Posted: 26 Aug 2015 12:08 PM PDT
By David C. Gibbons –
As we reported in a previous post, the House Committee on Energy and Commerce requested that FDA answer a number of questions regarding how FDA Centers issue and publicly disclose Untitled Letters (“ULs”). As readers may recall, the letter to FDA questioned whether FDA’s practices concerning the issuance and disclosure of ULs has been “consistently fair, effective, or efficient” and solicited responses to numerous questions to provide color to the same. In its brief response, FDA reiterated its general policies regarding the issuance and dissemination of ULs, clarified, to some extent, its approach on disclosure, and addressed the Committee’s assertion that FDA had ulterior motive in the timing of public disclosure of certain ULs.
FDA answered the Committee’s questions concerning the issuance of ULs by stating that ULs are means to “communicate and provide formal notice” to companies that FDA has determined a violation of FDA regulations has occurred that does not rise to the threshold of a WL. FDA further stated that ULs provide “the factual basis regarding the violation,” communicate FDA’s concerns, but do not commit FDA to take enforcement action for such violation. In answering these questions, FDA generally related information from its Regulatory Procedures Manual (“RPM”). For example, FDA pointed to the RPM sections that describe certain types of Warning Letters (“WLs”) and ULs reviewed as a matter of course by FDA’s Office of Chief Counsel – additional detail can be found in RPM Exhibit 4-1 (here).
More noteworthy was FDA’s response regarding public disclosure – that is, posting to FDA’s website – of ULs. FDA clarified that Center-specific policies concerning the posting of ULs apply, but only when such policies do not conflict with the Agency’s approach to posting ULs proactively in consideration of its obligations under the Freedom of Information Act (“FOIA”). FDA said that FOIA requires FDA to post “any Agency record subject to the FOIA,” including ULs, if:
FDA took issue with Congress’ suggestion that FDA had motives other than achieving regulatory compliance in issuing and posting some ULs. In its letter to FDA, Congress questioned whether the timing of issuing ULs was meant to advance new FDA policy or interpretation outside the routine administrative process or impact investment decisions. In its response to this issue, FDA expressly rejected the notion that it uses ULs to “announce new regulatory approaches or policy.” With respect to timing, FDA responded by stating that it does not “investigate or evaluate” whether companies receiving WLs or ULs are publicly traded on a U.S. or foreign exchange or “seek to time [the] release [of WLs or ULs] based on market considerations.” In a final point on this issue, FDA stated it “does not believe the Agency has a special expertise or a mission to change its own processes to attempt to time impacts on the stock market and determine whether impacts are desirable.”
It will be interesting to see where this goes from here. Was the Committee’s intent to take FDA to task over what FDA Centersshould do, having FDA describe its existing policies regarding the issuance and posting of ULs? If so, then we may not hear more from either Congress or FDA on the subject. Or was it a more searching inquiry into what FDA Centers actually do? If it was the latter, then FDA’s response likely does not provide Congress with what it was looking for and we may see more activity from the Committee, such as a request for a public hearing on the matter.
As we reported in a previous post, the House Committee on Energy and Commerce requested that FDA answer a number of questions regarding how FDA Centers issue and publicly disclose Untitled Letters (“ULs”). As readers may recall, the letter to FDA questioned whether FDA’s practices concerning the issuance and disclosure of ULs has been “consistently fair, effective, or efficient” and solicited responses to numerous questions to provide color to the same. In its brief response, FDA reiterated its general policies regarding the issuance and dissemination of ULs, clarified, to some extent, its approach on disclosure, and addressed the Committee’s assertion that FDA had ulterior motive in the timing of public disclosure of certain ULs.
FDA answered the Committee’s questions concerning the issuance of ULs by stating that ULs are means to “communicate and provide formal notice” to companies that FDA has determined a violation of FDA regulations has occurred that does not rise to the threshold of a WL. FDA further stated that ULs provide “the factual basis regarding the violation,” communicate FDA’s concerns, but do not commit FDA to take enforcement action for such violation. In answering these questions, FDA generally related information from its Regulatory Procedures Manual (“RPM”). For example, FDA pointed to the RPM sections that describe certain types of Warning Letters (“WLs”) and ULs reviewed as a matter of course by FDA’s Office of Chief Counsel – additional detail can be found in RPM Exhibit 4-1 (here).
More noteworthy was FDA’s response regarding public disclosure – that is, posting to FDA’s website – of ULs. FDA clarified that Center-specific policies concerning the posting of ULs apply, but only when such policies do not conflict with the Agency’s approach to posting ULs proactively in consideration of its obligations under the Freedom of Information Act (“FOIA”). FDA said that FOIA requires FDA to post “any Agency record subject to the FOIA,” including ULs, if:
- FDA has received three or more FOIA requests for a copy of such record; or
- The “content relates to a matter of significant public interest” and FDA expects to receive multiple FOIA requests for the record.
FDA took issue with Congress’ suggestion that FDA had motives other than achieving regulatory compliance in issuing and posting some ULs. In its letter to FDA, Congress questioned whether the timing of issuing ULs was meant to advance new FDA policy or interpretation outside the routine administrative process or impact investment decisions. In its response to this issue, FDA expressly rejected the notion that it uses ULs to “announce new regulatory approaches or policy.” With respect to timing, FDA responded by stating that it does not “investigate or evaluate” whether companies receiving WLs or ULs are publicly traded on a U.S. or foreign exchange or “seek to time [the] release [of WLs or ULs] based on market considerations.” In a final point on this issue, FDA stated it “does not believe the Agency has a special expertise or a mission to change its own processes to attempt to time impacts on the stock market and determine whether impacts are desirable.”
It will be interesting to see where this goes from here. Was the Committee’s intent to take FDA to task over what FDA Centersshould do, having FDA describe its existing policies regarding the issuance and posting of ULs? If so, then we may not hear more from either Congress or FDA on the subject. Or was it a more searching inquiry into what FDA Centers actually do? If it was the latter, then FDA’s response likely does not provide Congress with what it was looking for and we may see more activity from the Committee, such as a request for a public hearing on the matter.
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