Oct 16, 2014 - bring transparency to the Drug Enforcement Agency (DEA) scheduling process and get new treatments to pati
October 16, 2014
The Honorable Harry Reid Senate Majority Leader United States Senate Washington, DC 20510
The Honorable Mitch McConnell Senate Minority Leader United States Senate Washington, DC 20510
The Honorable John Boehner Speaker of the House United States House of Representatives Washington, DC 20515
The Honorable Nancy Pelosi House Minority Leader United States House of Representatives Washington, DC 20515
Dear Senators Reid and McConnell and Representatives Boehner and Pelosi: On behalf of the epilepsy community, we, the undersigned organizations, urge you to support the Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act (S. 2862) and the Improving Regulatory Transparency for New Medical Therapies Act (H.R. 4299). This legislation would bring transparency to the Drug Enforcement Agency (DEA) scheduling process and get new treatments to patients in a timely and transparent manner. Our organizations represent the more than 2.8 million Americans living with epilepsy and seizure disorders. Together we work to foster the wellbeing of children and adults affected by seizures through research programs, educational activities, advocacy and direct services. We have seen firsthand the devastation that uncontrolled seizures can bring, including developmental delays, medical complications and even death. This is why, as organizations that represent individuals living with severe forms of epilepsy and uncontrolled seizures, we are committed to advocating for legislation that will give access to new and promising treatments without unnecessary delays. Epilepsy is a neurological condition that produces seizures affecting a variety of mental and physical functions. Approximately 1 in 26 Americans will develop epilepsy at some point in their lifetime. There is no “one size fits all” treatment option and about one third of them live with uncontrolled or intractable seizures, and many more with disabling physical, cognitive and behavioral side-effects, despite available treatments. People with uncontrolled seizures live with the continual risk of serious injuries and loss of life. Some of these people may be helped by surgery or other non-drug treatments, but for many, no answers have been found yet. For the more than one million individuals living without seizure control and significant side-effects, new therapies bring hope for seizure control. People with epilepsy, their caregivers and parents should not have to wait an undetermined amount of time for the new hope of seizure control. Currently when a new therapy 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 DEA and labeled within the controlled substance schedule. FDA provides a recommended schedule to the DEA based on the extensive medical and scientific research performed on the medication during the approval process. The recommended schedule is designed to ensure patients with legitimate health needs have access to necessary medications, while making it hard for people who could abuse them to gain access to these medications. Upon receiving the FDA’s recommendation for scheduling, the DEA then undertakes its own unpredictable and often lengthy review. There is no formal deadline or requirement that a timeline for agency action be provided to patients or physicians.
Without apparent cause or justification, the time period between initial drug approval by FDA and final scheduling by DEA has been increasing over the years. Between 1997-1999 and 2009-2013, 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, an almost five-fold increase. DEA has always adopted the FDA recommended schedule, and must rely on the science provided by FDA when conducting its review. Patients cannot access these new FDA-approved therapies while they are under DEA review. In addition, the sponsoring company continues to lose time on their product's data exclusivity and patents, and we are concerned that uncertainly at the end of the drug approval process could lead to a decrease in innovation and investments in new epilepsy therapies. S. 2862 and H.R. 4299 would speed up the scheduling process and make it more transparent by requiring that DEA schedule a new therapy within 45 days of FDA approval. 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. Access to new therapies is particularly important for the more than one million people living with epilepsy who experience intractable or uncontrolled seizures or have significant adverse effects to medication, as well as those living with other poorly managed medical conditions. Bureaucratic processes should not stand in the way of patients gaining access to proven and potentially lifesaving treatment once they have been reviewed and approved by FDA. We urge you to support S. 2862 and H.R. 4299, which would improve the DEA scheduling process and help bring new therapies to vulnerable Americans who most sorely need them. Your actions will help bring new treatments to market in a timely and transparent manner. Please do not hesitate to contact Angela Ostrom at the Epilepsy Foundation at 301-918-3766 or
[email protected], with any questions or concerns. Sincerely, 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
