Article Summary:
This week, FDA Commissioner Marty Makary announced the agency will shift its evidence standards for drug approvals, requiring only a single pivotal trial rather than the traditional two well-controlled clinical trials. Makary believes a single trial can achieve the same statistical power when properly designed and controlled. This change aims to expedite the review and approval process.
However, the decision has contributed to the recent departure of top drug regulator Richard Pazdur, raising concerns about leadership instability at the FDA. Twelve former FDA officials also published criticism of the agency’s tightening of vaccine policies, arguing the changes could undermine the safety and availability of vaccines.
FDA on Wednesday announced that Tracy Beth Høeg has been named acting director of CDER. Høeg, a physician and epidemiologist, was a visiting scholar at the Massachusetts Institute of Technology Sloan School of Management and practiced physical and interventional spine and sports medicine before joining the FDA as senior advisor for clinical sciences in the Office of the Commissioner and the Center for Biologics Evaluation and Research (CBER).
Elsewhere, the FDA has removed Theresa Michele as director of the Office of Nonprescription Drugs, and appointed Karen Murry as the new director. The agency also launched new “agentic AI” capabilities for employees and ended the decades-long recommendation that all newborns be immunized against hepatitis B.
In the drugs and biologics space, the FDA published final guidance on heart rate-corrected QT interval prolongation, sent an untitled letter to Daiichi Sankyo, and posted warning letters to two companies over quality issues. It also approved Bristol Myers Squibb’s Breyanzi for marginal zone lymphoma and Eli Lilly’s Jaypirca for chronic lymphocytic leukemia/small lymphocytic lymphoma.
Finally, the FDA issued guidance on its eCopy program for medical device submissions, alerted the public about issues with Abbott’s glucose monitor sensors, and signaled increased scrutiny of wearable devices with medical features.