Always meticulously prepared and quick on his feet, Peter Mathers has relished in the privilege of helping clients understand and negotiate their way through complex and unprecedented regulatory issues for over 40 years. As Peter would say, “I believe that regulatory practice ideally involves the balancing of opportunities and risks in light of applicable legal standards as well as the policies and practicalities, both industrial and bureaucratic, that underlie those standards.”
Peter was key to litigating generic drug approval procedures with the FDA before the Hatch-Waxman Amendments were in place and has continued to be responsible for the ongoing interpretation, application, negotiation and litigation of the critical issues arising under those Amendments.
Peter regularly advises clients through the development and approval process and all aspects of the subsequent manufacturing and marketing activities for their products. During his career, he has also served as the representative for numerous firms and individuals facing substantial legal jeopardy arising from civil, criminal and administrative enforcement actions arising out of alleged good manufacturing practice violations, marketing violations and/or “integrity” issues. Peter also has unparalleled experience in advising and defending clients manufacturing and distributing prescription drug products traditionally marketed without FDA approval. In all of these areas, Peter’s advice reflects the critical need for proactive strategies to minimize and to defend against foreseeable, yet unpredictable risks of regulatory action, competitive disputes, and product liability claims.
In addition to his extensive work with manufacturers of drugs, medical devices, APIs and other FDA-regulated products and components, Peter has also had broad experience with all areas of DEA regulation. This experience includes registration proceedings for importers, manufacturers and distributors of controlled substances (including bulk manufacturers), regulation of listed chemicals, related security, recordkeeping and reporting requirements, drug scheduling proceedings, and quota allocations.
Peter has been recognized in The Best Lawyers in America© for FDA Law since 2013 and has also been listed on the Super Lawyers list since 2013. Peter also received a Client Choice award in the Healthcare & Life Sciences category in 2014.
Publications & Speaking Engagements
Recognition & Professional Activities
Best Lawyers® in America, FDA Law, 2013-Present
Super Lawyers, Food and Drugs, 2013-2017
Client Choice Award, Healthcare and Life Sciences, 2014
Member, Thomas Swan Barristers Union
B.S., Rensselaer Polytechnic Institute (cum laude)
Omicron Delta Epsilon, Economics honor society
U.S. District Court for the District of Columbia
U. S. Court of Appeals, D.C. Circuit and other Federal Circuits
United States Supreme Court