Montana Passes Bill Allowing Doctors To Prescribe Experimental Drugs Without FDA Approval

How are new drugs tested?

Normally, all new drugs and certain types of medical devices marketed in the USA must undergo FDA approval. The FDA must be satisfied that the product is safe, effective, and can be manufactured in accordance with federal quality standards.

The process can be long, but it’s only part of the sometimes decades-long procedure of developing and testing a new drug. Before clinical trials, there are reams of preclinical tests that need to be done, usually in lab experiments and then in animal models. Then clinical trials typically work in three phases, gradually ramping up the number of participants each time – assuming that your trial milestones are reached and no concerning adverse effects start to emerge.

And it doesn’t stop once a drug has been approved, either. Once a drug is on the market, monitoring of adverse effects continues to look for patterns that might have been missed in a clinical trial. Though the process has been honed over many years and is considered the gold standard of testing, there’s a big difference between a Phase 3 trial of a few thousand people and millions of members of the public being prescribed a drug by their doctor.

We saw this recently with the AstraZeneca COVID-19 vaccine. After the rollout of the jab had begun, a pattern began to emerge of a very rare side effect that had not been identified previously. In some people, the vaccine was causing unusual blood clots coupled with abnormally low platelet levels.

Importantly, the benefits associated with the vaccine continued to far outweigh the risk to those receiving it at the time – the case is evidence of the system working as intended. Once the, albeit rare, risk was known, informed decisions could be taken as to the suitability of the vaccine for an individual patient based on their past medical history.

SB 535 and the “Right to Try”

Under the new Montana bill, called SB 535, you’ll essentially be able to stop at Phase 1. According to the FDA, this trial stage usually only involves 20-100 people, and about 70 percent of new drugs pass this phase.

The state already had quite permissive “Right to Try” legislation, which was originally intended to allow access to treatments without final FDA approval for terminally ill patients. This was extended in 2023 to grant access to any patient, regardless of medical condition. The new bill opens things up even more, formalizing the process by which clinics can provide these experimental treatments.

As reported by MIT Technology Review, SB 535 was drafted and lobbied for by longevity enthusiasts – scientists and influencers who want to push the boundaries of the human lifespan.

Given some of the questionable activities partaken of by members of this group (penis rejuvenation therapy, anyone?) taking unapproved experimental drugs doesn’t sound all that wild.

Some have expressed significant concerns about the bill. Bioethicist Alison Bateman-House of New York University told MIT Technology review, simply, “I hate it.”

The reason why we go through multiple phases of clinical testing is to try to weed out dangerous off-target effects, as well as to establish that new drugs actually work better than existing treatments. By allowing doctors to prescribe drugs that have only gone through Phase 1, the concern is that many more people could be at risk from unforeseen harms, potentially for no gain.

Others claim the bill gives people more freedom over medical decisions and could have the added benefit of turning Montana into a medical tourism destination.

“One: let’s keep the money in the country, and two: if I was a millionaire getting an experimental gene therapy, I’d rather be in Montana than Honduras,” Dylan Livingston, founder and CEO of the Alliance for Longevity Initiatives, told MIT Technology Review.

“We obviously don’t want to be killing people,” Livingston added – but then demonstrated that even he was not inured to the potential safety risks by explaining that he was not keen to be first in line for experimental treatments himself.

There’s no getting around the fact that clinical testing works the way it does for a reason. Even with robust trials over several years, adverse effects can and do emerge after a drug has gone to market. According to a 2023 study, only 7.9 percent of clinical trials are successful – that means over 90 percent of candidate drugs are not found to be safe or effective enough to make the cut.

The new bill makes Montana a trailblazer among US states for this kind of legislation; no doubt people will be keeping a close eye on how things pan out.