SHOCKING: FDA Chief Floats Gene Therapies for 30 Million — No Randomized Trials
New “plausible mechanism” pathway could replace gold-standard testing with observational data — including for children.
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FDA Commissioner Marty Makary revealed a sweeping regulatory shift: new cell and gene therapies for ultra-rare diseases may be approved without randomized controlled trials.
Instead, the agency could rely on “plausible mechanism,” biomarker signals, and individual patient outcomes, potentially affecting treatments for up to 30 million Americans.
Makary noted that “there have been incentives in place” for companies to develop these therapies, but is now pushing for even broader regulatory flexibility.
He previously told pregnant women to take the Covid jabs, and his latest proposal bypasses traditional clinical trials despite the risks.
Source: Sense Receptor
FDA head Marty Makary wants to be able to use "new cell and gene therapies" on up to 30,000,000 Americans, including kids, without any randomized controlled trials because they're not "feasible."
(Makary told pregnant women to take the poison Covid jabs, BTW.)
This clip of Makary is taken from a video posted to YouTube on February 26, 2026.
Partial transcription of clip
"Yeah, about 30 million people in the United States have a rare disease. So in aggregate, they're pretty common. And there have not been the market incentives that we need to really allow companies to develop cures and meaningful treatments for that population. They've been forgotten.
"And so we've made it a massive priority in this administration to create pathways to have regulatory flexibilities and to cut the red tape for new cell and gene therapies and other exciting, new promising therapies that can potentially benefit this community.
"There have been incentives in place, but we went hard to renew a pediatric priority voucher program that creates massive incentives for companies developing drugs in this space. And we also announced the plausible mechanism pathway this week, guidance that officially says, here's a new route to get drugs approved.
"And you don't have to do a randomized controlled trial when you're dealing with an ultra-rare condition, because we all know it's not feasible. We can learn from individual patients, and I've learned from individual patients as a doctor, and that is a pathway that we're going to take."
Full Video
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Individually…we just have to say NOT MY BODY…let them keep pushing… we must keep pushing back!🇺🇸💪🏻🗣️
Horrifying.
Victims of rare diseases that were likely triggered by the very same experimental gene therapy that's to be used on them as guinea pigs. What could go wrong?