William McConagha

Practice Areas

Bill McConagha, a nationally recognized life sciences attorney, helps global clients navigate a full spectrum of US Food and Drug Administration (FDA)-related business and legal issues, drawing on extensive compliance, regulatory, and legislative experience.

A former Associate Chief Counsel and Assistant Commissioner at the FDA, Bill counseled 5 FDA Commissioners. He brings 17 years of high-level public sector experience and a seasoned legal perspective to complex matters related to:

- FDA compliance, including preparing for and managing FDA inspections, responding to FDA 483s and warning letters, and complying with post-market safety requirements

- FDA regulatory issues, including pre- and post-market requirements and related commercial activities such as product importation and supply chain oversight

- FDA-related diligence and regulatory counsel, including negotiating representations and warranties, in corporate transactions

Internal investigations involving clinical trial oversight, post-market safety reporting, and risk management

Bill advises clients active in a range of sectors, including pharmaceuticals, medical devices, biologics, foods, tobacco, and cosmetics, leveraging his on-the-ground experience in manufacturing facilities around the globe to better understand the challenges biotechnology and life sciences companies face.

During his tenure in government, he served as senior counsel to FDA’s Office of Criminal Investigation and was a lead compliance counsel to FDA’s Center for Drug Evaluation and Research, its Office of Combination Products, and its Office of Policy. He also served as a health policy advisor on the Senate Committee on Health, Education, Labor, and Pensions (HELP), where he worked on the Biologics Price Competition and Innovation Act, the Food Safety Modernization Act, the FDA Safety and Innovation Act, and the Drug Supply Chain Security Act.

He received more than a dozen government awards, including:

- Excellence in Legal Services, Office of the General Counsel, Department of Health and Human Services

- Commissioner’s Special Recognition Award, FDA

- Director’s Award for Outstanding Service, FDA’s Office of Criminal Investigations

Bill routinely speaks at leading conferences and publishes articles on enforcement trends and legal developments. He teaches on Food and Drug Law as an adjunct professor at Georgetown University Law Center. He also serves on the board of the Mid-Atlantic Innocence Project and on the medical products committee of the Food and Drug Law Institute.