Lawmakers Call for Speedy Approval of Rapid COVID Tests

Fourteen bipartisan House lawmakers have sent a letter to Administrator of Food and Drugs Stephen Hahn calling for expedited authorization and lower sensitivity standards for rapid, in-home COVID-19 tests. The letter was led by Reps. Ro Khanna (D-Calif.) and Rodney Davis (R-Ill.). The lawmakers underscore the promise of low-cost, saliva-based, self-administered tests in supporting the affordable and frequent testing that is necessary for Americans to return to a normal way of life. They urge the FDA to “utilize its existing authority and consider options such as providing an expedited pathway for authorization” for the tests.

Lawmakers Press White House for Vaccine Distribution Plans

House Oversight and Reform Chair Carolyn Maloney (D-N.Y.), Economic and Consumer Policy Subcommittee Chair Raja Krishnamoorthi (D-Ill.), and Coronavirus Crisis Select Subcommittee Chair Jim Clyburn (D-S.C.) have written to the U.S. Department of Health and Human Services (HHS) requesting written information as well as a staff briefing on the administration’s plans to distribute an eventual COVID-19 vaccine. The letter expresses concerns that the White House has not yet begun to engage with communities of color about a vaccine or determined how vaccine prioritization decisions will be made. The lawmakers request the information within three weeks. Senate Appropriations Subcommittee Health and Human Services Chairman Roy Blunt (R-Mo.) also sent a letter to Centers for Disease Control and Prevention (CDC) Director Robert Redfield requesting information about the agency’s plans for distributing an eventual COVID-19 vaccine in a fair and equitable way. Blunt’s panel plans to hold a hearing later this month on vaccine development and distribution.

Energy and Commerce Advances 26 Health Bills

The House Energy and Commerce Committee considered 26 health bills during a September 9 markup. Legislation included H.R. 1379, the Ensuring Lasting Smiles Act; H.R. 4078, the EARLY Act Reauthorization; H.R. 4861, the Effective Suicide Screening and Assessment in the Emergency Department Act; as well as bills to expand access to mental health services, combat the opioid epidemic, reauthorize key public health programs, and provide access to marijuana for research. During the markup, Chairman Frank Pallone (D-N.J.) stated his hope that the bills can be considered by the full House.

Democrats Release Report Questioning CMS Administrator Verma’s Spending

Democrats have released a report detailing Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma’s nearly $6 million in spending on private communications consultants. The report follows a 17-month probe into the CMS administrator and calls on the Government Accountability Office (GAO) to investigate potential violations of federal spending laws. The report was compiled by the staff of House Energy and Commerce Committee Chair Frank Pallone (D-N.J.), House Oversight and Reform Committee Chair Carolyn Maloney (D-N.Y.), Senate Finance Committee Ranking Member Ron Wyden (D-Ore.), and Senate Health, Education, Labor, and Pensions (HELP) Ranking Member Patty Murray (D-Wash.). “Congress did not intend for taxpayer dollars to be spent on handpicked communications consultants to promote Administrator Verma’s public profile and personal brand,” the lawmakers said in a statement.

Senator Murray Calls for FDA Action on E-Cigarettes

Following the passage of the deadline for manufacturers of e-cigarettes and other tobacco products to file marketing applications with the FDA, Senator Patty Murray (D-Wash.), ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee called on the Food and Drug Administration to immediately clear the market of those products that failed to comply. She also called on the FDA to ensure transparency in this effort.

Hart Health Strategies COVID-19 Resources

Hart Health Strategies Inc. continues to update the following resources related to the coronavirus pandemic. Please remember to clear your cache to ensure you download the most recent documents.

Upcoming Congressional Hearings and Markups

Senate Appropriations Committee hearing to examine the Department of Health and Human Services’ Coronavirus response, focusing on a review of efforts to date and next steps; 10:00 a.m., G50 Dirksen Bldg.; September 16

House Oversight and Reform Committee markup of legislation including: H.R. 4774, Internet of Things Cybersecurity Training for Federal Employees Act; H.R. 7496, COVID PREPARE Act; and H.R. 7548, PPE Buy America Act; 10:00 a.m., 2154 Rayburn Bldg.; September 16

House Veterans’ Affairs Subcommittee on Oversight and Investigations hearing “Modernizing VA’s Medical Supply Chain: Lessons Learned From the Pandemic;” 2:00 p.m., 210 House Visitors Center; September 16

Senate HELP Committee hearing “COVID-19: An Update on the Federal Response;” 10:00 a.m., G50 Dirksen Bldg.; September 23

Senate Judiciary Committee hearing “Examining Threats to American Intellectual Property: Cyber-attacks and Counterfeits During the COVID-19 Pandemic;” 2:30 p.m., 226 Dirksen Bldg.; September 23

Senate Armed Services Readiness and Management Support Subcommittee hearing “Supply Chain Integrity;” 9:15 a.m., G50 Dirksen Bldg.; October 1

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