FDA regulatory lawyer Melissa Mannion joins Jones Day in Washington
Melissa Mannion has joined Jones Day as of counsel in its Health Care & Life Sciences Practice, based in Jones Day's Washington Office.
Ms. Mannion has served for the past 12 years at the U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER), most recently as Senior Regulatory Counsel for the CDER Office of Generic Drug Policy. During her tenure, she represented the FDA domestically and internationally on matters related to drug development and global distribution of drugs, led agency-wide programs under the Drug Supply Chain Security Act, participated in negotiations with the White House on foreign drug importation programs, and testified as an expert witness during criminal proceedings involving violations of the Food, Drug & Cosmetic Act and other federal statutes. Melissa also previously served as the Acting Branch Chief for each of CDER's Recalls and Shortages Branch and Imports Exports Compliance Branch, supervising compliance efforts related to potentially harmful and ineffective drugs and developing strategies to address challenges to the U.S. drug supply chain.
"Melissa provides experience and strategic insights for navigating complex regulatory processes to bring drugs to market around the globe," said Alexis Gilroy, co-leader of Jones Day's Health Care & Life Sciences Practice. "This depth of knowledge on FDA requirements and drug supply chain consideration will be a tremendous asset to our clients worldwide."
At Jones Day, Ms. Mannion joins a cross-disciplinary team of lawyers who advise clients worldwide on high-stakes issues across the entire spectrum of the health care and life sciences industry. The Firm's Health Care & Life Sciences Practice represents hospitals and academic medical centers; provider organizations; health care investors and private equity funds; pharmaceutical, biotech, and medical device companies; and food and cosmetics companies.
Ms. Mannion, who is also a licensed pharmacist, began her legal career working on the Government Affairs team at the American Pharmacists Association.
"Melissa is a respected regulatory attorney here in Washington, where she has acquired more than a decade of experience with the FDA in matters of great importance to health care and life sciences clients," said Noel Francisco, Partner-in-Charge of Jones Day's Washington Office. "Her knowledge of regulation and other related policy developments in public health is an excellent addition to our team. I am pleased to welcome her to Jones Day."
Ms. Mannion earned her law degree from the University of Maryland Baltimore Francis King Carey School of Law, her Doctor of Pharmacy degree from the University of Maryland Baltimore School of Pharmacy, and her undergraduate degree from U.C. San Diego.
"It has been a distinct honor to serve the American public at the FDA for the past dozen years, where I had the opportunity to identify, plan and lead regulatory policy development efforts pertaining to consumer drugs," said Ms. Mannion. "I am gratified to join a remarkable global team of health care and life sciences lawyers at Jones Day, as well as the elite group of lawyers in Washington and throughout the Firm."
