Trump is promising a big shake-up at the FDA — Here’s what that could mean

"We're going to be cutting regulations at a level that nobody's ever seen before," Trump said in a meeting with pharma executives on January 31, saying that he estimates 75-80% of regulations will be slashed.

Trump also said he has a "fantastic person" lined up for the role of FDA commissioner that will be named soon.

But how would those changes play out? And what exactly is the FDA responsible for?

At its core, the FDA is responsible for regulating food and drugs to make sure they're safe and — in the case of drugs — how effective those drugs are. Trump's comments have left the drug industry worried about what that deregulation would mean for the drug approval process. The agency is a part of the department of Health and Human Services, and is also responsible for regulating medical devices, blood, veterinary products, cosmetics, and tobacco.

Here are some examples of the FDA at work

22 new drugs
the year before
banned antibacterial soap
cracked down in April 2016
class of antibiotics
drugs aren't misleading

The FDA was officially founded in 1906, when the Food and Drugs Act was signed into law, prohibiting mis-branded food, drinks and drugs from interstate commerce. This cracked down on misleading claims that treatments could "cure" patients.

Following the thalidomide birth defect crisis that happened in western Europe, the FDA got more leeway to make sure drugs were not just safe but effective as well. That's been the standard for the past 55 years, but it's possible that Trump's pick will be interested in changing back the regulation to make it just revolve around safety.

The candidates for FDA commissioner

So far, there are three main contenders in the race, with varying degrees of interest in changing how prescription drugs get approved.

Jim O'Neill
before they're shown to be effective
Dr. Scott Gottlieb
favorite among drug executives
Dr. Joseph Gulfo
advocates for a color-coded approval system

What the drug industry thinks

In theory, getting more drugs approved at a faster pace would seem like a good idea. Drug development from start to finish can often take longer than a decade, and it can be an expensive process.

But the process also builds up evidence that the drug companies can point to to show that their drugs work they way they're approved to. That can help get the drugs paid for by insurance plans. So far, the response from industry executives and experts has been against cutting regulations that would make the FDA approve drugs solely based on their safety.

There's a fair amount of concern that by making sure drugs are just safe, and not necessarily effective, the US might start to have more "snake oil" treatments.

Trump is promising a big shake-up at the FDA — Here’s what that could mean

Here are some examples of the FDA at work

The candidates for FDA commissioner

What the drug industry thinks

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