STAIR XIII Statement of Support for the FDA

The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) have actively participated in STAIR conferences since 2013.

Traditionally, CDER and CDRH representatives participating in STAIR meetings, have offered valuable insights concerning study design and the evaluation process for drug and device approvals. However, at this year's STAIR XIII meeting, current government policy prohibited FDA representatives from actively participating. The absence of FDA input and guidance on regulatory issues was disappointing to attendees, left a critical gap in the discussion and disrupted a process that has proven very fruitful in the past.

In response STAIR XIII participants resolved that they wished to formally express their support for FDA, specifically the CDER and CDRH offices and their personnel. Immediately following the STAIR XIII conference, STAIR leadership drafted a statement of support of the FDA and shared it with all 160 STAIR XIII participants who were afforded the opportunity to suggest edits and further affirm their support of the FDA, it's mission and personnel. The STAIR leaders incorporated helpful suggestions and submitted the final statement to the the American Heart and Stroke Association's Stroke journal to be published as an editorial.

The AHA Stroke Journal editors agreed to include the statement in the next journal issue. The STAIR XIII Statement of Support for the FDA was published on May 10, 2025. Subsequently the STAIR XIII statement was shared with other leading healthcare organizations similarly advocating on behalf of the FDA.

Statement of Support for the FDA from the Stroke Treatment Academic Industry Roundtable (STAIR)

Marc Fisher, M.D., Gary Houser, Gregory W. Albers, M.D.

The Stroke Treatment Academic Industry Roundtable (STAIR), established in 1999 by leading stroke researchers, aims to advance stroke research and accelerate the development of safe and effective new therapies for acute stroke. STAIR brings together experts from academic medicine, industry, and government, the three key sectors responsible for the discovery, translation, and evaluation of new data for safety and efficacy of novel therapies to help make new stroke treatments available for patients in need. The engaged participation of leading representatives from academia, industry, and government groups has been critical to the success of STAIR, ultimately facilitating advancements in stroke care that improve the lives of patients. In our experience, the Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Device and Radiological Health have exceptional expertise, unwavering dedication, and a deep commitment to their vital role in reviewing and approving new stroke therapies.

STAIR strongly supports the mission and work of the FDA. In our extensive experience with the FDA, the agency is uniquely skilled, highly qualified and committed to enhancing the development and approval of innovative therapies for the treatment of stroke. A strong and fully functional FDA is essential to bring new effective therapies to patients in need.

To this end, STAIR emphasizes our strong support for maintaining and protecting three particularly important requirements for an optimally effective FDA:

Critical staffing levels must be maintained to ensure sufficient workflow capacity and ensure timely reviews and responsiveness.
The integrity of the review process must be protected to ensure scientific independence and rigor.
Engagement with external experts must remain a priority to allow meaningful input from the broader scientific and clinical communities.

The stroke field has seen remarkable progress in recent years with the approval of novel drugs and devices that significantly improve outcomes for patients with acute ischemic stroke. Despite the enormous success of these therapies, a large unmet medical need remains. Many promising new treatments to address these needs are currently being studied in clinical trials, and scientific development activity continues to increase. Successfully bringing these therapies to patients relies on the continued active collaboration between many key stakeholders including industry sponsors, physician investigators, and the FDA.

The FDA is widely regarded as the most trusted and influential regulatory authority in the world. The approval of new therapies in the U.S. involves a comprehensive, multi-phase evaluation by the FDA. This process begins with an internal review of new scientific data by agency regulators, followed when appropriate by additional review and input from qualified external experts. This collaboration has consistently ensured over the past decades that only safe and effective treatments are approved for use, while those lacking sufficient evidence of efficacy evidence or safety are appropriately rejected.

STAIR develops and publishes best-practice recommendations that have improved the quality and design of clinical trials submitted to the FDA. The publications generated by past STAIR meetings have been extensively cited and have influenced development programs for novel drugs and devices. These guidelines are an example of the success that occurs when there is collaboration between industry, academia and the FDA. The impact of STAIR has been greatly facilitated by FDA’s participation in prior STAIR conferences, where they consistently offered valuable insights into optimal trial design and regulatory policy.

STAIR was deeply concerned that current government policy did not allow FDA representatives to participate in the recent STAIR XIII meeting held March 27–28, 2025 near Washington, D.C. Their absence left a critical gap in the discussion and disrupted a process that has proven fruitful in the past. Attendees also expressed concerns about the FDA’s future capacity to ensure timely review and approval of prospective novel therapies with favorable safety and efficacy profiles.

STAIR reaffirms its strong support for FDA’s essential role in advising clinical trial sponsors and assisting in the development of innovative therapies for acute ischemic stroke and other conditions. Ongoing collaboration between the FDA and external experts is essential to ensure timely, objective, evidence-based reviews. The process must remain scientifically rigorous and free from external interference. To achieve this, the FDA must be independent, well-resourced and sufficiently staffed with appropriately qualified and capable personnel.