FDA approval process

They haven’t developed a drug for this yet? What does it mean to get a drug “approved”? Will my insurance cover it if it’s not FDA approved? 

I hear these questions all the time! They’re  challenging to explain and a perfect opportunity for a blog post! 

When a company or a manufacturer thinks that they may have come up with a recipe for a medication, they have to test it on animals to make sure that it’s safe. Then, based on animal results, they need to let the FDA know, “hey, we think this would work well for people!”, and they submit an application called Investigational New Drug. This will allow them to enter the clinical stage of the testing, which has 3 phases in it. 

Phase one typically consists of making sure that the drug is as safe for humans as it was for animals. This will also help the manufacturer to know what kind of side effects they’re dealing with. So, now we know that the drug is safe for humans and animals, but does it work for what it’s supposed it? 

That is determined in phase two. Say that it works for many people, because remember, it won’t work for every single person out there. But let’s imagine that the studies have shown that it works for a decent number of people. That’s when the manufacturer and the FDA get together and discuss doing phase three, which encompasses large numbers of people that the drug is being studied on to determine different dosages and to have more data to work it. 

Let’s say now the manufacturer completed phase three clinical trial with good results. Great! Let’s put the drug on the market! 

Ha! Not so fast. There’s a lot more to do...

The manufacturer needs to submit a New Drug Application for review. A label needs to be developed. And not only the label that you see on your medication bottle but also what you get in the paper bag from the pharmacy; explaining what the drug is made of, how it works and what the side effects could be. Then, the FDA has two months to decide if this is worth creating a team to look into all this. Let’s say they think, "sure, let’s consider this application". In that case, the team reviews aaalllll the data gathered. That team and the manufacturer's team meet to discuss the application and to approve our new medication! 

Yes! We’re all done! 

But are we really? Is it possible to know everything about a medication based on studying it on couple thousand people? Of course not. This is why, even when the drug is already approved, the manufacturer needs to keep the FDA up to date with the latest safety information. 

As you can see, this all takes a very long time and a lot of money, too! ( If you want to know how much it costs, you can read an article HERE). So even if something may work great and a lot of people swear by it, it doesn’t mean that it’ll be FDA approved. Many insurance companies won’t cover a treatment choice that’s not FDA approved, especially if it’s expensive. So no, Bob’s Health Insurance Company will probably not pay for your essential oil use for headaches, even if you swear by it because they have to draw a line somewhere. 

If you’re more of a visual learner, there is a wonderful graph depicting FDA drug approval process HERE.