Navigation Links
Epilepsy Foundation Calls on Drug Enforcement Agency to Improve Review Process for New Treatments

WASHINGTON, Aug. 20, 2013 /PRNewswire-USNewswire/ -- The Epilepsy Foundation calls on the Drug Enforcement Administration (DEA) to revise its process for reviewing new treatments. 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 (FDA), 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 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 CEO of the Epilepsy Foundation. "It is even more disheartening to know that the system is not required to have a clear timeline for consumers." 

Access to new therapies is particularly important for the 20 to 30 percent of people living with epilepsy who experience intractable or uncontrolled seizures or have significant adverse effects to medication. Patients who have drug-resistant epilepsy, defined as a failure to achieve seizure freedom after adequate trials of two tolerated, appropriately chosen and used antiepileptic drug schedules (whether as monotherapies or in combination), can develop brain damage or experience other life threatening effects.

The Epilepsy Foundation agrees on the need to be vigilant regarding the serious problem of prescription drug abuse, but an open ended regulatory barrier for new products that have met FDA standards for efficacy and safety is not the answer. The Epilepsy Foundation is concerned about the lack of transparency and certainty in the DEA review process and welcomes changes that would bring hope to those living with epilepsy, especially those currently living with uncontrolled seizures. 

The Foundation recently sent a letter to DEA Administrator Michele Leonhart requesting that the agency review its policies, processes, and timelines so patients and their physicians can know with more certainty a timeline for availability of these needed treatments. Such a timeline would provide hope and certainty, and could also provide more safety and stability for access to FDA approved therapies.

About Epilepsy  
When a person has two or more unprovoked seizures, they have epilepsy, which affects more than 2 million people in the U.S. and 65 million people worldwide. This year, another 150,000 people in the U.S. will be diagnosed with epilepsy. 

Epilepsy Foundation  
The Epilepsy Foundation, a national nonprofit with affiliated organizations throughout the United States, has led the fight against seizures since 1968. The Foundation's goals are to ensure that people with seizures are able to participate in all life experiences and to prevent, control and cure epilepsy through services, education, advocacy and research so not another moment is lost to seizures. For additional information, please visit and

SOURCE Epilepsy Foundation
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Upsher-Smith Teams Up With Epilepsy Foundation Of Minnesota For 2013 Stroll For Epilepsy
2. Epilepsy Foundation Launches The "Epilepsy Innovation Seal Of Excellence" Recognizing Groundbreaking Product Candidates For People With Epilepsy
3. Upsher-Smith Announces Patient Enrollment In Open-label Safety Study Of USL261 (Intranasal Midazolam) For Rescue Treatment Of Seizure Clusters In Epilepsy
4. Surveyed U.S. and European Neurologists Identify Better Seizure-Free Efficacy as One of the Greatest Unmet Needs in Treating Partial-Onset Seizures in Refractory Epilepsy Patients
5. NeuroSigma Launches Dedicated Website to Introduce Its Monarch eTNS System for Epilepsy and Depression
6. Upsher-Smith Successfully Completes Phase III Study Of USL255 (Extended-Release Topiramate) For Adjunctive Treatment Of Epilepsy In Patients With Refractory Partial-Onset Seizures
7. UCB and IBM Collaborate to Personalize Care for Epilepsy Patients
8. Alexza Pharmaceuticals to Present at Antiepileptic Drug and Device Trials (AED) XII Conference Highlighting Advances in the Treatment of Epilepsy
9. NeuroSigma Receives Health Canada Approval for Its Monarch eTNS System for the Treatment of Drug-Resistant Epilepsy and Major Depressive Disorder
10. Epilepsy Foundation To Present Epilepsy Therapy Project Lifetime Accelerator Award To Henrik Klitgaard, Ph.D., Recognizing Contributions To New Therapies
11. Eisai To Sponsor 7th Annual National Walk For Epilepsy To Help Raise Epilepsy Awareness
Post Your Comments:
(Date:11/26/2015)... , November 26, 2015 ... the addition of the  "2016 Future ... European Therapeutic Drug Monitoring (TDM) Market: ... Intelligence, Emerging Opportunities"  report to their ... has announced the addition of the  ...
(Date:11/26/2015)... , November 26, 2015 ... the "Self Administration of High Viscosity Drugs" ... ) has announced the addition of the ... report to their offering. --> Research ... addition of the "Self Administration of High ...
(Date:11/26/2015)... DUBLIN , November 26, 2015 /PRNewswire/ ... the addition of the "Radioimmunoassay Market ... User (Hospital, Pharmaceutical Industry, Academics, Clinical Diagnostic ... - Global Forecast to 2020" report ... ) has announced the addition of the ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... November 27, 2015 , ... ProSidebar: Fashion ... Cut Pro X. With ProSidebar: Fasion, video editors can easily add an informative ... a minimalist title opener. Utilize presets featuring self-animating drop zones, lines, bars, and ...
(Date:11/27/2015)... ... November 27, 2015 , ... Consistent with the ... 2016 Building Better Radiology Marketing Programs meeting will showcase some of ... 6, 2016, at Caesars Palace in Las Vegas with a pre-conference session on ...
(Date:11/27/2015)... ... ... A simply groundbreaking television series, "Voices in America", which is hosted by Hollywood ... issues that are presently affecting Americans. Dedicated to providing the world with a wide ... subjects consumers focus on, one episode at a time. , In the latest ...
(Date:11/27/2015)... ... November 27, 2015 , ... Keeping ... platform for mental health and wellness consultation, has collaborated with a leading web-based ... the knowledge gap experienced by parents and bring advice from parenting experts within ...
(Date:11/27/2015)... ... 2015 , ... The men and women on this list ... the country. They have overseen financial turnarounds, shown commitment to their community through ... as a whole through their advocacy and professional efforts. , Becker's Hospital Review ...
Breaking Medicine News(10 mins):