On Thursday, the Senate voted 86-11 to pass legislation containing nearly $40 billion in military and humanitarian aid for Ukraine. The legislation overwhelmingly passed the House last week, in a vote of 368-57. The package will now head to President Joe Biden to be signed into law.

Also on Thursday, the Senate passed the Access to Baby Formula Act, which will authorize the U.S. Department of Agriculture (USDA) to waive baby formula contract requirements during emergencies, disasters, and supply chain disruptions affecting participants of the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). Currently, WIC participants are only able to use their WIC formula benefits for formula made by the manufacturer that their state holds a contract with. The House also passed the legislation this week, in a striking bipartisan vote of 414-9. Congress worked swiftly to get the legislation passed due to the baby formula shortage affecting the nation.

On Tuesday, Senate Health, Education, Labor and Pensions (HELP) Committee Chairwoman Patty Murray (D-WA) and Ranking Member Richard Burr (R-NC) released a discussion draft of the FDA Safety and Landmark Advancements (FDASLA) Act. This legislation would reauthorize the Food and Drug Administration’s (FDA) prescription drug, generic drug, biosimilar, and medical device user fee agreements, which are slated to expire on September 30, 2022. The legislation also includes provisions to “strengthen oversight of cosmetics and dietary supplements, modernize the regulation of diagnostic tests, bring more competition to the market, and prepare the FDA for the next generation of medical products to benefit Americans.” The section-by-section summary can be found here.

On Wednesday, the House Energy and Commerce (E&C) Committee held a markup on six health bills, including legislation that reauthorizes Food and Drug Administration (FDA) user fees for an additional five years. This markup came one week after the E&C Subcommittee on Health advanced the same bills. The Subcommittee also marked up legislation that would create the Advanced Research Projects Agency for Health (ARPA-H), which would be an independent agency within HHS that would work to speed up the development of new, life-saving cures for diseases such as cancer and Alzheimer’s, as well as a bill to reauthorize several mental health and substance abuse programs. The results of the markup can be found in Mehlman Castagnetti’s summary, here.

Additionally, Healthy Future Task Force co-chairs, Congressman Vern Buchanan (R-FL) and Congressman Brett Guthrie (R-KY), announced the Task Force’s solutions to permanently ban fentanyl and ensure that the U.S. is prepared for future pandemics. These initiatives include permanently scheduling fentanyl-related substances, strengthening the Strategic National Stockpile, building upon Operation Warp Speed, and requiring the Department of Health and Human Services (HHS) to collaborate with the private sector. Additional information can be found in the one pager here.

On Tuesday, Senate Health, Education, Labor and Pensions (HELP) Committee Chairwoman Patty Murray (D-WA) and Ranking Member Richard Burr (R-NC) released a discussion draft of the FDA Safety and Landmark Advancements (FDASLA) Act. This legislation would reauthorize the Food and Drug Administration’s (FDA) prescription drug, generic drug, biosimilar, and medical device user fee agreements, which are slated to expire on September 30, 2022. The legislation also includes provisions to “strengthen oversight of cosmetics and dietary supplements, modernize the regulation of diagnostic tests, bring more competition to the market, and prepare the FDA for the next generation of medical products to benefit Americans.” Senator Murray said that she is “laser-focused” on lowering drug prices, and that the legislation would increase drug competition by “helping cheaper generic and biosimilar drugs get to market and ensuring drug approvals are always driven by what is best for patients and families—not pharmaceutical companies’ bottom lines.” The section-by-section summary can be found here.

On Wednesday, the House Energy and Commerce (E&C) Committee held a markup on six health bills, including legislation that reauthorizes Food and Drug Administration (FDA) user fees for an additional five years. This markup came one week after the E&C Subcommittee on Health advanced the same bills. The Subcommittee also marked up legislation that would create the Advanced Research Projects Agency for Health (ARPA-H), which would be an independent agency within HHS that would work to speed up the development of new, life-saving cures for diseases such as cancer and Alzheimer’s, as well as a bill to reauthorize several mental health and substance abuse programs. The results of the markup can be found in Mehlman Castagnetti’s summary, here.

On Tuesday, the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies held a hearing to discuss the National Institutes of Health (NIH) fiscal year (FY) 2023 budget request. President Joe Biden is requesting approximately $62.5 billion for the NIH. The request includes discretionary budget authority of $49.04 billion, which includes $1.09 billion for the 21st Century Cures Act, $83 million for Superfund research activities, and $5.0 billion for ARPA-H. In her opening statement, Chairwoman Patty Murray (D-WA) said that she is “working hard right now to pass the Prevent Pandemics Act” and to “ensure ARPA-H can complement NIH’s expertise, while still operating independently to nimbly seize opportunities to accelerate innovation and breakthroughs.” Senator Jerry Moran (R-KS) expressed concern that research into diseases such as cancer, Alzheimer's and diabetes could be duplicated by the NIH and ARPA-H. Dr. Lawrence Tabak, the Acting Director of the National Institutes of Health (NIH), assured Moran that there will be communication between the agencies to avoid any potential duplication.

Healthy Future Task Force co-chairs, Congressman Vern Buchanan (R-FL) and Congressman Brett Guthrie (R-KY), announced the Task Force’s solutions to permanently ban fentanyl and ensure that the U.S. is prepared for future pandemics. These initiatives include permanently scheduling fentanyl-related substances, strengthening the Strategic National Stockpile, building upon Operation Warp Speed, and requiring the Department of Health and Human Services (HHS) to collaborate with the private sector. Additional information can be found in the one pager here.

The Centers for Medicare and Medicaid Services (CMS) unveiled a more “user-friendly” Medicare.gov website. The design update makes the home page easier to navigate and adds more detailed pricing information about Medicare Supplement Insurance (Medigap) Policies. CMS said that this will help provide individuals with the information they need to compare Medigap plan costs and coverage options. CMS also noted that additional updates will come in the next few months to streamline the Medicare Plan Finder landing page and the Medicare Account landing page. More information can be found here. 

Senate Indian Affairs Committee - Hearing

Nomination Hearing to consider Roselyn Tso to be Director of the Indian Health Service, Department of Health and Human Services

Wednesday, May 25 at 2:30 PM ET

Senate Health, Education, Labor, and Pensions Committee – Hearing

Infant Formula Crisis: Addressing the Shortage and Getting Formula on Shelves

Thursday, May 26 at 10:30 AM ET

House Committee on Financial Services - Hearing

Subcommittee on Diversity and Inclusion Hearing: Diversity Includes Disability: Exploring Inequities in Financial Services for Persons with Disabilities, Including Those Newly Disabled Due to Long-Term COVID

Tuesday, May 24 at 12:00 PM ET

House Committee on Energy and Commerce - Hearing

Subcommittee on Oversight and Investigations Hearing: "Formula Safety and Supply: Protecting the Health of America's Babies"

Wednesday, May 25 at 11:00 AM ET

House Committee on Appropriations - Hearing

Subcommittee on Defense Hearing: Defense Health and Medical Readiness

Wednesday, May 25 at 12:00 PM ET