Torrey Cope

Torrey has a wide range of experience counseling and advising clients in matters involving issues arising under the Federal Food, Drug, and Cosmetic Act (FDCA) and U.S. Food and Drug Administration (FDA) regulations. He is a widely trusted advisor, an influential advocate, and a recognized thought leader in many areas of FDA and related law, including:

• Drug and Device Development: Life sciences companies currently face numerous challenges when seeking approval for new drugs, biological products, and devices. In this environment, clients routinely seek assistance from Torrey on the design and execution of their product development strategies, given his over 15 years of experience with development successes and failures and his in-depth knowledge of current opportunities and challenges at FDA. He has assisted with successful resolution of many development-related disputes and has a proven track record of helping draft effective FDA submissions that achieve positive regulatory outcomes. Torrey also leads on interdisciplinary work related to new product development, which frequently involves working with others at Sidley to provide counseling on FDA strategy, pricing and reimbursement issues, and SEC-required disclosures. He does this work for numerous development programs each year and regularly speaks and publishes on development-related topics.
• Advertising and Promotion: Torrey has over 15 years of experience advising life sciences companies on advertising and promotion policies, procedures, and strategies that enable commercial success in highly competitive markets while mitigating significant enforcement and litigation risk. This includes leading training on promotional requirements and risks in the U.S. and other major global jurisdictions (the EU, UK, China, and Japan), advising on proposed promotional claims and materials, and assisting with competitor complaints to FDA and others. As acknowledgments of his ability to provide practical guidance for mitigating risks in this important and challenging area, one client remarked in 2023 that he provided “the best device promotion deck I’ve seen,” and another remarked that he provided “the most helpful training I’ve had yet.” Torrey also regularly speaks and publishes on promotion-related topics.
• Medical Affairs Activities: Torrey is an industry leading advisor and advocate with respect to Medical Affairs communications and activities, particularly those involving unapproved products and “off-label” uses. He has over 15 years of experience defending companies in off-label enforcement matters, collaborating with Sidley colleagues on relevant healthcare law issues, and leading on advocacy efforts to influence FDA policy in this area. Torrey is co-lead counsel to the Medical Information Working Group (MIWG), the industry-leading advocacy organization formed by several top life sciences companies to seek clarity in the FDA regulatory scheme regarding scientific communications. He also helps companies develop policies, conducts compliance audits, and advises on myriad practical issues related to Medical Affairs activities, including proactive communication of off-label information and interactions between Medical Affairs and Commercial personnel.
• Product Safety: Torrey is lead counsel to the pvlegal network, a membership-based forum for in-house counsel and compliance personnel working on drug and device safety issues in the life sciences sector. Based on years of experience with the group and safety-related matters, he routinely provides clients with practical, risk-based, and well-informed advice and assistance in U.S. and global matters relating to the monitoring, surveillance, detection, assessment, and regulatory reporting of adverse events. This is supported by an extensive library of benchmarking and best practice sharing obtained through pvlegal, as well as experience with several major matters per year involving product safety issues. Examples of recent work in this area have included development of a “playbook” for negotiation of pharmacovigilance agreements (PVAs), advising on safety reporting implications of digital health initiatives by life sciences companies, and investigating and remediating instances of noncompliance with safety reporting requirements.
• Audits and Internal Investigations: Torrey frequent leads Sidley teams on performing audits and internal investigations involving a wide variety of FDA requirements, and helping clients develop practical, effective responses to any findings. Recent matters have involved the areas of clinical trials/good clinical practice (GCP), advertising and promotion, Medical Affairs activities and interactions with Commercial, product safety, and post-marketing commitments and requirements (PMCs/PMRs).