Michael N. Druckman
Mike Druckman leverages his prior experience at the FDA — and what he has learned since then while extricating companies from regulatory problems — to anticipate and prevent life science clients from getting into trouble in the first place. Mike understands the business challenges that companies face in a highly regulated environment. He actively works with other Hogan Lovells lawyers experienced with government reimbursement, anti-kickback limits, product liability, and a full range of other regulatory areas to craft approaches that will maximize clients' opportunities and minimize their risks.
Mike formed and now chairs the firm's Cell, Tissue, and Gene Therapies Working Group, a cross-disciplinary team that advises companies in this emerging space on the evolving regulatory and business challenges they face. Mike and the team work closely with companies developing stem cells, cord blood, placental tissues, gene therapies, proteins, and other cellular products to help people with serious health problems.
Mike also advises companies with a full range of regulatory challenges involved in investigating new drugs, biologics, and combination products, obtaining FDA approval for those products, and in promoting, selling, and distributing those products. His experience also includes the Drug Supply Chain Security Act, pharmacy compounding, expanded access/compassionate use clinical trials, orphan drug exclusivity, and precision medicine and companion diagnostics.
While in the FDA's Office of the Chief Counsel, Mike also advised on medical countermeasures. He served on the FDA's Pandemic Influenza Planning and Preparedness Team, and helped draft guidance on pandemic and seasonal flu vaccines and a regulation on Strategic National Stockpile product labeling. Since joining the firm, he has advised on Emergency Use Authorizations, select agents and toxins and Dual Use Research of Concern (DURC), and various issues involving vaccines and other products.
Areas of Focus
Helped obtain orphan drug designation for a vaccine.
Guided a company in bringing a blood derivative back to market after a complete recall.
Helped prevail on a Prescription Drug User Fee Act (PDUFA) fee dispute with the FDA.
Crafted stem cell legislation and regulations.
Worked with the FDA and colleagues in Government Contracts group to ensure that a tissue company's products remained on the Federal Supply Schedule.
Helped convince the FDA to change a long-standing policy, increasing incentives for innovative drug combinations.
Helped win two formal dispute resolutions, allowing the client to market a new drug formulation with a new brand name under a separate NDA.