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# Gottlieb, McClellan Hit FDA Reorganization Plan
- URL: https://www.fdaweb.com/gottlieb-mcclellan-hit-fda-reorganization-plan/
- Published: 2025-05-08T12:00:00.000Z
- Updated: 2026-09-14T15:11:23.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5159147

Former FDA commissioners **Scott Gottlieb** and **Mark McClellan** say a plan circulated by the Department of Health and Human Services to restructure FDA by consolidating the product Centers that review drugs, biologics, animal health, medical devices, and tobacco into a single regulatory office would face many challenges. Writing in an open-access [article](https://jamanetwork.com/journals/jama-health-forum/fullarticle/2833970?ref=fdaweb.com) in *JAMA Health Forum*, the two say such proposals have been considered in the past and rejected because it was determined that such a consolidation would create more inefficiencies than it would solve.

Gottlieb and McClellan write that having separate Centers “reflects the unique characteristics of each product type. Regulating products as diverse as food, human and animal drugs, tobacco, and medical devices demands reviewers with corresponding expertise and a management structure steeped in the nuances of each field.”

They suggest that consolidating boosts efficiency when a unified office achieves economies of scale and reduces redundancy. “Yet there is little evidence that such benefits would materialize under the proposed plan,” they say. “Specialized personnel will still be essential for the core functions of each distinct product category. FDA’s capacity to implement effective end-to-end reviews would diminish by shifting from managers with comprehensive domain knowledge to generalists without the required expertise. New bureaucratic layers would need to be added to these new offices to ensure that the functional components still include scientists with expertise in FDA’s various scientific and medical product areas.”

They suggest that a successful reorganization needs to address functions not just with similar names but with common features across multiple product types, such as developing and maintaining the IT infrastructure and public/private collaborations to use postmarket data more effectively.

Gottlieb and McClellan conclude that policymakers “should regularly consider new opportunities for efficiency, but they should also recognize that the current structure of FDA reflects deliberate choices made through decades of bipartisan congressional policymaking and ongoing adaptation to technological advances and emerging risks…. Exchanging imagined redundancies for the expert-based regulation that the proposed HHS reorganization would dismantle risks fracturing the crucial alignment between premarket evaluation and postmarket oversight. Doing so courts prolonged upheaval within the FDA workforce, without any compelling evidence that efficiencies would justify these disruptions.”