Dear Secretary Kennedy, Director Vought, Acting Director Ezell and Acting Commissioner Dudek:
On behalf of the Cystic Fibrosis Foundation, we write to express our grave concern about the rapid and large-scale reductions in force (RIFs) across government agencies and how these abrupt changes could result in loss of access to lifesaving therapies, care, and resources for the CF community. We believe that it is reasonable to consider a range of tactics to ensure agencies are operating effectively and efficiently, including identifying areas of duplication. However, the rapidity of the recent RIFs without thoughtful assessment to ensure maintenance of key agency functions has the potential to significantly hinder critical scientific advances in cystic fibrosis, impede the development of safe and effective therapies, and disrupt access to specialized care, financial support, and other needed resources. This disregard for essential programs will do irreparable harm to health care delivery and the scientific infrastructure. As a result of these cuts to essential programs, some people with CF will be sicker and may die prematurely. We urge the administration to reverse these rapid, large-scale RIFs.
About Cystic Fibrosis and the Foundation
Cystic fibrosis is a rare genetic disease that affects nearly 40,000 people and can affect every racial and ethnic group in the United States. In people with CF, mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene result in a buildup of thick mucus in multiple organ systems, leading to lung damage, life-threatening infections, and other complications. To facilitate the development of CF therapeutics, the CF Foundation is engaged in virtually every element of the research and development process, from preclinical discovery and identification of new therapeutics to conducting clinical trials and post-marketing surveillance.
Through the successful development of multiple transformative therapies and careful, aggressive, and continuously improving disease management over several decades, the average life expectancy for people with cystic fibrosis has risen dramatically. These gains reflect over 50 years of focused work to improve CF treatments, develop evidence-based standards of care, and encourage adherence to a lifetime of chronic care. However, this system of care and the improvements in length and quality of life for those with CF can only be realized if patients have access to essential care and services.
As the world’s leader in the search for a cure for CF and an organization dedicated to ensuring access to high-quality, specialized CF care, we outline below how these sudden and large-scale RIFs across federal agencies will impact the CF community.
Food and Drug Administration
The Food and Drug Administration (FDA) is vital for ensuring access to safe and effective therapeutics for people with CF. Time after time, the FDA has demonstrated its dedication to facilitating the rapid development and approval of CF therapies — from utilizing expedited programs for serious conditions to bring transformative CF therapies to patients in record time, to allowing the first-ever use of in vitro laboratory data to support label expansions for CFTR mutations too rare for traditional clinical trials, and most recently working with stakeholders in the CF community to develop innovative clinical trial design strategies for new CF therapeutics such as gene therapies. Through this work, the FDA — from leadership to reviewers — has built a vast body of institutional knowledge regarding the CF therapeutic landscape, the loss of which would be a significant blow to CF therapeutic development. Furthermore, insufficient staffing will diminish the FDA’s ability to perform core functions related to drug development, including working with and providing feedback to sponsors, reviewing drug product applications, innovating trial designs in new scientific areas, and performing inspections required for product approval – threatening significant delays in developing and providing patient access to ground-breaking CF therapeutics.
National Institutes of Health
Ensuring that the National Institutes of Health (NIH) is fully functional is critical for furthering our knowledge of the biology of CF and advancing CF therapeutic development. Large-scale government RIFs will diminish the ability of the NIH to review and administer grants, reduce the amount of research and clinical trials performed within and outside the agency, and result in the loss of critical institutional knowledge — meaning people with CF will have to wait longer for, or may potentially never see, a scientific breakthrough that leads to a new, transformative therapy. These RIFs may also destabilize the biomedical research workforce and hamper CF therapeutic development for years to come as career scientists leave the sector or move abroad, vital programs for trainees are cut, and instability within the field dissuades future students from pursuing research careers.
Centers for Medicare and Medicaid Services
In the Department of Health and Human Services’ announcement on the dramatic restructuring of the department and its subagencies, the Secretary claimed that these reductions will not impact Medicare and Medicaid services. This is without explanation and has not been our experience. Regional office consolidation has already impacted state Medicaid benefits, as we are hearing from patients and at CF care centers around the country that there are delays in processing applications and no response to phone calls or emails. For instance, one patient waited for hours to turn in a Medicaid application in-person and eventually had to leave before the application was processed because he was running out of supplemental oxygen. In another state, we learned that babies with positive CF newborn screens are not able to get a sweat test — the diagnostic test for CF — because of new delays in Medicaid enrollment. These infants are uninsured while they wait for Medicaid to process their applications, and families are not able to confirm whether their newborn has cystic fibrosis and needs urgent treatment.
Sudden disruptions to Medicaid and the Children’s Health Insurance Program (CHIP) can have a devastating and irreversible impact to the CF community. These programs and services are a key resource for people with CF and their families to afford the highly specialized care they need. Consistent care and access to specialized therapies are necessary for people with cystic fibrosis as this is progressive chronic disease for which delaying or forgoing daily therapies has serious implications, including increased risk of lung exacerbations, irreversible lung damage, and costly hospitalizations. Even a loss of or gap in coverage for as little as one month can put people with CF at risk of declining health and may put additional financial strain on patients who may already be struggling to afford their care.
Furthermore, the consolidation of the Office for Civil Rights (OCR) leaves patients and providers without critical protections. OCR enforces our nation’s federal civil rights laws, including fundamental rights of nondiscrimination, which help protect people with CF in their workplace and children with CF at school. Any consolidation deprioritizes the vital work OCR does to protect patients with chronic conditions, like cystic fibrosis.
Social Security Administration
In the Office on Management and Budget and Office of Personnel Management joint memo about slashing the federal workforce, there are references to ensuring that any workforce reductions that provide direct services to citizens, such as Social Security, will have a positive effect on delivery of services. Since the memo was issued, there have been reports announcing the closure of multiple social security field office and plans to cut 7,000 workers.
People with CF who are unable to work due to their illness rely on benefits administered by the SSA through either Social Security Disability Insurance (SSDI), Supplemental Security Income (SSI), or both, for financial support. For SSI claimants, even when they are able to work, they can only hold a few thousand dollars in assets without losing their benefits, making it impossible to save. For people with CF and their families who rely on these programs, lengthy periods with limited or no income while waiting for an answer on benefits may have profound consequences, leading many to run up credit card debt, sell their home, or struggle to put food on the table, all while trying to manage a costly chronic condition. Moreover, disability benefits are an essential path to accessing health insurance – SSI recipients qualify for Medicaid immediately, while SSDI recipients qualify for Medicare after two years. Longer waits to receive these benefits mean delays in access to essential coverage and care, particularly since applicants awaiting an answer on disability benefits often lack health insurance in the interim.
Within just six weeks of the announcement to cut thousands of workers from the frontlines, our community is already experiencing exacerbated delays in wait and processing times, meaning patients with CF and other chronic conditions do not receive vital financial support or insurance coverage for which they are eligible.
Additional Government Programs
This is just a sample of how people with CF are being harmed by the ongoing rapid dismantling of our federal infrastructure. Our community also relies on programs to support newborn screening to ensure early diagnosis; public health surveillance programs to monitor the spread of respiratory illnesses, so those most vulnerable can take appropriate precautions; mental health programs; and the organ donation and transplantation systems, to name a few. We are deeply disturbed by the rapid and reckless disruption of programs our community relies on, making people with CF sicker and leaving them without support.
Given the significant impact these changes are already having on the CF community, we strongly urge the administration to reverse these rapid, large-scale RIFs.