Seth A. Mailhot

Mr. Mailhot is a special counsel in the Intellectual Property Practice Group in the firm's Washington D.C. office. He is also a member of the firm's Food and Drug Law Group, as well as the firm's Life Sciences Group.

Areas of Practice

Mr. Mailhot's 14 years working in the U.S. Food and Drug Administration (FDA) provides a unique perspective in his counseling of clients on a broad range of matters involving the FDA.

While working at the FDA, Mr. Mailhot served in a variety of capacities and oversaw activities of pharmaceutical, biologic, medical device, food, cosmetic, and dietary supplement companies. Mr. Mailhot’s FDA regulatory experience includes enforcement and recall matters, preparation and prosecution of FDA premarket submissions (such as 510(k)s, PMAs, NDAs, ANDAs, INDs, IDEs, pre-INDs and pre-IDEs), product promotion and labeling issues, pharmaceutical exclusivity matters, and compliance with quality, regulatory, and manufacturing requirements.

With his education and experience as a chemical engineer, Mr. Mailhot is equipped with very strong science skills. Coupled with his knowledge of regulatory issues, Mr. Mailhot is invaluable to clients developing long-term product marketing strategies. While at the FDA, Mr. Mailhot coauthored numerous technical articles on regulatory science.

Mr. Mailhot also has significant experience with corporate matters that touch on FDA regulation. His work includes counseling FDA-regulated clients through the initial public offering process, assisting underwriters with various financing, and offering transactions involving FDA-regulated targets, and preparing and reviewing agreements related to clinical trials, mergers between FDA-regulated companies, and licensing of FDA-regulated products.

Mr. Mailhot’s understanding of manufacturing regulations and current good manufacturing practices spans all industries, with a focus on regulatory issues involving foreign manufacturing. While at the FDA, Seth was a Level II certified medical device investigator and conducted foreign and domestic inspections.

Mr. Mailhot’s additional background as a patent attorney who has worked on major intellectual property litigation cases allows him to offer insights to clients about how regulatory issues can impact intellectual property interests. Mr. Mailhot also worked closely with the District of Massachusetts U.S. Attorney’s Office Health Care Fraud Unit on matters involving civil and criminal charges under the Federal Food, Drug and Cosmetic Act, and brings significant added value in the defense of various government investigations.

Mr. Mailhot’s practice includes lobbying and government relations work on behalf of clients in matters involving the FDA. He writes and lectures, both domestically and internationally, on cGMP requirements and FDA’s foreign inspection program.

Mr. Mailhot is an Adjunct Faculty and Lecturer at The Catholic University of America- Columbus School of Law, where he currently teaches the course "Federal Regulation of Food and Drugs."

Education

• J.D., New England School of Law, 2004, Valedictorian, summa cum laude
• B.S., Chemical Engineering, University of Massachusetts at Amherst, 1994

Admissions

• District of Columbia
• Commonwealth of Massachusetts
• U.S. Patent and Trademark Office

Articles

• Chinese Outbound Newsletter - March 2013, March 11, 2013

•  “Age of Uncertainty,” Medical device regulatory experts provide their perspectives on how healthcare reform proposals make orthopedic device competition more challenging, Orthopedic Design & Technology, March/April 2010
• "Strong Purchasing Control System Can Help Guard Against Recalls," The GMP Letter, December 2009
• Coping With Change,” Medical device regulatory experts provide their perspectives of what changes might take place under the new U.S. Food and Drug Administration leadership, Medical Product Outsourcing, November/December 2009.
• “Tips for Effectively Responding to a Form FDA-483 for Foreign Medical Device Manufacturers,” Provide a detailed response plan, thorough documentation and translations, Medical Product Outsourcing, November/December 2009.
• Co-Author, “What You Don’t Know Can Hurt You: Understanding the FDA’s Foreign Inspection Program,” Andrews Litigation Reporter, Vol. 14, No. 25 (February 4, 2008).
• Co-Author, “Ask the Expert,” Devices & Diagnostics Letter, February 25, 2008.
• Co-Author, “What Every Foreign OEM, Importer Should Know. A review of medical device warning letters issued to foreign manufacturers by the FDA, 1997-2007,” Medical Product Outsourcing, July/August 2009.
• Co-Author, “What Every Foreign Medical Device Manufacturer and Importer Should Know. A review of medical device warning letters issued to foreign manufacturers by the FDA, 1997-2007, Part II,” Medical Product Outsourcing, September 2009

FDA Law Blog Articles

• "Cybersecurity: FDA Risks for Medical Devices," June 13, 2013
• "Thoughts on Regulatory Constraints of Business Models," April 5, 2013
• "Supreme Court Hears Arguments on "Pay for Delay" Agreements," April 3, 2013
• "The Impact of Cloud Computing on FDA's Regulation of Medical Products," February 14, 2013
• "FDA Issues Two Proposed Rules That Will Significantly Change Regulatory Requirements For Food Safety," January 24, 2013
• "FDA Issues Final Guidance on Filing PMAs and 510(k)s," January 3, 2012
• "Congress Contemplates Action on Rolling Machines," April 3, 2012
• "State-by-State Differences in Retailer Enforcement," March 15, 2012
• "Institute of Medicine Report: Dead on Arrival," August 1, 2011
• "Sunscreen in the Spotlight: FDA Illuminates New Sunscreen Regulations," June 17, 2011

Speeches

• Panelist, "Fundamentals of FDA Regulatory Device Law," American Conference Institute, FDA Boot Camp Devices Edition, October 25-26, 2011
• "Medical Device Reporting," American Conference Institute, FDA Boot Camp Devices Edition, October 25-26, 2011
• "Software as a Medical Device: Understanding the Nuances of FDA Regulation," American Conference Institute, FDA Boot Camp Devices Edition, October 25-26, 2011
• "Burning Issue #4: Tobacco Compliance and the FDA," 2011 National Advisory Group Conference, September 13, 2011
• Panelist, "Navigating Increased Risks and Regulatory Challenges when Undertaking Global Product Recalls," American Conference Institute, March 22, 2011
• "Post-Market Requirements and concerns for Medical Devices," American Conference Institute, FDA Boot Camp, March 17, 2011
• "Labeling Drugs, Biological, and Medical Device Products in a Litigious Environment,” Products Liability Boot Camp for Life Sciences, July 21, 2010
• Panelist, “Understanding the Jurisdiction and Interplay of the FDA and PTO in the Patenting of Drugs and Biologis,” American Conference Institute, Hatch-Waxman Boot Camp, July 19-20, 2010
• Panelist, “Regulatory Compliance – Changes in Review Practices,” Orthopedic Design & Technology Forum, April 28, 2010
• “REMS Risk Evaluation and Mitigation Strategies,” American Conference Institute, April 19–20, 2010
• "Post-Market Requirements and Concerns for Medical Devices,” American Conference Institute, FDA Boot Camp, March 24–25, 2010
• Panelist, "FDA Express Lane: Efficiently Navigating the FDA Approval Process," University of Maryland Start-Up Boot Camp, October 23, 2009