24 Epilepsy Groups Urge Congress to Maintain Orphan Drug Tax Credit

Epilepsy News From: Tuesday, December 07, 2021

Organizations Come Together to Advocate for Removal of Provision in Build Back Better

Bowie, Md., December 7, 2021 — The Epilepsy Foundation led an effort supported by 23 organizations representing people and families living with, and affected by, the epilepsies urging Congress to maintain the Orphan Drug Tax Credit (ODTC). The letter—sent to Capitol Hill on November 22—asks Congress to remove a provision included in the House version of the Build Back Better legislation that would undermine the ODTC incentive by limiting its availability to only the first approved rare indication of a drug.

Epilepsy is a medical condition that produces seizures, which affect a variety of mental and physical functions, and often includes serious comorbidities like anxiety, depression, cognitive or behavioral issues, or sleep disorders. In the past two decades, the understanding of epilepsy has evolved and is now viewed as a spectrum of diseases with different underlying causes and varied experiences. Advances in genetics and mechanistic understanding have accelerated the discovery of many epilepsy-causing gene variants and complex chromosomal anomalies. As a result, there are an increasing number of rare epilepsy diagnoses.

Since Congress passed the Orphan Drug Act in 1983, there has been a significant development of rare disease drugs. According to the FDA, today, there are 652 treatments approved for 1,006 rare disease conditions. While there has been progress and treatment approvals for a few of the rare, severe epilepsies, such as Dravet Syndrome and Lennox-Gastaut Syndrome, there is much more work to be done. There are still no standardized clinical guidelines for many rare epilepsy syndromes and no curative treatments other than surgery in a very few diagnoses. There are also limited treatments to reduce seizure frequency or improve developmental outcomes and quality of life, and no centralized method for identifying individuals with rare epilepsies to improve surveillance, understanding of population, or to conduct comparative effectiveness research. There must be continued encouragement through incentives, like the ODTC, for the development of new orphan indicated drugs.

We urge Congress to maintain the ODTC as it stands today so that people with rare epilepsy and their families can maintain hope that new orphan uses of drugs will continue to be pursued, approved and made available to them.

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Undersigned Organizations

  1. BDSRA (Batten Disease Support and Research Association)
  2. BPAN Warriors
  3. CACNA1A Foundation
  4. CURE Epilepsy
  5. DEE-P Connections
  6. Dup15q Alliance
  7. Epilepsy Alliance America
  8. Epilepsy Foundation
  9. FamilieSCN2A Foundation
  10. Glut1 Deficiency Foundation
  11. GRIN2B Foundation
  12. Hope for HIE
  13. International Foundation for CDKL5 Research
  14. International SCN8A Alliance
  15. Koolen-de Vries Syndrome Foundation
  16. NORSE Institute
  17. NR2F1 Foundation
  18. Phelan-McDermid Syndrome Foundation
  19. Project 8p Foundation
  20. Rare Epilepsy Network (REN)
  21. Ring14 USA
  22. SYNGAP1 Foundation
  23. Tbc1d24 Foundation
  24. TSC Alliance

Reviewed Date

Tuesday, December 07, 2021

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