This is historical material “frozen in time”. The website is no longer updated and links to external websites and some internal pages may not work.

Search form

FDA Takes Action on Prescription Drug Abuse

Yesterday, the Food and Drug Administration (FDA) took an important step in addressing America’s prescription drug abuse epidemic.


Yesterday, the Food and Drug Administration (FDA) took an important step in addressing America’s prescription drug abuse epidemic.

The FDA announced that it approved updated labeling for reformulated Oxycontin that describe the drug’s abuse-deterrent properties, the first time such a claim has been approved by the agency. FDA also said it will not accept or approve generics of the original OxyContin formulation, which lacks these properties.”

For over a century, the FDA has applied the principles of science, evidence, and common sense to protect public health and safety in America. Yesterday’s action demonstrates yet again that when it comes to our Nation’s prescription drug abuse epidemic, there are significant and important steps we can take to save lives and protect public health.

This announcement builds upon already unprecedented actions by the Administration to drive down the number of Americans affected by prescription drug abuse. Director Kerlikowske and ONDCP commend the FDA for its work to keep non abuse-deterrent formulations of this drug from reaching the marketplace while continuing to ensure access to powerful opioid analgesic drugs that – when properly used and prescribed –provide relief to those suffering from acute and serious illnesses.

The Centers for Disease Control and Prevention has classified prescription drug overdoses as an epidemic. National data show that by 2010, drug overdose deaths were the second leading cause of injury death in America. Additionally, the overall drug overdose death rate in the United States roughly tripled between 1991 and 2011, and in 2007 about 100 people per day died from drug overdoses in the U.S.

To address the threat of prescription drug abuse and diversion while also protecting legitimate access to these drugs for those suffering from pain, the Administration released Epidemic: Responding to America's Prescription Drug Abuse Crisis in 2011.  This action plan provides a national framework for reducing prescription drug diversion and abuse by supporting education for patients and healthcare providers, recommending more convenient and environmentally responsible disposal methods to remove unused medications from the home, supporting the expansion of state-based prescription drug monitoring programs, and reducing the prevalence of pill mills and doctor shopping through enforcement efforts.