Posted 16 October 2014
By Alexander Gaffney, RAC
The US Food and Drug Administration (FDA) is finally preparing to launch the Office of Pharmaceutical Quality (OPQ), a new effort to focus on the quality of drug products.
The creation of OPQ was proposed in September 2012 by Janet Woodcock, the director of the Center for Drug Evaluation and Research (CDRH).
"Quality is the underpinning of everything we do, and it is imperative that we have a drug quality program as robust as those programs we presently have for drug efficacy and drug safety," said Woodcock at the time. "We must be strategic and have systems in place to identify and respond to quality issues before they become problems. This is especially critical due to the global nature of drug manufacturing and the sourcing of raw materials outside of the US."
OPQ was envisioned as a way to oversee drug quality throughout the product lifecycle, instead of the fragmented pre-market/post-market approach now taken by FDA. Accordingly, Woodcock announced that the Office of Pharmaceutical Science (OPS), Office of Generic Drugs (OGD) and Office of Manufacturing and Product Quality (OMPQ) and Office of Compliance (OC) would both be ceding some of their quality functions to OPQ.
But since then, CDER's plan for OPQ has hit several setbacks. In March 2013, then-director of the Office of Generic Drugs Greg Geba announced he would be resigning from the agency, citing the "realignment of OGD's Chemistry, Manufacturing and Controls (CMC) functions into the new OPQ." Geba had only joined FDA around nine months prior to his resignation.
Then, in September 2013, Keith Webber, the acting director of FDA's Office of Pharmaceutical Science, announced that he would step down as well to join the pharmaceutical company Perrigo. Webber was heavily involved in the planning process for OPQ, but said the offer he received from Perrigo was too good to pass up.
OPQ Gets Launch Date, Leadership
But despite those minor setbacks, CDER has never backed down from its plans to get OPQ up and running—unsurprising given the full-throated support it has received from Woodcock.
And now OPQ has gotten final approval to launch from FDA, along with an expected launch date—1 January 2015—and a slate of leaders for the new "super office."
In an email to CDER employees on 16 October 2014, Woodcock said she would serve as the first acting director of OPQ, with support from Deputy Director Lawrence Yu, who replaced Webber as acting director of OPS in September 2013.
Also joining OPQ will be a large slate of other leaders:
- Office of Program and Regulatory Operations (OPRO): Giuseppe Randazzo (Acting)
- Office of Policy for Pharmaceutical Quality (OPPQ): Ashley Boam (Acting)
- Office of Biotechnology Products (OBP): Director: Steve Kozlowski
- Office of New Drug Products (ONDP): Sarah Pope Miksinski (Acting)
- Office of Lifecycle Drug Products (OLDP): Susan Rosencrance (Acting)
- Office of Testing and Research (OTR): Lucinda (Cindy) Buhse (Acting)
- Office of Process and Facilities (OPF): Christine Moore (Acting)
- Office of Surveillance (OS): Theresa Mullin (Acting)
"The acting and vacant leadership positions will be formally competed through FDA’s human resources process so that they may be filled on a permanent basis," Woodcock explained in an email.
In her statement to CDER staff, Woodcock said she was "pleased" at the reorganization of CDER, and OPQ in particular. The new structure "is expected to provide better alignment among all drug quality functions at CDER, including review, inspection and research," she said.
"The organizational structure, along with new processes and policies, will support our mission to ensure that safe, effective, high quality drugs are available for the American public," Woodcock added.
There will also be benefits for the pharmaceutical industry, Woodcock explained. "This office will provide internal customers with a single drug quality assessment that captures the overall OPQ recommendation on approvability, and OPQ will provide feedback on quality deficiencies earlier in the review cycle."
OPQ will also create a "uniform drug quality program" for all drug manufacturing sites—domestic and foreign—and all product types—new drugs, generic drugs, and over-the-counter (OTC) drugs, she said.
Big Changes at FDA
Woodcock also outlined major changes occurring at CDER as a result of the OPQ reorganization:
- Some functions and personnel from OPS will be transferred to OPQ.
- The Office of Compliance will cede its preapproval and surveillance inspection activities to OPQ.
- The Office of Scientific Investigations will cede its inspection-related activities for bioequivalence/bioavailability and non-clinical studies to the Office of Translational Sciences (OTS).
- The Office of Compliance will focus on compliance and enforcement operations and policy to minimize consumer exposure to unsafe, ineffective, and poor quality drugs.
- The Office of Translational Sciences' Division of New Drug Bioequivalence Evaluation and the Division of Generic Bioequivalence Evaluation will now be under CDER's new "Office of Study Integrity and Surveillance."
- The Office of Biostatistics will have a new division, the Division of Biometrics VIII to focus on supporting the delivery of comprehensive statistical services to the Office of Generic Drugs.