FDA unveils details about major proposed changes to organization, including ORA and Office of the Commissioner

FDA Today | By ALEXANDER GAFFNEY, MS, RAC

Dec. 13, 2023

The FDA today announced that it has concluded work on a draft plan that – if enacted following an extensive feedback process – would result in some of the most sweeping FDA reforms in decades, including an extensive overhaul of the Office of Regulatory Affairs, revamped authorities within the agency’s medical product centers, select reforms within the Office of the Commissioner and more. But as much as we know about the reforms, one thing remains missing: The plan itself.

Regulatory background

  • The FDA’s Office of Regulatory Affairs (ORA) is “the lead office for all agency field activities,” according to the FDA (as of 2021). In practical terms, this means that ORA houses the FDA employees who conduct inspections – once called “inspectors,” but now dubbed “investigators.” Recalls, market withdrawals, safety and import alerts, and reports on enforcement activities are all overseen by and issued from ORA. Broadly, the Office also oversees the FDA’s import program, which encompasses all products regulated by the FDA. The Office of Enforcement and Import Operations within ORA is responsible for most of these activities.
  • In January 2023, the FDA announced its plans to overhaul ORA as part of its new Human Foods Program. The “reimagined” ORA would support FDA’s entire portfolio with better “risk prioritization and public health impact of the FDA’s field activities,” with goals to be “set by the regulatory programs” with a bigger prevention focus for food safety inspections. Also, the document indicated that field activities would be modernized, with the “core operations” of ORA strengthened.
  • Notably, FDA also indicated that “Certain ORA functions will be realigned into the Human Foods Program (HFP) and other regulatory programs or with agency-wide services to create a more streamlined organization,” according to the document. This seemed to indicate support for longtime challenges previously noted by FDA leaders, including that center-specific workflows – including inspections – were not integrated with ORA’s systems. [ Read AgencyIQ’s analysis of Janet Woodcock’s remarks on the ORA program from August 2022.]
  • At a January 31 press conference, Califf and Woodcock shed little light on what the details of the ORA shakeup would look like. “Our plan also will propose to restructure the Office of Regulatory Affairs, which contains our field-based operations, to focus on their core areas of investigation, inspections, imports, sampling, and regulatory lab work, to allow this organization to really shine upon all of these capabilities,” said Woodcock. “I’m spearheading an implementation and change management group that’s focused on developing detailed plans to ensure the successful execution of this program.”
  • ORA investigators will continue to have cross-cutting functions – a necessary aspect of their work, said Califf, citing the work of import teams as an example. “We currently have a workgroup to work through the specific operations […] And this will be uniform change that we’re envisioning,” he added. “We consider that the changes we’re going to make are across all the programs – so this similar change is for the device program, the drugs program, and so forth.” And the work of ORA means that inspection capacity may have to be reallocated in the event of an emergency, so ORA will need to continue to have personnel oversight. Even the foods investigators will remain with ORA, but budgets and priorities will be set by the new Human Foods Deputy Commissioner, he confirmed.
  • Woodcock gave some hint of the technological changes she’s envisioning. As she indicated in August 2022, the FDA has been working on “building a workflow management system that will join the centers for the first time in ORA. So the ordering inspections, carrying out the inspections, and then eventually dealing with the back end of the inspections,” along with compliance actions, will all be conducted on the same platform. [ Read our full analysis of the ORA reorganization announcement here.]

Since the initial announcement about ORA’s reorganization, the emerging details reflect an evolving understanding of what is truly needed to address systemic issues

  • According to Califf, the life sciences industry needs to understand that the proposed changes go far beyond just food. “I cannot stress enough that my vision is focused on a new, agency-wide model where the activities and responsibilities of the regulatory programs and ORA are better synced to improve efficiency and effectiveness with clear decision rights so that everyone knows who has authority,” he said in a statement in February 2023.
  • In this new model, FDA would rethink how programs and field functions “are organized and operate,” with the goal of better integrating “ORA’s enterprise-wide expertise in field-based operations with product subject matter experts who sit in all the agency’s programs.” To do this, the agency said it had started the process of “analyzing inspection and compliance functions that sit within both ORA and program offices across the agency to determine opportunities to streamline operations and clarify decision-making authority at each step of the inspection process as well as integrate new automation and information technology (IT) support.”
  • The goal, FDA wrote, is to have ORA staff and expert personnel “function as a multidisciplinary team, eliminating sequential steps, immediately bringing the best expertise to bear on the problem at hand, and speeding decisions.” FDA also noted that it plans to evaluate its training programs “to see how they can best serve the needs of both the FDA, regulatory partners and regulated industry.” The assessment is set to look at whether training functions and roles “should be unified,” the statement said.
  • “We’ve heard loud and clear that the current resource distribution and operational model between the FDA’s regulatory programs and field operations are siloed and there’s too much duplication,” said Califf. “We intend to fix this and strengthen both the regulatory programs and field force. Both subject matter experts in the programs and the expertise of our investigators in the field will see more interaction as part of multidisciplinary teams that have clarity on who is in charge of making decisions.”

In June, Califf announced changes to the ORA reforms based on continuing feedback

  • On June 28, the FDA unveiled what it called a “new model” for ORA to “further enhance coordination, prevention and response activities across the FDA.” Notably, FDA’s thinking about how to transform ORA appears to have changed since its plans were first unveiled.
  • In practice, this new model seems to involve ceding significant parts of ORA’s authority back to regulatory review centers like CFSAN, CDER, CBER and CDRH – or at least with respect to certain activities. Compliance functions that are currently managed by ORA will instead be managed by product centers, “to streamline operations and expedite decision-making.” Other authorities will also be transitioned to ORA, including “certain functions” under the Office of Security and Emergency Management that currently helps to monitor and manage coordinated responses to emergency situations.
  • Instead, ORA will have as its “core mission” the conduct of investigations, inspections and imports for all FDA-regulated products. “These proposed changes are designed to help ensure the most strategic use of resources to meet the demands of our increasingly complex public health mission,” said FDA Commissioner Robert Califf in a statement.
  • With changing authorities will come changing staff, the FDA said. Certain employees who are currently aligned to ORA will be shifted to other product centers and offices. In addition, ORA is planning to leverage the FDA’s Title 21 authorities, which allow it to hire staff more quickly and at higher levels of pay than federal government employees are normally entitled to. That could help FDA solve a growing problem with employee hiring and retention.
  • The new ORA would be led by the Associate Commissioner for Regulatory Affairs (ACRA), who would report directly to the FDA Commissioner. The ACRA would oversee 14 different offices and inspectorates with oversight over discrete product areas and certain functions. For example, there would be seven different inspectorates with inspection authority over product areas like human drugs, medical devices, biologics and bioresearch. There would also be offices overseeing field regulatory operations, emergency response, criminal investigations, imports and information systems, among others.
  • If enacted, these changes would mark a significant rethink of ORA’s role at FDA. In the last decade, ORA had assumed significantly more authority from medical product centers in a big to centralize expertise in one location within the agency. However, this new model would in many ways limit ORA’s scope and authorities, leaving regulatory compliance activities up to individual product centers, while ORA would be more focused on “planned” assignments. In theory, this will allow centers to take faster action in response to emerging issues.

Now Califf has released a final draft of the design for ORA – and some other FDA divisions – revealing further unexpected changes and additional tweaks

  • Goodbye, Office of Regulatory Affairs. Hello, Office of Inspections and Investigations (OII). One of the FDA’s oldest offices is now getting a new name, which is intended to solidify “its role as the frontline of the FDA’s field-based inspection, investigation and import operations.” The leader of that office will no longer be known as the Associate Commissioner of Regulatory Affairs (ACRA), but instead the Associate Commissioner for Inspections and Investigations (ACII).
  • OII will oversee 12 different offices (instead of the previously proposed 14), including six different “Inspectorate Offices” charged with overseeing specific product portfolios. These include the Offices of Bioresearch Monitoring; Biologics; Medical Devices and Radiological Health; Human and Animal Drugs; Animal Food; and Human Food. Tobacco products (which were previously slated to have a separate inspectorate office) are now to be managed under another office, the Office of Field Operations and Response, which is also charged with providing “enterprise inspectorate support” and responding to emergencies and natural disasters.
  • Another office that has been eliminated from the final ORA/OII reorganization is the Office of Medical Product & Specialty Labs. Newly added offices within OII include the Offices of Criminal Investigations; Imports Operations, Management; Business Informatics and Solutions Management; and Training, Education and Development.
  • The Office of the Commissioner, which hadn’t previously been mentioned as part of the reform effort, also has newly proposed changes. Some of these changes will have significant impacts on the oversight of medical products that were wholly unrelated to FDA’s human foods mission, which is somewhat unexpected given the original scope of the FDA’s proposal. For example, a new Office of the Chief Medical Officer (OCMO) is meant to “strengthen central coordination of cross-agency medical issues, including special populations such as people with rare diseases and children.” Another example is a new Office of Enterprise Transformation, intended to “work across the FDA to drive high-priority cross-cutting business process improvement efforts.”
  • There are also some new clarifications regarding the role of FDA’s medical product centers. Specifically, the product centers will now be “solely responsible for receipt, triage and closing consumer and whistleblower complaints, rather than this role being split between Centers and field Offices.” This helps respond to concerns that food-related whistleblower complaints languish at the agency without action for too long, and FDA wrote that it hoped the change would “refine the processing of complaints, ultimately improving our ability to detect problems faster.”
  • Several changes appear related to medical countermeasures and emergency response. For example, OCMO will include an Office of Public Health Preparedness and Response intended to “support medical countermeasure policy, emergency preparedness work and medical product shortage coordination across the agency.” In addition, the FDA’s Office of the Chief Scientist (OCS) will include a new Office of Regulatory and Emerging Science (ORES), which will be formed by merging the Office of Counterterrorism and Emerging Threats (OCET) and the Office of Regulatory Science and Innovation (ORSI). The merger is intended to “strengthen support of regulatory science and preparedness research efforts,” although no rationale is provided and these two divisions have historically had very different missions.

Analysis

  • One thing we don’t have yet is the actual plan. Everything we know so far has been pieced together from press releases, interviews and the odd organizational chart posted to the agency’s website. As a result, there’s a decent amount that we do know, but there’s also plenty that remains unknown. For example: Are there any organizational plans that the FDA hasn’t announced, because they are potentially not as popular? What are the exact authorities that are being transferred from ORA to the medical product centers? How many staff are proposed to move between ORA and FDA’s centers? What activities are considered to be strictly “compliance” in nature, and which ones are purely related to inspections or investigations? What will become of ORA’s Compliance Policy Guides (CPGs) – will each FDA center need to develop its own CPGs? Why does the FDA insist on changing so many long-used and easy pronounced acronyms (i.e., ORA and ODSP) with nigh-unpronounceable ones (i.e., OII, OFCSDSI)?
  • From a process standpoint, the plan won’t be final for months at the very least. FDA’s statement makes clear that the plan still needs to undergo several rounds of review, including by the Department of Health and Human Services (the parent agency of FDA), the White House Office of Management and Budget (OMB, which is a sort of regulator of regulators), Congress (which requires a 30-day notification period), the Office of the Federal Register (which must post the plan for notice and comment), and the FDA’s own staff (which, as part of a union, are entitled to negotiate). In a statement, the FDA said that it hopes the reforms will be implemented “sometime in calendar year 2024.”
  • One other important point: Given the erosion of the FDA’s reputation and political support in recent years, as well as the extraordinary number of review steps that this reform will be put through, there are plenty of reasons to doubt that the plan will make it through unscathed. Whether those changes are minor (as perhaps those from HHS or the White House might be) or more substantial in nature (such as those from Congress) remains to be seen. As we’ve noted before, some elements of the plan, such as the FDA’s proposed changes to its Office of Dietary Supplement Products, have already attracted Congressional scrutiny. Others haven’t, but might in the future.
  • One non-policy-related issue that attracted our attention: The Deputy Commissioner for Human Foods (JIM JONES) has a whopping 14 offices reporting directly to him. The ACII (MICHAEL ROGERS) will have 12 different offices reporting to him. Neither of those are inconceivable numbers of direct reports, but it does raise questions about the ability of both positions to structurally manage an incredible amount of issues without significantly delegating duties now entrusted to them. Ultimately, it might be worth rethinking each role’s “ span of control” over direct-reporting offices.
  • Compliance-related questions remain: Ultimately, many of the terms used by ORA – “compliance,” “inspection,” and “investigation” – are terms of art that will need to be closely defined and operationalized in any ultimate plan. Until they are, there will be ambiguity about what this emerging plan means for each regulatory center. There’s a key problem here that we’ll be looking for FDA to address upon the publication of its actual plan: The more that FDA leadership distributes ORA’s activities to individual product centers, the less efficient the agency becomes and the more potential there is for duplication of efforts. In the long-term, this also increases the potential for systems to diverge.
  • We expect that individual Centers’ Directors of Compliance (or similar roles) might get a significant amount of new authority (and, potentially, budget and staff as well). For example, the Center for Drug Evaluation and Research (CDER) has the Office of Compliance and the Office of Pharmaceutical Quality; the Center for Biologics Evaluation and Research (CBER) has the Office of Compliance and Biologics Quality; and the Center for Devices and Radiological Health (CDRH) has the Office of Product Evaluation and Quality. If ORA is giving up staff, budget and authority, all of that needs to go somewhere. We’ll be keeping a close eye on where that somewhere is.

Featuring prior analysis by Kari Oakes

To contact the author of this analysis, please email Alec Gaffney ( [email protected]).

Key Documents and Dates

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