man and woman doing research in a laboratory

While there has been much progress in terms of understanding the epilepsies, significant gaps remain. Seizures in epilepsy may be related to a brain injury or family tendency, but the cause is unknown for about half of people living with the epilepsies. Despite available treatments, 30-40% of people with epilepsy still live with uncontrolled seizures. There are also differences in how epilepsy affects people of different races and ethnicities that are not fully understood. For instance, the number of people who develop epilepsy over a lifetime is higher in blacks than whites.

Position

The Epilepsy Foundation supports funding and policies that promote research and innovation into better understanding of the epilepsies and into developing new treatments and devices. The Epilepsy Foundation also supports including the patient voice and perspectives of people with the epilepsies in the drug development process and consideration of what represents value to patients, from the beginning of the process through post-market analysis. To promote research and innovation, the Foundation:

  • Supports $44.7 Billion for the National Institutes of Health in Fiscal Year (FY) 2021;
  • Supports an increase of $120 million in budget authority above the FY 20 appropriations level for the Food & Drug Administration in FY 2021;
  • Supports $5 Million for the National Neurological Conditions Surveillance System (NNCSS) in FY 2021, which the Centers for Disease Control and Prevention is building to provide better prevalence estimates and explain how prevalence and mortality vary by demographic characteristics such as age, sex, race and ethnicity;
  • Supports increased funding for the Congressionally Directed Medical Research Programs (CDMRP) at the Department of Defense which funds high impact, high risk research projects including post-traumatic epilepsy (PTE) resulting from traumatic brain injury (TBI) and the tuberous sclerosis complex (TSC);
  • Supports funding for the Patient-Centered Outcomes Research Institute (PCORI) which funds comparative effectiveness research that helps patients, caregivers and the broader healthcare community make informed decisions to achieve their desired health outcomes;
  • Supports breaking down barriers to facilitate research into the potential therapeutic benefits and risks of cannabis;
  • Opposes use of Quality Adjusted Life Years (QALY) in measuring health care and treatments’ value, as the model undervalues people with disabilities;
  • Supports bringing patients’ voices into the FDA’s review of drugs and devices including through the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Amendments (MDUFA).

Status

For the issues that are managed through the federal appropriations process (NIH, FDA, NNCSS, CDMRP and PCORI), the House of Representatives has passed several of its FY 2021 spending bills, but the Senate has not. Because both chambers are not expected to pass all spending bills by the deadline of October 1, 2020, Congress passed a Continuing Resolution (CR) which averts a government shutdown and keeps federal government departments, agencies and programs operating through December 11.

Related to QALY, the Foundation has successfully included language barring the use of QALYs in major legislative packages regarding prescription drugs and drug pricing. The Foundation has also engaged at the state level to encourage states to bar the use of QALYs and rely on other measures of value.

Public meetings and discussions have started on the next reauthorization of PDUFA, but the work does not need to be completed and passed by Congress until September 30, 2022.

Engagement & Resources

on: 
Wednesday, December 28, 2016