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.

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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 $46.1 Billion for the National Institutes of Health in Fiscal Year (FY) 2022;
  • Supports increased funding for the Food & Drug Administration;
  • Supports $5 Million for the National Neurological Conditions Surveillance System (NNCSS) in FY 2022, 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

In the final FY 2021 spending bill, Congress provided $42.934 billion for the NIH, as well as $1.250 billion in emergency funding for NIH for COVID-19-related efforts; a $42.45 million increase for the FDA, as well as $55 million for the FDA specifically for COVID-19-related efforts; a suggested increased investment in the VA Epilepsy Centers of Excellence; $5 million for the National Neurological Conditions Surveillance System; and $12 million for epilepsy-related research and $8 million for tuberous sclerosis-related research through the CDMRP.

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.

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Engagement & Resources

Reviewed By: 
Epilepsy Foundation Advocacy
on: 
Thursday, January 28, 2021