FDA Denies Approval of Generic OxyContin
Roy Franco
April 19, 2013

On April 16, 2013, the Food & Drug Administration announced that it will not be approving generic OxyContin, the same day the patent expired for the abuse resistant type.  The FDA action appears in line with national concern over the meteoric rise in opiates use since 2000.  Today, this drug turns into a gummy substance if an addict attempts to crush it for an injection.  Production of generic drugs, according to Activists, would not be required to have such abuse-resistant technology, resulting in even more oxycodone abuse.

The FDA does not have the power to require abuse-resistant technologies for generics.  Congress is therefore exploring legislation to deny applicants for generic drugs that do not use such technology.  Until Congress acts, the FDA’s power is limited and can only deny certain drugs not be available for generic manufacturers.  This of course adds cost to those who are legitimate patients.

These added costs are clearly visible in the Workers’ Compensation Medicare Set Aside (WCMSA) where opiates, such as OxyContin, are included.  Generics would be helpful as one tool to reduce these costs.  Another tool would be our pharmacy and peer to peer review service designed to reduce the overall use of opiates in the workers’ compensation claim.

According to the Centers for Disease Control, prescription drug overdose death rates have more than tripled since 1990.  Opioids, benzodiazepines and Amphetamine-like drugs are the leading cause.  These painkillers are responsible for three out of four prescription drug overdoses.  These prescription painkillers cause death by binding to receptors in the brain that creates a feeling of euphoria, and slows down breathing.  Combined with alcohol, its potency is significantly enhanced, not to mention its known addictive properties.  It’s no wonder that in 2010 over 2 million people reported using prescription painkillers non-medically for the first time – nearly 5,000 a day.  Stated another way, enough painkiller prescriptions were prescribed in 2010 to medicate every American adult around-the-clock for one month.  Click here to read more.

The action by the FDA is an attempt to plug the dyke.  It will require a group effort to reach a final solution.  Washington State is an excellent example of Government and Industry reaching consensus on an approach on Opioid use.  Click here to read about the new Washington State Law.  This author recently attended a hearing at the California legislature on March 20, 2013 where testimony was provided to urge action in this area.  Click here to read about California hearing.

We will continue to monitor efforts in this area as States react to this important topic.