Call for US DEA to improve review process for new "controlled" treatments

The Washington DC, USA-based Epilepsy Foundation has called on the Drug Enforcement Administration (DEA) to revise its process for reviewing new treatments, arguing that the current method dampens innovation and lacks transparency for both consumers and industry.

Currently, when a new treatment with abuse potential is approved by the Food and Drug Administration, the sponsors may not commercially market the drug until it has been scheduled by the DEA and labeled with the controlled substance schedule. This delay between FDA approval and DEA scheduling has no set time limit, and there is no formal deadline or requirement that a timeline for agency action be provided to patients or physicians. During this interim timeframe, patients may not access these new therapies, regardless of FDA approval, the Foundation points out. The unpredictable DEA process results in patients being denied access to important medicines that can improve, and in some cases save, their lives.

"People with epilepsy, their caregivers, or parents of children with epilepsy find it very frustrating to wait for an additional treatment option for seizure control due to DEA delay," said Phil Gattone, president and chief executive of the Epilepsy Foundation, adding: "It is even more disheartening to know that the system is not required to have a clear timeline for consumers."