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Congressional Update

-Benjamin Krinsky, PhD

As the second session of the 118th Congress gets underway, the House and Senate face rapidly approaching budget deadlines to try and resolve the fiscal year (FY) 2024 federal budget. On January 7, congressional leaders announced that they had reached an agreement on topline spending levels for FY 2024. Under the agreement, defense and non-defense programs would receive approximately $886 billion and $773 billion, respectively, in line with the budget agreement struck by Congress and the White House last spring (see below). However, despite reaching an accord on overall spending levels, much work remains: Congress must decide on how to allocate these funds among the twelve appropriations subcommittees, write appropriations bills, and come to an agreement on numerous contentious policy riders.

Resolving all these issues will be difficult because there is little time to spare to keep the government open. The federal government is currently operating under a temporary spending measure — a continuing resolution (CR)— which maintains federal spending at FY 2023 levels. The current situation is somewhat unusual in that under the CR, funding expires for different portions of the federal government on different dates. The CR funds programs covered by the following four bills through January 19: Agriculture, Rural Development, Food and Drug Administration (FDA); Energy and Water Development; Military Construction and Veterans Affairs; and Transportation, Housing, and Urban Development. The agencies and programs encompassed by the remaining eight appropriations bills are funded through February 2nd. This second group includes the Labor, Health and Human Services, Education, and Related Agencies bill, which funds (among other programs) the National Institutes of Health (NIH) and the National Cancer Institute (NCI). Even with an agreement in place on topline spending levels for FY 2024, Congress will likely need at least one more short-term CR to give legislators time to finalize the budget.

Debates on FY 2024 spending have been unfolding for many months. Back in the spring of 2023, President Biden and then-Speaker of the House Kevin McCarthy (R-CA) reached an agreement that raised the federal debt limit and set overall levels of discretionary spending in FY 2024 and FY 2025. Congress passed the debt limit law, the Fiscal Responsibility Act (FRA) in June, 2023. However, in addition to the FRA, the debt limit deal struck between Biden and McCarthy included several so-called “handshake” agreements not codified in law that would provide more money for nondefense programs than was included in the text of the FRA. Under the new agreement reached on January 7, FY 2024 spending levels would match the totals included in the FRA and the “handshake” agreements.

If Congress cannot resolve debates on policy riders, etc., it may still be forced to pass a year-long CR to keep the government open. Instead of freezing spending at FY23 levels, however, a year-long CR would lead to additional cuts in discretionary spending due to another provision of the FRA. Under the law, unless FY 2024 appropriations bills are passed by April 30, spending levels are subject to across-the-board-cuts that could significantly impact domestic programs, including NIH and NCI.

As Congress debates FY 2024 appropriations, the AACR will continue to advocate for the highest possible appropriations for biomedical research and training programs.

Dr. W. Kimryn Rathmell Begins Work as Director of the National Cancer Institute

-Blake William Rostine

On December 18, 2023, W. Kimryn Rathmell, MD, PhD, began her tenure as director of the National Cancer Institute (NCI). She succeeds former NCI director Monica Bertagnolli, MD, who, after a bipartisan 62-36 Senate confirmation vote, became director of the National Institutes of Health (NIH) on November 9, 2023.

A kidney cancer expert, Dr. Rathmell previously served as the Hugh Jackson Morgan Chair in Medicine at Vanderbilt University Medical Center (VUMC) and physician-in-chief for Vanderbilt University Adult Hospital and Clinics. As a former AACR Team Science Award recipient and an AACR-supported research grant awardee, Dr. Rathmell was selected by President Biden to be tasked with leading the NCI toward the Biden administration’s Cancer Moonshot goals, to “end cancer as we know it.” 

Register Now! FDA-AACR Workshop on Optimizing Dosages for Oncology Drug Products 

Nicholas Warren, PhD

The U.S. Food and Drug Administration (FDA), Office of Clinical Pharmacology, and the American Association for Cancer Research (AACR) are collaborating on a day-and-a-half-long hybrid workshop titled “Optimizing Dosages for Oncology Drug Products: Quantitative Approaches to Select Dosages for Clinical Trials,” which will take place February 15-16 at the Grand Hyatt in Washington D.C. This follows previous FDA-AACR workshops in 2015, 2016, and 2017 on dosage optimization. Free registration is now available to attend the new workshop in person or virtually.

Historically, dose-finding trials for oncology drugs have been primarily designed to determine the “Maximum Tolerated Dose” (MTD), which is determined by gradually increasing the dose in a small number of patients at each dose for short periods of time until it is too toxic for patients. This strategy was developed for cytotoxic chemotherapy because of the small therapeutic window for that class of drugs. However, this approach may lead to poorly tolerated dosages for modern oncology drugs with novel mechanisms of action, including targeted therapies and immunotherapies. Continued reliance on the MTD may lead to unnecessary side effects without added benefits for patients.

FDA and the AACR strongly encourage a more holistic approach that leverages all available nonclinical and clinical data. In January 2023, the FDA published new draft guidance intended to help sponsors identify an optimized dosage for oncology products. The February workshop aims to: discuss best practices and methods for evaluating all nonclinical and clinical data; talk about how to incorporate modeling and simulation to identify optimized dosages; consider innovative clinical trial designs; and highlight ongoing efforts in academia, industry, and regulatory agencies. These changes may require a culture change in drug development and, in some cases, additional investments earlier in drug development. However, strategies to improve dosage selection hold great promise for improved long-term patient outcomes.

We hope you can join us February 15-16. Please visit the workshop website for more information.

Oncology Drug Development in 2024

 -Rukiya Umoja, PharmD

2023 was a year of regulatory overhaul at the U.S. Food and Drug Administration (FDA). This year is expected to continue that trend as drug sponsors begin to implement many initiatives aimed at improving oncology drug development. As we begin 2024, the landscape of drug development will continue shifting toward improved clinical trial diversity, changes to laboratory-developed tests, and tightened pathways to accelerated approval.

In recent years, there has been sustained focus on achieving diverse representation in oncology clinical trials. FDA has demonstrated its commitment to ensuring that approved medical products are not only effective but also accessible to a broader population. FDA’s Oncology Center of Excellence (OCE) is expected to finalize guidance this year that will provide strategies for sponsors on the approach to developing diversity plans (DPs) that will inform the entire clinical trial framework, from design to post-study. In 2024, a growing number of oncology drug sponsors will begin implementing these plans. OCE acknowledges that these efforts will be a significant undertaking after publishing its Year One Experience reviewing DPs, but a necessary step to addressing healthcare disparities in the oncology community. 

FDA is also signaling an end to its enforcement discretion approach for Laboratory-Developed Tests (LDTs). The agency has proposed a rule to begin regulating LDTs as medical devices. Cancer diagnostic assays, offered as LDTs have largely been regulated under enforcement discretion by the agency. Many oncology stakeholders have emphasized that the proposed rule may impose a huge burden on diagnostic testing and delay patient access. The comment period has ended with the agency left to review over 25,000 comments. FDA is required to address major substantive issues and has indicated that a final rule may be published in April 2024.

More changes are on the horizon as FDA tightens the regulatory pathway to accelerated approval by requiring confirmatory studies to be underway at the time of accelerated approval. Over the past few decades, an increasing number of cancer drugs have been approved through FDA’s accelerated pathway. Although the approval pathway has increased in popularity, it has also been met with uncertainty regarding the long-term efficacy as many of the confirmatory studies for these products have not been completed. This has led to 26 withdrawn oncology indications. After FDA released draft guidance in March 2023 aimed at improving oncology clinical trials for accelerated approval, it is clear the agency is striving to find the balance between speed, safety, and efficacy.

With the increased regulatory oversight expected in 2024, there will be many challenges to oncology drug development, but also innovation. As the year unfolds, the oncology community will see unprecedented advances to drug development that have the potential to transform the treatment landscape.

NIH Panel Recommends Higher Postdoc Pay to Lower Attrition

-Matt Gontarchick

In a new report, a group of National Institutes of Health (NIH) advisors recommended increasing minimum postdoctoral salaries from $56,484 to $70,000 to increase the recruitment and retention of scientists in academic research. The Working Group on Re-envisioing NIH-Supported Postdoctoral Training was formed in late 2022 by the NIH Advisory Committee to the Director (ACD) in response to reports that principal investigators were struggling to recruit postdocs.

The attrition rate for scientists from academia to industry has reached its highest level in nearly 30 years, according to National Center for Science and Engineering Statistics (NCSES) survey data. In addition to boosting salaries to address turnover, the advisory group recommended a five-year cap on the length of postdoc positions, enhanced childcare benefits, and annual wage adjustments to account for inflation. The advisory group also warned that failure to improve the postdoc research system could threaten the competitiveness of US biomedical research programs.

To implement these recommendations, the advisors urged NIH to partner with nonprofit organizations and other institutions that share similar interests in improving conditions for postdoctoral scholars. The group also called for NIH to engage with postdoctoral researchers on possible changes.

As a next step, NIH Director Monica Bertagnolli will review the report, although NIH has yet to specify a timeline for the review process.