The Epilepsy Foundation supported the reauthorization of the Food and Drug Administration’s (FDA) user fee programs. These programs were reauthorized in August 2017 when the president signed the FDA Reauthorization Act of 2017 (H.R. 2430) into law. The law ensures that the FDA can sustain its important work and continue to develop and refine its processes to get more valuable therapies to the market in a timely manner.
The Epilepsy Foundation is committed to accelerating the development and approval of new therapies, especially to benefit those in our community with difficult to control seizures and those who experience significant side effects from existing therapies. We support a strong FDA that is responsive to the needs of the patient community and the innovations of scientific research and health care delivery.
The ability of the FDA to properly evaluate and approve therapies so they can enter the market in a timely manner is critically important to the Epilepsy Foundation because of our interest in and need for medical innovation. While many significant advances have been made in epilepsy over the past several years, including the development of innovative medications, medical devices, and surgical options, unfortunately, the number of people with epilepsy who are still experiencing seizures, despite being treated for the condition, has not changed. Currently, no cure exists for epilepsy and one third of people with epilepsy live with uncontrollable or intractable seizures. Uncontrolled seizures can lead to disability, injury, and even death. Innovation is of particular importance to the people with epilepsy for whom available treatments do not work, as well as all Americans living with complex chronic and rare conditions that are not appropriately managed with current treatment options.
These user fee agreements were the result of many years of discussion with all relevant stakeholders, including the FDA, industry, and the patient community. The policies and goals included in the agreements reflect what these stakeholders value and will help ensure advancements and improvements within the FDA and ultimately health care more broadly.
The Epilepsy Foundation applauds Congress and the Administration for enactment of the FDA Reauthorization Act, and we will encourage the FDA to implement the agreements as intended.