FDA responds to Congressional inquiry regarding the Agency’s policies on Untitled Letters.

  • As previously covered on this blog, the U.S. House Committee on Energy and Commerce requested information from FDA regarding the Agency’s policies on the issuance and publication of Untitled Letters.  Congress seemed concerned that FDA may be using Untitled Letters to advance new policies or interpretations without giving adequate notice to industry.  Congress also questioned FDA’s decision to post a specific Untitled Letter under circumstances where the timing and nature of the posting adversely affected the recipient’s stock price.
  • FDA now has issued a written response to the Congressional inquiry.  In the response, FDA’s Associate Commissioner for Legislation:
    • clarifies the differences between Untitled Letters and Warning Letters;
    • notes the Agency’s policy of having the Office of Chief Counsel (OCC) review certain letters prior to their issuance (Specific to food and supplements, OCC reviews Untitled Letters that involve novel, controversial, or sensitive legal issues and those that allege violations of the dietary supplement good manufacturing practice regulations);
    • explains that FDA’s policies regarding the posting of Untitled Letters are specific to individual Centers within the Agency, but reiterates that there also is an Agency-wide proactive approach to posting records that are the subject of three or more requests under the Freedom of Information Act (FOIA) or that are expected to generate multiple FOIA requests;
    • asserts that the Agency uses Untitled Letters to communicate with regulated industry about FDA’s assessment of violations that do not meet the regulatory threshold for a Warning Letter; and
    • expressly denies that FDA uses Untitled Letters as a way to announce new regulatory approaches or policies.
  • FDA’s response does not provide novel or controversial information about the Agency’s policies on the issuance or posting of Untitled Letters.  As a result, this letter does not signal any greater predictability for regulated industry in terms of the timing or nature of a particular Untitled Letter’s release.