McDermottPlus Check-Up: May 20, 2022

May 20, 2022

This Week’s Dose

The Senate passed, by a vote of 86-11, the $40 billion Ukraine funding bill on May 19, sending it to President Biden for his signature. In the House, the Energy & Commerce Committee passed bipartisan health legislation, including FDA user fee legislation, a bipartisan mental health bill and a bill authorizing ARPA-H as a free-standing agency within HHS. This week also focused on the baby formula shortage, with the House approving two bills on this topic and the President invoking the Defense Production Act to attempt to improve availability. Dr. Ashish Jha, the White House COVID-19 response coordinator, held his first briefing and warned Congress once more that additional COVID-19 funding is needed.

Congress

Energy & Commerce Committee Clears Bipartisan FDA User Fee Agreements and Senate Releases Draft. On May 18, the House Energy & Commerce Committee unanimously approved the “Food and Drug Amendments of 2022” (H.R. 7667). H.R.7667 reauthorizes the Food and Drug Administration’s (FDA) user fee programs and incorporates various programmatic improvements across the whole of FDA.

On May 17, the Senate Health, Education, Labor & Pensions Committee Chair Patty Murray (D-WA) and Ranking Member Richard Burr (R-NC) released their draft user fee legislation. Their draft proposal is similar in many respects to the House legislation, but also includes provisions not in the House legislation, such as strengthening FDA oversight of cosmetics and dietary supplements and clarifying FDA’s regulatory oversight of lab-developed tests, as included in the Verifying Accurate, Leading-edge IVCT Development (VALID) Act. The Senate draft does not include some provisions in the House legislation, such as updates to the FDA’s accelerated approval pathway or expanded authority requiring medical device companies to report shortages. The Senate draft section-by-section summary can be found here and full text here.

User fee legislation needs to be enacted into law by August 1, 2022 to avoid FDA furloughs.

Mental Health Reform, ARPA-H, and Other Bills Passed with Bipartisan Support. On May 18, the Energy & Commerce Committee also approved the “Advanced Research Project Agency-Health Act” or the “ARPA-H Act” (H.R. 5585) by a vote of 53-3. This bill would accelerate innovation in health and medicine by investing in high-risk, high-reward research projects. This bill is notable as it authorizes ARPA-H within HHS, conflicting with the Administration’s efforts already underway to establish ARPA-H within the National Institutes of Health. ARPA-H is a signature priority for President Biden and was included in his FY 2022 budget proposal. ARPA-H will invest in breakthrough technologies and broadly applicable platforms, capabilities, resources, and solutions that have the potential to transform medicine and healthcare that cannot be accomplished through traditional research activity.

Additionally, the Committee approved by voice vote the “Restoring Hope for Mental Health and Well-Being Act” (H.R. 7666) to reauthorize key programs within the Substance Abuse and Mental Health Services Administration and Health Resources and Services Administration that address national mental health and substance use disorders.

Other bills approved by the committee include the following: “Keeping Incarceration Discharges Streamlined for Children and Accommodating Resources in Education Act” (H.R. 7233), “Gabriella Miller Kids First Research Act 2.0” (H.R. 623), and the “South Asian Heart Health Awareness Act of 2021” (H.R. 3771). Links to the bills and amendments can be found here.

Congress Acts to Address the Baby Formula Crisis. On May 18, the House passed H.R. 7790, a $28 million emergency supplemental funding bill to provide emergency funding for the FDA to address the infant formula crisis. The bill would increase FDA inspection staff, provide additional resources, address fraudulent baby formula from entering the marketplace and improve data collection on the infant formula marketplace. H.R.7790 passed by a vote of 231-192. The bill’s fate in the Senate is unclear.

The Senate on May 19 voted unanimously, and the House voted 414 -9 the previous day, to pass the “Access to Baby Formula Act” (H.R. 7791), with President Biden signing the bill into law on May 20. The legislation will provide permanent flexibility to the Agriculture Secretary to waive certain requirements of the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). This is especially important as 50-66% of infant formula sold in the US is purchased through the WIC program. The bill would also require formula manufacturers to have contingency plans to protect against disruptions in supply in the event of another recall.

Administration

President and Federal Agencies Acts to Address Baby Formula Shortage. President Biden announced on May 18 that he will invoke the Defense Production Act (DPA) to increase the infant formula supply in the US. The DPA will require suppliers of formula ingredients to send infant formula companies the necessary resources and ingredients before other customers. Also, under this authority, the Administration has announced “Operation Fly Formula” to increase importation of formula by requiring the Department of Health and Human Services and Department of Agriculture to use Department of Defense commercial aircraft to pick up U.S.-approved formula from other countries and deliver to high-need regions.

Additionally, on May 16 the FDA announced that the agency will be temporarily exercising enforcement discretion with respect to certain requirements for infant formulas in an effort to increase supply of imported formula. The USDA is encouraging states to implement flexibilities around the WIC program including the ability to exchange recalled baby formula and use WIC benefits to purchase product that has not been recalled.

Public Health Emergency Continues. Having made it through mid-May (the 60-day notice date) without an announcement from the Biden Administration regarding the end of the COVID-19 Public Health Emergency (PHE), the PHE is now expected to be renewed again, keeping the current authorities and flexibilities in place through at least mid-October. It is highly unlikely that the Administration would announce the end of the PHE during the August recess or going into the election season (when the next 60-day notice date will come). As a result, it is probable that the Biden Administration will continue to extend the PHE through at least the end of the year, and quite possibly into early 2023.

White House Reinstates COVID-19 Briefing. On May 18, the Biden Administration held its first COVID-19 briefing in six weeks, led by the new COVID-19 response Coordinator Dr. Ashish Jha. Federal health officials warned that COVID-19 infections have risen 19% over the previous week and that one-third (32%) of Americans live in areas where COVID-19 cases have increased so much that indoor masking in public settings is recommended. However, hospitalization rates remain low likely due in part to the prescribing of the Paxlovid pills to prevent severe illness, at a rate of approximately 20,000 patients per day receiving the treatment. Dr. Jha also called on Congress to pass the additional $22 billion in COVID-19 funding needed to replenish supplies (i.e., tests, treatments, and vaccines).

Quick Hits

  • The Biden Administration relaunched the COVIDtests.gov to allow Americans to order up to another eight free rapid antigen tests.

  • The Centers for Medicare & Medicaid Services unveiled on May 18 new updates to Medicare.gov to make navigating the website and finding information on selected health and drug coverage and find providers easier for the millions of people who use it.

  • The Centers for Disease and Control and Prevention Independent Advisory Committee voted 11 to 1 on May 19 to recommend the Pfizer-BioNTech COVID-19 booster shot for children ages 5 through 11 years of age, just days after the FDA authorized the booster. Shortly after the vote, the CDC Director Rochelle Walensky officially endorsed the recommendation.

  • The World Health Organization (WHO) on May 19 issued an emergency use listing for China’s CanSino Biologics COVID-19 vaccine, bringing the total number of WHO approved coronavirus vaccines to 11.

  • The First Lady Jill Biden convened a White House event on May 18 to kick off the Administration’s efforts to address the mental health crisis, particularly for youth struggling with anxiety and depression.

  • The Health Resources and Services Administration hosted a National Telehealth Conference, on May 16 and 17, bringing together public and private sector leaders to discuss telehealth best practices and lessons learned during the COVID-19 pandemic. Recordings will be made available here.

 

Next Week’s Diagnosis

The Senate will be in session. The House will be in a committee work week. The Energy and Commerce Committee will hold a hearing on the infant formula crisis on Wednesday, May 25 that will include FDA Director Califf, additional FDA officials, and representatives for baby formula manufacturers. Both chambers will enter Memorial Day recess at the end of next week.

© 2022 McDermott Will & Emery
National Law Review, Volume XII, Number 140
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