The FDA Approval Process: What You Need to Know
WEST LAFAYETTE, Ind. — You may have heard about the FDA approval process, or maybe you’ve heard the term “emergency use authorization.” But for some people, those terms can be a mouthful and hard to understand.
That’s where Aaron Lottes comes in. Lottes is an Associate Professor of Engineering Practice at Purdue University. He’s been through the process of FDA approval before when he submitted a medical device that needed to be placed in a person’s body for the rest of their life.
That’s a high-risk level product. That doesn’t mean it’s a high risk to you; it means that the product is trying to protect you from something that is a high risk to your life.
And that’s what the FDA approval process revolves around.
“It [the FDA process] really revolves around the risk, what’s the benefit and what’s the risk to patients,” Lottes tells WIBC, “So if it’s a lower risk product, that may require a lower amount of data and if it’s a higher risk product, certainly that would require a large amount of safety and effectiveness data.”
So what does he mean by a lower-risk product and a higher-risk product? Basically, a lower-risk product could be something like new surgical gloves. A higher-risk product would be something like a pacemaker, or a vaccine.
Of course, this directly relates to the concerns surrounding the COVID-19 vaccine, which would qualify as a high-risk product.
But Professor Lottes assures that high-risk products undergo extremely strict reviews.
Lottes explains, “There’s going to be hundreds, thousands of patients with long-term follow-ups, so once we finally have that data, we’ll package all that up, send it off to the FDA and this could take many years as you could imagine.”
Even if a product is put through an emergency use review, the FDA uses every ounce of data it has to properly examine a product. The FDA also brings in several different experts to review a product with their own eyes.
“Is it bio-compatible,” Lottes explains, “once it’s in contact with your body, does it cause any sort of reaction? Someone else could look at it from a physician’s viewpoint and ask is this the right information? We need to know if it works in patients, or is this how I would treat my patients?”
“So we [researchers] may be in contact with one main person [at the FDA] but there’s a whole big team of FDA reviewers behind the scenes that are reviewing every part of that submission,” Lottes continues, “and typically were in contact well before, we don’t just show up and send in this huge document. We’ve been talking with the FDA back and forth so they understand the product well before they receive it.”
Professor Lottes says many people fall into the trap of believing in extremes, such as believing something is either perfect because the FDA reviewed it, or believing it’s not good for you because it was “rushed” got an emergency use authorization.
Lottes believes the truth lies somewhere in the middle. It all comes down to the current ongoing risk to your life. If a product’s benefits outweigh the current ongoing health risk, then the FDA will give it consideration.
More than anything, Professor Lottes says he hopes people come away from the extremes and try to understand the actual scientific process.
“So I think we just need to have confidence in knowing how much review goes into any product that goes to FDA, and they’re not trying to rush things through. They’re just trying to work as quickly as they can, but they’re also reviewing all the available evidence they have,” says Lottes.
You can hear the full interview with Professor Lottes here:
