• A global pharmaceutical company in a confidential matter before the FDA involving eligibility for New Chemical Entity (NCE) Exclusivity
  • A private equity client on FDA compliance issues faced by an acquisition target medical device company; also advised the company on corrective action plans post-acquisition
  • Achieved reversal of FDA decision to refuse to file a new drug application in confidential pre-litigation advocacy before the FDA Chief Counsel's Office
  • The promotional review committee of a major pharmaceutical company, as regulatory counsel with responsibility for prescription anti-infective, cardiovascular, pain, and women's health drug products
  • Provided successful regulatory strategy for a third-party-initiated OTC switch of a blockbuster prescription drug
  • Managed the legal, regulatory, and public relations aspects of a major nationwide recall of roasted tree nuts shellnuts, engaged and directed scientific experts in conducting the internal root-cause investigation, and negotiated terms and conditions of a recall with FDA and California Department of Health officials, with no warning letter or additional enforcement actions taken
  • On behalf of a top-10 global pharmaceutical company, prevailed in a contested citizen petition proceeding involving the scope of coverage of the three-year Hatch-Waxman new clinical study exclusivity
  • On behalf of a pharmaceutical company, through confidential negotiation with FDA and public advocacy strategies, achieved the market withdrawal of unapproved prescription drug products being unlawfully marketed in competition with the client's approved product
  • On behalf of a research-based pharmaceutical company, served as FDA counsel in a successful US Supreme Court case broadening the scope of the FDA research exemption to patent infringement under the Hatch-Waxman Amendments (Merck KGaA v. Integra Life Sciences)
  • On behalf of a national wine industry trade association, drafted and filed a Supreme Court amicus brief in a successful Constitutional challenge to state law restrictions on interstate mail-order delivery of wine (Granholm v. Heald)
  • On behalf of two leading orphan drug patient advocacy groups, drafted a Supreme Court amicus brief in a case striking down state law restrictions on the use of physician prescribing data by pharmaceutical companies for marketing purposes (IMS v. Vermont)