Trump often invokes the Right to Try Act. Who wouldn't want to let people who are dying and desperate try something that might help? But the appealing name belies the law's critical shortcomings.
We already had the Expanded Access Program (thank you ACT UP) and we don’t want a repeat of thalidomide babies like we had before there were strong protections on how drugs get tested.
So now we have Expanded Access (EAP) with FDA oversite and Right to Try (RTT) without that oversight. Having both is confusing for everyone and most people don’t know which covers what. From Journal of Law and the Biosciences (they only sampled 17 neuro-oncologists from 15 different academic medical centers):
Many physicians described having difficulty in distinguishing between RTT and EAP or demonstrated misconceptions in their responses. A physician with knowledge of both pathways spoke about his colleagues generally: ‘I don’t think a lot of people understand the difference between expanded access and Right-To-Try’ [Participant 1]. The confusion resulted in conflation with the different features between EAP and RTT including structure, intent, and processes of these pathways. In response to our question ‘Have you provided a drug through Right-to-Try?’ one clinician erroneously replied, ‘I think most compassionate use is under that category’ [Participant 2]. Another drew a rough equivalence between the two despite the absence of FDA oversight for RTT: ‘I guess the way I try to think about Right-to-Try is like compassionate use.
I’m unfamiliar with the details of these programs. I thought the point of right to try was if you were going to die anyway, being allowed to try an experimental treatment as long as you had exhausted all other options where as the existing program (assuming EAP) still prevented people accessing some experimental treatments?
Essentially what it comes down to is that the manufacturers don’t have to give you the experimental treatments. You can request them, but there’s nothing forcing them to comply with your request.
We already had the Expanded Access Program (thank you ACT UP) and we don’t want a repeat of thalidomide babies like we had before there were strong protections on how drugs get tested.
So now we have Expanded Access (EAP) with FDA oversite and Right to Try (RTT) without that oversight. Having both is confusing for everyone and most people don’t know which covers what. From Journal of Law and the Biosciences (they only sampled 17 neuro-oncologists from 15 different academic medical centers):
I’m unfamiliar with the details of these programs. I thought the point of right to try was if you were going to die anyway, being allowed to try an experimental treatment as long as you had exhausted all other options where as the existing program (assuming EAP) still prevented people accessing some experimental treatments?
Essentially what it comes down to is that the manufacturers don’t have to give you the experimental treatments. You can request them, but there’s nothing forcing them to comply with your request.
And with right to try now there is?
Nope! He essentially just changed the name to something more wholesome sounding. It’s apparently been a thing for decades.
How very trump of him