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 profession 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.

Bill’s representative experience includes advising:

Enforcement 

  • A global pharmaceutical manufacturer in a drug recall and related internal investigation a cGMP remediation plan 
  • A global manufacturer of drugs to treat rare diseases on pharmacovigilance requirements as well as a promotion and advertising review 
  • A global manufacturer of infant formulas on an FDA engagement strategy and successful resolution of a dispute relating to testing methodologies
  • A global medical device company, as lead FDA enforcement and government strategies counsel, on confronting two 483s, a related warning letter, two simultaneous congressional investigations, and simultaneous FDA and Department of Justice (DOJ) enforcement investigations*

Regulatory 

  • A global consumer products company on legal issues relating to FDA’s OTC drug monograph system and drafting a Citizen Petition for submission to FDA on relate compliance issues (Kenvue)
  • A food processing company in relation to a nationwide produce recall
  • A global pharmaceutical company on premarket review requirements for drugs, an FDA engagement strategy, enhancing its pharmacovigilance program, clinical trial requirements, and DEA regulation (Purdue)
  • A global pharmaceutical company on an internal investigation regarding qualify issues and separate compliance review relating to its compensation program
  • A 503B outsourcing facility with respect to cGMP requirements and DEA regulation (AIS Healthcare)
  • A manufacturer of OTC drug and device products on response to a FDA 483 and development of a Compliance Action Plan
  • Innovative food companies on navigating FDA and US Department of Agriculture (USDA) premarket pathways for cell-cultured meat products*
  • A large, publicly traded medical products company on developing procedures to comply with FDA’s post-market safety reporting requirements for combination drug-device products*

Transaction Diligence

  • Representative clients include: 
  • Apollo Global Management
  • ICV Partners
  • One Rock Capital Partners
  • Purdue
  • Radial Equity Partners
  • Reliant Care Solutions

*Matter handled prior to joining Latham 

Bar Qualification

  • District of Columbia
  • Maryland

Education

  • JD, Georgetown University Law Center, 1993
    cum laude
  • BA, Carleton College, 1989
    magna cum laude