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 Food & Drug Administration (FDA) regulations.
  
For example, Torrey regularly helps clients develop approval and marketing strategies, identify and mitigate regulatory risk associated with strategic initiatives, and develop FDCA-based defenses to healthcare enforcement investigations. He also handles challenges to competitor advertising, including challenges before the National Advertising Division (NAD), and serves as FDA counsel in product liability cases, civil litigation and FDA enforcement proceedings.

Torrey also collaborates regularly with Sidley colleagues in a variety of other practice areas to help clients with matters raising complex, multidisciplinary issues.  This includes colleagues in Sidley’s Healthcare and Government Strategies practices.  He also works hand-in-hand with colleagues in Sidley’ Emerging Companies and Venture Capital, Private Equity, Securities, M&A, and Technology and Life Sciences Transactions groups to provide clients with integrated, strategically-oriented regulatory advice on a wide variety of life sciences transactions.

Specifical examples of Torrey’s experience include:

• Led the FDA regulatory team, with Carlo Felizardo, advising the underwriters in the US$129.4 million initial public offering by Immuneering Corporation, a biopharmaceutical company with an emerging pipeline focused on improving patient outcomes across a spectrum of debilitating oncologic and neurologic diseases by applying translational bioinformatics to every stage of the drug development process.
• Led the Sidley regulatory team that advised Tricida on its $222 million initial public offering (IPO) of common stock, the second largest biotechnology IPO in two years.
• Advising development-stage companies on regulatory considerations and FDA engagement strategies related to development and launch of products based on disruptive technologies
• Working collaboratively with colleagues in Sidley’s Healthcare and Government Strategies groups to develop policy positions related to FDA regulation of laboratory-developed tests (LDTs)
• Leading an international team of Sidley and non-Sidley lawyers in seven countries to advise on device regulatory issues associated with worldwide sales of product intended for use only in non-clinical research, to a customer using the product in therapeutic procedures
• Representing manufacturers in matters involving regulatory letters, inquiries, advisory comment proceedings, competitor complaints and citizen petitions focused on their products and policy issues affecting their strategic priorities
• Advising on issues related to promotion of drugs and medical devices, including communication of pharmacoeconomic/healthcare economic information (HCEI), communications by medical science liaisons (MSLs) and communications directed primarily to managed care audiences
• Developing policies and training for in-house legal, medical and regulatory (LMR) reviewers, aimed at assuring compliance with current FDA expectations for promotion of drugs and medical devices, including drugs being switched from prescription to over-the-counter (OTC) status
• Advising manufacturers on remediation and reporting strategies to address pharmacovigilance failures, and serving as FDA counsel in litigation premised on failure to report drug safety issues to FDA
• Conducting a full evaluation of a company’s adverse event reporting system, supervising remediation efforts and providing training to employees involved in collecting event information
• Leading a global review of a product’s regulatory status in over seven countries
• Serving as FDA counsel in off-label enforcement actions, DOJ investigations (both civil and criminal) and internal reviews for drug and medical device manufacturers
• Providing strategic advice, conducting regulatory assessments and negotiating key FDA-related terms in connection with due diligence for transactions and post-acquisition integration activities
• Providing solutions-oriented advice to development-stage companies confronting FDA regulatory issues for the first time, including good clinical practices (GCP), investigator-initiated research (IIR), pre-approval communications and strategies for obtaining FDA approval
• Successfully developing FDA-based arguments to support client interpretations of key contractual terms in post-transactional disputes related to merger and collaboration agreements 
• Developing FDA-related arguments in successful defense against an investigation by the Securities and Exchange Commission (SEC) into a client’s disclosures regarding a consent decree 
• Working collaboratively with Sidley colleagues to advise a client on FDA, ethical and product liability issues associated with early termination of a clinical study involving an implanted medical device
• Advising a company on all major issues related to implementation of a GMP-related consent decree at a pharmaceutical manufacturing site
• Representing a dietary supplement company in dialogue with FDA regarding requirements for new dietary ingredients (NDIs)

Torrey is involved in the firm’s Emerging Enterprises Pro Bono Program, which provides free legal support to eligible small and medium-sized for-profit enterprises and market-focused NGOs and non-profits that have a clear social impact in developing countries across Africa, Asia, Central and South America and the Caribbean. Torrey’s work with the program was recently featured in The American Lawyer.

Torrey is a member of the Food and Drug Law Institute and the ABA’s Health Law Section and Administrative Law and Regulatory Practice Section.

Torrey served as co-chair for the Diversity Committee of Sidley’s Washington, D.C. Office. He is currently an active member of the committee and a member of the LGBT Bar Association of the District of Columbia.

Torrey is also a member of the Steering Committee of the Corcoran Contemporaries, a group of contemporary art enthusiasts associated with the Corcoran Gallery of Art.