Tag: fda

Appeals Court Blocks Nationwide Access to Abortion Pills Via Mail

A federal appeals court on Friday blocked nationwide access to abortion pill prescriptions via telehealth and mail.

A three-judge panel on the Fifth Circuit Court of Appeals unanimously ruled that abortion pills such as Mifepristone must be distributed in person.

Louisiana filed the lawsuit after the FDA allowed Mifepristone to be distributed via telehealth and mail during the Covid pandemic.

In 2023, the ‘Covid’ change to how abortion pills were distributed became permanent.

The American Civil Liberties Union (ACLU) lashed out at Louisiana’s ‘anti-abortion politicians’ after the ruling came down from the appeals court.

“Anti-abortion politicians have just made it much harder for people everywhere in the country to get a medication that abortion and miscarriage patients have been safely using for more than 25 years,” said Julia Kaye, senior staff attorney for the Reproductive Freedom Project of the ACLU.

“Louisiana’s legal attack on mifepristone shamelessly packaged lies and propaganda as an excuse to restrict abortion — and the Fifth Circuit rubber-stamped it,” they said.

“This decision defies clear science and settled law and advances an anti-abortion agenda that is deeply unpopular with the American people,” the ACLU said.

“For countless people, especially those who live in rural areas, face intimate partner violence, or live with disabilities, losing a telemedicine option will mean losing access to this vital medication altogether,” the ACLU added.

NBC News reported:

A federal appeals court on Friday granted the state of Louisiana’s request to reinstate a nationwide requirement that abortion pills be dispensed in person.

The ruling represents a victory for opponents of abortion rights, since it limits access by blocking people’s ability to obtain mifepristone — one of the two pills used in medication abortions — through telehealth and by mail.

Telehealth prescriptions have been key to maintaining abortion access in states that outlawed or restricted the practice after the Supreme Court overturned Roe v. Wade in 2022.

During the Covid pandemic, the Food and Drug Administration temporarily eliminated a requirement for mifepristone to be dispensed only in clinics, medical offices and hospitals. The change was then made permanent in 2023.

Louisiana challenged that FDA regulation in federal court last year, alleging that the data to support it was flawed or nonexistent. Multiple studies have shown that mifepristone is safe and effective when taken at home after a consultation with a clinician.

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Behind Closed Doors vs. Public Messaging: What Health Officials Knew—and What They Didn’t Say

The FDA knew the COVID shots would kill and maim countless Americans.

They kept injecting anyway.

One government employee tried to sound the alarm about “49 examples” of deadly side effects that conventional safety analyses weren’t detecting.

She was shut down.

Her name was Dr. Ana Szarfman.

On March 1, 2021, less than three months after the rollout of the COVID-19 injections, Dr. Ana Szarfman, an employee at CDER and safety data mining developer, warned that the FDA’s existing system could hide vaccine safety signals due to a flaw called “masking.”

She proposed a newer method developed by statistician Dr. William DuMouchel that corrected for this issue and, when applied, detected “49 examples of extreme masking” that the standard system did not.

These “49 examples of extreme masking” include not “minor” but serious adverse events:

• Bell’s palsy

• Cardiac failure

• Acute left ventricular failure

• Agonal rhythm (severe end-of-life arrhythmia)

• Pulmonary infarction

• Cerebral artery occlusion

• Aortic stenosis

• Sudden cardiac death

• Hypertensive emergency

• Basal ganglia stroke

When Dr. Szarfman proposed a new method, she was told to “hold off on creating and sending data mining reports and analyses.”

Later, they “made it clear” that she “needs to focus on her assigned work” and “should not be discussing or providing internal analyses externally.”

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Senator Finds More Evidence Federal Officials Evaded FOIA

A U.S. senator and his team say they have uncovered additional evidence that federal officials worked to evade requests made under the Freedom of Information Act (FOIA).

Several emails obtained by Sen. Ron Johnson (R-Wis.) showed personnel with the Food and Drug Administration and the Centers for Disease Control and Prevention were aware of FOIA requests and sought to evade them. FOIA enables people to request records from the government. It requires officials to retain and produce requested records, subject to certain exemptions.

In a Nov. 26, 2022, missive, Allison Lale, a medical officer with the CDC, asked a colleague about receiving safety analyses of COVID-19 vaccination from the FDA.

Pedro Moro, a CDC epidemiologist, responded. “I think that because of the FOIAs we may have asked FDA to stop sending these weekly data mining outputs,” Moro wrote.

“Oh interesting,” Lale said. She added that during calls for a CDC-managed program, “we used to just verbally mention” that certain terms had not triggered safety signals, or signs vaccines were causing problems.

“But we could also leave it out if that [sic] this creates more hassle,” she added.

In a separate email chain, FDA officials were told by an FDA vaccine safety analytic expert, Dr. Ana Szarfman, that the approach they were using to analyze the safety of COVID-19 vaccines was faulty. The information sparked a long discussion, during which officials considered asking the expert to contact an outside expert on the matter.

“Before we potentially reach out to Ana, we should meet internally – many considerations not suited to email…” David Menschik, an FDA official who distributed the data mining reports, wrote on April 15, 2021.

“Sounds good,” Bethany Baer, another FDA worker, responded. “Happy to meet and discuss anytime open on my calendar.”

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Leaked FDA Memo Shows Feds Masked Sudden Cardiac Deaths in Our Children Says Senator Ron Johnson

Senator Ron Johnson raised concerns during an exchange with Robert F. Kennedy Jr. regarding a memo he said originated from a senior official within the Food and Drug Administration, describing findings tied to child deaths following COVID-19 mRNA vaccinations.

Johnson said the memo was “apparently from CBER director, Doctor Prasad,” and referenced its contents as part of an FDA review.

He stated the document described an internal analysis involving “96 autopsies of child death following the covid mRNA injection.”

According to Johnson, the memo included language he described as significant in acknowledging outcomes tied to the vaccines.

“In that memo, Doctor Persad writes, this is a profound revelation,” Johnson said.

He continued, “For the first time, the US FDA will acknowledge that covid 19 vaccines killed American children, healthy young children who face tremendously low risk of death.”

Johnson added that these children were “coerced at the behest of the Biden administration via school and work mandates to receive a vaccine that could result in death.”

Johnson said the memo raised questions about the impact of pandemic-era mandates. “In many cases, such mandates were harmful,” he said.

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A Reckoning Is Underway At The FDA

For months, a quiet battle has been unfolding inside the US Food and Drug Administration (FDA).

It began with an analysis of child deaths after Covid vaccination, followed by strategic leaks to major media outlets, and has now erupted into the open with a memo from the regulator’s own vaccine chief.

In September, it was reported that FDA officials had privately investigated 25 paediatric deaths following Covid vaccination — the first systematic review of such cases since the rollout began.

The findings were meant to be presented to the CDC’s Advisory Committee on Immunization Practices (ACIP). But the presentation never came. The meeting passed without a word. Something had happened behind closed doors.

Now we know what.

On 13 November 2025, STAT published an extraordinary insider account describing a tense internal meeting in which FDA scientist Dr Tracy Beth Høeg presented evidence of young people who had died after Covid vaccination.

According to STAT, her findings triggered pushback from career FDA regulators who feared the implications of acknowledging fatal cases.

Now, comes the explosive memo from FDA vaccine chief Dr Vinay Prasad, confirming — for the first time — that US regulators have formally attributed at least 10 of these children’s deaths to Covid vaccination.

Prasad called it “a profound revelation” with far-reaching implications for American vaccine policy, adding that the true number is “certainly an underestimate.”

Here, I’ll take you through the memo, the leaks, the internal rebellion at FDA, and what this means — not just for Covid vaccines, but for all vaccine approvals going forward.

This story marks a turning point in US vaccine regulation.

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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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