March-In Deadline Looms

Janson Silvers  0:03  
Welcome to Healthcare Policy Pop, I'm Janson Silvers. It's Thursday, February 1, 2024, and we're excited to be back.

Today's pop topics, the deadline to submit comments on the proposed march-in rights framework is fast approaching, and experts are sounding the alarm. Late last year in an effort to deliver on promises to reduce drug prices, the Biden administration announced a proposed framework that would allow march-in rights to be used when a company's drug price is deemed unreasonable. But keep in mind, there is no definition of what unreasonable actually is. Joe Allen is the executive director of the Bayh-Dole Coalition. For context, the Bayh-Dole act is what actually created march-in rights. Allen says this was never how the bill was intended to be used. 

Joseph Allen  0:50  
There have been a number of petitions filed in the last 20 years for price control. Everyone has been dismissed because people looked at it including the Biden administration saying that's not how the law works. And then on December 7th, all of a sudden, the Biden administration came out with a proposal that says "no, that is how the law works." Now you can do price control. So that's what the current issue is all about. 

Janson Silvers  1:11  
Allen worries about the future of creating medicines altogether, because it's already hard enough to develop drugs. Now, this framework says if the government doesn't like your price, they could take your product from you. So why would anyone invest? 

Joseph Allen  1:25  
A venture capital person just told me federal funding now is toxic, I'm staying away from. As a manager of other people's money, I cannot in good conscience, invest money in a startup company, knowing that could be taken away from me. And no one can even tell me what the rules are. No one can tell you what a reasonable price is. That's completely arbitrary. Allen says, even this being proposed is going to have major consequences. After we passed Bayh-Dole it took years for companies to have confidence that government could be a reliable partner. Now all that's in jeopardy, because now these people can just change the rules whenever they want to. And if one things that companies don't want, particularly small companies is, tell me what the rules are. Let me understand the rules. Well now somebody can pull the rug out from under them, and then no one can tell you what the rules are. 

Janson Silvers  2:13  
While Allen says this proposal isn't a good thing. At this point, it's still a proposal. So the battle isn't lost quite yet. 

Joseph Allen  2:21  
Show I'm really hopeful that the more that people learn about this, the more the public learns about it, it'll be pulled back because, again, the shame is it can't do what it says it's gonna do. But it has incredibly unintended consequences, which really are fundamentally harming the American innovation system. This is not a small thing. This is not some obscure patent bill. You know, it's not some little deal. This impacts the whole ability of the public sector and the private sector to work together. 

Janson Silvers  2:50  
The deadline to submit public comments is February 6.

Patients Rising was one of the first organizations to publicly come out against this proposal. The very day this framework was announced Patients Rising released a statement in part saying quote "make no mistake, patents have nothing to do with drug pricing. The half hearted proposal is an attack on business, a slippery slope for other industries and erodes future treatment development that directly hurts sick Americans they are trying to help." Patients Rising will be submitting comments on the issue and will continue to track this as it moves forward. More information about how to submit public comments is in the shownotes. That's all for today. We're back on Tuesday for another Healthcare Policy Pop, a resource of Patients Rising Now. I'm Janson Silvers, have a great day.