Legislator Targets FDA's 'Inconsistent' Use of Untitled Letters

Posted 29 May 2015 | By Alexander Gaffney, RAC 

Legislator Targets FDA's 'Inconsistent' Use of Untitled Letters

The chairman of the US House of Representatives' Subcommittee on Oversight and Investigations is pressing the US Food and Drug Administration (FDA) to explain its "use and publication" of Untitled Letters—a type of letter used by regulators to warn companies about alleged advertising infractions.


The letters, most often issued by FDA's Office of Prescription Drug Promotion (OPDP), are often read closely by members of the trade press and other companies. Due to their thorough examination and explanation of advertising issues, they are sometimes seen as tantamount to non-binding guidance for other companies.

The Untitled Letters, of which only about a dozen are sent in a typical year, consist of two parts: the letter itself, and a copy of the promotional item which earned the ire of FDA officials. Companies most often find themselves cited in Untitled Letters for failing to list all risks associated with a drug, for overstating the benefits of a drug, for indicating the drug is useful in populations for which a drug is not approved, and for minimizing the risks of a drug relative to its benefits.

While Untitled Letters differ from FDA Warning Letters in that they do not threaten immediate enforcement action (such as marketing restrictions) if an alleged problem is not remedied, they still request action on the part of the company.

A typical letter from OPDP concludes:

"OPDP requests that [Company] immediately cease violating the FD&C Act, as discussed above. Please submit a written response to this letter on or before [date] stating whether you intend to comply with this request, listing all promotional materials (with the 2253 submission date) for [drug name] that contain presentations such as those described above, and explaining your plan for discontinuing use of such materials. "

Other FDA centers also send Untitled Letters (or their equivalents), including the Center for Devices and Radiological Health (CDRH), the Center for Veterinary Medicine (CVM) and the Center for Biologics Research and Evaluation (CBER).

Congressional Concern

But as Tim Murphy (R-PA) explained in a letter this week to acting FDA Commissioner Stephen Ostroff, the agency doesn't always appear to be consistent when sending these letters.

"Each center has its own policy on which letters get posted," Murphy wrote. For example, some centers only post letters related to a single topic, while others only post letters authored by the headquarters office. There is no single, central policy dictating letters, Murphy added.

Murphy also expressed concern about the effects letters can have on small companies, citing one unusual letter which resulted in a massive plunge in a company's stock price and a subsequent shareholder lawsuit.

Murphy said in the future, Untitled Letters should contain more information to allow investors to make better sense of the information contained in the letter, should be made public only after the company has been notified, and should be posted after the stock market has ceased trading for the day. (Warning Letters are typically posted during trading hours, we should note).

"It is not clear that FDA's practices are consistently fair, effective or efficient," Murphy charged, noting that FDA subsequently released a second, more detailed letter as well as a guidance document containing even more information. "This raises questions about whether the FDA center was using an untitled letter to advance new policies or interpretations without providing adequate prior notice to the firm and other manufacturers in this product category," Murphy wrote.

Murphy's letter goes on to ask FDA to respond to nine questions about its Untitled Letters process, including the agency's awareness of their "economic and legal sensitivities."


Murphy's Letter to FDA

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