Lawmaker Presses for Consistent Untitled Letter Practices

A House subcommittee chairman wants the FDA to explain its practices relating to publication and distribution of untitled letters, after hearing complaints from companies that the agency’s policies are inconsistent and, in some cases, unfair.

In a letter last week to Acting Commissioner Stephen Ostroff, Tim Murphy (R-Pa.), head of the Subcommittee on Oversight and Investigations, complains that FDA centers are not consistent in the way they publicize untitled letters. For example, CDER posts only letters relating to advertising and promotional labels, while the Center for Food Safety and Nutrition posts letters dealing with manufacturing controls or labeling violations, the letter says.

Murphy also takes the FDA to task for its treatment of a specific company that received a “No Action Indicated” stamp following an inspection that did not prompt a Form 483. The congressman alleges that more than a year later, the agency sent an untitled letter alleging a violation, but didn’t clearly connect the allegation to any conclusions made at the inspection.

The FDA posted the letter on its website just three days later, before the company had a chance to respond to the agency’s concerns and take corrective actions, Murphy says.

The lawmaker wants the FDA to establish codified untitled letter practices specifying the timing of release and whether the agency adequately justifies its conclusion of a violation and adequately notifies the offender.

The letter gives the FDA until June 10 to answer a number of questions, including:

• Whether different agency centers have different specifications for issuing untitled letters;
• How each center comes up with criteria for posting or not posting these letters online;
• Whether any agency centers use frequency of FOIA requests to determine whether to post a letter online;
• Whether the agency would consider posting the letters online only after trading has closed after 4 p.m.;
• Why the FDA sometimes sends letters alleging violations not mentioned at inspections;
• Whether any centers use untitled letters to announce new regulatory approaches or policies;
• Whether the agency realizes the economic and political sensitivities that might stem from posting untitled letters to publicly traded companies; and
• What the agency considers relatively minor violations that are the basis for untitled letters issued as a result of an inspection.

The FDA plans to respond directly to the lawmaker, spokesman Christopher Kelly said. Read Murphy’s letter at www.fdanews.com/05-29-15-untitledletters.pdf. — Lena Freund