FDA Policy/General

Integrating ORA in Centers Has Risks: Analysis

David McFarland

— 1 min read
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Attorney Tim Philips (Gardner Law) says both industry and consumers should be concerned about the proposed FDA reorganization of the Office of Regulatory Affairs (ORA). In a detailed online analysis of the proposal, Philips says that over the years many regulated companies have developed good relationships with their FDA district office compliance officers. “If the agency eliminates the ORA/district compliance organization,” he writes, “industry officials could be forced to deal directly with Center staff (in the Washington, DC, area) for all compliance issues.”

Consumers, Philips says, should object to any reorganization that eliminates or dilutes their access to local assistance from FDA. He notes that “ORA compliance officers routinely interact with consumers who contact the agency to ask questions about a product, file a complaint, get updates on the status of compliance actions, or inquire about FDA policy.”

After reviewing current ORA functioning and past reorganizations, Philips says that for the coming revamp to improve the agency’s handling of compliance cases, it must, at a minimum:

  • retain a fully staffed and highly proficient corps of compliance officers by leveraging the existing talent and experience in ORA;
  • design an efficient and timely case processing procedure using expertise in ORA and the Centers, being careful not to lose important elements like case development (now in ORA) and expert medical and scientific review (now in the Centers); and
  • retain resources in ORA so industry and consumers can readily obtain local assistance on FDA compliance issues.

“It is too soon to predict the outcome of FDA’s compliance revamp,” Philips concludes. “In a worst-case scenario, the agency squanders years of ORA field compliance experience, makes it more difficult for industry to interact with the agency, and exposes consumers to products that are less safe and effective. Best-case, FDA effectively integrates ORA and Center compliance staff, increases the efficiency of compliance case work, continues to interact well with industry and consumers, and protects all of us from adulterated and/or misbranded products.”

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