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Thank you for providing a training for Mitchell/Thames Academy. Each time I see one of your presentations I learn something new, a sign of an excellent... Stacey A. Torpey LPC, NCC Mitchell College
Epilepsy Foundation Provides Recommendations to FDA on Treatment for Infantile Spasms05/10/2010
Epilepsy Foundation President and CEO Eric Hargis recently delivered remarks to an FDA advisory committee about ACTHAR Gel, a treatment for infantile spasms, a rare but devastating pediatric epilepsy. Infantile spasms sometimes occur hundreds of times a day and can lead to long-term developmental delay and intellectual disability. ACTHAR gel is approved for treatment of infantile spasms by the American Academy of Neurology and has been in use by pediatric neurologists for years, however because ACTHAR is difficult to manufacture and not FDA approved for this indication, there is a long history of continuity-of-supply problems.
The Epilepsy Foundation has worked with the FDA to continue to make the product available, even while manufacturers of ACTHAR changed. Unfortunately, problems of access have resurfaced periodically and, in each case, the Epilepsy Foundation and experts have had to work with the shortages branch of the FDA to ensure continued availability. Hargis said the Foundation hopes that the FDA will approve ACTHAR for infantile spasms, which would help resolve chronic supply issues. FDA approval could also alleviate difficulties in insurance coverage and cost of coverage for a product that is necessary but off-label for use in infantile spasms.
Hargis pointed out that there are a number of existing medications for infantile spasms and the Epilepsy Foundation does not endorse any specific treatment option, however, he said, other treatment options do not preclude the need for ACTHAR. He emphasized that FDA approval of ACTHAR will be beneficial for families dealing with this devastating condition.
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