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# Questions Remain After FDA Response to Hill on OCI
- URL: https://www.fdaweb.com/questions-remain-after-fda-response-to-hill-on-oci/
- Published: 2017-01-27T12:00:00.000Z
- Updated: 2026-09-14T22:03:26.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137840

FDA failed to address all issues outlined in a House Energy and Commerce Committee request about performance measures involving the Office of Criminal Investigations (OCI). Last September, committee leaders wrote the agency ([see story](https://www.fdaweb.com/house-committee-leaders-want-oci-update/)) asking for information in the wake of information from independent watchdogs that identified weaknesses in the organization. OCI also has been the subject of a Reuters [investigation](http://www.reuters.com/article/us-usa-fda-congress-idUSKCN11R1E4?ref=fdaweb.com).

“Two independent reports, one from the Government Accountability Office (GAO) in 2010 and one from the Department of Health and Human Services Inspector General in 2012, have identified OCI management issues and made recommendations for improvements,” the committee wrote at the time. “The GAO report on FDA OCI found that FDA maintained limited oversight of the investigations conducted by OCI and lacked sufficient performance measures. The GAO report also raised concerns about the OIA (Office of Internal Affairs), a component of OCI comprised of OCI detailees, responsible for conducting (sic) internal allegations of misconduct by FDA employees.”

Committee chairman **Greg Walden** (R-OR) said 1/27 that “there continue to be more questions than answers regarding the U.S. Food and Drug Administration’s (FDA) Office of Criminal Investigations (OCI).” Addressing [FDA’s delayed response](https://energycommerce.house.gov/sites/republicans.energycommerce.house.gov/files/documents/20170119FDA%5FResponse.pdf?ref=fdaweb.com), Walden noted that the agency failed to include basic information like a copy of their performance plan or details on how strategic investigative priorities were chosen or ranked.

  
In its response, FDA said OCI’s performance can be difficult to measure because it’s centered on protecting the public health. For example, it said that during an investigation, a determination could be made to refer a matter to an appropriate product Center for “immediate regulatory review” to protect public health rather than OCI delaying regulatory intervention while gathering evidence. Such referrals are not tracked under performance measures, the agency said.