WASHINGTON — When President Trump criticized the Food and Drug Administration drug approval process as “slow and burdensome” on Tuesday, you may have heard a mysterious noise. And that noise may have been the sound of thousands of agency staffers banging their heads against the wall.

FDA officials have long bristled at the notion that they move too slowly to approve new drugs. Part of their job, after all, is to ensure that any drugs they approve are both safe and effective — and that, they point out, can take time.

The standard review process now takes a median of 10 months, down from nearly 13 months in 2005, according to the FDA. Companies can shrink that process to eight months if they get a priority review.


The FDA also happens to move faster than regulatory agencies in many other countries.

According to a December 2016 agency report, the United States leads Japan, Canada, and the European Union in speed of drug approvals.

Over a third of novel drugs the FDA approved that year were for rare diseases; almost 4 out of 10 were the first in their class of drug; and almost a third of new drugs approved last year received breakthrough therapy designations — for drugs that will treat, alone or in combination with others, serious or life-threatening diseases, and which have shown some early indication of working.

That story, experts say, doesn’t square with the way Trump portrayed the approval process on Tuesday. In his address to a joint session of Congress, he asserted that the FDA approval process “keeps too many advances … from reaching those in need.”

Even the FDA’s traditional adversaries, among them, Dr. Michael Carome, director of Public Citizen’s Health Research Group, took issue with that remark.

It reflected “complete ignorance about the FDA’s current regulatory schemes for ensuring that medications and medical devices are safe and effective,” he said.

Noting it was Rare Disease Day, Trump also cited the case of Megan Crowley, a young woman suffering from Pompe disease, who was a guest of the first lady’s during his address. Her father, John, founded a biotechnology company that developed a drug to treat the condition.

But that drug was hardly a testament to a “slow and cumbersome” FDA process.

Former FDA chief Dr. David Kessler made that point on Twitter.

None of this is to say that there aren’t critics of the agency’s process.

But Suchira Ghosh, an attorney with Axinn, Veltrop & Harkrider, who advises biotech and pharmaceutical firms, said that while she disagreed with Trump’s characterization of the process, it’s true that it can take a very long time for companies to meet the FDA’s stringent standards.

Indeed, a report released jointly by QuintilesIMS Institute and STAT earlier this year found that new drugs are moving more to market no faster than they were two decades ago. But that speaks largely to biological hurdles, not regulatory ones.

Ghosh, for instance, pointed out that in the case of drugs for rare disease, researchers have to rely on small set of patients to work with in clinical trials and unusual genetic factors.

Many public health advocates believe the FDA is already going too fast — a point that lawmakers raised in the House and Senate, during the debates over the 21st Century Cures Act.

“The regulatory pendulum for the FDA’s review of medical products already has swung too far toward promoting speed over the rigor of evidence demonstrating safety and effectiveness,” said Carome.

Many pharmaceutical industry and biotech executives say that the real problem at FDA are the frozen jobs: although the 21st Century Cures Act provides for the agency to hire more drug reviewers and other staff, the new administration’s freeze has thus far prevented that.

“When I talk to CEOs, they’re not telling me that they’re finding the FDA particularly difficult,” said Geoffrey Porges, a biotech analyst with Leerink. “Rather, they want the FDA to be fully staffed to have the resources to do the job they’re required to do. That’s their biggest concern.”

And one more thing, the agency still needs a commissioner.

Damian Garde contributed reporting.

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  • We pt.s know how the still slow 20th century trial process is a factor. Take 3 pt.s give them a drug wait 6 wks. see if they die or not.repeat with 3 more …. 7 to 10 years . Then you add the FDA regulatory pressure . The nit picky reviewers who fought the recent duchennes drug. Give dying kids a chance !

  • If I worked at the FDA, I would be a bit demoralized today. So this is a shout-out to FDA staffers that not everyone shares Trump’s view. I routinely review FDA materials about new drugs as part of my job as a pharmacist. Just today, I am reviewing a new drug for carcinoid syndrome diarrhea that was just approved approximately 1 year after the NDA was filed. It was approved on the basis of a study in 90 patients. It got a priority review because it fits a small niche where there aren’t other options. In my opinion, this is NOT slow and burdensome. I can think of 4-5 accelerated approvals like this in the past year for drugs that fill badly needed niches.

    Trump’s remarks show how shallow his understanding is about the complex evaluation that’s needed to be relatively sure that a drug is both safe and effective when it reaches the market. We’ve had some bad experiences in the past. Why would we want to risk having to recall drugs that haven’t been properly ‘vetted’ after people are harmed? Trump needs to understand that adverse drug reactions are estimated to kill 100,000 people each year in the US (a much greater number than the risk of terrorism within the US). FDA is our front-line defense against this under-appreciated threat. I wish someone would acknowledge that hard-working FDA staffers take their jobs extremely seriously, have the needed expertise, and give them the resources to do their job properly.


  • They had an excellent Commissioner who was moving the agency in the right direction in Dr Califf. He should have been kept on

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