Tag: fda

FDA Exposed: Hundreds of Drugs Approved without Proof They Work

The US Food and Drug Administration (FDA) has approved hundreds of drugs without proof that they work—and in some cases, despite evidence that they cause harm.

That’s the finding of a blistering two-year investigation by medical journalists Jeanne Lenzer and Shannon Brownlee, published by The Lever.

Reviewing more than 400 drug approvals between 2013 and 2022, the authors found the agency repeatedly ignored its own scientific standards.

One expert put it bluntly—the FDA’s threshold for evidence “can’t go any lower because it’s already in the dirt.”

A System Built on Weak Evidence

The findings were damning—73% of drugs approved by the FDA during the study period failed to meet all four basic criteria for demonstrating “substantial evidence” of effectiveness.

Those four criteria—presence of a control group, replication in two well-conducted trials, blinding of participants and investigators, and the use of clinical endpoints like symptom relief or extended survival—are supposed to be the bedrock of drug evaluation.

Yet only 28% of drugs met all four criteria—40 drugs met none.

These aren’t obscure technicalities—they are the most basic safeguards to protect patients from ineffective or dangerous treatments.

But under political and industry pressure, the FDA has increasingly abandoned them in favour of speed and so-called “regulatory flexibility.”

Since the early 1990s, the agency has relied heavily on expedited pathways that fast-track drugs to market.

In theory, this balances urgency with scientific rigour. In practice, it has flipped the process. Companies can now get drugs approved before proving that they work, with the promise of follow-up trials later.

But, as Lenzer and Brownlee revealed, “Nearly half of the required follow-up studies are never completed—and those that are often fail to show the drugs work, even while they remain on the market.”

“This represents a seismic shift in FDA regulation that has been quietly accomplished with virtually no awareness by doctors or the public,” they added.

More than half the approvals examined relied on preliminary data—not solid evidence that patients lived longer, felt better, or functioned more effectively. 

And even when follow-up studies are conducted, many rely on the same flawed surrogate measures rather than hard clinical outcomes.

The result: a regulatory system where the FDA no longer acts as a gatekeeper—but as a passive observer.

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FDA Plan To Include Hemp-Derived Cannabinoids In Federal Adverse Health Event Reporting System Goes To White House For Approval

The U.S. Food and Drug Administration (FDA) is moving forward with a proposal that aims to better track the health impacts of hemp-derived cannabinoid products by adding CBD and other hemp-derived cannabinoids as selectable options on federal documents used by healthcare professionals, patients and consumers to report adverse events.

Initially unveiled in January, the proposal would revise the “Product Type” field of FDA safety reporting documents to include a selection for “Cannabinoid Hemp Products (such as products containing CBD).” An initial round of comments was open until mid-March.

In a post published in the Federal Register this week, FDA announced that the “proposed collection of information” has now been submitted to the White House Office of Management and Budget (OMB) “for review and clearance.”

The new filing says that two comments were received in the initial round of public feedback supporting the addition of a “cannabinoid hemp product” category “but encouraged FDA to include additional categories as well that would allow for specific data as it pertained to a wider variety of individual products.” A third called for changes to make entries easier by respondents.

“FDA appreciates each comment and although we continue to modify applicable forms to increase the utility of the information collection as our limited resources allow,” the agency said, “we are proposing no other modifications at this time.”

An additional round of feedback is now being accepted on the submission of the information, with comments due by July 25.

The move—designed to more actively gather information about adverse health effects that might be linked to hemp-derived products—comes amid a number of other CBD-focused actions at the federal level and state levels.

Earlier this week, for example, a powerful House committee approved a spending bill containing provisions that hemp stakeholders say would devastate the industry, prohibiting most consumable cannabinoid products that were federally legalized during the first Trump administration.

The House Appropriations Committee passed the agriculture appropriations legislation in a 35-27 vote on Monday. It now heads to the Rules Committee to be prepared for floor consideration.

While the panel adopted a manager’s amendment to a report attached to the bill earlier this month that provided clarifying language stating that members did not intend to prohibit non-intoxicating cannabinoid products with “trace or insignificant amounts of THC,” the underlying bill went unchanged, despite the industry’s concerns about the proposal.

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FDA, CDC advisers say lost pregnancies higher than expected following early mRNA vaccination

President Trump’s second-term agenda has been careful not to cast doubt on his signature first-term achievement, the development of COVID-19 vaccines through Operation Warp Speed, which congressional Republicans continue to laud and even claim was sabotaged by Pfizer to deny Trump a consecutive term despite his base souring on the therapeutics.

A new preprint study on mRNA COVID vaccines in early pregnancy, coauthored by top advisers to Trump’s Food and Drug Administration and Centers for Disease Control and Prevention, may fuel the splintering of the Make America Healthy Again movement as the jabs’ opponents ramp up pressure on Health and Human Services Secretary Robert F. Kennedy Jr. to ban them.

Not yet peer-reviewed, the study analyzed hundreds of thousands of Israeli medical records on pregnant women in the three years before and after SARS-CoV-2 emerged in China, finding 43% more “observed-to-expected” fetal losses per 100 pregnancies — 13 instead of nine — when the first mRNA dose is taken between 8-13 weeks’ pregnancy.

Pregnant women who took a booster between 8-13 weeks lost an additional two pregnancies per 100, a “potential dose-response relationship,” the study said.

By using pregnant women who got flu vaccines between 8-27 weeks and women who received either vaccine before their pregnancy as “comparative controls,” the authors said they were able to show the association is unique to COVID vaccines. 

The former had a “consistently lower-than-expected observed number of fetal losses, likely the result of healthy vaccinee bias” – in which people with overall better health tend to have higher vaccination rates – while the latter had “according-to-expected or lower-than-expected numbers of fetal losses,” the study found.

It said “almost all” mRNA doses were made by Pfizer, whose own 2021 report to the FDA – which the agency hid for 16 months until a court made it public – shows 44% of women in Pfizer’s clinical trial lost their pregnancies.

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FDA halts Biden-era program of sending Americans’ DNA to China for genetic engineering

The Trump administration is halting companies from conducting clinical trials in China using Americans’ DNA samples in a program authorized by the Biden administration, according to the Food and Drug Administration.

The FDA said an immediate review has begun on new clinical trials that involve sending living cells of U.S. citizens to China and other hostile states for “genetic engineering and subsequent infusion back into U.S. patients — sometimes without their knowledge or consent.”

The agency moved to halt the program based on what it said is mounting evidence that some of the trials were conducted without informing people involved that their biological material was being transferred and manipulated.

The activity “may have exposed Americans’ sensitive genetic data to misuse by foreign governments including adversaries,” the FDA said in a statement Wednesday.

FDA Commissioner Marty Makary said the unacknowledged transfer of DNA samples has raised questions about the integrity of U.S. biomedical research.

“We are taking action to protect patients, restore public trust and safeguard U.S. biomedical leadership,” Dr. Makary said. “The previous administration turned a blind eye and allowed American DNA to be sent abroad — often without the knowledge or understanding of trial participants,” he said.

The FDA said the suspect transfer of Americans’ biomedical samples was the result of a December 2024 policy by the Biden administration that was put in place by the Justice Department in April.

The Biden rule imposed export controls that limited the transfer of sensitive data to countries of concern. But the Biden administration specifically approved a “sweeping exemption” that allowed U.S. companies to send trial participants’ biological samples, including DNA, for processing overseas in FDA-regulated clinical trials.

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Second Patient Dies After Gene Therapy for Duchenne Muscular Dystrophy: Company

A second patient has died after receiving the gene therapy Elevidys, which was approved by the Food and Drug Administration (FDA) over concerns of staffers, according to the company that makes it.

The 15-year-old boy who died, and the 16-year-old boy whose death was reported earlier in the year, had both received Elevidys, the only gene therapy approved by the FDA for the treatment of a rare form of muscular dystrophy called Duchenne muscular dystrophy (DMD), Sarepta officials said in a call on June 16.

The boys were both non-ambulatory and both died within 90 days of treatment, according to Sarepta.

The 15-year-old died from acute liver failure, Sarepta said in a statement on Sunday. Acute liver injury is listed as a side effect of the product.

Sarepta said it was investigating the cases independently and in relation to each other to identify any common risk factors. The company suspended its Elevidys sales forecast for this year and said it would provide an update with its second-quarter results.

Sarepta officials said the company is pausing shipments of Elevidys for non-ambulatory patients and halting a clinical trial while it develops an “enhanced immunosuppressive regimen,” utilizing the sirolimus drug. They said there is no timeline right now for resuming dosing for the population and that they would try to speak soon with FDA officials about the situation.

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Top FDA Official Admits She Refused the Covid-19 Vaccine While Pregnant

One of the most powerful figures at the US Food and Drug Administration (FDA) has admitted she refused the Covid-19 mRNA vaccine while pregnant—even as her agency promoted it as “safe and effective” for all pregnant women.

Dr Sara Brenner’s explosive disclosure, made on 15 May 2025 at the MAHA Institute Round Table in Washington, DC, is as revealing as it is troubling.

A preventive medicine physician, Brenner has worked at the FDA since 2019. As the FDA’s Principal Deputy Commissioner—and briefly its Acting Commissioner—Brenner was at the centre of decision-making.

Prior to that, she was Chief Medical Officer for diagnostics and was detailed to the White House to support the Biden administration’s Covid-19 response. She didn’t just participate in the pandemic response, she helped shape it from within.

“Knowing what I knew—not only about nanotechnology, about medicine, about the medical countermeasures—but also having a very strong and firm grounding in bioethics…there were many things that were not right,” she told the audience.

That someone with her seniority and access to internal data privately rejected the vaccine, while her agency promoted it to millions of pregnant women, presents a profound ethical dilemma.

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Smells Like Bureaucratic Overreach: FDA Greenlights Lab-Grown Salmon

In a move that reeks of bureaucratic overreach and questionable priorities, the Food and Drug Administration (FDA) has rubber-stamped Wildtype Inc.’s lab-grown salmon, the first of its kind approved for human consumption in the U.S.

Derived from mesenchymal lineage cells and mixed with plant-based goo to mimic sushi-grade saku cuts, this franken-fish is being hailed as a “sustainable” solution to overfishing. 

Meanwhile, HHS Secretary Robert F. Kennedy Jr. is shaking up the public health establishment, firing all 17 members of the CDC’s Advisory Committee on Immunization Practices (ACIP) in a bid to root out conflicts of interest and restore trust in vaccine science. 

The contrast couldn’t be starker: one agency pushes untested biotech food on the public, while another tries to clean house of industry-aligned insiders. Welcome to the brave new world of “Gold Standards.”

Wildtype’s cultured salmon, approved in June 2025 under FDA consultation CCC 000005, is grown in bioreactors over four to six weeks, sidestepping nature’s blueprint for a lab-bred alternative. 

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Texas Governor Signs Bill To Create Ibogaine Research Consortium, Aiming To Develop FDA-Approved Psychedelic Drug

Texas Gov. Greg Abbott (R) has signed into law a bill to create a state-backed research consortium to conduct clinical trials on ibogaine as a possible treatment for substance use disorders and other mental health conditions. The ultimate goal of the project is to develop the psychedelic into a prescription drug with U.S. Food and Drug Administration (FDA) approval, with the state retaining a portion of the profit.

“Texas is now leading the way in the United States for the evaluation of ibogaine as a potential medication that can help improve the lives of so many Americans,” the governor said at a signing event on Wednesday. He called the psychedelic “a therapy that has shown great promise in treating” conditions such as depression, PTSD and opioid use disorder.

“I’m about to sign a law that will lead to an FDA-approved drug development clinical trial that will seek approval of ibogaine as a medication for the treatment of opioid use disorder and other behavioral health conditions, especially those suffered by our veterans,” he added. “Texas will invest $50 million to support this research, and these funds can be matched by grants and private investments.”

Under the new law, approved by the state legislature earlier this month, Texas will retain a commercial interest in “all intellectual property that may be generated over the course of the drug development clinical trials,” the legislation says, with an aim of making Texas a hub for “ibogaine-related biomedical research, development, treatment, manufacturing, and distribution.”

A quarter of revenue taken in by the state from any resulting intellectual property would fund veterans programs.

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FDA Greenlights Merck’s RSV Shot for Newborns — Clinical Trials Showed 11.71% Rate of Serious Adverse Events, Including Death

The U.S. Food and Drug Administration (FDA) on Monday approved Merck’s new monoclonal antibody shot, which the company said is designed to protect newborns and infants against respiratory syncytial virus (RSV).

The antibody shot, clesrovimab, will be marketed as Enflonsia and launched this coming RSV season to challenge Sanofi and AstraZeneca’s blockbuster Beyfortus shot.

Beyfortus, first approved in 2023, generated $1.8 billion in sales last year, FiercePharma reported.

PR Newswire projected that the global RSV vaccine and antibody market would reach $13.59 billion by 2030.

Merck said its monoclonal antibody has about the same efficacy rate as Beyfortus. In clinical trials, the shot reduced RSV-related hospitalization by 84.3% compared to placebo, and the incidence of RSV that needed to be medically attended by 60.5% versus placebo, through age 5 months in the clinical trials.

The company also said in a press release that the drug’s safety profile was “generally comparable” to placebo. The most common adverse reactions were injection-site erythema or swelling, and a rash 14 days after the dose, all of which were more common in the vaccine group.

However, the clinical trial results posted on the government website ClinicalTrials.gov included other serious neurological adverse reactions that Dr. Peter Selley, a U.K. general practitioner who has closely followed the development of the drugs for RSV, called “concerning.”

These included febrile convulsions, seizures, facial paralysis and brain injury at about three times the rate in the vaccine group (25 of 2,409) as the placebo group (4 of 1,202).

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FDA Approved Hundreds of Drugs With No Evidence They Work

The U.S. Food and Drug Administration (FDA) has approved hundreds of drugs over the last several decades with little to no evidence that they work, according to a new investigation by The Lever.

Many of the drugs are permitted to stay on the market, despite ample evidence that they don’t work and that they cause serious and irreparable harm.

The Lever’s two-year investigation into the FDA-approved drugs analyzed government reports, internal FDA documents, investigators’ notes, congressional testimony, court records and more than 100 interviews with researchers, federal officials and patients.

The investigation found that from 2013 through 2022, 73% of drugs approved by the FDA didn’t meet the agency’s four foundational standards required to show the drugs work as expected. Fifty-five of the approved drugs met only one of those four standards, and 39 met none of them.

More than half of drug approvals were based on preliminary data, which meant the pharmaceutical companies didn’t submit evidence that patients had fewer symptoms, showed improvement or had their lives extended.

The approval rate of such drugs has accelerated over the last decade, according to the U.S. Department of Health and Human Services Office of Inspector General.

Cancer treatments, in particular, raised serious red flags. Only 2.4% of the 123 cancer drugs met all of the criteria, and 29 met none. The FDA approved 81% of cancer drugs based on preliminary data.

The report did not evaluate any vaccines.

The Lever wrote:

“These statistics come after billions of dollars and years of lobbying by the pharmaceutical industry and patient advocacy groups pressuring Congress to loosen the FDA’s scientific standards.

“The resulting seismic shift from proving drugs work before they are approved to showing they work only after approval — if ever — has been quietly accomplished with virtually no awareness by doctors or the public.

“Insurers and taxpayers effectively pay for research after drugs hit the market as pharmaceutical companies reap the profits. Patients serve as the unwitting guinea pigs — with very real consequences.”

The outlet also reported that an estimated 128,000 people are killed each year by side effects from prescription drugs prescribed as indicated.

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