The past few weeks have been among the most disturbing in recent years, raising renewed concerns about how to address mass casualty shootings. Several efforts are underway in Congress, however, partisanship remains a major barrier despite national polling indicating broad support for some gun control measures. Inflation is also top of mind these days. Gas and food prices are soaring, hitting Americans on a daily basis, and the baby formula supplies are far from pre-pandemic levels. Congress returns from the annual Memorial Day recess on June 7th and will work on nomination votes and legislation addressing the health of veterans exposed to burn pits, the annual defense authorization, and the appropriations funding levels for FY2023.
BUDGET & APPROPRIATIONS
The House and Senate Appropriations Chairs Rosa DeLauro (D-CT) and Patrick Leahy (D-VT) have not agreed on top line numbers for each of the 12 subcommittees, however, Chair DeLauro said she is full steam ahead with getting the bills drafted in the House by July. She is aiming to move bills to the floor by the August recess. Chair Leahy is aiming for the same in the Senate. While amiable, it is unrealistic due to partisan differences that are even more heightened going to midterm elections. We will keep tracking the hearings and markup schedules and share updates.
Check out House hearings all recorded and available here.
Check out Senate hearings all recorded and available here.
FDA User Fee Bill:
On June 8, the Senate HELP Committee will mark up the bipartisan user fee legislation that includes reforming FDA’s accelerated approval pathway, strengthening the agency’s oversight of cosmetics and dietary supplements, improving regulation of laboratory-developed tests (LDTs), and allowing multiple interchangeable biosimilars to share exclusivity. Chair Patty Murray (D-WA) and Ranking Republican Richard Burr (R-NC) introduced the bill May 27 with language that would shorten FDA’s decision-making around whether 505(b)(2) drugs can be automatically substituted at the pharmacy for the brand drugs they reference. The bill also would require FDA to quickly finish its over-the-counter hearing aid rule and provide Congress with more information about its inspection activities. Meanwhile, the House version of the bill passed out of the Energy & Commerce Committee on May 18th and does not contain the LDT, cosmetics, dietary supplement, or interchangeable biosimilar measures. It contains similar accelerated approval reforms except the Senate bill would create an intra-agency coordinating council to ensure uniform usage of accelerated approvals. The House indicated it might increase FDA’s oversight of cosmetic products and add LDTs to align with the Senate bill.
The FY22 Omnibus, which was enacted March 15, 2022 and expires Sept 30, 2024, included $1 billion for the Advanced Research Projects Agency for Health (ARPA-H) to prioritize high-risk, high-reward biomedical and health research. It allowed Secretary Becerra to move ARPA-H outside NIH, but on May 25 Becerra announced he was placing it within NIH with the Director reporting directly to him. He named Adam Russell, DPhil, as the acting deputy director of the new initiative, with an anticipated start date of June 6. Russell currently serves as the chief scientist at the University of Maryland's Applied Research Laboratory for Intelligence and Security and previously served in the Intelligence Advanced Research Projects Activity and the Defense Advanced Research Projects Agency (DARPA). Without new legislation, the Biden Administration has the authority to set up ARPA-H, appoint its director, has hiring powers and flexibilities, can make awards, and can exempt NIH peer-review process. However, Congress wants to establish more authorities and control over this new entity.
There are three authorization measures: HR 5585 (introduced Oct 15, 2021 by Chair Anna Eshoo (D-CA) that places ARPA-H outside NIH but within HHS; HR 6000 (introduced Nov 17, 2021 as part of Cures 2.0 by Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) that places ARPA-H inside NIH; and S 3799 (introduced March 10, 2022 and part of the PREVENT Pandemics Act by Chair Patty Murray (D-WA) and Richard Burr (R-NC) that prohibits ARPA-H from being located on the NIH campus and in close proximity to the National Capital Region and the Director from appointing personnel to the agency who were employed by NIH three years prior to such appointment. HR 5585 and S 3799 have each passed their committees of jurisdiction in each chamber.
On May 11, the House Energy and Commerce Health Subcommittee passed by voice vote Chair Anna Eshoo’s (D-CA) bill that would make the newly authorized ARPA-H an independent agency within HHS and located outside the DC area, seemingly overriding HHS’ recent decision to put ARPA-H under the NIH. One week later, the legislation passed the full committee and will next be sent to the House floor. It included new language requiring timely information sharing with the Centers for Medicare & Medicaid Services to assist in coverage determinations and with the FDA to get therapies more quickly to patients as well as $500 million authorization per year through FY2027.
Environmental Health Justice:
The White House has established a new office charged with protecting the health of vulnerable communities by dealing with pollution, climate change and other environmental issues. The new office will sit within the Office of Climate Change and Health Equity at the Department of Health and Human Services, which President Biden created as part of his Executive Order on Tackling the Climate Crisis at Home and Abroad to strengthen and safeguard the health and well-being of the American people in confronting climate change. By securing historic and long overdue investments, implementing the Justice40 commitment to deliver 40% of the overall benefits of certain Federal investments to disadvantaged communities, and creating new offices like Office of Environmental Justice, the White House is working to ensure that all federal agencies address the disproportionately high and adverse health, environmental, economic, climate, and other impacts on communities that are marginalized, underserved, and overburdened by pollution.
Medicaid Postpartum Coverage
California, Florida, Kentucky and Oregon have all joined the states that will offer Medicaid and Children’s Health Insurance Plan coverage for beneficiaries up to one year after they give birth, covering 126,000 families. The four new states join South Carolina, Tennessee, Michigan, Louisiana, Virginia, New Jersey, and Illinois that have already expanded coverage, and CMS says it is working with an additional nine states – Indiana, Maine, Minnesota, New Mexico, Pennsylvania, West Virginia, North Carolina, Washington and Connecticut – as well as D.C. Up to 720,000 pregnant and postpartum people would have access to services if these additional expansions are finalized. The new authority was created in the American Rescue Plan, which gave all states an easier pathway to extend postpartum coverage beyond the critical first weeks for a new family.
However, some advocates worry that the end of the public health emergency – and the extensive Medicaid eligibility renewal process that will result – could complicate beneficiaries’ access to these services, with as many as 16 million beneficiaries at risk of losing their Medicaid or CHIP coverage. As a result, some states, including Oregon, are exploring longer continuous enrollment periods that would reduce the number of renewals each year and prevent beneficiaries from being booted for short-term changes in income.
In May, Congress passed and President Biden enacted $40 billion emergency Ukraine spending package for arms, economic relief, and humanitarian aid. The bill includes $19.7 billion for the Defense Department, over $3 billion above what the Biden administration asked for. It includes the $6 billion in direct security assistance to Ukraine that Biden sought last month and $9 billion to replenish arms stocks sent from the Pentagon to Ukraine. It funds $4.35 billion for global food and humanitarian aid to be administered by the US Agency for International Development and another $700 million in global food funding at the Department of State. The bill also contains language to allow Ukrainian refugees to access US government benefits, over the objections of some Republicans.
Biden is set to visit Saudi Arabia as part of an international trip for NATO and Group of Seven meetings. Meanwhile the record high US gas prices are weighing on his party’s political prospects. Traveling to Saudi Arabia would mean Biden would almost inevitably meet its effective ruler, Crown Prince Mohammed Bin Salman, whom the US president blames for the 2018 murder of a US-based columnist in the kingdom’s Istanbul consulate
National Defense Authorization Act:
Both the House and Senate have held several hearings thus far with Defense Department leaders in both the Appropriations Subcommittees on Defense and within the Armed Services Committees. The latter committees, often referred to as HASC and SASC, are moving the fastest to introduce and pass legislation. They are each preparing to respond to DoD’s FY23 budget request of $733 billion in their legislation. Biden’s budget is a continuation of last year’s innovation budget focused on building capabilities to deter China as the “pacing threat”, investing heavily in research and development for new military capabilities, retiring older, less capable weapons that are expensive to maintain, and increasing investments in climate resilience and industrial capabilities.
The House NDAA (H.R. 7900) will be marked up in committee in June. On June 8th the Military Personnel Subcommittee plans to unveil its section that covers military medical programs and services spanning from the Defense Health Agency’s service member management to military medical research programs. On June 22nd, the full House Armed Services Committee will complete markup of HR 7900. The full schedule for markup is here.
Meanwhile, the Senate Armed Services Committee is planning to markup its NDAA on a similar schedule. On June 13th, the Military Personnel Subcommittee will markup its section then the full committee markup is on June 15th. Unlike the House, the Senate markup will be closed and not open to the public. The full schedule for markup is here.
Boosting the Food Supply Chain:
The Biden administration is pushing for $2.1 billion in new funding to bolster food supply chains, including initiatives to expand small- and mid-sized processing plants. Funds will also be used to finance new infrastructure such as cold storage facilities and to assist farmers shifting to organic production. With the nationwide shortage of baby formula following the shutdown of a single Abbott Labs production facility, the empty grocery shelves during early phases of the COVID pandemic and soaring food prices over the past year have all underscored weaknesses in the country’s food supply chains. Grocery prices in April were up 10.8% from a year earlier, the highest annual increase since November 1980, when Jimmy Carter was in the White House.
Agriculture Secretary Tom Vilsack plans to move U.S. food supplies away from dominance by a few highly concentrated businesses and addressing climate change challenges in announcing a “framework” for strengthening supply chains. His initiative includes $600 million for independently owned supply-chain infrastructure, such as cold storage facilities and refrigerated trucks. It also includes $400 million to create regional food business centers to support small- and mid-sized farms and food processors, $300 million to assist farms transitioning to organic production, and a $155 million increase to promote healthy options in “food deserts” in low-income areas underserved by grocery stores. Funding for the initiatives will come from the $1.9 trillion COVID relief plan Congress passed last year and other relief legislation.
Treasury Secretary Janet Yellen recently acknowledged her error last year in predicting that elevated inflation wouldn’t pose a continuing problem, stating, “There have been unanticipated and large shocks to the economy that have boosted energy and food prices and supply bottlenecks that have affected our economy badly that at the time I didn’t fully understand.” On May 31st, President Biden met with Federal Reserve Chairman Jerome Powell and said he is fighting price increased but also respects the US central bank’s independence, an attempt to improve optics of his administration during the worst inflation ever seen in the United States in 40 years. This was Biden’s third in-person session with Powell and aligns with his op-ed published in The Wall Street Journal, stating the Fed has “a primary responsibility to control inflation.” With the November midterm elections a little over five months away, the public stating inflation ranks as the number one concern, and many predicting the Democrats’ slim congressional majorities to flip, reigning in inflation is a top priority.
news of the day
Congress Responds to Mass Casualty Shootings:
President Biden is calling for a ban on the sales of assault weapons and high-capacity magazines, pleading with Congress to toughen gun laws following a spate of mass shootings. Polling shows strong support for additional restrictions in the aftermath of the Texas elementary school shooting and ahead of November’s crucial midterm elections. A bipartisan group in the Senate led by John Cornyn (R-TX) and Chris Murphy (D-CT) is attempting to come up with compromise gun legislation that could attract at least 10 Republicans, whose votes would be needed to pass legislation in the Senate. Meanwhile, the House Judiciary Committee voted 25-19 along party lines to pass the Protecting Our Kids Act (HR 7910) introduced by Chair Jerry Nadler (D-NY), teeing up a floor vote soon. The legislation combines several gun-safety bills from House Democrats, including provisions that would:
- Increase to 21, from 18, the minimum age for sales of certain semiautomatic rifles and shotguns, with exceptions for active-duty service members and authorized government employees;
- Make gun trafficking a federal crime, covering individuals who buy firearms for a third party through “straw purchases;”
- Prohibit unauthorized production or sales of untraceable “ghost guns” that lack unique serial numbers, including gun frames and receivers;
- Set federal requirements for secure firearms storage, including in homes where young people are likely to gain access;
- Authorize federal grants to distribute firearms storage devices and provide a tax credit for some retail sales; and
- Restrict sales of bump stocks and large-capacity ammunition-feeding devices.