Despite FDA action, Deston still believes Auralgan as a safe and effective drug product

Deston Therapeutics LLC ("Deston") announced today that it is currently exploring its options to respond to a recent seizure of its Auralgan Otic Solution ("Auralgan") by the Federal Government and that it still believes that Auralgan is a safe and effective drug product.

"Despite the recent actions by the government, we believe that Auralgan is still a safe and effective treatment for ear pain and inflammation," said David Preston RPh, CEO of Deston.  "Auralgan has a long history of safe marketing and use, the medical literature supports the effectiveness of this product, and the side effects associated with this product are well-known.  The current situation is a result of a misunderstanding between FDA and Deston and not of a product safety concern."

On February 14, 2011, the Federal Government initiated an action in United States District Court of the Western District of Kentucky to condemn shipments of Auralgan located at Deston's distributor asserting that this drug product was a "new drug" that had not received prior approval from the Food and Drug Administration ("FDA") before it was sold.  

"While the government has seized shipments of Auralgan, the current complaint is not directed against Deston, its suppliers, or its distributors," said Edward John Allera, who is Deston's legal counsel, a partner at Buchanan Ingersoll & Rooney PC, a former FDA attorney and an expert in this area. "Instead, the current complaint focuses only on those units of Auralgan held by one distributor."

The central issue in this proceeding is the precise legal status of Auralgan as a "new drug" or an "old drug."  In its pleadings, the Federal Government asserts that Auralgan is a "new drug", but these allegations did not provide any new information regarding the safety or efficacy of Auralgan.  According to Mr. Allera, "The government has not provided any new evidence in its statements or its pleadings that undermines the safety and efficacy of Auralgan as a treatment for ear pain and inflammation."

At this time the government's claims are only allegations in a legal proceeding.  Until a court makes a determination on this issue, it remains legally unresolved whether Auralgan qualifies as a "new drug" product.  

Recently, FDA has begun to take actions against classes of products that it believes should not be categorized as "old drugs" and instead should be regulated as "new drugs".  Unlike previous actions, FDA did not take action against both Auralgan and its generic substitutes, but instead, has solely focused its actions on Auralgan.  Currently, Auralgan represents 3% of the market for this class of drug products, with generic substitutes accounting for the other 97%.  FDA has not announced any action against any of these generic competitors or explained whether it intends to take any action against these products in the future.