Right to try bankruptcy?

The first case concerning the recent Right to Try legislation has come along and it involves Matt Bellina, one of the patients who pushed to pass the legislation in the first place. Before diving in this writer just wants to say—damn this guy is really a fighter. He’s not only a veteran battling ALS, but he also got legislation passed in freaking Congress, which isn’t easy. His case involves a cell therapy being developed by BrainStorm Cell Therapeutics, a biotech with no currently marketable treatments. It’s planning on addressing Right to Try applicants in a semicommercial model that they say won’t exploit patients. But since the company is pre-revenue there’s some big ethics concerns about how to charge vulnerable patients for the expensive treatments, which the law may not address.

Now we’re not going to begrudge anyone at the end of their rope looking for anything that can help, but we do have some strong opinions on the subject. Listen to our recent discussion on Right to Try here in our second InsightCity podcast.

Right to try, is it alright?

The FDA’s Compassionate Use program helps patients that seek access to medications still in the development pipeline. But legislation signed into law this week allows patients to completely bypass the regulatory agency should they so choose. The “Right to Try” bill gives patients access to investigational drugs with the permission of just their physician and the drug manufacturer. It also shields those drug companies from the legal risks involved. Critics, including the American Cancer Society, say the bill gives false hope to patients, and champion the current process of compassionate use and clinical trials. After all, the FDA approves 99% of compassionate use applications, and can even do approvals over the phone. When asked for comment, some formerly prominent musicians said “You gotta fight for your right… to paaaaaaaaarty.”

The right-to-try again

Last week proposed legislation dubbed the “right-to-try” bill failed to pass the US House of Representatives, despite a lopsided 259-140 vote in favor of the law. Republicans who submitted the bill used a process that required a two-thirds majority to pass and the numbers fell just short of that. The new submission will require on a simple majority to pass—and it will. Here’s Austin Powers in a nutshell. More importantly, here’s the law in a nutshell… critically ill patients can gain access to experimental drugs if their physician and the drug company agree to it. The FDA would no longer need to sign off. Supporters say the law removes red tape. Critics say the FDA already approves 99% of requests and, according to Scott Gottlieb, FDA Commish, requests are usually approved immediately or within a few days anyway. So, where’s the beef?