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.
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.
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteractionsLabeling/ucm110632.htm
They had an excellent Commissioner who was moving the agency in the right direction in Dr Califf. He should have been kept on