Amidst Unprecedented Shortage, Lawmakers Urge Change to Blood Donation Guidelines

More than 20 Democratic senators have sent a letter to administration officials urging the Food and Drug Administration (FDA) to update its blood donation guidelines to allow men who have had sex with men to donate blood without a deferral. The lawmakers highlight the “urgent crisis” facing America’s blood supply and ask that the agency reassess the existing three-month deferral period for gay and bisexual men. A similar letter was penned by House Oversight and Reform Committee Chair Carolyn Maloney (D-N.Y.) and signed by Reps. Alexandria Ocasio-Cortez (D-N.Y.), Jamie Raskin (D-Md.), and Katie Porter (D-Calif.).

McConnell to Run for Reelection

Senate Minority Leader Mitch McConnell (R-Ky.) announced that he will seek another term as GOP leader in the U.S. Senate at the end of this year. McConnell is currently serving his seventh term in the Senate and will not be up for reelection until 2026. The Senate Republican Conference’s term-limit rules for leadership positions do not apply to the top leadership post. No Republican senators have announced that they will challenge McConnell for the position.

Democrat to Fill Late-Hastings Seat

Sheila Cherfilus-McCormick (D) will fill the Florida district #20 seat of the late Rep. Alcee Hastings (D) having defeated Republican challenger Jason Mariner. This increases the Democratic majority in the House of Representatives to 222- 212. Cherfilus-McCormick has most recently worked as the CEO of Trinity Health.

Katko, Hollingsworth to Retire

Adding to the list of lawmakers announcing that they will not run for re-election this year include Rep. John Katko (R-N.Y.) and Rep. Trey Hollingsworth (R-Ind.). Katko has represented the 24th Congressional District of New York since 2015, and currently serves as the ranking member of the House Homeland Security Committee. Hollingsworth has represented Indiana’s 9th District since 2017, and currently serves on the House Financial Services Committee.

GOP Requests Stakeholder Input on Medical Innovation

The Republican Healthy Future Task Force Subcommittee on Treatments has issued a request for information (RFI) from health care stakeholders regarding medical innovation to inform legislation to speed the development and availability of treatments, devices, and diagnostics and to address increasing patient costs. The Republican Healthy Future Task Force was created by House Minority Leader Kevin McCarthy (R-Calif.) as a part of an effort to craft a patient-focused agenda for the future. Parties interested in responding to the RFI should fill out this form by March 11, 2022.

Additional COVID-19 Cases in the House of Representatives

More lawmakers have announced that they have tested positive for breakthrough cases of COVID-19. The latest list includes Rep. John Katko (R-N.Y.), Ben Cline (R-Va.), Nancy Mace (R-S.C.), Jim Cooper (D-Tenn.), Sean Casten (D-Ill.), Young Kim (R-Calif.), and Dutch Ruppersberger (D-Md.).

Regulators Miss Deadline for MDUFA Submission

The Food and Drug Administration (FDA) and the medical device industry have missed a statutory deadline to submit an agreement on a reauthorization of the Medical Device User Fee Amendments (MDUFA) to Congress. While negotiations between the agency and industry are ongoing, there has not been a formal meeting between the two parties since before Thanksgiving. Disagreements remain about an appropriate funding level, how user fees should be spent, the basic structure for the program, and what the cost of a full-time employee is. Last week, the U.S. Department of Health and Human Services (HHS) sent its user fee agreements for prescription drugs, generic drugs, and biosimilars to Congress. If an agreement on medical devices is not reached, it may be necessary for Congress to make updates to the existing MDUFA framework on its own. The current user fee agreements run through the end of the fiscal year (September 30, 2022).

CDC Encourages Broader Use of N95s

According to updated guidance posted on Friday, the Centers for Disease Control and Prevention (CDC) is now encouraging more Americans to wear N95 or KN95 masks to help slow the spread of coronavirus. The agency had previously been concerned about ensuring an adequate supply of the masks, which better filter the virus from the air, for health care workers. President Joe Biden has also stated that the administration plans to make more high-quality masks available to Americans for free, with more details on this effort expected to be announced this week.

Upcoming Congressional Hearings and Markups

House Science, Space, and Technology markup of legislation including H.R. 4521, the Bioeconomy Research and Development Act of 2021 and H.R. 847, the Promoting Digital Privacy Technologies Act; 10:00 a.m.; January 19

House Foreign Affairs Europe, Energy, the Environment and Cyber Subcommittee hearing “Transatlantic Cooperation on Critical Supply Chain Security;” 2:00 p.m.; January 19

House Oversight and Reform Subcommittee on the Coronavirus Crisis hearing “A View from the States: Governors Respond to the Omicron Variant;” 3:00 p.m.; January 20

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