Since joining the firm in 1979, Peter Mathers has had the privilege of helping clients understand and negotiate their way through regulatory issues from the routine to the unprecedented. He believes 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 has been recognized since 2013 in The Best Lawyers in America for FDA Law, and has been listed on the Super Lawyers list since 2013. Peter received a Client Choice award in the Healthcare & Life Sciences category in 2014.
Peter was involved in litigation with FDA over the development of generic drug approval procedures even before the Hatch-Waxman Amendments, and has continued to be involved in the ongoing interpretation, application, negotiation and litigation of the critical issues arising under those Amendments. He has extensive experience helping clients through the development and approval process and all aspects of the subsequent manufacturing and marketing activities for their products. Peter has defended 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 pro-active 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.
Best Lawyers®, FDA Law, 2013-2019
Super Lawyers, Food and Drugs, 2013-2017
Client Choice Award, Healthcare and Life Sciences, 2014