U.S. Rep. Steve King (R-Iowa) praised the Food and Drug Administration for its decision to speed up treatment for a 25-year-old Iowa woman battling amyotrophic lateral sclerosis, or Lou Gehrig’s disease.
In a statement issued on May 24, King said that internal discussions with the FDA indicated that time-consuming “toxicity studies” will not need to be completed prior to the first administration of an experimental gene-therapy treatment for Jaci Hermstad.
“This is a significant development which shortens the timeline Hermstad faces for receiving a potentially life-saving treatment,” said the congressman.
Hermstad was diagnosed with a rare and aggressive form of ALS eight years to the day the same disease claimed the life of her twin sister. She and her family attempted to contact the FDA numerous times to let her use the antisense oligonucleotides but were unsuccessful.
In response, King filed House Resolution 2855, known as “Jaci’s Bill”, which will give the legislation’s namesake and similarly situated individuals access to the drug.
According to King, H.R. 2855 was key to convincing the FDA to expedite Hermstad’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.”
King is currently working with House Speaker Nancy Pelosi (D-California) 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,” the statement said.
