CDER Compliance Office Director Must Recuse Herself From Most Duties
This article was originally published in The Pink Sheet Daily
Executive Summary
HHS General Counsel determines that to prevent potential conflicts of interest Cynthia Schnedar must no longer handle substantive issues for compliance actions and policy.
Ilisa Bernstein once again is handling operations at the Center for Drug Evaluation and Research's Office of Compliance after an ethics decision forced the director's recusal from many matters.
CDER Director Janet Woodcock announced Jan. 5 that as of Jan. 1, compliance office Director Cynthia Schnedar will no longer be the lead for most of its compliance, enforcement and policy issues.
That role fell to Bernstein after the HHS Office of General Counsel's Ethics Division determined that "a change in [Schnedar's] husband's employment status," also effective Jan. 1, forces Schnedar to "recuse herself from working on substantive issues relating to compliance actions and policy," according to a memo Woodcock sent to staff.
The change was necessary to avoid potential conflict of interest concerns, Woodcock said in the memo.
Schnedar's husband, Mark Polston, an attorney at King and Spalding, was promoted to an equity partner, allowing him to share in the firm's profits. He had been an income partner at the firm.
FDA said in a Jan. 6 statement that it could not publically discuss personnel matters involving an employee's financial disclosure information.
The agency added that it works with ethics officials "to ensure an employee's proposed duties will not create a conflict with the employees' personal or imputed financial interests, including the financial interests of an employee's spouse, and will not create an appearance of a loss of impartiality."
Conflict of interest concerns due to spousal employment also kept Jonathan Jarow from becoming permanent director of the Office of Medical Policy. In October 2015, the agency said he left as acting OMP director and moved to the CDER Office of the Center Director (Also see "FDA Drug Policy Office Reshuffled Over ‘Spousal Employment’ Conflict" - Pink Sheet, 23 Oct, 2015.).
Bernstein was acting director of the Office of Compliance for parts of 2011 and 2012 following Deborah Autor's promotion to deputy commissioner for global regulatory operations and policy.
Bernstein returned to the deputy director position when Howard Sklamberg was named permanent CDER compliance director (Also see "CDER’s New Compliance Director Sklamberg Brings Experience On Compounding Issues" - Pink Sheet, 28 Nov, 2012.).
Sklamberg later replaced Autor as deputy commissioner for global regulatory operations and policy (Also see "FDA Again Taps Compliance Director For Globalization Post" - Pink Sheet, 8 Jan, 2014.).
That opened the compliance director position for Schnedar. She came to FDA from the Department of Justice, where she was deputy inspector general (Also see "FDA’s Office Of Regulatory Policy To Be Headed By Covington & Burling Alum" - Pink Sheet, 16 Sep, 2014.).
Duties Limited To General Management
Schnedar will continue directing "general management" of the Office of Compliance, including "leading efforts in improving business processes and overseeing all human resource and budget issues," Woodcock wrote in the memo.
"In particular, [Schnedar] will continue to lead the Office of Compliance’s efforts in working with the Office of Regulatory Affairs and with CDER’s Office of Pharmaceutical Quality to implement the new team-based work processes that will be part of Program Alignment," Woodcock said in the memo.
Program Alignment includes a major reorganization of the Office of Regulatory Affairs (ORA) to be more closely associated with the individual product centers within CDER.
Facility inspectors will be increasingly specialized as part of the realignment. ORA also expects to depart from the traditional geographic approach to its field office structure (Also see "Updated: FDA Manufacturing Inspectors Could Be Further Divided Into Subspecialties" - Pink Sheet, 29 Sep, 2015.).
The reorganization began in 2013 when former Commissioner Margaret Hamburg created a group to research methods to avoid duplication within FDA. In 2014, the group recommended fewer layers of management review (Also see "FDA Reorganization To Focus On Employee Specialization" - Pink Sheet, 4 Feb, 2014.).
It is among several changes the Office of Compliance has undergone recently.
CDER also launched OPQ in early 2015, which took some duties that had been handled by the Office of Compliance (Also see "CDER’s Drug Quality Office Separates Oversight Of ‘New’ And ‘Lifecycle’ Products" - Pink Sheet, 16 Oct, 2014.).
During a Dec. 9 appearance at the Food and Drug Law Institute's Enforcement, Litigation and Compliance Conference, Schnedar said among her ongoing priorities was to hire more people.
She said the office is leaner following the OPQ implementation, but still is understaffed in some areas.
Another goal she mentioned during the panel discussion was to improve the office's Standard Operating Procedures.
CDER 'Fortunate' She Will Remain…
Even though Schnedar's duties will be limited, Woodcock wrote in the memo that CDER is "fortunate that [Schnedar] will remain … to continue the critical work of improving business operations in the Office of Compliance."
Woodcock also said Schnedar "has done an outstanding job" running the compliance office during the last 15 months.
The office has been dealing with a number of major policy changes in recent months, including implementation of drug shipment tracking legislation.
The 2013 Drug Quality and Security Act required creation of a new track-and-trace system for manufacturers, wholesalers, repackagers and other stakeholders to help prevent counterfeit and adulterated medicines from entering the supply chain (Also see "Track & Trace Requirement's Surprising Upside: Industry Efficiency" - Pink Sheet, 26 Oct, 2015.).