Article Summary:
This week’s FDA news from RAPS.org covers several developments, including the departure of more top FDA officials, concerns over the agency’s capacity constraints, and potential policy changes under the new leadership.
Notably, FDA Commissioner Marty Makary reportedly sought to issue a Complete Response Letter (CRL) to deny approval of KalVista Pharmaceuticals’ rare disease drug, which the article suggests was an attempt to punish the company for publicly announcing the drug’s delay due to the FDA’s limited resources. This incident highlights Makary’s apparent willingness to guard the agency’s reputation, even if it means breaking norms.
The report also indicates that recent staff cuts at the FDA are making it difficult for the agency to host advisory committee meetings, with at least three meetings being postponed or canceled since the new administration took over. Additionally, the FDA published its annual report on the demographics of clinical trial participants for approved drugs, which revealed that several drugs were approved based on trials that did not include any U.S. participants. This could raise questions about whether federal regulations are discouraging U.S.-based clinical trials.
The article also covers several medical device recalls and import alerts, including issues with anesthesia delivery systems, automated resuscitation systems, and esophageal pH monitoring capsules. These recalls underscore the FDA’s ongoing efforts to ensure the safety and quality of medical products.
Overall, this week’s FDA news paints a picture of an agency grappling with staffing challenges, policy changes under new leadership, and the ongoing task of regulating drugs and medical devices to protect public health.