fda

under-rfk-jr.,-covid-shots-will-only-be-available-to-people-65+,-high-risk-groups

Under RFK Jr., COVID shots will only be available to people 65+, high-risk groups

anti-vaccine, boosters, CDC, COVID-19, fda, health, robert f kennedy jr, vaccines / /

FDA will require big, pricy trials for approvals for healthy kids and adults

U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. testifies before the Senate Committee on Health, Education, Labor, and Pensions on Capitol Hill on May 20, 2025 in Washington, DC. Credit: Getty | Tasos Katopodis

Under the control of anti-vaccine advocate Robert F. Kennedy Jr., the Food and Drug Administration is unilaterally terminating universal access to seasonal COVID-19 vaccines; instead, only people who are age 65 years and older and people with underlying conditions that put them at risk of severe COVID-19 will have access to seasonal boosters moving forward.

The move was laid out in a commentary article published today in the New England Journal of Medicine, written by Trump administration FDA Commissioner Martin Makary and the agency’s new top vaccine regulator, Vinay Prasad.

The article lays out a new framework for approving seasonal COVID-19 vaccines, as well as a rationale for the change—which was made without input from independent advisory committees for the Food and Drug Administration and the Centers for Disease Control and Prevention.

Normally, the FDA’s VRBPAC (Vaccines and Related Biological Products Advisory Committee) and the CDC’s ACIP (Advisory Committee on Immunization Practices) would publicly review, evaluate, and discuss vaccine approvals and recommendations. Typically, the FDA’s scope focuses on licensure decisions, made with strong influence from VRBPAC, while the CDC’s ACIP is principally responsible for influencing the CDC’s more nuanced recommendations on usage, such as for specific age or risk groups. These recommendations shape clinical practice and, importantly, health insurance coverage.

Makary and Prasad appear to have foregone those norms, even though VRBPAC is set to meet this Thursday to discuss COVID-19 vaccines for the upcoming season.

Restrictions

In the commentary, Markary and Prasad puzzlingly argue that the previous universal access to COVID-19 vaccines was patronizing to Americans. They describe the country’s approach to COVID boosters as a “one-size-fits-all” and write that “the US policy has sometimes been justified by arguing that the American people are not sophisticated enough to understand age- and risk-based recommendations. We reject this view.”

Previously, the seasonally updated vaccines were available to anyone age 6 months and up. Further, people age 65 and older and those at high risk were able to get two or more shots, based on their risk. So, while Makary and Prasad ostensibly reject the view of Americans as being too unsophisticated to understand risk-based usage, the pair are installing restrictions to force their own idea of risk-based usage.

Even more puzzlingly, in an April meeting of ACIP, the expert advisors expressed clear support for shifting from universal recommendations for COVID-19 boosters to recommendations based on risk. Specifically, advisors were supportive of urging boosters for people age 65 and older and people who are at risk of severe COVID-19—the same restrictions that Makary and Prasad are forcing. The two regulators do not mention this in their NEJM commentary. ACIP would also likely recommend a primary series of seasonally matched COVID-19 vaccines for very young children who have not been previously exposed to the virus or vaccinated.

ACIP will meet again in June, but without a permissive license from the FDA, ACIP’s recommendations for risk-based usage of this season’s COVID-19 shots are virtually irrelevant. And they cannot recommend usage in groups that the FDA licensure does not cover. It’s unclear if a primary series for young children will be available and, if so, how that will be handled moving forward.

New vaccine framework

Under Makary and Prasad’s new framework, seasonally updated COVID-19 vaccines can continue to be approved annually using only immunology studies—but the approvals will only be for people age 65 and over and people who are at high risk. These immunology studies look at antibody responses to boosters, which offer a shorthand for efficacy in updated vaccines that have already been through rigorous safety and efficacy trials. This is how seasonal flu shots are approved each year and how COVID boosters have been approved for all people age 6 months and up—until now.

Moving forward, if a vaccine maker wants to have their COVID-19 vaccine also approved for use in healthy children and healthy adults under age 65, they will have to conduct large, randomized, placebo-controlled studies. These may need to include tens of thousands of participants, especially with high levels of immunity in the population now. These trials can easily cost hundreds of millions of dollars, and they can take many months to complete. The requirement for such trials will make it difficult, if not impossible, for drug makers to conduct them each year and within a timeframe that will allow for seasonal shots to complete the trial, get regulatory approval, and be produced at scale in time for the start of the respiratory virus season.

Makary and Prasad did not provide any data analysis or evidence-based reasoning for why additional trials would be needed to continue seasonal approvals. In fact, the commentary had a total of only eight references, including an opinion piece Makary published in Newsweek and a New York Times article.

“We simply don’t know whether a healthy 52-year-old woman with a normal BMI who has had COVID-19 three times and has received six previous doses of a COVID-19 vaccine will benefit from the seventh dose,” they argue in their commentary.

Their new framework does not make any mention of what will happen if a more dangerous SARS-CoV-2 variant emerges. It also made no mention of vaccine usage in people who are in close contact with high-risk groups, such as ICU nurses or family members of immunocompromised people.

Context

Another lingering question from the framework is how easy it will be for people deemed at high risk to get access to seasonal shots. Makary and Prasad lay out a long list of conditions that would put people at risk of severe COVID-19 and therefore make them eligible for a seasonal booster. The list includes: obesity; asthma; lung diseases; HIV; diabetes; pregnancy; gestational diabetes; heart conditions; use of corticosteroids; dementia; physical inactivity; mental health conditions, including depression; and smoking, current or former. The FDA leaders estimate that between 100 million and 200 million Americans will fit into the category of being at high risk. It’s unclear what such a large group of Americans will need to do to establish eligibility every year.

In all, the FDA’s move to restrict and hinder access to seasonal COVID-19 vaccines is in line with Kennedy’s influential anti-vaccine advocacy work. In 2021, prior to taking the role of the country’s top health official, Kennedy and the anti-vaccine organization he founded, Children’s Health Defense, petitioned the FDA to revoke authorizations for COVID-19 vaccines and refrain from issuing any approvals.

Ironically, Makary and Prasad blame the country’s COVID-19 policies for helping to erode Americans’ trust in vaccines broadly.

“There may even be a ripple effect: public trust in vaccination in general has declined, resulting in a reluctance to vaccinate that is affecting even vital immunization programs such as that for measles–mumps–rubella (MMR) vaccination, which has been clearly established as safe and highly effective,” the two write, including the most full-throated endorsement of the MMR vaccine the Trump administration has issued yet. Kennedy continues to spread misinformation about the vaccine, including the false and debunked idea that it causes autism.

“Against this context, the Food and Drug Administration seeks to provide guidance and foster evidence generation,” Makary and Prasad write.

Photo of Beth Mole

Beth is Ars Technica’s Senior Health Reporter. Beth has a Ph.D. in microbiology from the University of North Carolina at Chapel Hill and attended the Science Communication program at the University of California, Santa Cruz. She specializes in covering infectious diseases, public health, and microbes.

Under RFK Jr., COVID shots will only be available to people 65+, high-risk groups Read More »

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From birth to gene-edited in 6 months: Custom therapy breaks speed limits

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In the boy’s fourth month, researchers were meeting with the Food and Drug Administration to discuss regulatory approval for a clinical trial—a trial where KJ would be the only participant. They were also working with the institutional review board (IRB) at Children’s Hospital of Philadelphia to go over the clinical protocol, safety, and ethical aspects of the treatment. The researchers described the unprecedented speed of the oversight steps as being “through alternative procedures.”

In month five, they started toxicology testing in mice. In the mice, the experimental therapy corrected KJ’s mutation, replacing the errant A-T base pair with the correct G-C pair in the animals’ cells. The first dose provided a 42 percent whole-liver corrective rate in the animals. At the start of KJ’s sixth month, the researchers had results from safety testing in monkeys: Their customized base-editing therapy, delivered as mRNA via a lipid nanoparticle, did not produce any toxic effects in the monkeys.

A clinical-grade batch of the treatment was readied. In month seven, further testing of the treatment found acceptably low-levels of off-target genetic changes. The researchers submitted the FDA paperwork for approval of an “investigational new drug,” or IND, for KJ. The FDA approved it in a week. The researchers then started KJ on an immune-suppressing treatment to make sure his immune system wouldn’t react to the gene-editing therapy. Then, when KJ was still just 6 months old, he got a first low dose of his custom gene-editing therapy.

“Transformational”

After the treatment, he was able to start eating more protein, which would have otherwise caused his ammonia levels to skyrocket. But he couldn’t be weaned off of the drug treatment used to keep his ammonia levels down (nitrogen scavenging medication). With no safety concerns seen after the first dose, KJ has since gotten two more doses of the gene therapy and is now on reduced nitrogen scavenging medication. With more protein in his diet, he has moved from the 9th percentile in weight to 35th or 40th percentile. He’s now about 9 and a half months old, and his doctors are preparing to allow him to go home from the hospital for the first time. Though he will have to be closely monitored and may still at some point need a liver transplant, his family and doctors are celebrating the improvements so far.

From birth to gene-edited in 6 months: Custom therapy breaks speed limits Read More »

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Trump admin picks COVID critic to be top FDA vaccine regulator

COVID-19, fda, health, nazis, pandemic, vinay prasad / /

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.”

Trump admin picks COVID critic to be top FDA vaccine regulator Read More »

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Seasonal COVID shots may no longer be possible under Trump admin

COVID-19, fda, health, makary, Trump, vaccines / /

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.

Seasonal COVID shots may no longer be possible under Trump admin Read More »

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FDA backpedals on RTO to stop talent hemorrhage after HHS bloodbath

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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.

FDA backpedals on RTO to stop talent hemorrhage after HHS bloodbath Read More »

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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 / /

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.

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

“this-will-be-a-painful-period”:-rfk-jr-slashes-24%-of-us-health-dept.

“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 / /

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.

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

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

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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.

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

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

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“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.”

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

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

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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.”

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

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

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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.

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

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

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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.

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