A small biotech company called Brainstorm Cell Therapeutics Inc. is among the first companies considering selling an experimental therapy directly to patients under the “right to try” measure, signed into law late last month. And if the company moves forward, it may give its unproven therapy a price tag in the ballpark of $300,000, according to a recent report by Bloomberg,
The experimental stem cell-based therapy, called NurOwn, is aimed at treating amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease). But despite the potentially hefty price tag that patients would likely pay out of pocket, there’s no evidence that the therapy stops the progression of the disease or improves symptoms. So far, NurOwn has only passed early clinical trials showing safety, not efficacy. But under the new “right-to-try” law, the biotech company doesn’t need such proof to sell its therapy.
The law was pitched as a compassionate measure to allow patients with life-threatening illnesses easier access to experimental drugs. But the bill was controversial, with critics noting that the Food and Drug Administration already had a swift and lenient pathway for such patients to obtain experimental drugs. Critics also worried that the law would simply weaken the FDA and open vulnerable patients to unscrupulous companies that might try to peddle unproven—and potentially sham—therapies as profit-driven endeavors.