Least Burdensome: A Lighter Lift for FDA’s “Substantial Evidence” Gold Standard

ZACHARY A. ZALEWSKI, KELLY L. GRIFFIN & GILLIAN WOOLLETT

ABSTRACT

Medical products continuously evolve in both complexity and sophistication. As the number of products in development—and urgency of patient access—grows, it is stakeholders’ collective responsibility to optimize regulatory oversight to enable more robust access to safe and efficacious products; such optimization is integral to the U.S. Food and Drug Administration’s (FDA or agency) mission to safeguard public health. As regulatory policy evolves, incorporating the “Least Burdensome” principles as mandated by Congress and developed across the Center for Devices and Radiological Health (CDRH), Center for Drug Evaluation and Research (CDER), and Center for Biologics Evaluation and Research (CBER) can help achieve this sought-after optimization. Patients waiting for access to new and genericized medical products are not FDA’s fault, but neither are they an “Act of God” to be ignored.1 This Paper examines the Least Burdensome principle as a solution to benefit all stakeholders, while maintaining FDA’s gold standard of regulatory rigor Americans trust and depend upon for their individual and collective health.