For people living with epilepsy – and especially those whose seizures are not well controlled by existing treatments – each new medicine approved as safe and effective by the U.S. Food and Drug Administration is a source of hope and opportunity for a healthier life.
Yet, FDA approval often is not the last step in delivering new treatments to patients. In fact, patients can wait up to a year or more for new medicines thanks to the lengthy and growing delays in the regulatory review process at the Drug Enforcement Administration (DEA).
The existing delays are the result of a flaw in the Controlled Substances Act, which requires new FDA-approved medicines with the potential for abuse to undergo a controlled substance “scheduling” by the DEA before they can be marketed. The FDA provides, based on its medical and scientific expertise, a recommended schedule to the DEA. This schedule is designed to ensure patients with legitimate medical needs have access to medicines while keeping them from people who could abuse them. The Epilepsy Foundation understands and applauds the public health needs, but this process is flawed and these delays are harming patients with critical needs.
Under the law, however, the DEA is under no time limit to act – and that is a growing problem for patients. Between 1997-1999 and 2009-2013, the time between FDA approval of a medicine and DEA’s final scheduling increased from an average of 49 days to an average of 238 days, an almost five-fold increase.
The DEA has never deviated from FDA’s schedule recommendation, making a 12-month wait unfair and unexplainable to those suffering with conditions like epilepsy. While the FDA human drug review process is largely transparent with predictable timelines, the DEA’s process is not. Unfortunately, as DEA’s unpredictable and often lengthy review occurs, patients are denied access to important medicines that can improve, and in some cases save, their lives. The DEA process undermines the public’s faith in the government process.
A new 45-day requirement included in Pitts and Pallone’s bipartisan H.R. 4299 will bring certainty, clarity and a commitment to patients who are in need of new treatment options. 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 existing medicines.
This last point is especially important. Patients who continue to experience seizures face many dangers including developmental delays, brain damage, injury, or death.
For patients, the drug-development process seemingly moves at a glacial pace. When new medicines are developed, it is vital to their health and well-being that they be made available as efficiently – and, yes, safely – as possible. Time is critical.
I know that feeling of hope and anxiety as a parent who waited and watch for new options for my son. As president and CEO of the Epilepsy Foundation, I have the honor of championing that message and applaud champions like Pitts and Pallone for introducing this needed legislation. Families and patients who are in need of new treatment options deserve a regulatory process that provides certainty and clarity on when new, innovative medicines will be available.
We at the Epilepsy Foundation agree 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 simply 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.
Gattone is president and CEO of the Epilepsy Foundation.