US Congressman Challenges FDA’s Untitled Letters

FDA routinely uses “Untitled Letters” which are akin to Warning Letters but are issued when FDA does not have a clear violation description since these violations were identified by measures other than an audit. These letters which are often released to the public at the same time they are sent to the accused company could have a huge negative effect on the company under attack by FDA leading to loss in revenue, valuation and huge legal expenses. The US Congressman, Tim Murphy (R-PA) recently took FDA to task for issuing Untitled Letters without due process. In a letter to the FDA’s active Commissioner, Mr. Murphy raised several concerns about FDA’s practice and asked FDA to answer 9 questions to clarify and justify its process. These include definition of the criteria for issue of Untitled Letters consistently across various FDA offices, criteria for public posting of such letter prior to giving the affected company chance to respond, what is FDA’s motive for releasing such letters publicly, if such letters are used to announce new rules or practices, and does FDA understand and appreciate the potential impact such letters could have on the affected companies. Now that sets us up for an interesting response from FDA and a high impact Congressional Hearing. We will keep you posted.