Deston Therapeutics Stands By Safety and Efficacy of Auralgan After FDA Action

CHAPEL HILL, N.C., Feb. 25, 2011 /PRNewswire/ -- 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.

History of Auralgan

Auralgan, is a solution of antipyrine and benzocaine and has been marketed in the United States since 1947 as a treatment for ear pain and inflammation associated with acute otitis media ("AOM").  

When Deston acquired the rights to Auralgan in 2006, this product and other generic equivalents had been marketed for over fifty years.  During this fifty year period, FDA had never taken enforcement action against any manufacturer for selling these types of drug products as unapproved "new drugs".  FDA's last official statement regarding the regulatory status of Auralgan occurred in 1981 when the Agency's Assistant to the Director, Division of Drug Labeling Compliance said that the Agency had not made a determination whether Auralgan qualified as a "new drug."

During this fifty year period of marketing, Auralgan was the subject of clinical trials supporting its use as safe and effective.  Additionally, numerous health organizations and institutions have stated that Auralgan is safe and effective.  The United States National Library of Medicine's Medline Plus and the National Institute of Health's National Center for Biotechnology Information have stated on their webpages that Auralgan is a safe and effective treatment for ear pain and inflammation associated with AOM.  The American Academy of Pediatric and American Academy of Family Physicians along with the Institute for Clinical Systems Improvement published guidances recognizing Auralgan as a safe and effective treatment for ear pain in pediatric patients with AOM.

According to Mr. Preston, when Deston acquired Auralgan, it believed that this product qualified as an "old drug" because of the long marketing of Auralgan, the evidence supporting its safe and effective use, and the fact that the Federal Government has never concluded that it was a "new drug" or took action against the previous manufacturer of Auralgan.  

Deston was unaware that FDA believed that Auralgan was a "new drug" until the FDA informed Deston of this position last year.  In response to this information, Deston's legal counsel prepared and filed, on May 28, 2010, a "Citizen Petition" with the FDA, to make the case, point by point, why Auralgan was not a 'new drug'. Deston had expected a due process period whereby FDA would provide an in-kind formal response, explaining why they believed it was a 'new drug'.

Deston also began discussions with FDA regarding how to obtain FDA approval for Auralgan if, after addressing the Citizen Petition, the FDA decided the product qualified as a "new drug."  On February 15, 2011 – a day after the Federal Government seized Auralgan – Deston received a partial response to its Citizen Petition implying that the FDA has not yet made a determination on whether Auralgan qualifies as a "new drug" or an "old drug."  Because FDA has yet to review the evidence presented in its Citizen Petition, provide a thorough explanation for the reasons that it believes the combination is not GRAS/E, the matter is now up to a court to make a final legal decision on the new drug status of the articles that have been seized.  Until the court rules on the old drug- new drug issue for the seized goods,  the matter has not been legally resolved Mr. Allera noted.  

"We continue to believe, as we always have, that Auralgan is a safe and effective treatment for ear pain and inflammation," said Mr. Preston.  "Deston looks forward to working with the government to resolve all outstanding issues related to the regulatory classification of this drug product."

According to the original complaint, Deston has thirty-five days to claim the seized Auralgan, and after claiming the seized goods, Deston has 20 days to file an answer to the complaint.  Mr. Preston said that Deston is currently exploring its legal options regarding how best to respond to this seizure.

SOURCE Deston Therapeutics LLC