Life Sciences Regulatory

• A US CRO on the implementation of certain clinical trial-related services following the acquisition of Illingworth Research Group in more than 50 jurisdictions worldwide. In particular, we advised the client on the provision of nursing services in the context of clinical trials to be rendered at trial subjects’ homes and at the direction of the trial’s principal investigator.
• A global medical device company in relation to its diabetes business across 29 jurisdictions, on whether it is possible to market, sell and ship its products directly to customers in each jurisdiction.
• A US medical technology company on all aspects of medical device regulation including: (i) on discontinuing a previous version of their medical device in 40 countries; (ii) rolling out a sampling program with HCPs throughout Europe; and (iii) on transparency obligations in the MedTech and national industry codes.
• A global biopharmaceutical company on cell and gene therapy (CGT) regulation in the EU, including in relation to compliance with the EU Tissue and Cells Directive, ATMP Regulation, and broader regulatory challenges arising from the company’s CGT business.
• A US pharmaceutical company in reviewing their internal compliance policies related to medicinal product promotion and HCP interactions in 31 jurisdictions worldwide.
• A global pharmaceutical organization on its negotiations for the supply of its COVID-19 vaccine across EU and EEA countries.
• A large medical products manufacturer on a multi-billion euro patent collaboration in relation to a medical contrast agent. Our cross-border, cross-practice team worked on a wide range of complex commercial, competition, IP and patent issues to secure a landmark agreement for the client.

FDA Experience

• Represented a global pharmaceutical company in a confidential matter before the FDA involving eligibility for New Chemical Entity (NCE) Exclusivity
• Represented 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
• A major pharmaceutical company’s promotional review committee 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
• 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 top-10 global pharmaceutical company,
• Achieved the market withdrawal of unapproved prescription drug products being unlawfully marketed in competition with the client's approved product on behalf of a pharmaceutical company, through confidential negotiation with FDA and public advocacy strategies,
• 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 on behalf of a research-based pharmaceutical company, (Merck KGaA v. Integra Life Sciences)
• Drafted and filed a Supreme Court amicus brief in a successful Constitutional challenge to state law restrictions on interstate mail-order delivery of wine on behalf of a national wine industry trade association, (Granholm v. Heald)
• 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 on behalf of two leading orphan drug patient advocacy groups, (IMS v. Vermont)