JIM JOHNSON guides life sciences companies through complex U.S. Food and Drug Administration (FDA) compliance and enforcement matters. Positioned at the forefront of FDA compliance and regulatory issues critical to the business of his clients, Jim excels at knowing what’s ahead. He counsels life sciences companies on a range of FDA matters, including inspections, current good manufacturing practices (GMP) requirements, data integrity responsibilities, product quality issues, pharmacovigilance obligations, and enforcement actions. He helps clients around the world identify compliance risks early, prevent problems from happening, efficiently resolve issues with minimal corporate pain, and improve agency relationships.
Jim knows the FDA well, having served as Associate Chief Counsel for Enforcement in the FDA's Office of the Chief Counsel. At FDA Jim handled GMP enforcement and provided legal counsel on a range of inspectional and compliance issues to agency components, particularly the FDA's Office of Regulatory Affairs (ORA) and Center for Drug Evaluation and Research’s (CDER) Office of Compliance.
Whether preparing an international manufacturing site for an FDA inspection, or working with a U.S.-based facility in response to FDA inspectional observations (a Form FDA 483), Jim uses his extensive agency and private practice experience to assist pharmaceutical and biotechnology companies worldwide. He regularly conducts GMP assessments and investigations, resolves warning letters and import alerts, and appears in front of the FDA on behalf of companies to resolve enforcement actions.
Jim also advises life sciences companies on drug approval and life-cycle management strategies, and represents clients in related litigation against the FDA and U.S. Patent and Trademark Office. Jim honed these skills at the FDA, where he defended the agency in Hatch-Waxman cases involving agency exclusivity and patent-term extension determinations.