S. Department of Health and Human Services’ (HHS) cybersecurity incident response capabilities. Their request is based on the agency’s own expressed concerns and recent past cybersecurity incidents. “Given the types of information created, stored, and shared on the information systems owned and operated by HHS, it is important that the agency implement effective incident response handling processes and procedures to address persistent cyber-based threats,” the lawmakers stress, especially in the midst of the COVID-19 pandemic.


E&C GOP Request Information on HHS Program Support Center


Republican leadership of the House Energy and Commerce Committee sent a letter to U.S. Department of Health and Human Services (HHS) Secretary Alex Azar to share their concerns about the HHS Program Support Center (PSC), which was created to provide comprehensive acquisition management services for HHS and federal agencies. The PSC recently abruptly terminated several agreements facilitated between non-HHS agencies. The lawmakers question whether HHS contracting for non-HHS agencies is appropriate and legal. “Even if HHS believed that the PSC had the legal authority to administer contracts for other agencies, it is not clear why the PSC did not have policies, procedures, and internal controls in place to support this activity. This not only has ramifications for the PSC’s non-HHS agency contract actions valued at more than a half billion dollars in FY 2019, but possibly for other HHS revolving funds that might be used to support non-HHS agencies,” the letter states. Ranking Member Greg Walden (R-Ore.) and Oversight and Investigations Subcommittee Ranking Member Brett Guthrie (R-Ky.) request information about how the PSC works and what fees it charges.


2nd Presidential Debate Cancelled


The Commission on Presidential Debates has canceled the second Presidential debate of this election cycle originally scheduled for October 15 between President Trump and Joe Biden. The President objected to participating in a virtual debate, after the event format was changed from an in-person town hall in Miami following his diagnosis with COVID-19.


Whistleblower Scientist Bright Resigns from NIH


Dr. Rick Bright submitted his resignation from the National Institutes of Health (NIH) last week. Bright is the former director of the Biomedical Advanced Research and Development Authority (BARDA) and the person at the center of a whistleblower complaint against the administration’s hydroxychloroquine strategy. Bright claims that NIH leadership opposed his recommendations related to the COVID-19 pandemic response for political reasons and sidelined him from doing meaningful work at the agency. Bright was transferred to NIH from BARDA this spring after raising concerns about political interference in scientific decision-making.


Providers Call for Fix to MPFS Budget Neutrality


A coalition representing 47 organizations and 1.4 million physician and non-physician providers have sent a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma expressing concerns about the proposed budget neutrality reduction proffered by the agency in its 2021 Medicare Physician Fee Schedule (PFS) proposed rule. The organizations warn that the change could jeopardize the financial viability of providers, reduce access to medically necessary specialty services, and decrease lifesaving cancer screening services. The letter argues that CMS has significant administrative discretion in administering the budget neutrality provision, and that the administration could mitigate the impact of budget neutrality by utilizing funds outside of the PFS under the unique circumstances of the current public health emergency (PHE).


FDA Releases Vaccine Guidance


The Food and Drug Administration (FDA) has released the standards it will use in the emergency use authorization (EUA) of an eventual COVID-19 vaccine. The guidance will require manufacturers to monitor clinical trial participants for a median of two months after administering the last shot, a time frame which could be shortened depending on the data. The White House temporarily blocked the agency from publishing the guidance last week, following insistence from President Trump that a vaccine could be available before the November 3 election. While administration officials claimed that the pharmaceutical industry had expressed opposition to the FDA benchmarks, the FDA stated that it had heard no such complaints and the industry has publicly supported the agency’s expectations for demonstrating safety and efficacy. The guidance decreases the likelihood that any vaccine will receive an EUA before the election.



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