Congress is Taking FDA to Task on its Use and Posting of Untitled Letters

June 1, 2015

By David C. Gibbons

In a letter sent to Acting FDA Commissioner Ostroff on May 27, 2015, the House Committee on Energy and Commerce (“EC Committee”) informed FDA that it is examining FDA’s “policies and practices regarding the use and publication of untitled letters, including whether such policies and practices are consistently fair, effective, and efficient in gaining compliance.”

Two types of advisory actions taken by FDA include Warning and Untitled Letters.  FDA Warning Letters (“WLs”) are issued by the Agency for violations of the Federal Food, Drug, and Cosmetic Act that, if not promptly and adequately corrected, may lead to enforcement action.  FDA’s Regulatory Procedures Manual (“RPM”) makes it clear that WLs are “informal and advisory.  [They] communicate[] the agency’s position on a matter but [do] not commit FDA to taking enforcement action.”  FDA, Regulatory Procedures Manual, Chapter 4, 2-3 (July 2012).  Untitled Letters (“ULs”) issued by FDA are for violative conduct that does not reach the same level of regulatory significance as Warning Letters.  Id. at 33. 

FDA policy on public dissemination of WLs issued to individuals or firms states that all FDA-issued WLs should be posted on its internet page once a redacted version has been made available by FDA’s Division of Freedom of Information.  Id. at 22.  Conversely, FDA’s RPM does not stipulate a policy or contain any direction on if, when, or how ULs should be disseminated publicly.

In its letter to FDA, the EC Committee related its findings that FDA Centers have been inconsistent in which ULs are posted and when.  The letter describes examples of the various Centers’ policies regarding posting ULs:

  • CDER: posts ULs related to advertising and promotional labeling;
  • CFSAN: posts ULs related to violations from manufacturing controls or labeling that do not meet the threshold of regulatory significance for a WL, or that are issued to internet websites;
  • CVM: posts all ULs issued by the Center but not by field offices.

The broad concerns expressed by the EC Committee include the apparent decentralized and inconsistent practices with ULs, especially as it concerns public dissemination.  The EC Committee noted that FDA will post some ULs quickly on its website; however, other ULs become publicly available only after FDA has received multiple requests under the Freedom of Information Act (“FOIA”).  The EC Committee also noted concerns regarding the need for FDA to be “more thoughtful about the consequences from the impact of both disclosure and timing of [ULs] on FDA-regulated companies . . . .” 

To this point, the EC Committee relates a case where FDA issued a UL to a publicly-traded company, a year after an inspection of the company, noting a violation based on information collected during the inspection.  The FDA inspection a year earlier had resulted in a No Action Indicated classification, and no FDA 483 had been issued.  FDA posted the UL on its website just three business days after sending it to the company.  The UL was posted during a business day, leading to a tumultuous day of trading that ultimately saw the company’s stock drop 36% in value.  Additionally, a shareholder lawsuit related to the UL was filed against the company.

The EC Committee noted that FDA had posted the UL during the business day when it would affect the market, and before the company had an opportunity to work with FDA to address its concerns.  The EC Committee further noted that a year after the UL was issued, FDA issued a draft guidance document governing the firm’s product and the basis for its conclusion in the UL, using similar language in FDA’s post-UL correspondence with the company.

To further the EC Committee’s “examination,” it requested that FDA provide written responses to numerous questions regarding FDA’s policies and practices concerning ULs.  Some questions concern the criteria used by FDA centers to issue and post ULs as well as the apparent inconsistency among FDA centers; to this end, the EC Committee’s letter requested an explanation as to “why FDA does not have consistent policies and practices among its centers for publishing untitled letters.”  The EC Committee goes on to ask whether FDA uses a numerical threshold of FOIA requests as a basis for posting a UL on its website and, if so, to identify the threshold.  The EC Committee asks whether FDA’s practice of posting ULs issued to publicly-traded firms could be modified to posting after the trading session has ended and, if such practice cannot be modified, to explain why.  FDA was also asked whether its approach relating to the issuance of ULs is the most efficient in obtaining compliance by the firms it regulates.

One of the more interesting questions to which FDA’s response is being sought likely relates to the stated example mentioned above and concerns whether FDA uses ULs as “a way to announce new regulatory approaches or policies.”  We know that many readers of this blog have just responded with an emphatic “YES!” to this question without any need to see FDA’s response.  We previously blogged about how this was true years ago regarding FDA’s policy on risk communication in promotional activities carried out using social media.  In addition, FDA’s Draft Guidance: Presenting Risk Information in Prescription Drug and Medical Device Promotion, issued in 2009, is an accumulation of issues previously cited in Untitled Letters (see our previous post here).

FDA’s written response to the EC Committee’s request is due no later than June 10. 

It’s rare that Congress reproaches FDA in the manner done so in the EC Committee letter.  But in the case of FDA’s practices with respect to the issuance and public dissemination of ULs, there are many out there who believe it is well deserved.

Categories: Enforcement