Comment from Bower, Kaylin

This comment regards FDA docket FDA-2026-N-3947: "Impacts of Patient-Focused Drug Development Meetings; Established of a Public Docket; Request for Information and Comments": *This is Comment 1 of 2 regarding the EveryLife Foundation* This comment concerns the growing role of industry-funded “patient advocacy” organizations in FDA policymaking and regulatory proceedings, with the EveryLife Foundation for Rare Diseases serving as a particularly clear example of this problem. The EveryLife Foundation presents itself as an independent representative of rare disease patients and caregivers. However, the organization’s own 2024 annual report demonstrates that it is deeply and pervasively financed by the pharmaceutical and biotechnology industry and by pharmaceutical trade associations whose members have direct financial interests before the FDA. Top-tier donors ($300,000 and above) include Alexion Pharmaceuticals, Amgen, Sanofi, and Ultragenyx Pharmaceutical. Additional six-figure contributors include Biogen, Genentech, Novartis, and Pfizer. The donor roles also include pharmaceutical lobbying and trade organizations such as Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Innovation Organization (BIO). Importantly, this industry dominance is not limited to a few top sponsors. Across virtually every disclosed donor tier in the Foundation’s 2024 annual report—including the $100,000–$299,999, $50,000–$99,999, $25,000–$49,999, and $10,000–$24,999 categories—the overwhelming majority of donors are pharmaceutical companies, biotechnology firms, pharmaceutical service companies, or industry trade associations. The donor structure is therefore not merely supplemented by industry funding; it is overwhelmingly composed of industry funding at nearly all levels. This is not merely “support” from industry. It is an organizational funding model built around industry financing. The EveryLife Foundation was also founded in 2009 by an individual who went on to found Ultragenyx Pharmaceutical in 2010, underscoring the close and longstanding relationship between the organization and the commercial rare disease drug development sector. Importantly, these financial relationships align closely with the organization’s public policy agenda. The EveryLife Foundation has repeatedly advocated for expanded FDA “regulatory flexibility,” accelerated approval pathways, broader use of surrogate endpoints, streamlined evidentiary requirements for rare disease products, and policies designed to speed or facilitate approvals for industry sponsors. For example, the organization has publicly urged Congress and the FDA to ensure that “all the tools” intended to accelerate rare disease therapy development are used aggressively and consistently, including expanded regulatory flexibility and expedited pathways. The organization has also defended accelerated approval pathways against payer and Medicaid scrutiny and has promoted policies intended to preserve or expand access to drugs approved under those standards. These positions directly benefit many of the pharmaceutical companies funding the organization. This creates a serious conflict-of-interest problem. Organizations like the EveryLife Foundation are routinely presented to regulators, lawmakers, journalists, and the public as independent “patient voices,” when in reality they often operate in substantial financial alignment with the industries most affected by FDA regulatory decisions. The result is a form of institutionalized astroturfing in which industry-aligned policy preferences are conveyed through organizations framed as grassroots patient advocates. This structure gives pharmaceutical industry positions an added veneer of moral authority and emotional legitimacy because they are delivered through organizations publicly identified as representing vulnerable patients and families. The EveryLife Foundation is not unique. A broader ecosystem of nominally independent patient advocacy organizations now depends heavily on pharmaceutical and biotechnology funding while actively lobbying the FDA and Congress on issues directly affecting their donors’ commercial interests. This increasingly blurs the line between authentic patient representation and industry-sponsored advocacy. This dynamic risks: Skewing FDA policymaking toward industry-preferred regulatory standards Marginalizing independent patient and caregiver perspectives that may not align with sponsor interests Weakening evidentiary standards under the banner of “patient-centered” flexibility Undermining public trust in the independence and integrity of the FDA regulatory process