Congressional Letter Criticizes FDA Over 'Inconsistent' Untitled Letters
The House Committee on Energy and Commerce recently took the Food and Drug Administration to task over the agency’s practices regarding “untitled letters.” In a May 27 letter (here) from Energy and Commerce oversight subcommittee Chairman Tim Murphy, R-Pa., the committee noted inconsistencies in how the agency makes the untitled letters available to the public, and questioned the circumstances under which an untitled letter was issued in one particular case where an agency inspection had found no violations.
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Like warning letters, FDA issues untitled letters to notify companies that they need to correct violations identified by the agency. While warning letters address violations that may lead to enforcement action if not immediately corrected, untitled letters generally address less significant violations, said the letter. All warning letters are posted to FDA’s website, but policies for posting untitled letters vary between product-based centers, said the letter.
The posting of one untitled letter by FDA had consequences for a company that saw its stock prices plummet after a letter was put on the agency’s website only three days after it was sent out. The price of the company’s shares fell nearly 70 percent before stabilizing at a 36 percent loss, and shareholders filed a lawsuit against the company that is still in litigation, said the letter. To make matters worse, the underlying FDA inspection had occurred a year earlier and had not reported a violation, and the untitled letter did not say how the inspection supported FDA’s findings that led to the untitled letter.
The committee asked FDA for clarification to aid in its examination of the untitled letter process, including on the criteria under which untitled letters are posted. It also asked whether it’s prudent to issue untitled letters to companies without first giving them notice of the violation on the inspection report and an opportunity to correct it, and whether FDA should be issuing untitled letters during the day, while stock markets are open for trading.