Jason works with clients investigating and developing a wide range of FDA-regulated products. Some might be inventors developing their first medical devices while others are multinationals determining what evidence they should gather before launching innovative food additives. Jason helps these clients chart their pathways to market — taking into consideration their marketing objectives, resource constraints and legal requirements — and prepare for critical FDA meetings and submissions.
Jason advises food, drug and device companies preparing to raise funds (privately or publicly) and companies looking to grow their businesses through acquisitions or mergers. He helps them evaluate compliance history, identify operational considerations, review current product labeling and advertising, and assess critical relationships with suppliers, manufacturing partners and distributors from the standpoint of regulatory risk.
Jason has participated firsthand in FDA facility inspections and uses this experience to advise companies in addressing and mitigating areas of compliance risk. This includes evaluating existing practices and procedures as well as assisting clients in developing new materials to respond to shifting regulatory requirements. Jason conducts internal FDA investigations and audits to identify areas of weakness and also to help management respond to and correct known individual and systemic production and marketing lapses.
Investigations, Enforcement and Recalls
Jason provides strategic and practical guidance, on-site or remotely, to clients preparing for and undergoing FDA inspections. He helps clients determine whether and when to submit product reports and how to respond to formal and informal FDA actions. He also assists clients in all phases of product recalls as they face their most challenging business decisions.
Food & Drug Administration
While at FDA, Jason advised the agency on investigations, seizures, injunctions, product recalls and other enforcement actions against drugs, dietary supplements and adulterated foods. He participated in regulatory actions such as FDA’s promulgation of rules and guidance regarding fresh produce, food safety, and nutritional and menu labeling. He also helped to execute FDA’s initiative to expand the scope of federal/state enforcement cooperation.
Jason’s diverse legal and public health background includes serving as assistant attorney general for the Maryland Attorney General’s office in the Maryland Department of Health and Mental Hygiene, the Maryland Health Care Commission and the Maryland Community Health Resources Commission. Jason served as faculty at the John Hopkins Bloomberg School of Public Health, working closely with state departments of public health, the CDC, NIH and USAID.