CDER Begins Search for New Regulatory Policy Chief
This article was originally published in The Pink Sheet Daily
Executive Summary
Search for permanent director for the Office of Regulatory Policy comes after several leadership departures in the last year.
FDA has started its search for a new regulatory policy director in the drug center, adding to the list of open or temporarily-filled executive positions within the agency.
A notice
asking for applications to head the Center for Drug Evaluation and Research’s Office of Regulatory Policy was posted Feb. 24 and will close March 24.
The position is the principal center advisor for issues related to planning, developing and administering regulations affecting CDER programs. It also will be responsible for “planning the reform of the center’s regulatory programs, policies and activities,” according to the notice.
ORP is one of the main offices within CDER, but does not have any offices below it in the organizational chart.
Nancy Hayes will remain acting ORP director until the position is filled permanently, FDA said.
Finding a permanent director could bring more stability to a group that underwent several management changes in early 2013.
In January 2013, Jane Axelrad left as ORP director after being asked to handle FDA’s response to the meningitis outbreak associated with medications compounded at the New England Compounding Center.
Denise Esposito, deputy ORP director at the time, took over briefly, but was expected to move to another position in February 2013, at which point Hayes became the acting director (Also see "CDER Compounding Oversight Challenge Forces Axelrad To Narrow Her Focus" - Pink Sheet, 19 Dec, 2012.).
Esposito now is FDA deputy chief counsel for program review for drugs and biologics.
More recently, Deputy ORP Director Carol Bennett was named acting director of the CDER Office of Compliance after Howard Sklamberg was named deputy commissioner for global regulatory operations (Also see "FDA Again Taps Compliance Director For Globalization Post" - Pink Sheet, 8 Jan, 2014.).
Leadership Changes Amid Restructuring
FDA has been racing to restock its senior leadership after several have departed for industry jobs or retirement over the past year.
Sklamberg, former CDER compliance office director, was promoted to the globalization position after Deborah Autor took a job at Mylan NV (Also see "FDA’s Autor Moves To Mylan: Company’s Gain May Also Be Company’s Loss" - Pink Sheet, 6 May, 2013.).
John Taylor, counselor in the Office of the Commissioner, also recently left the agency (Also see "FDA Reorganization Will Not Include John Taylor, Hamburg’s Great Actor" - Pink Sheet, 13 Dec, 2013.).
In August 2013, the agency began looking for another deputy commissioner for medical products and tobacco, after Stephen Spielberg and his temporary replacement departed. A selection has not been announced (Also see "FDA Ready To Hire New Deputy Commissioner For Medical Products And Tobacco" - Pink Sheet, 16 Aug, 2013.).
A number of leaders within CDER also retain acting status.
Bennett remains acting Office of Compliance director. The agency said a notice looking for a permanent director has not been posted.
Kathleen Uhl also is nearing a year since being named the acting director of the Office of Generic Drugs (Also see "GDUFA Success Depends On Industry Changes As Much As Review Improvements, FDA Says" - Pink Sheet, 4 Nov, 2013.).
Lawrence Yu became acting head of the Office of Pharmaceutical Science when Keith Webber, who also was an acting director, retired and took a job at Perrigo Co. PLC (Also see "CDER’s Pharmaceutical Science Office Gets New Director, Probably Its Last" - Pink Sheet, 20 Sep, 2013.).
Denise Hinton also took over as acting Office of Medical Policy director after Rachel Sherman retired (Also see "FDA Policy In Biosimilars, “Breakthrough” And Social Media Under New Management" - Pink Sheet, 18 Dec, 2013.).
Many of the new leaders also will take over as FDA continues a major restructuring effort.
The agency’s Program Alignment Group recommended encouraging more employee specialization and a de-layering of management and review levels to increase efficiency. The group did not call for any center’s elimination (Also see "FDA Reorganization To Focus On Employee Specialization" - Pink Sheet, 4 Feb, 2014.).
CDER also awaits final approval of its plans to create the Office of Pharmaceutical Quality (Also see "Generic Drugs Office Becomes Super; Safety Organizational Challenges Remain" - Pink Sheet, 9 Dec, 2013.).
A Senior Level Executive Position
The ORP director position is part of the Senior Executive Service. The job description offers few insights into the actual rigors of the post.
Potential candidates must have at least five years specialized experience providing legal counsel for development, interpretation or implementation of federal regulations, laws and policies, as well as three years experience managing legal and non-legal staff.
Candidates also must have experience developing federal regulatory policy, according to the notice.
FDA prefers a law degree and an ability to work with engineering and scientific stakeholders on drug manufacturing, marketing and other regulatory issues, as well as knowledge of the Food, Drug and Cosmetic Act and Public Health Service Act.