FDA Transparency Blueprint Issued

Most everyone even tangentially related to the pharmaceutical industry knows and understands that right now, transparency is a hot topic. In Winter 2017, The Journal of Law, Medicine & Ethics published a Special Supplement to Volume 45:4, a written companion to a January 16, 2018 symposium entitled, “Blueprint for Transparency at the U.S. Food and Drug Administration.” According to the Letter from the Editor included in the Special Supplement, “guest editors Anna L. Davis, James Dabney Miller, Joshua M. Sharfstein, and Aaron S. Kesselheim and their co-authors have tackled the challenging topic of transparency at the respected government agency. A team of researchers from various universities wrote the main “Blueprint” article of this supplement issue, which is followed by six commentary articles.” This blueprint includes a lengthy article written by a group of authors, with the subtitle, “Recommendations to Advance the Development of Safe and Effective Medical Products.” The Blueprint article recommends eighteen specific ways the FDA can be more transparent so that the public at large can be better informed about medical products, applications, and scientific studies. The recommendations were all separated into five different “focus areas,” including: (1) the FDA should disclose more information about key milestones in the application process; (2) the FDA should disclose more of its own analysis and decision-making; (3) the FDA should disclose more ...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs