King Welcomes FDA’s Decision to Expedite Jaci Hermstad’s Treatment
“‘Jaci’s Bill’ encouraged the FDA to find unprecedented solutions that have expedited Jaci Hermstad’s treatment.”
Washington, D.C.- Congressman Steve King releases this statement following internal discussions with the Food and Drug Administration that indicate time-consuming “toxicity studies” will not need to be completed prior to the first administration of an experimental gene-therapy treatment for ALS to Jaci Hermstad of Spencer, Iowa. This is a significant development which shortens the timeline Hermstad faces for receiving a potentially life-saving treatment. King introduced “Jaci’s Bill” (HR 2855) to address the “toxicity studies” barrier to Hermstad’s treatment, and the legislation has played a significant role in persuading the FDA to take this unprecedented action to accelerate Jaci’s treatment timeline.
“Jaci Hermstad is fighting for her life, time is of the essence, and I introduced ‘Jaci’s Bill’ to help get her the experimental gene-therapy treatment she needs before her condition deteriorates further,” said King. “Introducing HR 2855 worked to accelerate her treatment schedule. ‘Jaci’s Bill’ encouraged the FDA to find unprecedented solutions that have expedited Jaci Hermstad’s treatment. Jaci will now be able to receive her first dose of medicine prior to the completion of a toxicity study, and this means she will be receiving the treatment at the earliest possible opportunity when it will do her the most good. This is a wonderful result for Jaci and her family. I couldn’t have asked for better cooperation from, or be more grateful to, both Speaker Pelosi and the FDA for working with me to help Jaci.”
The Hermstad family is no stranger to the ravages of ALS. Jaci’s identical twin sister, Alex, previously succumbed to the same mutation of the same disease. While there is currently no treatment or cure for the disease attacking Jaci Hermstad, there is an experimental treatment called “ASO” (antisense oligonucleotides) that researchers believe may save her life if she is able to receive it in time.
King worked closely with House Speaker Nancy Pelosi during consideration of this legislation. The two had multiple productive discussions concerning moving this legislation quickly through the House’s “unanimous consent” process, and Speaker Pelosi contacted the Food and Drug Administration to discuss both the details of Jaci Hermstad’s case and King’s legislation with the agency.
King’s “Jaci’s Bill” legislation is available for review at this link.