Activities

FDAAA December 8 Luncheon Featuring Dr. Gerald Dal Pan

Those of us who gathered at Far East on Wednesday, December 8 were well instructed by Gerald Dal Pan, Director, Office of Surveillance and Epidemiology (OSE) in CDER. Special thanks to Dr. Dal Pan who came despite he was missing part of his office Holiday Party.

A neurologist, by training, Dr. Dal Pan has been with FDA for 10 years and is the first Director of OSE. Recently the Office has received lots of attention especially with their role in Post Market safety and with their work with OND and Compliance. Dr. Woodcock’s mantra is “Safety First.” And clearly carrying out the mantra is the responsibility of OSE.

The office has moved from a role as consultant to truly integrating into the CDER review process. As the review of an NDA is carried out, the voice of the safety reviewer has an equal voice to the other reviewers.

The work being done by OSE, like the work throughout the Agency, is becoming more transparent. FDAAA also requires that FDA become more transparent to the American public. Other issues that were delivered to OSE by the FDAAA include REMS (Risk Evaluation and Mitigation Strategies) and post marketing requirements. While the OSE staff has grown over the last 5 years, 224 FTE’s are not sufficient so individuals could be assigned full time to any one division. They spend much time training CDER reviewers re safety processes and procedures.

In addition OSE has the lead in such issues as new proprietary claims, look alikes, sound alikes, and more. An additional responsibility tied to safety evaluation being carried out by OSE is the Sentinel Initiative. This agency-wide initiative will evaluate data from initially 25 million patient records in 2010 to 100 million in the year 2012. Much of the development of the program is being carried out through a contract with Harvard University.

Needless to say, the OSE is a busy place with lots of interesting and important responsibilities. Their emphasis and attention to product safety is making a major impact on the lives of all of us touched by the FDA.



Prepared by Dr. Marlene Haffner