Major FDA reorganization adds structures to support gene therapy, diagnostics, AdPromo and more
In late 2021, the FDA reorganized several of its internal operations to concentrate or delegate certain organizational functions – including bracing for an expected influx of complex biological products, new drug promotion research activities and breaking the CDRH Diagnostics and Radiological Health Office into two different divisions.
The internal reorganizations move certain divisions and functions around within their Centers, and task specific Offices with specific tasks.
- The statements of organization, function and delegations of authority were published on January 3, 2022, but “were approved by the Deputy Secretary of health and Huan Services and effective on November 24, 2021.” In general, the reorganizations are intended to ensure that the FDA is efficiency organized, and that specific Division Offices are responsible for certain policy areas or functions.
- Limited changes in the Office of the Commissioner: The statement indicates that the FDA is moving its Technology Transfer Program directly into the Immediate Office of the Office of the Chief Scientist (OCS-IO). Previously, the FTTP was housed under the OCS Office of Regulatory Science and Innovation (OSRI). This change to pull FTTP directly under OCS-IO, rather than in one of its subsidiary offices, will “further enhance the effectiveness of FDA’s partnership programs,” the agency states. Further, the agency is abolishing the OSRI Division of Science Innovation & Critical Path, since “OSRI’s programs have evolved away from the need for this division.”
- Operational support within the Center for Biologics Evaluation and Research (CBER) will be re-defined to “better support the expected growth” in certain product areas. Going forward, the CBER Office of the Director (OD) will only focus on activities that “require intensive engagement from the Center Director and have no other natural home,” while other responsibilities in supporting product offices will be realigned within the Office of Management and the Office of Communications, Outreach and Development. Further, CBER is establishing a new Office – the Office of Regulatory Operations – to support the Center’s regulatory programs. In addition to supporting these processes, the Office of Regulatory Operations will “provide strategic direction as the Center works to modernize its supporting information technology (IT) infrastructure,” which is a significant pain point for the biologics center.
- CBER’s Office of Biostatistics and Epidemiology will take point on RWE policy within the Center, and the changes to streamline OD’s role and enhance strategic support from the Offices of Management and Communications, Outreach and Development will “position the center to advance real-world evidence priorities for biologics,” states the notice. OBE is also getting new Branches, including a Device and Non-Clinical Evaluation Branch, while the Therapeutics Evaluation Branch will be expanded into Branch 1 and Branch 2, as the Pharmacovigilance Branch will be expanded into Branches 1-3.
- The Office of Tissues and Advanced Therapies (OTAT) will also get a series of new divisions, including a Gene Therapies Branch 2 (the current Gene Therapies Branch will now be called Gene Therapies Branch 1), a Tissue Engineering Branch, and new branches related to hematology (both benign and malignant), as well as additional Regulatory Project Management branches. The statement cites the high levels of interest in Regenerative Medicine Advanced Therapy (RMAT) designations, with 129 designations granted since 2016 and the need to shore up capabilities within OTAT as the key impetus for the changes.
- The Office of Blood Research and Review (OBRR) is gaining new focus areas. The statement cites significant recent advancements in blood product development and safety, including pathogen reduction technologies. According to the new organizational chart in the notice, the Laboratory of Bacterial and Transmissible Spongiform Encephalopathy Agents will be discontinued, while the Laboratory of Emerging Pathogens will be renamed the Laboratory of Emerging Parasitic and Emerging Pathogens, while the Laboratory of Cellular Hematology will become the Laboratory of Cellular Hematology and Vascular Biology Branch.
- Notably, the changes for CBER largely reflect recently agreed-upon PDUFA commitments. Under the upcoming PDUFA VII reauthorization, CBER will prioritize shoring up staff for cell and gene therapy (CGT) regulation, given the expected influx of marketing applications for these products in coming years. With PDUFA VII, CBER will hire “approximately 160” new members of staff, largely concentrated in OTAT and “other review offices that directly support the review” of CGTs, as well as operational staff that can support the new product and regulatory staff. In addition, the new user fee reauthorization will fund new activities related to IT modernization, which is especially prescient as data files submitted to CBER are expected to become larger and more complex as the technologies advance.
- Within the Center for Drug Evaluation and Research (CDER), a new division in the Drug Promotion research office. CDER’s Office of Prescription Drug Promotion (OPDP) conducts research on the ways that drug promotion (claims language, advertisements) are understood and used by clinicians and patients. Under the new regorganization, OPDP will get a new division: the Division of Promotion Policy, Research and Operations. This Division will focus on “national prescription drug promotion policy,” while also supporting the Office’s social science research. “The reorganization will provide additional support and increased focus on the regulatory counsel functions necessary to develop sound and legally supportable policy documents and surveillance activities, particularly given First Amendment jurisprudence developments over the last few years,” FDA notes, likely referencing policies related to the 2012 federal court ruling that “truthful off-label promotion” is protected under the First Amendment.
- The Center for Devices and Radiological Health’s (CDRH) Diagnostics Division is being split in two. The CDRH Office of In Vitro Diagnostics and Radiological Health (within the Office of Product Evaluation and Quality, or OPEQ) is known as OIR or OHT7. Under the reorganization, OIR is officially “retitle[d]” OHT7, while a new Office of Health Technology – the Office of Mammography and Radiological Health – will be the newly-established OHT 8. In effect, OIR/OHT7 “will be solely focused on in vitro diagnostics with responsibility for regulating laboratory and in-home diagnostic tests,” while the previous mandate covering radiological and mammography devices will become a separate Office.
- This means that OHT7 will maintain four product divisions (chemistry and toxicology devices, immunology and hematology devices, molecular genetics and pathology, microbiology devices) in addition to its Division of Program Management and Operations, while two divisions (radiological health, mammography quality standards) will be moved into the newly established OHT8. Currently, the statement shows three divisions in OHT 8 (OHT 8 A-C), which may represent the two formerly OHT7 product divisions and an operations office.
- OHT7 has seen a significant workload jump during the pandemic, leading to regulatory delays for non-Covid response devices. With the scope of OHT7’s workload expanding as pandemic-bolstered innovation in testing and diagnostic methods advances – as well as the potential workload of an increased role in regulating laboratory-developed tests – the establishment of a new Office for non-IVD products could help alleviate stresses on OHT7 staff while mitigating regulatory delays for non-IVD radiological/mammographical products.