The FDA Has Revolutionized Drug Approvals Over the Past Decade

Facts matter: Sign up for the free Mother Jones Daily newsletter. Support our nonprofit reporting. Subscribe to our print magazine.


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.

THE END...

of our fiscal year is Thursday, June 30, and we have a much larger fundraising gap than we can easily manage with only days left to go.

Right now is no time to come up short: If you value the hard-hitting, democracy-protecting, justice-advancing journalism you get from Mother Jones, please help us keep charging as hard as we possibly can with a much-needed and much-appreciated donation today.

payment methods

THE END...

of our fiscal year is Thursday, June 30, and we have a much larger fundraising gap than we can easily manage with only days left to go.

Right now is no time to come up short: If you value the hard-hitting, democracy-protecting, justice-advancing journalism you get from Mother Jones, please help us keep charging as hard as we possibly can with a much-needed and much-appreciated donation today.

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