Head of FDA's Rare Disease Division Departs, Leaving Agency Looking for New Leader

The US Food and Drug Administration (FDA) is looking for a new leader for its Rare Diseases Program.

In an email to staff on 16 July 2014, John Jenkins, director of the Office of New Drugs (OND), which oversees the rare disease program, said the program's current leader would be transitioning to a new role at FDA.

Anne Pariser, OND associate director for rare diseases, will take on a new position in the Office of Translational Sciences, Jenkins said. Pariser will still be working within the Center for Drug Evaluation and Research (CDER), OND's parent division, Jenkins added.

Jenkins noted that FDA has already closed a solicitation for a new leader for the program, and is in the process of "evaluating the candidates for the detail." In the meantime, Larry Bauer, a regulatory scientist within OND, will be managing the day-to-day operations of the rare diseases program, Jenkins wrote.

On its website, FDA describes the Rare Disease Program as being meant to "facilitate, support and accelerate the development of drug and biologic products for the benefit of patients with rare disorders," according to FDA's website. While it does not handle the orphan drug designation process, it is nevertheless influential in setting regulatory policy for the review of those products.