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Last week, during a brief return to session, the House passed听, the Continuing Appropriations and Extensions Act, 2027, which extends funding for federal agencies through December 11. President Trump听听the bill, which includes a provision temporarily preventing OMB from听finalizing its proposed rule on federal grants, into law the next day. The continuing resolution (CR) sets up the need for Congress to vote in December, after the mid-term elections, but before the new Congress begins, to continue funding federal agencies.听
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Key appropriators in the House and Senate have听听their听colleagues to听turn their attention to passing FY 2027 appropriations bills that would provide funding through September 30, 2027. While the House Appropriations Committee has already听听11 bills out of committee and secured House passage for three of those measures (Agriculture, Military Construction-Veterans Affairs, and National Security-State), the Senate Appropriations Committee has yet to mark up or release any FY 2027 appropriations bills.鈥�听
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However, House Appropriations Committee Ranking Member Rosa DeLauro (D-CT)听听the House bills 鈥渄eeply flawed鈥� and cautioned that they would lack the bipartisan support听required听to advance regular appropriations legislation in the Senate. As indicated by Ranking Member DeLauro, House Democrats are likely looking to the Senate鈥檚 more bipartisan appropriations process to produce bills that they find more palatable than those passed by their chamber, and to include certain guardrails related to the Administration鈥檚 use of Congressionally appropriated funds.鈥�听
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Just last week,听听and听 raised concerns that an interagency agreement between the National Institute of Allergy and Infectious Diseases (NIAID) and the Department of Defense/War (DoD/W) was intended to siphon money away from the NIH into the DoD/W, 鈥渃ircumventing鈥� Congressional authority. In his own statement, 听expressed frustration with his Democratic colleagues for their statements regarding the interagency agreement, stating that the partnership is 鈥渞outine,鈥� and that he personally spoke with NIH Director Jay Bhattacharya and received a commitment that 鈥渘o money would be taken from basic medical research to fund unrelated efforts at the Department of War.鈥� Separately, Dr. Bhattacharya听听on social media that the interagency agreement 鈥渇ocuses on research projects that will drive discoveries to improve the health of American citizens and members of the military. Led by the National Institute of Allergy and Infectious Diseases, all work will be 100% aligned with our public health mission.鈥�听
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White House Senior Deputy Press Secretary Kush Desai also chimed in on听,听stating, 鈥淭he NIH is not transferring any money to the Pentagon. This is a project-by-project research partnership.鈥� Senate Appropriations Chair Susan Collins (R-ME), who has previously expressed concern听regarding听the Administration鈥檚 conformity to Congressional funding directions, especially where funding intended for NIH is concerned, has yet to release a public statement on the agreement.鈥�鈥�听
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The interagency agreement, as well as OMB鈥檚 proposed rule on federal grants, are likely to be part of the discussion on further appropriations legislation in December, which could also include other health-related provisions such as price transparency requirements and public health program reauthorizations. If Congress听is not able to听find agreement on funding for the rest of FY 2027, it could pass another short-term continuing resolution.鈥�听

On September 8, 2026, HHS听听the听selection of听three FDA center directors and the agency’s first Deputy Commissioner for Technology and Artificial Intelligence. The appointments include:听听

• Jared Seehafer, M.S., as FDA’s first Deputy Commissioner for Technology and Artificial Intelligence;听
• Michael Davis, M.D., Ph.D., as Director of the Center for Drug Evaluation and Research (CDER);听
• Karim Mikhail, B.Pharm., MSc., as Director of the Center for Biologics Evaluation and Research (CBER); and
• Bret Koplow, Ph.D., J.D., as Director of the Center for Tobacco Products (CTP).

Dr. Davis, Mr. Mikhail, and Dr. Koplow had previously been serving in these roles on an acting basis. While Dr. Davis and Dr. Koplow are long-time FDA veterans, Mr. Mikhail joined the agency more recently as a Senior Advisor before being named Acting Director of CBER. While Mr. Mikhail has extensive experience in the pharmaceutical industry, he is the first CBER director without a medical degree. The creation of the Deputy Commissioner for Technology and Artificial Intelligence role reflects the Administration’s emphasis on advancing technological innovation and the application of AI within FDA-regulated sectors. Mr. Seehafer brings extensive experience in software, artificial intelligence, and regulated industry, and is expected to play a key role in modernizing FDA’s technology infrastructure and regulatory approaches. Filling these senior leadership positions on a permanent basis is expected to provide greater continuity, predictability, and stability for the agency following a period of significant organizational change over the past 18 months.听

On September 8, CMS released听a听 intended to support states in implementing the medical frailty exclusion for the Medicaid community engagement requirements. The slide deck expands on the Interim Final Rule, which permits individuals to be excluded from the work requirements based on medical frailty if the individual’s “physical, mental, or other behavioral health condition significantly impairs the individual鈥檚 ability to comply with the community engagement requirement.鈥� The slide deck reaffirms that states must develop a list of conditions to identify individuals who are medically frail and offers a three-tiered framework to identify individuals who may qualify as medically frail based on their conditions:听

• Tier 1 includes 鈥渃onditions from which the state can confirm that the individual鈥檚 ability to comply with the community engagement requirement is significantly impaired based on the information included in readily available鈥� ICD-10 code data. CMS also includes several ICD-10 codes states may consider in Tier 1, such as codes related to ALS, ESRD, pancreatic cancer, and HIV resulting in encephalopathy.
• Tier 2 includes individuals who have a condition on the state鈥檚 list but for whom the ICD-10 diagnosis code does not confirm that their condition significantly impairs their ability to comply with community engagement requirements. CMS suggests this tier could include individuals with 鈥渕ultiple serious chronic conditions in conjunction with high service utilization or repeated inpatient听admissions for serious or complex conditions.鈥�听
• Tier 3 includes individuals for whom there is insufficient data or no data and therefore require 鈥渕anual individualized review where states may seek documentation from the individual to verify whether the individual qualifies as medically frail.鈥� The slide deck also includes several examples of how states can implement this tiered framework, utilizing fictional examples of people with breast cancer, diabetes, coronary artery disease, and anxiety. States are not required to use the example tiered medical frailty framework and may instead use another data-driven approach.听

听On September 4, FDA听听an RFI requesting comments on opportunities to accelerate the development of botanical drug products, drugs 鈥渢hat include or may be derived from plant materials, algae, macroscopic fungi, or combinations of these materials.鈥� FDA is accepting input on barriers to research and development, challenges,听and opportunities including suggestions for potential updates to existing FDA guidance, quality standards for complex botanical products, clinical and nonclinical study design, and the use of real-world evidence in regulatory submissions. FDA officials听indicated听the effort is intended to modernize regulatory frameworks and听identify听practical approaches for bringing safe and effective botanical therapies to patients while听maintaining听rigorous scientific standards. To date, FDA has approved four botanical products for marketing as prescription drugs.听

As part of these efforts, FDA recently collaborated with the Reagan-Udall Foundation for the Food and Drug Administration on a听听to gather information on challenges and opportunities to advance botanical drug development. FDA will also听convene听a joint听听with the European Medicines Agency on September 25, 2026, to discuss regulatory considerations for herbal medicinal/botanical drug products intended for medicinal use. Public comments are due by November 3, 2026.听