The Food and Drug Administration is headed for a major revamp under the Trump presidency.
“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
- It, of course, approves new drugs. In 2016, 22 new drugs made the cut, compared to 45 the year before.
- In September 2016, the FDA banned antibacterial soap based on evidence that showed that the soaps weren’t any better, cleaner or safer than regular soap.
- The agency cracked down in April 2016 when diet supplements showed up containing a dangerous stimulant.
- The FDA keeps track of any side effects that come up after a drug’s approved, and can make changes accordingly. In July, the agency changed the label on a commonly used class of antibiotics to reflect more potentially permanent side effects.
- It makes sure ads for 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, managing director at Mithril Capital, a libertarian who has said he’s in favour of approving drugs that are safe, before they’re shown to be effective.
- Dr. Scott Gottlieb, a resident fellow at the American Enterprise Institute and former deputy commissioner of the FDA during George W. Bush’s presidency. Gottlieb has emerged as a favourite among drug executives.
- Dr. Joseph Gulfo, a former biotech executive who advocates for a colour-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.
“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 coloured water for cancer treatments and patients became the unwitting tools of unscrupulous marketeers,” Ovid Therapeutics CEO Jeremy Levin told Endpoints.