Enabling access to medical countermeasures for material threats is a top FDA priority, according to Commissioner Scott Gottlieb, who reviewed the agency’s efforts before a Senate committee Wednesday.
Medical countermeasure products can be uniquely challenging from an industry perspective, Gottlieb told the Senate Committee on Health, Education, Labor and Pensions, in a hearing on public health threats and government response preparedness.
Unlike other FDA fast-track programs, he said, “the prospect of commercializing something for stockpiling purposes often isn't enough of an incentive to offset cost.” Such drug products, he said, are “not a typical market with usual market-based incentives.”
Research at the FDA’s Center for Biologics is showing particular promise in developing cell-based therapies to address emerging threats, he said. The agency is planning a suite of product-specific guidances for the coming year, first addressing more common conditions and eventually progressing to rarer diseases.