fda

Trump admin picks COVID critic to be top FDA vaccine regulator

COVID-19, fda, health, nazis, pandemic, vinay prasad / Rejus Almole / May 7, 2025

Oncologist Vinay Prasad, a divisive critic of COVID-19 responses, will be the next top vaccine regulator at the Food and Drug Administration, agency Commissioner Martin Makary announced on social media Tuesday.

Prasad will head the FDA’s Center for Biologics Evaluation and Research (CBER), which is in charge of approving and regulating vaccines and other biologics products, such as gene therapies and blood products.

“Dr. Prasad brings the kind of scientific rigor, independence, and transparency we need at CBER—a significant step forward,” Makary wrote on social media.

Prasad, a professor in the department of epidemiology and biostatistics at the University of California, San Francisco, is perhaps best known for his combative social media postings and criticism of the mainstream medical community. He gained notoriety amid the COVID-19 pandemic for assailing public health responses, such as masking and vaccine mandates.

In an October 2021 newsletter, titled “How Democracy Ends,” Prasad compared the country’s pandemic responses to the rise of Adolf Hitler’s Third Reich. The post led New York University bioethicist Arthur Caplan to rebuke Prasad, writing in The Cancer Letter that the comparison is “ludicrous, dangerous, and offensive,” before adding “imbecilic.”

Prasad has also criticized the FDA for approving COVID-19 booster vaccines. Last year, he accused his predecessor as the head of the CBER, Peter Marks, of being “either incompetent or corrupt” for allowing the approvals.

“Absurd”

More recently, Prasad has heaped praise on new FDA Commissioner Makary, while continuing to criticize Marks. In early March, Prasad called Makary “smart, thoughtful, and disciplined” and “exactly what we need at the FDA.” Later in the month, he continued to take shots at Marks, writing: “You could replace Peter Marks with a bobblehead doll that just stamps approval and you would have the same outcome at FDA with lower administrative fees. Maybe something DOGE should consider.”

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Seasonal COVID shots may no longer be possible under Trump admin

COVID-19, fda, health, makary, Trump, vaccines / Tim Belzer / April 29, 2025

Under President Trump, the Food and Drug Administration may no longer approve seasonal COVID-19 vaccines updated for the virus variants circulating that year, according to recent statements by Trump administration officials.

Since the acute phase of the pandemic, vaccine manufacturers have been subtly updating COVID-19 shots annually to precisely target the molecular signatures of the newest virus variants, which continually evolve to evade our immune responses. So far, the FDA has treated these tweaked vaccines the same way it treats seasonal flu shots, which have long been updated annually to match currently circulating strains of flu viruses.

The FDA does not consider seasonal flu shots brand-new vaccines. Rather, they’re just slightly altered versions of the approved vaccines. As such, the regulator does not require companies to conduct lengthy, expensive vaccine trials to prove that each slightly changed version is safe and effective. If they did, generating annual vaccines would be virtually impossible. Each year, from late February to early March, the FDA, the Centers for Disease Control and Prevention, and the World Health Organization direct flu shot makers on what tweaks they should make to shots for the upcoming flu season. That gives manufacturers just enough time to develop tweaks and start manufacturing massive supplies of doses in time for the start of the flu season.

So far, COVID-19 vaccines have been treated the exact same way, save for the fact that the vaccines that use mRNA technology do not need as much lead time for manufacturing. In recent years, the FDA decided on formulations for annual COVID shots around June, with doses rolled out in the fall alongside flu shots.

However, this process is now in question based on statements from Trump administration officials. The statements come amid a delay in a decision on whether to approve the COVID-19 vaccine made by Novavax, which uses a protein-based technology, not mRNA. The FDA was supposed to decide whether to grant the vaccine full approval by April 1. To this point, the vaccine has been used under an emergency use authorization by the agency.

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FDA backpedals on RTO to stop talent hemorrhage after HHS bloodbath

drugs, fda, health, medical devices, trump administration / Kris Guyer / April 11, 2025

The Food and Drug Administration is reinstating telework for staff who review drugs, medical devices, and tobacco, according to reporting by the Associated Press. Review staff and supervisors are now allowed to resume telework at least two days a week, according to an internal email obtained by the AP.

The move reverses a jarring return-to-office decree by the Trump administration, which it used to spur resignations from federal employees. Now, after a wave of such resignations and a brutal round of layoffs that targeted about 3,500 staff, the move to restore some telework appears aimed at keeping the remaining talent amid fears that the agency’s review capabilities are at risk of collapse.

The cut of 3,500 staff is a loss of about 19 percent of the agency’s workforce, and staffers told the AP that lower-level employees are “pouring” out of the agency amid the Trump administration’s actions. Entire offices responsible for FDA policies and regulations have been shuttered. Most of the agency’s communication staff have been wiped out, as well as teams that support food inspectors and investigators, the AP reported.

Reviewers are critical staff with unique features. Staff who review new potential drugs, medical devices, and tobacco products are largely funded by user fees—fees that companies pay the FDA to review their products efficiently. Nearly half the FDA’s $7 billion budget comes from these fees, and 70 percent of the FDA’s drug program is funded by them.

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RFK Jr.‘s bloodbath at HHS: Blowback grows as losses become clearer

CDC, CMS, fda, health, HHS, NIH, robert f kennedy jr, trump administration / Mike M. / April 3, 2025

Last week, Health Secretary and anti-vaccine advocate Robert F. Kennedy Jr. announced the Trump administration would hack off nearly a quarter of employees at the Department of Health and Human Services, which oversees critical agencies including the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the Centers for Medicare and Medicaid Services (CMS).

The downsizing includes pushing out about 10,000 full-time employees through early retirements, deferred resignations, and other efforts. Another 10,000 will be laid off in a brutal restructuring, bringing the total HHS workforce from 82,000 to 62,000.

“This will be a painful period,” Kennedy said in a video announcement last week. Early yesterday morning, the pain began.

It begins

At the FDA—which will lose 3,500 employees, about 19 percent of staff—some employees learned they were being laid off from security guards after their badges no longer worked when they showed up to their offices, according to Stat. At CMS—which will lose 300 employees, about 4 percent—laid-off employees were instructed to file any discrimination complaints they may have with Anita Pinder, identified as the director of CMS’s Office of Equal Opportunity and Civil Rights. However, Pinder died last year, The Washington Post noted.

At the NIH—which is set to lose 1,200 employees, about 6 percent—new director Jay Bhattacharya sent and email to staff saying he would implement new policies “humanely,” while calling the layoffs a “significant reduction.” Five NIH institute directors and at least two other senior leaders have been ousted, in addition to hundreds of lower-level employees. Bhattacharya wrote that the remaining staff will have to find new ways to carry out “key NIH administrative functions, including communications, legislative affairs, procurement, and human resources.”

At CDC—which will lose 2,400 employees, about 18 percent—the cuts slashed employees working in chronic disease prevention, sexually transmitted diseases, HIV, tuberculosis, global health, environmental health, occupational safety and health, maternal and child health, birth defects, violence prevention, health equity, communications, and science policy.

Some leaders and workers at the CDC and NIH were reportedly reassigned or offered transfers to work at the Indian Health Services (IHS), an HHS division that provides medical and health services to Native American tribes. The transfers, which could require employees to move to a remote branch, are seen as another way to force workers out.

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“This will be a painful period”: RFK Jr. slashes 24% of US health dept.

CDC, fda, funding, health, HHS, NIH, reductions, research, robert f kennedy jr, Science, trump administration / Mike M. / March 28, 2025

Health Secretary and anti-vaccine advocate Robert F. Kennedy Jr. is slashing a total of 20,000 jobs across the Department of Health and Human Services—or about 24 percent of the workforce—in a sweeping overhaul said to improve efficiency and save money, Kennedy and the HHS announced Thursday.

Combining workforce losses from early retirement, the “Fork in the Road” deferred resignation deal, and 10,000 positions axed in the reductions and restructuring announced today, HHS will shrink from 82,000 full-time employees to 62,000 under Kennedy and the Trump administration. The HHS’s 28 divisions will be cut down to 15, while five of the department’s 10 regional offices will close.

“This will be a painful period,” Kennedy said in a video announcement posted on social media. Calling the HHS a “sprawling bureaucracy,” Kennedy claimed that the cuts would be aimed at “excess administrators.”

“I want to promise you now that we are going to do more with less,” he said in the video.

Kennedy and HHS said the cuts will save $1.8 billion each year. That’s about 0.027 percent of total federal spending, based on the $6.75 trillion the government spent in 2024, and about 0.06 percent of the $2.8 trillion HHS budget for that year.

The downsizing announced today includes significant cuts to the Food and Drug Administration, the Centers for Disease Control and Prevention, and the National Institutes of Health.

Cuts upon cuts

The FDA will lose 3,500 employees, which The Wall Street Journal reported was about 19 percent of its staff. HHS did not provide current staff levels at the agency level or percentage cuts. The CDC, which will absorb the Administration for Strategic Preparedness and Response (ASPR), will lose 2,400 employees (1,400 from CDC and 1,000 from ASPR). The Journal reported that to be about 18 percent of the total workforce. NIH will lose 1,200 employees, about 6 percent of its workers.

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Pixel Watch 3 gets FDA approval to alert you if you’re dying

fda, Google, Tech, wearables / Mike M. / February 27, 2025

Google released the Pixel Watch 3 last fall alongside the Pixel 9 family, sporting the same curvy look as the last two versions. The Pixel Watch 3 came with a new feature called Loss of Pulse Detection, which can detect impending death due to a stopped heart. Google wasn’t allowed to unlock that feature in the US until it got regulatory approval, but the Food and Drug Administration has finally given Google the go-ahead to activate Loss of Pulse Detection.

Numerous smartwatches can use health sensors to monitor for sudden health events. For example, the Pixel Watch, Apple Watch, and others can detect atrial fibrillation (AFib), a type of irregular heartbeat that could indicate an impending stroke or heart attack. Google claims Loss of Pulse Detection goes further, offering new functionality on a consumer wearable.

Like the EKG features that became standard a few years back, Loss of Pulse Detection requires regulatory approval. Google was able to get clearance to ship the Pixel Watch 3 with Loss of Pulse Detection in a few European countries, eventually expanding to 14 nations: Austria, Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and the United Kingdom. It noted at the time more countries would get access as regulators approved the feature, and the FDA was apparently the first to come through outside of Europe, boosting support to 15 countries.

loss of pulse pixel watch — Credit: Google

The Pixel Watch 3 doesn’t include any new or unique sensors to power Loss of Pulse Detection—it’s just using the sensors common to smartwatches in slightly different ways. The watch uses a “multi-path” heart rate sensor that is capable of taking readings once per second. When the sensor no longer detects a pulse, that usually means you’ve taken the watch off. It’s quick to make that determination, locking the watch in about a second. That’s great for security but a little annoying if you were readjusting it on your wrist.

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Judge orders Trump admin. to restore CDC and FDA webpages by midnight

CDC, contraceptives, datasets, Doctors for America, executive order, fda, gender, health, HIV, Policy, Teens, Trump, websites, Youth / Mike M. / February 11, 2025

“Irrational removal”

In his opinion, Bates cited the declarations from Stephanie Liou, a physician who works with low-income immigrant families and an underserved high school in Chicago, and Reshma Ramachandran, a primary care provider who relies on CDC guidance on contraceptives and sexually transmitted diseases in her practice. Both are board members of Doctors for America.

Liou testified that the removal of resources from the CDC’s website hindered her response to a chlamydia outbreak at the high school where she worked. Ramachandran, meanwhile, testified that she was left scrambling to find alternative resources for patients during time-limited appointments. Doctors for America also provided declarations from other doctors (who were not members of Doctors for America) who spoke of being “severely impacted” by the sudden loss of CDC and FDA public resources.

With those examples, Bates agreed that the removal of the information caused the doctors “irreparable harm,” in legal terms.

“As these groups attest, the lost materials are more than ‘academic references’—they are vital for real-time clinical decision-making in hospitals, clinics and emergency departments across the country,” Bates wrote. “Without them, health care providers and researchers are left ‘without up-to-date recommendations on managing infectious diseases, public health threats, essential preventive care and chronic conditions.’ … Finally, it bears emphasizing who ultimately bears the harm of defendants’ actions: everyday Americans, and most acutely, underprivileged Americans, seeking healthcare.”

Bates further noted that it would be of “minimal burden” for the Trump administration to restore the data and information, much of which has been publicly available for many years.

In a press statement after the ruling, Doctors for America and Public Citizen celebrated the restoration.

“The judge’s order today is an important victory for doctors, patients, and the public health of the whole country,” Zach Shelley, a Public Citizen Litigation Group attorney and lead counsel on the case, said in the release. “This order puts a stop, at least temporarily, to the irrational removal of vital health information from public access.”

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FDA approves first non-opioid pain medicine in more than 20 years

addiction, fda, health, opioid, pain medication, vertex / Paul Patrick / January 31, 2025

The approval “is an important public health milestone in acute pain management,” Jacqueline Corrigan-Curay, J.D., M.D., acting director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “A new non-opioid analgesic therapeutic class for acute pain offers an opportunity to mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option.”

The company behind the drug, Vertex, said a 50 mg pill that works for 12 hours will have a wholesale cost of $15.50, making the daily cost $31 and the weekly cost $217. The cost is higher than cheap, generic opioids. But, a report from The Institute for Clinical and Economic Review in December estimated that suzetrigine would be “slightly cost-saving” relative to opioids if the price was set at $420 per week, given the drug’s ability to avert opioid addiction cases.

In a statement, Reshma Kewalramani, the CEO and President of Vertex, trumpeted the approval as a “historic milestone for the 80 million people in America who are prescribed a medicine for moderate-to-severe acute pain each year … [W]e have the opportunity to change the paradigm of acute pain management and establish a new standard of care.”

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Biofilms, unwashed hands: FDA found violations at McDonald’s ex-onion supplier

E. coli, fda, food safety, health, inspection, mcdonalds, onions, outbreak, taylor farms / Tim Belzer / January 13, 2025

Perhaps most concerning, FDA inspectors noted that employees were never seen washing their hands. Instead, they wore gloves, and if they touched dirty surfaces or items, they would simply put hand sanitizer on their dirty gloves and carry on. What they should have been doing was removing their dirty gloves, washing their hands, and getting clean gloves. However, the FDA inspectors never saw this happen, and managers confirmed that hand sanitizing gloves was common practice.

The inspectors also noted that the facility’s equipment was always wet. Employees applied sanitizing solutions on knives and other equipment used to dice and chop fresh produce. The sanitizing solution is meant to be air-dried before use, but Taylor Farms employees immediately used the equipment—still dripping with sanitizing solution—to cut RTE produce.

On one day of the inspection, FDA agents saw employees chop RTE lettuce with equipment that was wet with sanitizing solution at the maximum concentration, which was 200 ppm. In another instance, the inspectors saw an employee mix cleaning chemicals together to make a sanitizing solution, which the employee said was done “routinely.” When inspectors asked about the mixture, Taylor Farms “could not find the source of this recipe,” nor could they find the manufacturer label or other information stating the mixture was designed for use.

“Highest expectations”

In a statement to CBS, Taylor Farms said that it “immediately took steps to address” the problems found in the FDA’s inspection, which resulted in no “administrative or regulatory action” against the company.

“Taylor Farms is confident in our best-in-class food safety processes, and in turn, the quality and safety of our products,” the company said in the statement. “As is common following an inspection, FDA issued observations of conditions that could be improved at one of our facilities.” The company added that “no illnesses or public health threat has been linked to these observations” in the inspection.

McDonald’s, meanwhile, said it had stopped getting onions from the facility.

“We hold our suppliers to the highest expectations and standards of food safety. Prior to this inspection, and unrelated to its findings, McDonald’s stopped sourcing from Taylor Farms’ Colorado Springs facility,” McDonald’s said in a statement.

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After decades, FDA finally moves to pull ineffective decongestant off shelves

decongestant, fda, health, phenylephrine, Science, sudafed / Kris Guyer / November 7, 2024

In a long-sought move, the Food and Drug Administration on Thursday formally began the process of abandoning oral doses of a common over-the-counter decongestant, which the agency concluded last year is not effective at relieving stuffy noses.

Specifically, the FDA issued a proposed order to remove oral phenylephrine from the list of drugs that drugmakers can include in over-the-counter products—also known as the OTC monograph. Once removed, drug makers will no longer be able to include phenylephrine in products for the temporary relief nasal congestion.

“It is the FDA’s role to ensure that drugs are safe and effective,” Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “Based on our review of available data and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant.”

For now, the order is just a proposal. The FDA will open up a public comment period, and if no comments can sway the FDA’s previous conclusion that the drug is useless, the agency will make the order final. Drugmakers will get a grace period to reformulate their products.

Reviewed reviews

The slow-moving abandonment of phenylephrine is years in the making. The decongestant was originally approved by the FDA back in 1976, but it came to prominence after 2006. That was the year when the “Combat Methamphetamine Epidemic Act of 2005” came into effect, and pseudoephedrine—the main component of Sudafed—moved behind the pharmacy counter to keep it from being used to make methamphetamine. With pseudoephedrine out of easy reach at drugstores, phenylephrine became the leading over-the-counter decongestant. And researchers had questions.

In 2007, an FDA panel reevaluated the drug, which allegedly works by shrinking blood vessels in the nasal passage, opening up the airway. While the panel upheld the drug’s approval, it concluded that more studies were needed for a full assessment. After that, three large, carefully designed studies were conducted—two by Merck for the treatment of seasonal allergies and one by Johnson & Johnson for the treatment of the common cold. All three found no significant difference between phenylephrine and a placebo.

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“Havard”-trained spa owner injected clients with bogus Botox, prosecutors say

botox, counterfeit, fda, fraud, health, Science, skin fillers, spa / Paul Patrick / November 5, 2024

Mounting evidence

Multiple clients and employees told investigators that Fadanelli also said she is a registered nurse, which is false. Though she is a registered aesthetician, aestheticians are not permitted to administer injections or prescription drugs.

Investigators set up an undercover operation where an agent went in for a consultation, and Fadanelli provided a quote for a $450 Botox treatment. Investigators also obtained videos and images of Fadanelli performing injections. And the evidence points to those injections being counterfeit, prosecutors allege. Sales records from the spa indicate that Fadanelli performed 1,631 “Botox” injections, 95 “Sculptra” injections, and 990 injections of unspecified “filler,” all totaling over $933,000. But sales records from the manufacturers of the brand name drugs failed to turn up any record of Fadanelli or anyone else from her spa ever purchasing legitimate versions of the drugs.

Despite the mounting evidence against her, Fadanelli reportedly stuck to her story, denying that she ever told anyone she was a nurse and denying ever administering any injections. “When agents asked Fadanelli if she would like to retract or modify that claim if she knew there was evidence showing that she was in fact administering such products, she reiterated that she does not administer injections.”

Ars has reached to Fadanelli’s spa for comment and will update this story if we get a response. According to the affidavit, clients who received the allegedly bogus injections complained of bumps, tingling, and poor appearances, but no infections or other adverse health outcomes.

In a press release announcing her arrest, Acting United States Attorney for Massachusetts Joshua Levy said: “For years, Ms. Fadanelli allegedly put unsuspecting patients at risk by representing herself to be a nurse and then administering thousands of illegal, counterfeit injections. … The type of deception alleged here is illegal, reckless, and potentially life-threatening.”

For a charge of illegal importation, Fadanelli faces up to 20 years in prison and a $250,000 fine. For each of two charges of knowingly selling or dispensing a counterfeit drug or counterfeit device, she faces up to 10 years in prison and a fine of $250,000.

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Drugmaker shut down after black schmutz found in injectable weight-loss drug

compounding pharmacies, eli lilly, fda, health, mounjaro, Novo Nordisk, Ozempic, safety, Science, wegovy, weight loss drugs, zepbound / Mike M. / November 4, 2024

It’s unclear how widely the pharmacy’s drugs were distributed. Fullerton Wellness could not be reached for comment.

Bigger battles

This is just the latest warning on weight-loss drugs from the FDA, which has repeatedly cautioned about quality and safety problems related to compounded versions of the drugs. The compounded drugs are intended to be essentially copycat versions of the blockbuster brand-name drugs. Compounding pharmacies can make copycat versions only as long as the drugs are in short supply, acting as a stopgap for patient access. But, with the popularity of the drugs and the high prices of the brand name versions, compounded formulations have become seen as affordable alternatives for many patients.

The situation has become a legal quagmire, with less-than-scrupulous compounding facilities drawing the ire of the FDA, and the big pharmaceutical companies fighting with their compounding competition. Eli Lilly, maker of Zepbound and Mounjaro (tirzepatide), and Novo Nordisk, maker of Wegovy and Ozempic (semaglutide), have both sued multiple compounding pharmacies over copycat versions of their lucrative drugs, which they claim are unsafe and fraudulent.

Meanwhile, in October, a trade organization for large-scale compounding pharmacies sued the FDA after the regulator removed tirzepatide from the drug shortage list, a move that blocks compounders from making copycat versions of the drug. But, the FDA quickly backpedaled in court, saying it would reconsider the removal and would allow compounders to keep producing off-brand versions in the meantime.

Also in October, Novo Nordisk asked the FDA to stop letting compounders make copycat versions of semaglutide, arguing that the drug is too complex for compounders to make and poses too many safety risks to patients. In response, the trade organization for compounders, the Outsourcing Facilities Association, submitted a letter to the FDA asking it to require Novo Nordisk to provide an economic impact statement to assess the cost and price increases that could occur if semaglutide were no longer available through compounding pharmacies.

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