The FDA Has Revolutionized Drug Approvals Over the Past Decade

Fight disinformation: Sign up for the free Mother Jones Daily newsletter and follow the news that matters.


I was reading something yesterday about President Trump’s desire to speed up FDA approvals for new drugs, so I decided to check: how long does FDA approval take these days? Here are the numbers over the past decade:

I’ve used a 3-year rolling average to smooth out the spikes, but the trend is pretty obvious. In the past ten years, the time to approve new drugs has been cut in half and the approval rate has tripled. Note that this is only for “standard” drugs, not “priority” drugs, so it’s not contaminated by special treatment given for certain lifesaving compounds.

I’m sympathetic to arguments that our narrow escape from the thalidomide disaster of the early 60s traumatized FDA scientists, and they overreacted by making approvals too hard. The problem is that the lesson of thalidomide approval in Europe isn’t that approvals were done too quickly, it’s that approvals shouldn’t be based on handwaving from pharmaceutical companies. As long as the testing regimen is rigorous enough, there’s no reason that approvals shouldn’t be done in a timely way.

That said, how much faster does Trump want approvals to go? A recent study suggests that the average FDA approval time is now considerably faster than Europe’s, and that “the vast majority” of new drugs were first approved for use in the United States:

If anything, the FDA may have become too aggressive. They’ve made some far-reaching reforms in only a decade. Ten years from now, the chart to look at will be a comparison of drug catastrophes before and after this change.1

1I don’t mean this in a snarky way. There’s no cosmic “right answer” for how fast new drugs should be approved. It’s all a matter of how much risk we’re willing to take vs. how long we’re willing to delay potentially effective therapies. A decade from now, we’ll need to look back and see just how much extra risk, if any, the FDA has introduced into the system.

TIME IS RUNNING OUT!

We have an ambitious $350,000 online fundraising goal this month and it's truly crunch time: About 15 percent of our yearly online giving usually comes in during the final week of the year, and in "No Cute Headlines or Manipulative BS," we explain why we simply can't afford to come up short right now.

The bottom line: Corporations and powerful people with deep pockets will never sustain the type of journalism Mother Jones exists to do. And advertising or profit-driven ownership groups will never make time-intensive, in-depth reporting viable.

That's why donations big and small make up 74 percent of our budget this year. There is no backup to keep us going, no alternate revenue source, no secret benefactor. If readers don’t donate, we won’t be here. It's that simple.

And if you can help us out with a donation right now, all online gifts will be matched thanks to an incredibly generous matching gift pledge.

payment methods

TIME IS RUNNING OUT!

We have an ambitious $350,000 online fundraising goal this month and it's truly crunch time: About 15 percent of our yearly online giving usually comes in during the final week of the year, and in "No Cute Headlines or Manipulative BS," we explain why we simply can't afford to come up short right now.

The bottom line: Corporations and powerful people with deep pockets will never sustain the type of journalism Mother Jones exists to do. And advertising or profit-driven ownership groups will never make time-intensive, in-depth reporting viable.

That's why donations big and small make up 74 percent of our budget this year. There is no backup to keep us going, no alternate revenue source, no secret benefactor. If readers don’t donate, we won’t be here. It's that simple.

And if you can help us out with a donation right now, all online gifts will be matched thanks to an incredibly generous matching gift pledge.

payment methods

We Recommend

Latest

Sign up for our free newsletter

Subscribe to the Mother Jones Daily to have our top stories delivered directly to your inbox.

Get our award-winning magazine

Save big on a full year of investigations, ideas, and insights.

Subscribe

Support our journalism

Help Mother Jones' reporters dig deep with a tax-deductible donation.

Donate