FOR IMMEDIATE RELEASE
Doctors for America
PO Box 53313
1921 Florida Ave NW
Washington, DC 20009-9997
July 6, 2023
Doctors For America’s FDA Task Force: the FDA Failed to Prioritize Patient Safety by Granting Lecanemab Accelerated Approval
Full Funding For Nation’s Public Health Regulator is Desperately Needed
WASHINGTON, D.C. – In light of the full approval of Eisai’s lecanemab (Leqembi) by the U.S. Food and Drug Administration (FDA), Doctors For America’s FDA Task Force is calling on Congress to fully fund the agency such that staff have the resources and support to ensure future approval processes are determined by clinical evidence and are free of conflicts of interest.
The FDA Task Force acknowledges that the FDA heard our call earlier this year and held a public Advisory Committee meeting before today’s decision on the full approval of this therapy. It should also be noted that this Advisory Committee was comprised of only six members compared to the usual nine,raising questions of whether the typical rigorous standard for this group of independent experts was met. Three members of the Peripheral and Central Nervous System Drugs Advisory Committee resigned due to the controversial accelerated approval of monoclonal antibodies for Alzheimer disease like lecanemab, over concerns of efficacy and corporate influence. Another member chosen to be added was later recused because of their involvement in clinical trials for Biogen and Eisai. Moreover, the voting question posed to the Advisory Committee by the FDA did not reflect the standard for approval that is needed to be met – that is, whether the drug’s benefits outweigh its risks. Instead, the only voting question posed was on whether the drug demonstrated clinical benefit. These repeated disruptions of the standard Advisory Committee process set a dangerous precedent for the integrity of our evidence-based approval processes.
Last month, members of the FDA Task Force made public comments at the Advisory Committee meeting on our collective concerns about the serious risks and clinical efficacy of this therapy. The FDA Task Force is committed to increasing transparency at the FDA and ensuring patient safety is at the heart of all therapeutic approvals. The approval of lecanemab is being lauded by many groups as a huge advancement, but critical questions remain as to whether the benefits outweigh the risks, including reported patients deaths associated with the drug. As clinicians and scientists we cannot ignore the reports of brain swelling, brain bleeding, and death among patients who received this drug. We are particularly concerned about the safety of an already marginalized population of older patients with cognitive impairment, especially patients of color who were largely underrepresented in the clinical trial supporting approval of lecanemab. We want a treatment for our patients and our loved ones that is safe and meaningfully effective at slowing the progression of this devastating disease.
In the coming months as lecanemab is made more broadly available to patients by the manufacturer, it will be imperative for the Centers for Medicare and Medicaid Services (CMS) to be able to collect information in a timely manner on the utilization of this drug among patients, particularly Medicare beneficiaries who are disproportionately impacted by Alzheimer’s disease. We commend CMS for its efforts to ensure this data collection through a registry and urge that this registry is centralized so as to prevent disparate data elements from being collected where analysis of safety events and meaningful efficacy may be difficult. We look forward to reviewing further details of this registry and its implementation in hopes that this will provide our practicing members further guidance on which patients might be at most risk of harm due to the drug.
We believe that a fully funded, fully staffed FDA, with consistent, rigorous standards for evidence-based review, is empowered to make the right decisions for patients. The agency that the country relies on for unbiased decisions needs a robust line of federal funding that does not come from the pharmaceutical industry.
It is because of our commitment to a future with safe and effective treatments for our patients that we are asking Congress to ensure the FDA is adequately funded and able to maintain its ‘gold standard’ status. As we approach the end of the federal fiscal year, it is imperative that negotiators keep patients at the heart of their decisions. A fully funded FDA is needed to address on-going supply chain issues, ensure oversight of therapeutics are in place, and allow the agency to attract the talent needed to ensure that drug approval review and decisions are free from bias and influence.
For press inquiries and to speak more on this issue with members of the Doctors for America FDA Task Force please contact Claire Onyechi with Continuum Health Group ([email protected]).
About Doctors for America:
Doctors for America mobilizes doctors and medical students to be leaders in putting patients over politics to improve the health of our patients, communities, and nation. DFA is an organization of over 27,000 physician and medical student advocates in all 50 states, representing all areas of specialization. DFA teaches physicians and medical students advocacy skills and does advocacy at a state and federal level. Our impact areas focus on access to affordable care, community health and prevention, and health justice and equity. DFA focuses solely on what is best for our patients, not on the business side of medicine, and does not accept any funding from pharmaceutical or medical device companies, which uniquely positions DFA as the organization that puts patients over politics and patients over profits. Find out more at doctorsforamerica.org and on Twitter drsforamerica.