On Wednesday, President Trump signed the Right to Try Act, a law that allows people with terminal illnesses to try out experimental medications not yet approved by the U.S. Food and Drug Administration (FDA).
The idea is that people who are in pain and have no treatments available to them might want, if properly informed, to take a risk and try out a medication that could potentially help. It's hard to disagree with that. As the law's authors see it, these patients are suffering because of the FDA’s drawn-out regulatory process, during which it, you know, scrutinizes medications to make sure that they are safe and effective.
Unfortunately, that logic doesn’t quite hold up. Especially since Senator Ron Johnson (R-WI), the man who penned the act, apparently did so explicitly to weaken the FDA’s regulatory powers, as Stat News reports. This is, needless to say, not exactly what he said as the law was being debated — he had insisted it was intended to help people in need.
The biggest critique of the new law is that it will allow desperate people to try medications that could be dangerous because their effects are so unknown (that can happen even in approved medications — New Scientist noted the example of birth defects caused by thalidomide).
But here's the thing: the law is inherently redundant. The FDA already had a process that would allow people to acquire untested, experimental medications if they had no other option.
Under the FDA’s existing “compassionate use” protocol, people with serious and life-threatening conditions could apply to take an experimental medication that could potentially help if they and their doctor found that no other treatments were available or effective.
So the Right to Try Act doesn’t mean people will suddenly receive treatments that could help. It just cuts the FDA out of the picture.
In practice, this could mean that patients would encounter fewer delays and hurdles before trying out a medication that the FDA might have granted them anyway. And there’s nothing inherently dangerous about giving hope to people who are out of options, as long as the unregulated drug doesn’t cause direct harm.
But without oversight, there’s no way of knowing whether or not these medications will be safe. And since this new law weakens the regulatory organization designed to protect people from dangerous treatments, it may result in more lax safety standards for future drugs under development. Which, if you're a person who likes to take a medication and trust that it won't make you sicker, is less than ideal.