Trump wants to upend the 'slow and burdensome' drug-approval process at the FDA — here's what the agency actually does (FOLD)

Trump reiterated his interest in bringing down drug prices, telling Congress he wants to "work to bring down the artificially high price of drugs ... immediately."

Trump singled out Megan Crowley — a 20-year-old living with Pompe disease, a rare inherited disorder that leads to a buildup of a complex sugar in organs and tissues — to talk about the regulatory process at the FDA.

Shortly after she was diagnosed, Megan Crowley's father, John, started working to find a treatment, and Megan entered a clinical trial by 2003. John is the CEO of rare-disease company Amicus Therapeutics. The company's share price jumped 12% Wednesday after the presidential shout-out.

"But our slow and burdensome approval process at the Food and Drug Administration keeps too many advances, like the one that saved Megan's life, from reaching those in need," Trump said. "If we slash the restraints, not just at the FDA, but across our government, then we will be blessed with far more miracles just like Megan."

Not everyone agreed that the rare-disease drug was approved slowly. Dr. David Kessler, who served as FDA commissioner from 1990 to 1997, had a different take:

Regardless of how fast the particular drug was approved, Trump's anecdote is in line with his plans to deregulate the drug industry. "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. He estimated up to 80% of regulations will be slashed.

The FDA is responsible for regulating food and drugs. It's also responsible for regulating medical devices, blood donations, veterinary products, cosmetics, and tobacco. Trump's comments have left the drug industry concerned about what that deregulation could mean for the drug-approval process.

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 misbranded 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. 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.

While Trump still hasn't disclosed his FDA commissioner nod, there are three reported candidates:

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 about the FDA

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.

“The underpinnings of belief among patients, payers, even investors, is that somebody out there has tested these things and has shown, with some evidence, that they work,” Harvard professor Daniel Carpenter told The New York Times.

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.

"Without rigorous scientific and medical proof to establish that a drug is both Safe and Effective, we risk taking a step back into a time when people sold colored water for cancer treatments and patients became the unwitting tools of unscrupulous marketeers," Ovid Therapeutics CEO Jeremy Levin told Endpoints in February.