Regulatory Focus™ > News Articles > Influential FDA Drug Policy Office Gets New Leader

Influential FDA Drug Policy Office Gets New Leader

Posted 18 February 2015 | By Alexander Gaffney, RAC

Influential FDA Drug Policy Office Gets New Leader

The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) has announced the hire of a new leader for its Office of Medical Policy (OMP), an influential office tasked with developing the agency's pharmaceutical policies.

Background

The 150-person office is influential within FDA, and describes itself as the "driving force" behind drug policy development at the agency. Major policies recently developed and implemented by OMP include FDA's breakthrough therapy designation (BTD) and its policies on biosimilar development, which hasn't yet been completed.

With the potential passage of the 21st Century Cures Act and the start of the Prescription Drug User Fee Act reauthorization negotiations in 2015, OMP could be more influential than ever in the coming year.

The position was last permanently held by Rachel Sherman, who left OMP in early 2014 to join Greenleaf Health, a consulting firm. Since Sherman's departure, OMP has been led on an acting basis by Capt. Denise Hinton while FDA searched for a permanent successor.

New Leadership

Now FDA has announced the hire of a new—but not quite permanent—leader for the office.

On 18 February 2015, CDER Director Janet Woodcock said in an email to FDA staff that she had hired Jonathan Jarow as acting director of OMP. Jarow will serve "on a 120-day detail … beginning 23 February 2015," Woodcock explained.

Jarow is no stranger to FDA. Woodcock said he has worked at FDA since 2010, most recently as associate director of FDA's Office of Hematology and Oncology Products (OHOP).

"He has developed policies for management of neoplasm imbalance review in conjunction with the Office of Surveillance and Epidemiology (OSE), biostatistics, and pharmacologic toxicology," Woodcock continued. "He also supervises the Oncology Program and organizes educational programs for review staff."

Jarow is also a team leader for FDA's Clinical Trials Transformation Initiative (CTTI), and helped to create inter-governmental agreements between FDA and NIH, the email explained.

Hinton will stay on at FDA as deputy director of OMP, Woodcock said.


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