Improving Access to New Therapies
H.R. 639 Would Bring Transparency to DEA Scheduling Process so New Therapies Can Reach Patients Faster
On Monday, November 16 Congress unanimously passed the Improving Regulatory Transparency for New Medical Therapies Act (H.R. 639) which would improve the transparency and consistency of the Drug Enforcement Agency (DEA) review of new Food and Drug Administration (FDA) approved medications and bring these medications to patients faster. Access to new therapies is particularly important for the one third of people living with epilepsy who experience intractable or uncontrolled seizures, and the many more who experience significant adverse effects from their current medication.
“We applaud Congress for unanimously supporting this important piece of legislation that will help bring new medications to those who so desperately need them faster,” said Phil Gattone, president and CEO of the Epilepsy Foundation. “Each new medication brings hope to those living without adequate seizure control, and it is unacceptable to allow unnecessary delays to endanger the health and well-being of these individuals.”
Please take a moment to thank your members of Congress for supporting this important piece of legislation HERE.
Epilepsy Community Supports H.R. 639 and S. 481
The epilepsy community strongly supports legislation to improve the scheduling process at DEA so patients can gain access to new and promising treatments without unnecessary delays. Many of the groups that represent individuals living with rare and severe forms of epilepsy recently came together and sent a letter to Congressional leaders in support of H.R. 639 and S. 481. Read the letters at:
On January 27th, Nathan Fountain, MD, chair of the Epilepsy Foundation's Professional Advisory Board and Director of the F.E. Dreifuss Comprehensive Epilepsy Program at the University of Virginia School of Medicine, testified before the Energy & Commerce Subcommittee on Health in support of legislation that would speed up the scheduling process and make it more transparent by requiring that the Drug Enforcement Administration (DEA) schedule a new therapy within a set timeframe after approval by the Food and Drug Administration (FDA).
Last Congress, we supported two bills that 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 Improving Regulatory Transparency for New Medical Therapies Act (H.R. 4299) and the Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act (S. 2862). 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.
Read our position statement on the issue: End DEA Delays
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.