FDA NEWS RELEASE

FDA Names New Director of Drug Safety
Goals for Center for Drugs Reorganization Announced

The U.S. Food and Drug Administration (FDA) today announced the selection of Gerald J. Dal Pan, M.D., M.H.S. as Director, Office of Drug Safety in the Center for Drug Evaluation and Research (CDER). 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, M.D., 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, makes him eminently qualified to take on the challenge of leading this vitally important office."

As the Director of the Office of Drug Safety, Dal Pan will be at the center of critical issues facing the nation on safe and appropriate use of medications. He will work closely with stakeholders, including the patient and consumer groups, the healthcare community, and Congress; develop and maintain international and national contacts with regulators; implement policies and initiatives related to adverse drug events (such as the Drug Safety Oversight Board and the Medwatch program), and represent FDA and CDER in scientific and regulatory matters related to drug safety and risk management.

Dal Pan is currently the Director, Division of Surveillance, Research, and Communication Support, Office of Drug Safety in CDER, a position he has held since 2003. Dal Pan joined the agency in 2000 and spent three years as a medical reviewer in the Division of Anesthetic Critical Care and Addiction Drug Products, before moving to the Office of Drug Safety as a division director. 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 the appointment of the new Director of Drug Safety, as part of his annual State of CDER address to Center employees today, Galson outlined a proposed Center reorganization to better align staff functions with CDER’s goals and FDA’s public health mission. The goals of the proposed reorganization include:

1. Positioning CDER to fully participate in the Critical Path Initiative and improve regulatory and drug development science—the Agency’s top scientific policy initiative for the next five years.
2. Increasing the visibility of the sustained, multi-disciplinary, cross-Center approach to drug safety that engages more than 50 percent of CDER’s resources.
3. Centralizing risk communication efforts to ensure efficiency and consistency of CDER’s important public health messages.

 "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," said Dr. Galson.

Specific organizational changes will be announced by early November and implemented over the following six months.

#

RSS Feed for FDA News Releases [what is RSS?]