(COLUMBUS, Ohio) -- Ohio Attorney General Mike DeWine said today that he was pleased by the U.S. Food and Drug Administration's (FDA) decision to deny generic production of the pain medication OxyContin.
Attorney General DeWine was one of 48 state and territorial attorneys general who sent a letter to the FDA last month urging them to adopt standards requiring manufacturers and marketers of generic prescription painkillers to develop tamper-and-abuse-resistant versions of their products.
In 2010, the FDA approved a reformulated version of the original OxyContin tablets, making the painkillers much more difficult to abuse by those addicted to the pain medication. Current generic formulations of the drug do not have the abuse deterrent properties.
"Today's OxyContin tablet is much harder to crush and dissolve, making it difficult for drug abusers to snort or inject the painkillers," said DeWine. "Had the FDA approved the generic formulations, we would have been back at square one in our fight against prescription drug abuse."
"The development of abuse-deterrent opioid analgesics is a public health priority for the FDA," said Douglas Throckmorton, M.D., deputy director for regulatory programs in the FDA's Center for Drug Evaluation and Research. "While both original and reformulated OxyContin are subject to abuse and misuse, the FDA has determined that reformulated OxyContin can be expected to make abuse by injection difficult and expected to reduce abuse by snorting compared to original OxyContin."
Fatal drug overdoses are now the leading cause of death due to unintentional injury in the United States, exceeding even motor vehicle deaths, according to the U.S. Centers for Disease Control and Prevention.
Unintentional drug overdoses kill an average of four Ohioans each day.
Upon taking office in 2011, Attorney General DeWine made the fight against prescription drug abuse a priority. In that time, those with the Attorney General's Office have been involved in the permanent license revocation of more than two dozen doctors and pharmacists who improperly prescribed prescription medication, the conviction of more than a dozen doctors, pharmacists, traffickers and associates, and the seizure of more than $1.67 million worth of prescription pills.
Attorney General DeWine also partnered with the Ohio Department of Health and the Drug Free Action Alliance to provide free prescription drug collection bins to law enforcement agencies across the state as part of the Ohio Prescription Drug Drop Box Program.
Dan Tierney: 614-466-3840
Jill Del Greco: 614-466-3840