FDA’s Draft Public Disclosure Proposals and Their Potential Impact on Product Liability Litigation

July 10, 2010
A task force of the U.S. Food and Drug Administration (FDA), in conjunction with the Obama Administration’s Open Government initiative, recently released 21 draft proposals that would broaden FDA’s public disclosure policies. These draft proposals address several types of information that can be important in litigation, including adverse events, new drug applications, clinical findings, FDA inspections, and untitled letters. The Task Force seeks public comments on these proposals by July 20, 2010, and will then finalize proposals for submission to FDA’s Commissioner. This update provides a short summary of the most significant proposals, and analyzes their potential impact on product liability litigation.