EPILEPSY PATIENT ADVOCACY GROUPS URGE PASSAGE OF DEA SCHEDULING LEGISLATION

EPILEPSY PATIENT ADVOCACY GROUPS URGE PASSAGE OF DEA SCHEDULING LEGISLATION

WASHINGTON – A group of 15 epilepsy patient organizations sent a letter to congressional leaders urging them to pass legislation that would set a time limit on the Drug Enforcement Agency's (DEA) scheduling process of prescription medicines.

The Senate and House legislation would accelerate the scheduling process under the Controlled Substances Act and make it more transparent by requiring that the DEA schedule a new therapy within 45 days of approval by the Food and Drug Administration (FDA).

"This would allow safe and innovative treatments to reach patients in a more timely and predictable manner, while preserving DEA's role within the scheduling process," the groups said in the letter.

Federal law prohibits new FDA-approved therapies with abuse potential to be marketed until the medicine has been scheduled by DEA and labeled within the controlled substance schedule. FDA provides a recommended schedule based on extensive medical and scientific research performed during the approval process. There is no deadline on the DEA to act.

The epilepsy organizations note that the legislation is needed because of long and growing evaluation times associated with DEA scheduling decisions. Between 1997- 99 and 2009-13, the average time between FDA approval and DEA's final scheduling increased from an average of 49.3 days to an average of 237.6 days – with some waits extending to more than a year.

"For the more than one million individuals living without seizure control and significant side-effects, new therapies bring hope for seizure control," the letter said. "People with epilepsy, their caregivers and parents should not have to wait an undetermined amount of time for the new hope of seizure control."

The letter, led by the Epilepsy Foundation, was sent to Senate Majority Leader Harry Reid, Senate Minority Leader Mitch McConnell, House Speaker John Boehner and House Minority Leader Nancy Pelosi. It was signed by:

American Academy of Neurology (AAN)

American Epilepsy Society (AES)

Citizens United for Research in Epilepsy (CURE)

Danny Did Foundation

Dravet Syndrome Foundation

Dup15q Alliance

Epilepsy Foundation

Finding A Cure for Epilepsy and Seizures (FACES)

Hemispherectomy Foundation

Hope for Hypothalamic Harmartomas

ICE Epilepsy Alliance

International Foundation for CDKL5 Research

Lennox Gastaut Syndrome Foundation

PCDH19 Alliance

Phelan-McDermid Syndrome Foundation

Physician-Parent Caregivers

Ring14 USA Outreach

RE Children's Project

Seize The Facts

Tuberous Sclerosis Alliance

The legislation is the Regulatory Transparency, Patient access, and Effective Enforcement Act (S. 2862) and the Improving Regulatory Transparency for New Medical Therapies Act (H.R. 4299).

Contact:

Angela Ostrom Epilepsy Foundation 301-918-3766 [email protected]

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