Navigation Links
Epilepsy Foundation Calls on Drug Enforcement Agency to Improve Review Process for New Treatments
Date:8/20/2013

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 www.epilepsy.com and www.epilepsyfoundation.org


'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:10/4/2017)... to the Centers for Disease Control and Prevention (CDC), influenza vaccination ... is helping communities across Massachusetts , Connecticut ... flu shots through the end of the month. *Some exclusions ... ... shot is by the end of October, according to the Centers for ...
(Date:10/2/2017)... , Oct. 2, 2017 Diplomat Pharmacy, ... 8th Day Software and Consulting, LLC , and named ... 8th Day Software, based in Tennessee , ... 8th Day expands EnvoyHealth,s service offerings for health care ... "In an interoperable ...
(Date:10/2/2017)... 2017  AllianceRx Walgreens Prime, the combined central specialty ... pharmacy benefit manager Prime Therapeutics LLC (Prime), today officially ... the unveiling of new signage at its headquarters in ... at a few other company-owned facilities across the country. ... some of whom will begin to see the AllianceRx ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... ... On The Brink”: the Christian history of the United States and the loss of ... William Nowers. Captain Nowers and his wife, Millie, have six children, ten grandchildren, ... Navy. Following his career as a naval aviator and carrier pilot, he spent ...
(Date:10/12/2017)... ... October 12, 2017 , ... The company has developed a ... and regulatory authorities worldwide. From Children’s to Adults 50+, every formula has been ... standard. , These products are also: Gluten Free, Non-GMO, Vegan, Soy Free, ...
(Date:10/12/2017)... ... 2017 , ... Information about the technology: , Otomagnetics has ... prevention of a major side effect of chemotherapy in children. Cisplatin and carboplatin ... cisplatin, hearing loss is FDA listed on-label as a dose limiting toxicity. Hearing ...
(Date:10/12/2017)... ... October 12, 2017 , ... On Saturday, October 21, ... relay – Miles by Moonlight to raise money for the American Heart Association Heart ... , Teams will work together to keep their treadmills moving for 5 hours. ...
(Date:10/12/2017)... ... October 12, 2017 , ... Vohra Chief Medical ... to physician colleagues, skilled nursing facility medical directors and other clinicians at various ... Wound Care." , "At many of these conferences we get to educate other ...
Breaking Medicine News(10 mins):