Tag: fda

FDA Calls On Drug Companies to Release Missing Clinical Trial Data

The Food and Drug Administration is urging pharmaceutical companies to make public data from clinical trials.

About three in 10 studies deemed highly likely to fall under mandatory reporting requirements have no results filed with the government’s clinical trial website, the FDA said on April 13. That is in line with historical estimates.

The FDA sent more than 2,200 companies and researchers messages in late March that reminded them of the requirements, the agency said on April 13.

“Far too often, companies are suppressing unfavorable clinical trial results and keeping them secret from patients and the scientific community. Those sponsoring clinical trials have an ethical obligation to make results public regardless of the data’s influence on the company’s share price,” FDA Commissioner Dr. Marty Makary said in a statement.

“Too many clinical trial sponsors and researchers are failing to report their results, leaving important information unavailable to clinicians and other researchers. If you are a doctor deciding whether or not to prescribe a medication to a patient, you deserve to have the best data about clinical studies on that medication.”

Sponsors of many clinical trials, and researchers involved with them, are required by federal law to report at least a summary of results within one year of completion. Phase 1 trials are among those excluded from the requirements.

The FDA can initiate a process when the people responsible for submitting the information fail to do so, which can lead to fines of up to $10,000. The process includes sending notices of noncompliance.

Only two such notices were sent in 2025, and the agency is declining to issue any, at least for now.

“The messages issued on March 30, 2026, represent an extra step the agency is taking to provide the relevant responsible parties with the opportunity to comply with federal law before the agency considers whether to take further regulatory action,” the FDA stated.

The agency, under Makary, has favored pressing companies to voluntarily meet its demands, including the removal of synthetic dyes from food.

“I fully support this new initiative to increase the prompt publication—as required by law—of results information from interventional studies of the medical products we regulate,” Dr. Tracy Beth Hoeg, acting director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

“We hope that the thousands of messages sent to sponsors and investigators reminding them to publicly report their findings will improve patient safety and keep researchers and the public better informed of benefits and risks of new and investigational products.”

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Biden FDA Knew About COVID Vaccine Stroke Risk And Kept Americans In The Dark

Senate investigators spent months reviewing roughly 2,000 pages of federal records. What they found is damning. FDA and CDC officials under the Biden administration identified a significant stroke risk tied to Pfizer’s COVID-19 bivalent booster in seniors – and never breathed a word to the public.

Sen. Ron Johnson (R-WI), chairman of the Senate’s Permanent Subcommittee on Investigations, sent a formal letter to HHS Secretary Robert F. Kennedy Jr. laying out the evidence. He wasn’t speculating. He was citing the government’s own files.

“HHS records show that as early as October 2022, federal health officials identified a potential connection between the Pfizer-BioNTech COVID-19 bivalent booster and ischemic stroke for individuals over the age of 65,” Johnson wrote.

An ischemic stroke means a blockage of blood to the brain. Between November 2022 and March 2023, seven separate analyses of incoming data flagged the same stroke signal — specifically in adults over 65. CDC data cited by Johnson shows 226 stroke cases reported between August 2022 and February 2023, with additional cases surfacing throughout 2023 and 2024.

Despite the risk, the Biden administration issued no formal warnings. No Health Alert Network message. No changes to booster recommendations for seniors. Nothing.

Instead, in February 2023, HHS quietly hired a private contractor, Lukos LLC, to conduct a deeper internal investigation, dubbed “The Stroke Project.” Publicly, officials kept insisting the vaccines were safe.

“From the initial detection of the safety signal in late 2022 … health officials continued to say the vaccine was safe while simultaneously searching for evidence to support that assertion,” Johnson said.

It gets worse. Federal officials drafted a communications plan about the stroke risk that included a “Tough Questions and Answers” section prepared for President-ish Biden and his White House team. During final edits, the description of the stroke signal was quietly changed from “moderately elevated” to “slightly elevated.” Who made that change? Nobody knows. The language softened, the edit went unattributed, and the public remained in the dark.

The pattern is consistent. Senate investigators previously established that Biden officials also downplayed the risk of vaccine-induced myocarditis and kept that from the public. This wasn’t a one-time failure. It was a system.

Here’s what makes this cover-up even more infuriating. The Biden administration showed it was more than willing to pull the plug on a vaccine when it wanted to. 

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FDA Grants Speedy Approval to Eli Lilly’s Weight-Loss Pill for Obesity

Federal regulators on Wednesday approved Eli Lilly’s new weight-loss pill, a second daily oral medication to treat obesity and other weight-related conditions.

The Food and Drug Administration granted expedited approval to orforglipron, a GLP-1 drug that works like widely used injectable medications to mimic a natural hormone that controls appetite and feelings of fullness.

The drug, which will be branded as Foundayo, is expected to begin shipping Monday. The company said people with insurance may be able to get the drug starting at $25 per month with a Lilly discount card. Prices for people paying cash will range between $149 per month to $349 per month, depending on the dose.

The new pill joins drugmaker Novo Nordisk’s oral Wegovy pill, which has spurred more than 600,000 prescriptions in the United States since it was approved in December.

The FDA authorized Eli Lilly’s drug as part of a new program aimed at cutting drug approval times. The agency said it reviewed the company’s application in 50 days.

In a clinical trial of more than 3,000 adults with obesity, participants who received the highest dose of orforglipron, 36 milligrams, lost 11.2% of their body weight — about 25 pounds on average — over more than 16 months. That compared with a 2.1% weight loss, or less than 5 pounds, in patients who received a placebo, or dummy pill, according to the New England Journal of Medicine.

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FDA Warns of Deaths Linked to Drug It Wants Removed From Market

The Food and Drug Administration said in a March 31 alert that it has learned of eight deaths linked to a drug called avacopan that is used to treat blood vessel inflammation.

A review of studies, documents from avacopan manufacturer Amgen, and reports to the FDA’s adverse event reporting system resulted in the identification of 76 cases of drug-induced liver injury “with reasonable evidence of a causal association with avacopan use,” the FDA said in a drug safety alert.

Fifty-four of the cases led to hospitalization, and eight ended in death.

Some of the cases involved a syndrome that features the destruction of bile ducts in the liver, which can lead to permanent liver damage.

“Patients should contact their health care professional immediately if they develop any signs or symptoms that may indicate liver injury, such as: feeling more tired than usual; nausea; vomiting; unusual itching; light-colored stools; yellowing of skin or eyes; dark urine; swelling in the stomach or abdomen; or pain in the right upper abdomen,” the FDA stated. “Patients should talk to their health care professional about the safety risks associated with Tavneos and whether to continue therapy or switch to alternative treatments.”

Avacopan, also known as Tavneos, was approved by the FDA in 2021 for the treatment of severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis, or blood vessel inflammation.

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FDA Recalls Aphrodisiac Chocolates Containing Viagra Ingredients

The U.S. Food and Drug Administration has issued a recall for two chocolate products sold by a California adult novelty store, Gold Lion Aphrodisiac Chocolate and ilum Male Sexual Enhancement Chocolate, after discovering they contain high levels of the active ingredients found in prescription medications like Viagra and Cialis. Consuming these chocolates could lead to a life-threatening drop in blood pressure, especially for men with heart conditions who take nitrates.

Why it matters

The recall highlights the risks of purchasing unregulated sexual enhancement products that may contain undisclosed and potentially harmful pharmaceutical ingredients. Consumers should be wary of any over-the-counter products making claims about improving sexual performance, as they may contain dangerous adulterants.

The details

According to the FDA, the recalled chocolates were found to contain sildenafil, the active ingredient in Viagra, and tadalafil, the active ingredient in Cialis. These prescription drug components can interact dangerously with nitrates, potentially causing a severe and sudden drop in blood pressure that could be life-threatening. The chocolates were sold by Gear Isle, an adult novelty store in California, under the names Gold Lion Aphrodisiac Chocolate and ilum Male Sexual Enhancement Chocolate.

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FDA Launches New AI-Powered System to Track Drug and Vaccine Side Effects

For decades, the system designed to catch dangerous side effects from drugs, vaccines, and consumer products has been failing. Not because the problems weren’t happening — but because the infrastructure meant to track them was too fragmented, too slow, and too burdensome to keep up.

The result was a growing gap between what patients experienced and what showed up in federal safety records. Patterns of harm went undetected or took far too long to surface, and the public was left making health decisions based on an incomplete picture.

Now the U.S. Food and Drug Administration (FDA) is attempting to close that gap with a sweeping technology overhaul — one that could fundamentally change how quickly you see safety signals and how much control you have over your own health choices. Here’s what the new system does, what it replaces, and why it matters.

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Moderna threatens American jobs after FDA snubs mRNA flu shot, trial looked ‘scientifically lax’

For years before he became director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, epidemiologist Vinay Prasad openly railed against what he perceived as the shoddy design of drug trials and the deference regulators gave them, sending biotech stocks tumbling when Commissioner Marty Makary appointed him.

A vaccine maker that hit the federal jackpot during COVID-19 acted caught off-guard when the former University of California San Francisco medical professor put his gripes into practice, halting its FDA application for a new mRNA flu vaccine based on what he considered weak trial design.

Moderna accused Prasad, who described his predecessor Peter Marks as a “bobblehead” for drug approval, of changing the rules in the middle of the game by refusing to review its biologics license application (BLA) without citing “specific safety or efficacy concerns.”

Prasad’s Feb. 3 “refusal to file” letter – which Moderna posted a week later on its COVID resources page for some reason – says the FDA warned the company before it even started the mRNA flu trial that the proposed design raised red flags.

“CBER does not consider the application to contain a trial ‘adequate and well-controlled’ and the application is therefore, on its’ [sic] face, inadequate for review,” because the control arm “does not reflect the best-available standard of care in the United States at the time of the study,” Prasad said, which was “consistent with FDA’s advice” before the study.

This was just the agency’s “preliminary review of the application and is not indicative of deficiencies that would be identified later,” when the FDA conducts a “substantive review,” Prasad emphasized, implying fresh hurdles for Moderna even if it runs a new trial.

Moderna CEO Stéphane Bancel responded with his own thinly veiled threat against Prasad, who had already left the administration once under assault from populist and corporate conservatives who blasted his avowed support for progressive policies and more regulation before Prasad joined the administration. 

CBER’s decision, which Bancel reiterated “did not identify any safety or efficacy concerns with our product, does not further our shared goal of enhancing America’s leadership in developing innovative medicines,” said the billionaire Frenchman, who came to Boston-based Moderna from French diagnostics company BioMerieux.

“We look forward to engaging with CBER to understand the path forward as quickly as possible so that America’s seniors, and those with underlying conditions, continue to have access to American-made innovations,” Bancel said, hinting the company would take jobs overseas if the FDA continued its current trajectory.

Department of Health and Human Services spokesperson Andrew Nixon told Just the News Moderna ignored “very clear FDA guidance from 2024 to test its product in a clinical trial against a CDC-recommended flu vaccine to compare safety and efficacy.”

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FDA Requires Vaccine Makers to Include Febrile Seizure Warning on Flu Shot Labels

The U.S. Food and Drug Administration (FDA) notified six influenza vaccine manufacturers on Jan. 9, 2026 that they must add a warning about the risk of febrile (fever) seizures to their product information labels, citing newly identified postmarketing safety data. The notices, issued under the FDA’s statutory authority to mandate safety labeling changes, were sent to Sanofi, AstraZeneca, GlaxoSmithKline (GSK), and CSL Seqirus.1

According to the FDA, observational analyses conducted during the 2023–2024 and 2024–2025 influenza seasons identified a statistically significant increase in seizures caused by fevers occurring within one day of vaccination among children aged six months through four years, prompting the agency to conclude the findings constitute “new safety information” requiring disclosure in product labeling. In its notification letter, the FDA stated that the results of the analyses “suggest a causal relationship”—language the agency typically avoids unless compelled by evidence.2

The data suggested an “estimated attributable risk of 21.2 excess febrile seizure episodes per million standard-dose quadrivalent influenza vaccinations” and “an attributable risk of 44.2 excess febrile seizure episodes per million standard doses of trivalent [influenza] vaccinations.”

Risk of Febrile Seizures May Increase After Childhood Vaccinations

The Mayo Clinic website states that in some infants and young children fevers can cause convulsions (seizures). Doctors generally describe “simple” febrile seizures as associated with fevers over 100 F, short-lived and typically harmless, although “complex” febrile seizures can last longer than 15 minutes and occur more than once in a 24-hour period.3

It has been acknowledged in the medical literature that convulsions can include an increased risk of future epilepsy (uncontrolled seizure disorder).4 5 Febrile seizures have also been associated with a spectrum of brain dysfunction and rarely, severe brain injury or death.6 7

Bioengineer Brian Hooker, PhD said he disagrees with febrile seizures being characterized as harmless. He said:

Any seizure is bad, period. Mild’ febrile seizures can double a child’s chance of an epilepsy diagnosis and ‘complex’ febrile seizures—lasting more than 15 minutes —can increase that risk up to 10 times.8

On the topic of febrile seizures and childhood vaccines, Mayo Clinic states:

The risk of febrile seizures may increase after some childhood vaccinations. These include the diphtheria, tetanus and pertussis vaccine and the measles-mumps-rubella vaccine. A child can develop a low-grade fever after a vaccination. The fever, not the vaccine, causes the seizure.9

The U.S. Centers for Disease Control and Prevention (CDC) acknowledges that some vaccines are associated with a higher risk of febrile seizures than others, particularly in infants and young children, and that the risk increases when certain vaccines—such as the influenza, pneumococcal (PCV13), and DTaP vaccines—are administered during the same visit.

The agency also notes that measles-containing vaccines, especially the MMRV (measles, mumps, rubella, and varicella) combination, are associated with a higher risk of febrile seizures than their single-component counterparts, and that these events tend to occur within specific post-vaccination time windows. Still, CDC guidance emphasizes that the overall risk is small, that febrile seizures are typically short-lived and without lasting harm, and that vaccination should continue according to the recommended schedule.10

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Powdered whole milk may be culprit in botulism outbreak that sickened dozens of babies

Powdered whole milk used to make ByHeart infant formula could be the source of contamination that led to an outbreak of botulism that sickened dozens of babies.

The Centers for Disease Control and Prevention (CDC) reported the details on Friday.

Powdered whole milk may be culprit in botulism outbreak

What we know:

Testing by the U.S. Food and Drug Administration (FDA) found that bacteria in an unopened can of formula matched a sample from a sick baby — and it also matched contamination detected in samples of organic whole milk powder used to make ByHeart formula and collected and tested by the company, officials said. 

FDA testing also found contamination in a sample of whole milk powder supplied to ByHeart — and it matched the germ in a finished sample of the company’s formula.

What they’re saying:

A ByHeart official said the finding helps shed light on what has become a “watershed moment” for the company.

“We are focused on the root cause and our responsibility to act on what we’ve learned to help create a safer future for ByHeart and infant formula,” said Dr. Devon Kuehn, ByHeart’s chief scientific and medical officer.

What we don’t know:

While these results advance the agency’s understanding of the outbreak, the FDA said the findings are not conclusive, and the investigation continues “to determine the source of the contamination.”

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FDA Removes Web Content Saying Cellphones Are Harmless – HHS Launches Study

Without fanfare, the Food and Drug Administration has deleted multiple web pages asserting that cellphones are not dangerous. First reported by the Wall Street Journal, the move comes as the Department of Health and Human Services has begun a new investigation into potential health effects of cellphone radiation.

HHS Secretary Robert F. Kennedy Jr has previously declared that cellphones are causing harms that are not yet fully acknowledged. “There’s cellphone tumors. I’m representing hundreds of people who have cellphone tumors behind the ear. It’s always on the ear that you favor with your cellphone…We have the science,” Kennedy said in a 2023 appearance on the Joe Rogan Experience. “You should never put one next to your head… I put it on speakerphone or use earphones.” 

Responding to a Journal inquiry about the change to the FDA website, HHS spokesman Andrew Nixon said, “The FDA removed webpages with old conclusions about cellphone radiation while HHS undertakes a study on electromagnetic radiation and health research to identify gaps in knowledge, including on new technologies, to ensure safety and efficacy.” 

One of the deleted pages included a passage declaring that “the weight of scientific evidence has not linked exposure to radio frequency energy from cellphone use with any health problems.” There may be more scrubbing of the site to come: The Journal notes that the FDA’s site still has summaries of the deleted pages, but the links redirect to other generalized content about the agency’s regulatory mission. 

Kennedy, who had a career as an environmental litigator, has long engaged on this issue. Kennedy represented people suing phone companies for allegedly causing brain tumors, and won a 2020 case that compelled the Federal Communications Commission to reassess its wireless-radiation regulations. He was also chairman of Children’s Health Defense, which has been involved in litigation over 5G technology, and a case blaming an Idaho man’s cardiac issues on a cellphone tower. He has also pointed to radiation as a prime suspect in the mystery of widespread chronic illnesses among America’s children, “Our children are swimming around in a toxic soup, the Wi-Fi radiation is a lot worse than people think it is…yeah, from your cellphone,” Kennedy told Rogan in 2023.  

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