William A. McConagha
Partner
Washington, D.C.
william.mcconagha@lw.com
+1.202.637.2294
PRACTICES
- FDA Regulatory
INDUSTRIES
- Digital Health
- Healthcare & Life Sciences
EDUCATION
- JD, Georgetown University Law Center, 1993
cum laude - BA, Carleton College, 1989
magna cum laude
LANGUAGES SPOKEN
PROFILE
Bill McConagha, a former Associate Chief Counsel and Assistant Commissioner at the US Food and Drug Administration (FDA), is a nationally recognized life sciences attorney who advises clients on a range of complex issues spanning the FDA-regulated product life cycle, from premarket development and clinical trials, through product launch, post-market safety reporting, and manufacturing requirements, including cGMP.
Bill draws on extensive federal government experience to represent companies across the FDA’s regulatory spectrum, including companies that manufacture or market pharmaceuticals, medical devices, biologics, foods, tobacco, and cosmetics. He helps clients navigate:
- 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
A recognized industry leader, he worked at FDA for 17 years in various high-level roles and served as a Health Policy Advisor on the Senate Committee on Health, Education, Labor, and Pensions (HELP).
During his tenure in public service, he received the following awards: Secretary’s Award for Distinguished Service, Department of Health and Human Services; Excellence in Legal Services, Office of the General Counsel, Department of Health and Human Services; Commissioner’s Special Recognition Award, FDA; Commissioner’s Special Citation, FDA; and the Director’s Award for Outstanding Service, FDA’s Office of Criminal Investigations.
EXPERIENCE
Bill's representative experience includes advising:
- A global medical device company, as lead FDA enforcement and government strategies counsel, on confronting two Section 483s, a related warning letter, two simultaneous congressional investigations, and simultaneous FDA and DOJ enforcement investigations*
- A startup pharmaceutical company on developing appropriate promotional materials, sample distribution programs, and pharmacovigilance systems for a newly launched drug product*
- A large, publicly traded medical device company on responding to a warning letter and successfully defending a joint FDA-Department of Justice (DOJ) criminal investigation into the alleged sale of misbranded and adulterated products*
- A global vaccine company in preparing for and managing an FDA inspection and responding to a Section 483
- A global medical device company in responding to Section 483s and a Warning Letter
- A large international pharmaceutical company’s US subsidiary on defending a litigation regarding risk evaluation and mitigation strategy (REMS) and a related FDA dispute*
- Several FDA-regulated companies, including a pet food manufacturer, a consumer products company, and a large US-based pharmaceutical company, in conducting internal investigations*
- A large, publicly traded wholesale distributor on compliance with the FDA’s track-and-trace pedigree requirements for prescription drugs*
- Innovative food companies on navigating FDA and US Department of Agriculture (USDA) premarket pathways for cell-cultured meat products*
- A global cosmetic company regarding product labeling and claims
- 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*
*Matter handled prior to joining Latham