FDA to Create Office of Enforcement and Import Operations

The planned reorganization of the Food and Drug Administration's Office of Regulatory Affairs will create a new Office of Enforcement and Import Operations (OEIO), according to a Sept. 10 FDA fact sheet on the reorganization. The new office "will combine most of the functions of the Office of Enforcement and the operational aspects of the Division of Import Operations and Policy," it said. The OEIO will be overseen by the new Office of Operations, which will report to the Associate Commissioner for Regulatory Affairs (ACRA).

Permanent and acting leadership is planned to be in place by Oct. 1 to help move the implementation forward, said the fact sheet. Some positions will be filled on an interim basis by appointment to allow for continuity, it said. Email documents@brokerpower.com for a copy of the fact sheet.

Multiple New Offices

The new OEIO and two other new offices -- the Office of Food and Feed Operations and the Office of Medical Products and Tobacco Operations -- will take over most functions from the Offices of Regional Operations and Enforcement, the fact sheet said. The OEIO will combine much of the Office of Enforcement's Division of Compliance Management Operations (DCMO) and Division of Compliance Information and Quality Assurance (DCIQA) and ORO’s Division of Import Operations and Policy (DIOP), the sheet said. The Division of Import Operations in OEIO will have staff dedicated to implementing new programs like the "Foreign Supplier Verification Program" it said.

The Division of Compliance Systems in OEIO will consolidate current domestic enforcement, recalls, and import IT system business ownership and maintenance into one Division (and two branches) and "provide for more unified interactions with the ACRA IT staff."

The three new offices will be supported by a new Office of Regulatory Science, which will provide most of the services of the Division of Field Science and will include specialists in tobacco, medical products or food and feed. The Office of Operations will be led by a new Assistant Commissioner for Operations.

Policy Office Change

The reorganization will also create an Office of Policy and Risk Management that will "combine policy, risk management, and planning," which will report to the Deputy ACRA. It will consolidate current policy staff from various ORA HQ components such as the Office of Enforcement’s Division of Compliance Policy and policy staff from the Office of Regional Operations’ Division of Import Operations and Policy into specialized areas, have staff expert in each of the operational divisions, and will be headed by the Assistant Commissioner for Compliance Policy. The changes will allow ORA to "fully integrate risk management and data analysis into all policy decisions by bringing ORA’s risk management resources, data evaluation, and management resources into one office."

Reasons for the Reorganization

The FDA is updating its structure as the agency "faces a time of remarkable transformation due to the rapid modernization and globalization of our regulated products, and the new legislative authorities provided by Congress," it said. The changes will help it address new legislative authorities and increase partnerships with federal, state, local and foreign officials, among others things, said the fact sheet.