Montana Board Clears 1st Hearing-Loss Treatment, Bypassing FDA Oversight
Updated
Updated · POLITICO · Sep 15
Montana Board Clears 1st Hearing-Loss Treatment, Bypassing FDA Oversight
3 articles · Updated · POLITICO · Sep 15
Summary
Montana’s privately run review board approved its first treatment last month: a 30-day hearing-loss regimen pairing an FDA-approved antihistamine used off-label with 60 minutes a day of proprietary sound therapy.
The authorization stems from SB 535, a law that lets state-sanctioned boards clear experimental therapies after only phase 1 testing, allowing access far beyond federal right-to-try rules for terminally ill patients.
Patients still cannot receive the treatment because Montana has not yet licensed an experimental treatment center; two center applications are pending, and Infinita’s board currently charges companies a $12,500 application fee.
Biotech backers say the model could help small firms monetize treatments and fund trials, but critics including bioethicists warn the industry-written system lacks FDA oversight and invites conflicts of interest and unproven claims.
The broader test is whether the FDA intervenes: advocates have asked Washington not to punish companies using Montana’s pathway, while supporters are already pushing similar legislation in New Hampshire.
Are biotech startups risking severe FDA retaliation by using Montana's new private review boards to sell unapproved therapies?
Could a private board tied to a Honduran biotech hub safely replace the FDA for experimental medical treatments in Montana?
From Parley Neurotech’s LOOT to SB 535: How Montana Is Leading the U.S. in Experimental Therapy Access and Regulatory Disruption
Overview
Montana’s SB 535 law allows patients to access experimental therapies after only Phase 1 safety trials, bypassing traditional FDA approval. This means patients can try new treatments, like Parley Neurotech’s LOOT hearing therapy, before full proof of effectiveness. However, patients must sign away their right to sue if harmed and pay all costs themselves, as insurance will not cover these treatments or any complications. While this approach lets biotech companies fund further research through direct sales and gather real-world data, ethicists warn it exposes patients to unknown risks and potential exploitation, since safety and long-term effects remain uncertain.