MFIA represents Dr. Caleb Alexander, a professor at the Johns Hopkins University Bloomberg School of Public Health and an expert on drug safety. Dr. Alexander filed FOIA requests with the Food and Drug Administration for records related to its treatment of six drugs in the Risk Evaluation and Mitigation Strategies (REMS) program, which administers drugs with particularly serious potential side effects. As he has done in the past for opiates with MFIA’s assistance, Dr. Alexander seeks to shed light on how the FDA regulates these drugs and how its regulatory practices could be improved.
MFIA filed a lawsuit after FDA failed to respond to Dr. Alexander’s FOIA requests for over two years. The parties have agreed to a production schedule and the FDA is producing records on a monthly basis.