Even if the FDA were to provide some kind of assurance, it wouldn’t necessarily protect biotech companies in the long term, cautions Chris Robertson, a specialist in health law at Boston University. The FDA’s position could change with a new presidential administration, he says: “I wouldn’t bet on anything that the FDA is saying today being applicable when the rubber hits the road later.”
Companies that want to stay on good terms with the FDA would be safest taking the expanded-access route, says Robertson. That’s the pathway the FDA already uses for people who are seriously or terminally ill, have run out of options, and want to try experimental drugs that have not yet been through clinical trials. The FDA approves over 99% of these applications, says Harvard’s Kesselheim.
“The FDA isn’t a bottleneck but in fact exists to help ensure that expanded-access programs are aboveboard and that patients who receive [the drugs] are able to contribute knowledge about [them],” says Kesselheim. He says he doesn’t think that any “legitimate manufacturer” should fear having to go through the FDA’s expanded-access process, which the agency says takes “less than 45 minutes” to fill out.
The cost of experimenting
There are some key differences between expanded access, which allows seriously ill people to apply for access to experimental drugs that might not have been through any human trials, and Montana’s approach. In theory, a person doesn’t need to be seriously ill to access experimental drugs in Montana.
“In Montana, patients may be eligible for preventive or earlier-stage interventions if they provide informed consent and meet the program’s requirements, so the breadth of potential therapies and situations is much broader,” says Kaeberlein, the Montana ETRB member, who is an affiliate professor at the University of Washington in Seattle.
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