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Life-sciences companies frequently must determine what (if anything) to disclose about key developments in clinical trials or the Food and Drug Administration’s (“FDA”) review process. Determining what to disclose requires great nuance, especially because disclosure may be required even when a company has only incomplete information. This Briefing will provide best practices for life-sciences companies to reduce litigation risk -- both Securities and Exchange Commission (“SEC”) and Department of Justice (“DOJ”) enforcement as well as securities class-actions -- when making disclosures about clinical trials, the regulatory review process, and developments after product approval.
Paul M. Rodel, Paul D. Rubin and Jacob W. Stahl of Debevoise & Plimpton LLP will discuss the following:
- When making statements about clinical trials, life science companies should: make accurate statements about clinical trial data; provide appropriate caveats regarding clinical results; ensure “top line” results do not overstate the outcome of a clinical trial; and ensure that clinical trial data is accurate and reliable.
- When making statements about the regulatory review process, life sciences companies should: evaluate the need to disclose negative information obtained from the FDA about a pending application; assume that the SEC or DOJ will carefully compare what a company has been told by the FDA with what the company has told investors; and analyze public statements that are predicated on assumptions about the outcome of the FDA’s regulatory review process.
- When making statements about post-approval developments, life-sciences companies should: ensure that statements about a product are accurate even after FDA approval has been obtained; evaluate the need to disclose FDA inspection results; and evaluate whether unexpected adverse event reports require disclosure.
Program Level: Overview
Intended Audience: In-house counsel, outside counsel, board members, corporate officers, accountants, and other allied life sciences professionals responsible for SEC reporting and disclosure
Advanced Preparation: None