House To Vote On Senate-Approved 'Right To Try' Drug Bill

Mar 13, 2018
Originally published on March 13, 2018 11:24 am
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Those of us who have seen a loved one confront a terminal diagnosis know the desperation that can come near the end. And if there is something out there, anything that could give you a shot, you want to try it no matter the risk, no matter if it's experimental and not approved by the FDA. Today, the House votes on what is known as the right-to-try law, which, if passed, would let very sick people bypass the FDA altogether to use experimental treatments.

The Senate has already approved its own version unanimously. But there's a lot of controversy surrounding this bill. The American Cancer Society and many other medical organizations oppose it. They warn that the bill would allow patients access to unproven and possibly dangerous drugs. Joining me now - Congressman Brian Fitzpatrick. He's a Republican from Pennsylvania and a co-sponsor of the Right to Try Act.

Thanks so much for being with us this morning, Congressman.

BRIAN FITZPATRICK: Good morning, Rachel.

MARTIN: The FDA already has this sort of fast-track system for people with terminal diagnosis, just very sick people even, who want to try experimental drugs. Patients can get FDA approval in a matter of days, even hours, and 99 percent of applications are approved. So having said that, why do you believe we need this bill?

FITZPATRICK: Well, Rachel, those numbers are in dispute. And those of us that have been advocating for it on the Hill - and there's a number of us in a bipartisan matter. And I would also like to mention that right-to-try is the law in 39 states in this nation. And in those state legislative chambers, they passed in state legislative chambers with near-unanimous support for the simple fact that there are - we've all encountered patients in our districts that are not getting access to this treatment, and they're being rejected because they're being told that some of these drugs are not safe. And these are people with terminal illnesses, so that argument doesn't make a whole lot of sense to them.

MARTIN: So you're saying what's the risk for people who are already going to die, quite frankly? If this is the - their last option, you want to give it to them. But if they're using what could be a really dangerous drug, couldn't it bring about their passing earlier, in some cases, or just make their last days more unbearable? There are risks.

FITZPATRICK: Well, that - that's a criticism that's been rebunked (ph), Rachel. The Right to Try Act that has been - I mean, this is a nationwide movement. And it would ensure that terminally ill patients, together with their physicians and their pharmaceutical manufacturers, can administer these treatments where no alternative exists. And this would prevent the government from blocking access to potentially life-saving medications. And, you know, these patients, Rachel, and their family members, I mean, it's very important to them that they be the ones to make these decisions.

With the House version, we have patient protection provisions, we have physician protection provisions. All stakeholders have been heard out. There was originally some resistance from some groups, but a lot of these stakeholders have been brought to the table and are signing off on this. So this was not something that is being rushed to the floor, quite to the contrary. I mean, the reason that it's taken the amount of time it has is because we wanted to consider all stakeholders....

MARTIN: Although, the...

FITZPATRICK: ...And their concerns and...

MARTIN: Yeah, although the American Cancer Society still has a problem with this. And there are concerns that the negative consequences of these drugs won't be traced by the FDA. So if someone takes one of these experimental things that hasn't gone through the vetting system, and it turns out being really bad for them, that data won't find its way to the FDA. So the FDA will be hamstrung when it's making this decision about whether or not to release this medicine to the general public. It won't have all the data.

FITZPATRICK: Yeah, Rachel, that's actually been addressed in this new bill. So I think some of those criticisms may have been directed at prior ideas in prior versions. But in this current version, this obligates sponsors and manufacturers to report adverse events in real time through notification to the FDA, both within the existing expanded access program and through the new, alternative pathway.

MARTIN: Congressman Brian Fitzpatrick of Pennsylvania. He is the cosponsor of the right-to-try bill, which goes today before the House for a vote. Thank you so much for your time this morning. We appreciate it.

FITZPATRICK: Thanks, Rachel. Transcript provided by NPR, Copyright NPR.