Gabe Yanez
Friday. Super Bowl weekend is here, and with it comes another day full of snacks, beverages, and other temptations to throw you off your game. Just remember – regardless of how many chips or football-shaped cookies you eat on Sunday, one day of overindulging won’t make or break your health. Just make sure to stay on track tomorrow (Saturday) and get back on track by Monday, and you’ll be alright. Enjoy the big game! Go sports!
And now, for today’s topic – what is “accelerated approval,” and should that really be a thing? Let’s dive in.
“Move Fast and Break Things”
Facebook founder Mark Zuckerberg’s now-famous motto, “move fast and break things,” makes a lot of sense when you apply it to the fast-moving tech space. In a world where if you aren’t first, you’re last. Entrepreneurs across all sorts of industries now live by those words. But does the motto work when it comes to healthcare?
Probably not. I would prefer if drug companies didn’t just “move fast and break things,” especially when the things they might break could have real consequences on people’s health. It takes an average of ten years to get a new drug to market. This might seem like a long time, but it makes sense if you think about it. Between the required research, development, and both short-term and long-term safety studies, a decade for a drug to hit the market makes sense.
However, the U.S. Food and Drug Administration (FDA) does have an accelerated approval pathway. Created in 1992, the accelerated approval program came at the height of the AIDS epidemic. The goal was to get treatments approved faster for the deadly disease caused by HIV. According to the FDA, the pathway is intended only “to allow for the earlier approval of drugs that treat serious conditions and fill an unmet medical need.”
The major difference from the standard approval process is that the drugmaker isn’t required to prove that the drug is clinically beneficial through the accelerated pathway. Instead, they only have to prove that the drug is LIKELY to be beneficial.
Likely? What does that even mean? I am no expert, but proving that something is only likely to be beneficial leaves a lot of grey areas and loopholes for drug manufacturers to wiggle their way through.
In the early days of the accelerated approval process, only a few drugs were approved each year using the pathway. However, in 2021 Congress codified the process into law, leading to a boom in the number of drugs approved through this accelerated program. In 2021, 28% of FDA-approved drugs went through the expedited process.
All of a sudden, Big Pharma is also embracing “move fast and break things.” And trust me, they are breaking things. By the end of 2021, a total of 32 accelerated approval drugs had been withdrawn by the FDA, meaning they would never have been approved via the standard process in the first place.
The key takeaway? If you give drug manufacturers grey areas to navigate and loopholes to find, they will take advantage of it. Are there some cases where accelerated approval makes sense? Of course! But should the number of drugs going through this process continue to climb year after year? Probably not.
