FDA Names new director of the Office of Drug Safety

In other drug safety news, FDA has announced the selection of Gerald J. Dal Pan, MD, MHS, as director, Office of Drug Safety in the Center for Drug Evaluation and Research (CDER). Dr Dal Pan, selected from a strong field of candidates as part of a nationwide search, will lead the agency's post-marketing drug safety program.

"As part of our continuing commitment to drug safety and risk communication, we conducted a broad search for a candidate to lead our initiatives in this area," said Steven Galson, MD, CDER director. "Dr Dal Pan's extensive academic training and his practical experience in clinical medicine, drug development, and public health and risk management, coupled with his strong and vocal leadership within FDA, make him eminently qualified to take on the challenge of leading this vitally important office."

Prior to joining CDER, Dr Dal Pan directed clinical research, including clinical trial design and interpretation of clinical data, for Guilford Pharmaceuticals and HHI, LLC, Clinical Research and Statistical Services. He served on the faculty at Johns Hopkins University School of Medicine, where he conducted clinical research in addition to teaching medical students. He continues there as a part-time assistant professor in the Department of Neurology.

In addition to announcing the appointment of the new director of Drug Safety, as part of his annual State of CDER address to employees, Dr Galson outlined a proposed CDER reorganization to better align staff functions with CDER's goals and FDA's public health mission.

The goals of the proposed reorganization include:

"I am confident that these changes will lead to greater improvements in regulatory and drug development science and in how we evaluate and ensure the safety and efficacy of the products we regulate, and will result in greater protections for patients and consumers who depend on us every day," Dr Galson said.

Specific organizational changes were scheduled to be announced soon at press time; CDER leaders said they planned to implement them over the next 6 months.