This man has never met the FDA. The acronym "FDA" is not mentioned in the body of the article anywhere. My daughter is taking $4200 peanut flour. The little packets I poison her with every day describe "Palforzia" as "characterized peanut protein" right on the package. Literally getting peanut flour through the FDA is going to cost an estimated $4200 per patient per year. That peanut flour largely costs $4200 per patient per year because Aimmune has 20 years to recoup their expenses. Remember - this is a nonprofit that had to become a publicly traded company in order to get peanut flour through the FDA. Simple math dictates that if that window were to collapse to ten years, my daughter's peanut flour would cost $8400 a year. "Because they will somehow bypass the FDA..." My father-in-law did blood chemistry. He had meters that you could buy at Walmart. They were approved for use in healthcare facilities which meant they had to be sterilizable. Which meant they had to develop a protocol for wet wipes and UV sterilization such that their meter would not be a MRSA vector. If they wanted to buy plastic for the housings from a different vendor, they had to reapprove the device. Because the plastic was now no longer the FDA-approved plastic. If you were diligent and dotted your I's and crossed your T's, you could perhaps get a certificate from your new vendor demonstrating that they had been through an FDA clearance process substantially similar to your own in which case it was a twelve month wait rather than 36. Literally talkin' ABS here. Same stuff your car fender is made out of. The key question is why this guy thinks his investors have never heard of the FDA.Using current methods of inventing drugs, Borisy believes it will be possible to create new medicines that mimic the effects of existing big sellers, and bring them to market in a matter of years.
Then EQRx will sell them to insurers and large hospital systems at a discount, displacing the innovators.
Because its medicines will be cheaper to develop, EQRx will be able to make a handy profit despite these lower prices.
The key question is whether health insurers and giant hospital systems have gotten desperate enough to want to shake up the system.
It’s not possible given his experience that he’s naive about the FDA. His investors certainly are not. I’ve met with Arboretum. They likely know most of the relevant folk at the FDA. I’d say the opposite is more likely. He might know the FDA very well. This is likely a chemistry/ip/regulatory arbitrage play. You make a drug that is like another, show it is very much like the other to lower approval barriers, get it on the market at a cut rate, then undercut everyone.Other big venture firms, including GV, a16z, Casdin Capital, Section 32, Nextech, and Arboretum Ventures, have also signed on.
. . . That's why we're having tons of problems with failing medical devices like bad artificial hips and meshes and such. It's a total mess and has caused so many people undue stress, pain, and medical complications. I can only imagine that a similar approach to medicine would have similar results. Here's a scary yet entertaining twenty minutes.You make a drug that is like another, show it is very much like the other to lower approval barriers, get it on the market at a cut rate, then undercut everyone.
There is no regulatory arbitrage. You make a drug that is like another, show it is very much like the other and you still get to go through the full approval process. I have a friend whose very-much-like-the-other cancer treatment drug failed efficacy. Burned ten years of her life. Let's say you've got a honey at the FDA. Let's say that you've fellated all the right people and things are going to sail through. You think Merck isn't going to injunctify your ass until the end of time to keep you from undercutting them? This is an Uber play whereby the argument is that regulations will allow them to skate until the laws catch up... but since it's the FDA, the laws are already there. Not buyin' a word of this.