It gives me great pleasure to announce the appointment of Gerald Dal Pan, M.D., M.H.S., as the permanent director of the newly reorganized Office of Surveillance and Epidemiology (OSE). CDER conducted a nationwide search for this position, and I am happy to say that the best candidate was right here in CDER.
OSE plays a critical role in monitoring and safeguarding drugs once they are on the market. As OSE director since 2005 and then, more recently, as acting director of the reorganized OSE (super office) since June 2011, Gerald has been instrumental in conceptualizing, standing up, and managing CDER’s postmarket drug safety and risk assessment programs. Throughout this time, he has provided strong leadership and direction to his staff and to the Center on a broad range of drug safety, epidemiological, risk management, and information technology activities.
Gerald has extensive knowledge of the scientific basis, regulatory laws, and best practice guidelines used to evaluate the essential components of postmarket drug safety: pharmacovigilance, pharmacoepidemiology, risk management, and medication error prevention. He has implemented numerous projects that have proven critical to advancing our postmarket drug safety programs. Under Gerald’s leadership, OSE has grown from a staff of approximately 116 to 250 over the last five years.
He has been a dedicated leader on CDER’s Safety First Initiative--working effectively across lines within the Center to build collegial and team-based work groups. He has also forged new relationships with other federal health agencies and the international community—all of which are helping to advance our oversight of marketed drugs. Such efforts strengthen our credibility and transparency, and the public’s trust in our ability to protect them from harm.
Gerald first joined FDA in July 2000 as a medical officer in the Division of Anesthetic, Critical Care, and Addiction Drug Products. He became director of OSE (then known as the Office of Drug Safety) in November 2005. He holds a medical degree from Columbia University and a Master’s degree in clinical epidemiology from Johns Hopkins University. He is board certified in internal medicine and neurology.
Gerald has been a trusted and valued advisor to me due to his medical and scientific background, his ability to tackle complex regulatory issues, and his grasp of the expectations of the public and policymakers. He has done an excellent job in his role as acting director of OSE, especially as the depth and volume of work in OSE have continued to increase and the pace has quickened. I would like to extend my sincere appreciation for all that Gerald has accomplished, and for his dedication to our public health mission.
Please join me in congratulating Gerald on his permanent position and wishing him continued success in this role.