FDA Starts ORA Shift Toward Better Focus, Stricter Inspections
FDA’s Office of Regulatory Affairs officially began its transition to a program-based structure in mid-May, aligning inspection staff into seven product categories — more closely mirroring the organization of the agency’s centers and ultimately moving to what may seem like stricter inspections, especially at first.
The previous regional configuration is being replaced with separate divisions four years in the making, covering pharmaceuticals; biologics; bioresearch monitoring; medical devices and radiological health; human and animal food; tobacco; and import operations.
Changes at ORA are really the beginning of a two- to three-year long shift in the way the agency approaches inspections and quality procedures, culminating in the deployment of FDA’s new Inspection Protocol Project by 2019 or 2020, said John Avellanet, managing director and principal at Cerulean Associates, an independent consultancy focused on FDA quality systems and compliance analysis. Which also means a shift in the way quality professionals interact with the agency, he said.
Same Personnel, Different Roles
“Habits that we’ve gotten into will likely have to change — and I don’t mean that in a bad way,” Avellanet said. While many people at the FDA may be changing jobs and shifting offices, things that might have taken a couple days to get resolved over the phone now might take longer and individuals with whom there was already a rapport might be in a different role.
The changes may result in what seems like stricter inspections, especially at first, because they are conducted by FDA staff with more focused, specialized knowledge of a particular drug or process, paired with a quality systems data integrity guru.
“The reality is that it’s more modern and really more appropriate for where we are right now,” Avellanet said. “One could make the argument that they should have made this change 10 years ago.”
FDA published a series of fact sheets explaining what each product office does. For example, the Office of Pharmaceutical Quality Operations contains four divisions spanning several of the agency’s previous districts — OPQO staff will conduct drug product investigations and manage compliance activities across the ORA’s 20 district offices.
The OPQO will be led by Alonza Cruse, who previously served as acting director of the ORA’s Office of Medical Products & Tobacco Operations from 2013 to 2015.
Chrissy Cochran will direct the Office of Bioresearch Monitoring Operations, a new, stand-alone program that will work with each of the FDA’s product centers to ensure subject protection in clinical studies and that non-clinical research follows Good Laboratory Practices. Cochran previously led CDER’s Division of Enforcement and Postmarketing Safety.
The Office of Biological Products Operations will be led by Ginette Michaud, previously the deputy director of CBER’s Office of Blood Research and Review. OBPO will coordinate and conduct CBER-related investigative activities and support the development of policy and guidance for biological products.
The ORA will keep its 20 existing districts and district directors will keep their responsibilities, but will also specialize in one program as division directors, the FDA said. The agency has no plans to close offices or relocate personnel. ORA’s laboratories will also specialize into either human and animal food labs or medical product, tobacco and specialty labs.
For companies to better understand where the agency is coming from under the reorganization and new inspection protocols, they can start by reviewing FDA’s MDSAP inspection methodology, an 80 page document with lists of questions and subject areas, and the revised PIC/S on computerized systems and data integrity, Avellanet said.
The FDA has issued more than 100 guidance documents relating to clinical trials covering topics from the Animal Rule to validating software used in studies. Order your copy of Clinical Trial Compliance Guide: FDA Requirements — the digital manual you can search to find the clinical trial information you need.