We help pharmaceutical, medical device and biotech clients identify and mitigate potential future litigation risk from the earliest stage of developing innovative products and technologies. This counseling is informed by our experience in addressing scientific, regulatory, and legal challenges in nationwide litigation, which helps us spot areas of potential liability early, and offer solutions before litigation arises. Our attorneys are skilled and experienced in issues that affect research and development, including intellectual property, indemnification and regulatory compliance concerns. Clients find that the seasoned and nuanced analysis that we provide is essential as regulatory compliance issues and clinical trial paradigms become more complex, global, and increasingly involve third-party partners.
Pepper’s counseling practice includes:
- SOPs for research and development, adverse event reporting and analysis (based on both clinical and nonclinical data), compliance with FDA regulations, and consistency with ICH and CIOMS guidance materials
- prophylactic counseling about FDA regulatory requirements regarding Good Manufacturing Practices, Good Laboratory Practices, Good Clinical Practices, clinical trials, labeling, risk management plans (including REMS), and advertising and other promotional activities
- responding to inquiries and notices from FDA (including warning letters and label change requests) and foreign regulatory agencies
- identifying and mitigating potential litigation risks in proposed protocols, investigator brochures, informed consent documents, interactions with data monitoring boards and institutional review boards, regulatory submissions, scientific disclosures, medical letters, press releases, stand-by statements, websites and social media
- due diligence analysis of contract research organizations and biotechnology companies to inform decisions on licensing in compounds and to support or evaluate IPOs
- advising clients on safe harbors under federal and state fraud and abuse statutes and communicate on their behalf with FDA on compliance issues raised by competitors’ promotional activities.