The Latest NewsThe number of high school students who reported using e-cigarettes fell to 10 percent in the spring of this year from 14 percent last year, according to the results of an annual survey released on Thursday by federal health agencies.Vaping rose slightly among middle school students, to 4.6 percent this year from 3.3 percent in 2022. The use of traditional cigarettes among high school students remained at a record low of less than 2 percent.The decline in high school vaping rates was “encouraging,” said Linda Neff, an official with the Centers for Disease Control and Prevention and the lead author on the latest survey report. But she said the results for older teenagers were tempered by very small increases in middle school students reporting tobacco use.Puff Bar e-cigarettes.Jenna Schoenefeld for The New York TimesWhat’s Behind the Numbers: Flavor bans may have had an effect.One thing is clear about underage e-cigarette use: Adolescents like flavors. About 90 percent of the students who reported vaping said they used flavored products, citing favorites that tasted like fruit and candy.Teenagers identified Elf Bar and Esco Bar as their favorite brands, well-known for flavors such as strawberry kiwi and watermelon ice.Public health advocates in California recognized the allure, leading to a yearslong fight to pass a ban on flavored tobacco products, which took effect in December. It quickly led to falling sales, according to data from the C.D.C. Foundation. From December 2022 to June of this year, flavored e-cigarette sales fell by nearly 70 percent, to 179,000 from about 575,000 vapes or refills.The ban no doubt made it harder for young people to buy vapes in California, where you must be 21 to buy tobacco products.Public health experts also linked other state and local flavor bans and education campaigns to the falling high school vaping rate, which is the lowest in nearly a decade. And a few years ago, under public pressure, Juul, which had once been the most popular brand, withdrew most of its flavors from the market.The survey was given in about 180 schools nationwide, and was released by the C.D.C. and the Food and Drug Administration. It reported on e-cigarette use in the last 30 days but did not include any state-specific information.In all, about 2.1 million middle and high school students reported using e-cigarettes, down from 2.5 million last year. But surveys conducted during a few previous years since the peak of the vaping crisis in 2019 have carried notes of caution about drawing strict comparisons year-to-year because of pandemic conditions when students were in and out of school.Why It Matters: Studies identify health risks of vaping for teenagers.Federal officials who regulate e-cigarettes see their use as an aid in helping adult smokers quit traditional cigarettes, given the well-known cancer risks.But e-cigarette use has become wildly popular among nonsmokers. About 40 percent of people who use e-cigarettes are under 25, including many who started when Juul was first introduced. A majority of those young people never smoked before vaping, according to the C.D.C.The health effects are well known by now. One recent University of Southern California study noted the toxicity of the chemicals in e-cigarettes and sent questionnaires to adolescents who vaped. It found significant increases in wheezing, shortness of breath and bronchitis symptoms. And many experts have expressed concerns about the effect of nicotine addiction on the adolescent’s developing brain.What’s Next: A proposed menthol ban and heightened enforcement of illegal imports.The F.D.A. is moving toward a ban on menthol cigarettes and is advancing a proposal to drastically cut nicotine levels in cigarettes. That has led legacy tobacco companies to embrace e-cigarette sales as the way forward in the marketplace to offset overall declining cigarette sales.Yet those companies — along with many lawmakers in Congress and antismoking groups — say they have been dismayed with what they consider lax enforcement by the F.D.A. While the agency has authorized about two dozen vaping products for sale, thousands of illicit candy-colored flavored vapes have flooded the country and are top sellers.The F.D.A. said it would press ahead with its enforcement efforts, including its import ban on Elf Bar and Esco Bar products and fines on retailers who continue to sell them. The agency has issued warning letters to makers of those vapes and many others.Brian King, the F.D.A.’s tobacco division chief, welcomed the findings, but said: “We can’t rest on our laurels. There’s more work to be done to build on this progress.”Dr. Neff said her agency needed to better understand why there was a small but significant increase in middle school use of any tobacco product, to 6.6 percent this year from 4.5 percent last year.“Our work is far from done,” Dr. Neff said.Other researchers noted that the combined general use of tobacco products by middle and high school students barely fell, to 10 percent this year from 11 percent last year. “On balance, it’s no change in the overall youth tobacco use,” said Karen Knudsen, chief executive of the American Cancer Society. “And that’s concerning.”

The F.D.A. has approved many new programs that use artificial intelligence, but doctors are skeptical that the tools really improve care or are backed by solid research.In medicine, the cautionary tales about the unintended effects of artificial intelligence are already legendary.There was the program meant to predict when patients would develop sepsis, a deadly bloodstream infection, that triggered a litany of false alarms. Another, intended to improve follow-up care for the sickest patients, appeared to deepen troubling health disparities.Wary of such flaws, physicians have kept A.I. working on the sidelines: assisting as a scribe, as a casual second opinion and as a back-office organizer. But the field has gained investment and momentum for uses in medicine and beyond.Within the Food and Drug Administration, which plays a key role in approving new medical products, A.I. is a hot topic. It is helping to discover new drugs. It could pinpoint unexpected side effects. And it is even being discussed as an aid to staff who are overwhelmed with repetitive, rote tasks.Yet in one crucial way, the F.D.A.’s role has been subject to sharp criticism: how carefully it vets and describes the programs it approves to help doctors detect everything from tumors to blood clots to collapsed lungs.“We’re going to have a lot of choices. It’s exciting,” Dr. Jesse Ehrenfeld, president of the American Medical Association, a leading doctors’ lobbying group, said in an interview. “But if physicians are going to incorporate these things into their workflow, if they’re going to pay for them and if they’re going to use them — we’re going to have to have some confidence that these tools work.”From doctors’ offices to the White House and Congress, the rise of A.I. has elicited calls for heightened scrutiny. No single agency governs the entire landscape. Senator Chuck Schumer, Democrat of New York and the majority leader, summoned tech executives to Capitol Hill in September to discuss ways to nurture the field and also identify pitfalls.Google has already drawn attention from Congress with its pilot of a new chatbot for health workers. Called Med-PaLM 2, it is designed to answer medical questions, but has raised concerns about patient privacy and informed consent.Dr. Eric Topol is an optimist about A.I.’s potential in medicine. But, he cautioned, “you have to have really compelling, great data to change medical practice and to exude confidence that this is the way to go.”Kirsty O’Connor/PA Images, via AlamyHow the F.D.A. will oversee such “large language models,” or programs that mimic expert advisers, is just one area where the agency lags behind rapidly evolving advances in the A.I. field. Agency officials have only begun to talk about reviewing technology that would continue to “learn” as it processes thousands of diagnostic scans. And the agency’s existing rules encourage developers to focus on one problem at a time — like a heart murmur or a brain aneurysm — a contrast to A.I. tools used in Europe that scan for a range of problems.The agency’s reach is limited to products being approved for sale. It has no authority over programs that health systems build and use internally. Large health systems like Stanford, Mayo Clinic and Duke — as well as health insurers — can build their own A.I. tools that affect care and coverage decisions for thousands of patients with little to no direct government oversight.Still, doctors are raising more questions as they attempt to deploy the roughly 350 software tools that the F.D.A. has cleared to help detect clots, tumors or a hole in the lung. They have found few answers to basic questions: How was the program built? How many people was it tested on? Is it likely to identify something a typical doctor would miss?The lack of publicly available information, perhaps paradoxical in a realm replete with data, is causing doctors to hang back, wary that technology that sounds exciting can lead patients down a path to more biopsies, higher medical bills and toxic drugs without significantly improving care.Dr. Eric Topol, author of a book on A.I. in medicine, is a nearly unflappable optimist about the technology’s potential. But he said the F.D.A. had fumbled by allowing A.I. developers to keep their “secret sauce” under wraps and failing to require careful studies to assess any meaningful benefits.“You have to have really compelling, great data to change medical practice and to exude confidence that this is the way to go,” said Dr. Topol, executive vice president of Scripps Research in San Diego. Instead, he added, the F.D.A. has allowed “shortcuts.”Large studies are beginning to tell more of the story: One found the benefits of using A.I. to detect breast cancer and another highlighted flaws in an app meant to identify skin cancer, Dr. Topol said.Dr. Jeffrey Shuren, the chief of the F.D.A.’s medical device division, has acknowledged the need for continuing efforts to ensure that A.I. programs deliver on their promises after his division clears them. While drugs and some devices are tested on patients before approval, the same is not typically required of A.I. software programs.One new approach could be building labs where developers could access vast amounts of data and build or test A.I. programs, Dr. Shuren said during the National Organization for Rare Disorders conference on Oct. 16.“If we really want to assure that right balance, we’re going to have to change federal law, because the framework in place for us to use for these technologies is almost 50 years old,” Dr. Shuren said. “It really was not designed for A.I.”Other forces complicate efforts to adapt machine learning for major hospital and health networks. Software systems don’t talk to each other. No one agrees on who should pay for them.Dr. Nina Kottler, chief medical officer for clinical A.I. for Radiology Partners, has been leading a multiyear, multimillion-dollar effort to vet F.D.A.-cleared A.I. programs.Laylah Amatullah Barrayn for The New York TimesBy one estimate, about 30 percent of radiologists (a field in which A.I. has made deep inroads) are using A.I. technology. Simple tools that might sharpen an image are an easy sell. But higher-risk ones, like those selecting whose brain scans should be given priority, concern doctors if they do not know, for instance, whether the program was trained to catch the maladies of a 19-year-old versus a 90-year-old.Aware of such flaws, Dr. Nina Kottler is leading a multiyear, multimillion-dollar effort to vet A.I. programs. She is the chief medical officer for clinical A.I. at Radiology Partners, a Los Angeles-based practice that reads roughly 50 million scans annually for about 3,200 hospitals, free-standing emergency rooms and imaging centers in the United States.She knew diving into A.I. would be delicate with the practice’s 3,600 radiologists. After all, Geoffrey Hinton, known as the “godfather of A.I.,” roiled the profession in 2016 when he predicted that machine learning would replace radiologists altogether.Dr. Kottler said she began evaluating approved A.I. programs by quizzing their developers and then tested some to see which programs missed relatively obvious problems or pinpointed subtle ones.She rejected one approved program that did not detect lung abnormalities beyond the cases her radiologists found — and missed some obvious ones.Another program that scanned images of the head for aneurysms, a potentially life-threatening condition, proved impressive, she said. Though it flagged many false positives, it detected about 24 percent more cases than radiologists had identified. More people with an apparent brain aneurysm received follow-up care, including a 47-year-old with a bulging vessel in an unexpected corner of the brain.At the end of a telehealth appointment in August, Dr. Roy Fagan realized he was having trouble speaking to the patient. Suspecting a stroke, he hurried to a hospital in rural North Carolina for a CT scan.The image went to Greensboro Radiology, a Radiology Partners practice, where it set off an alert in a stroke-triage A.I. program. A radiologist didn’t have to sift through cases ahead of Dr. Fagan’s or click through more than 1,000 image slices; the one spotting the brain clot popped up immediately.The radiologist had Dr. Fagan transferred to a larger hospital that could rapidly remove the clot. He woke up feeling normal.“It doesn’t always work this well,” said Dr. Sriyesh Krishnan, of Greensboro Radiology, who is also director of innovation development at Radiology Partners. “But when it works this well, it’s life changing for these patients.”Dr. Fagan wanted to return to work the following Monday, but agreed to rest for a week. Impressed with the A.I. program, he said, “It’s a real advancement to have it here now.”Dr. Jesse Ehrenfeld, the American Medical Association president. “If physicians are going to incorporate these things into their workflow,” he said, “we’re going to have to have some confidence that these tools work.”David Kasnic for The New York TimesRadiology Partners has not published its findings in medical journals. Some researchers who have, though, highlighted less inspiring instances of the effects of A.I. in medicine.University of Michigan researchers examined a widely used A.I. tool in an electronic health-record system meant to predict which patients would develop sepsis. They found that the program fired off alerts on one in five patients — though only 12 percent went on to develop sepsis.Another program that analyzed health costs as a proxy to predict medical needs ended up depriving treatment to Black patients who were just as sick as white ones. The cost data turned out to be a bad stand-in for illness, a study in the journal Science found, since less money is typically spent on Black patients.Those programs were not vetted by the F.D.A. But given the uncertainties, doctors have turned to agency approval records for reassurance. They found little. One research team looking at A.I. programs for critically ill patients found evidence of real-world use “completely absent” or based on computer models. The University of Pennsylvania and University of Southern California team also discovered that some of the programs were approved based on their similarities to existing medical devices — including some that did not even use artificial intelligence.Another study of F.D.A.-cleared programs through 2021 found that of 118 A.I. tools, only one described the geographic and racial breakdown of the patients the program was trained on. The majority of the programs were tested on 500 or fewer cases — not enough, the study concluded, to justify deploying them widely.Dr. Keith Dreyer, a study author and chief data science officer at Massachusetts General Hospital, is now leading a project through the American College of Radiology to fill the gap of information. With the help of A.I. vendors that have been willing to share information, he and colleagues plan to publish an update on the agency-cleared programs.That way, for instance, doctors can look up how many pediatric cases a program was built to recognize to inform them of blind spots that could potentially affect care.James McKinney, an F.D.A. spokesman, said the agency’s staff members review thousands of pages before clearing A.I. programs, but acknowledged that software makers may write the publicly released summaries. Those are not “intended for the purpose of making purchasing decisions,” he said, adding that more detailed information is provided on product labels, which are not readily accessible to the public.Getting A.I. oversight right in medicine, a task that involves several agencies, is critical, said Dr. Ehrenfeld, the A.M.A. president. He said doctors have scrutinized the role of A.I. in deadly plane crashes to warn about the perils of automated safety systems overriding a pilot’s — or a doctor’s — judgment.He said the 737 Max plane crash inquiries had shown how pilots weren’t trained to override a safety system that contributed to the deadly collisions. He is concerned that doctors might encounter a similar use of A.I. running in the background of patient care that could prove harmful.“Just understanding that the A.I. is there should be an obvious place to start,” Dr. Ehrenfeld said. “But it’s not clear that that will always happen if we don’t have the right regulatory framework.”

R.J. Reynolds menthol e-cigarettes are top sellers with an estimated $1.6 billion in annual sales. The company vowed to fight the ruling in court.The Food and Drug Administration has ordered R.J. Reynolds to stop selling its popular Vuse Alto menthol e-cigarettes, a decision Reynolds immediately said it would challenge in court.On Thursday, the agency denied applications by Reynolds to keep its top-selling menthol products permanently on the market, saying that the company did not meet the federal standards that require the e-cigarettes to provide more of a health benefit than a risk. In the case of the Vuse vapes, the F.D.A. said the risks of attracting young people to the popular menthol and flavored products outweighed the potential for helping traditional smokers quit.The decision does not apply to the company’s tobacco-flavored products.Some public health experts have viewed the federal agency’s most recent rejections of menthol e-cigarettes as an indication that the agency is more strictly limiting menthol products. The F.D.A. is expected, perhaps by the end of this year, to move toward outlawing all menthol cigarettes, including Newports, a top seller for Reynolds with $7.5 billion in annual sales, according to Goldman Sachs research.British American Tobacco, the parent company of R.J. Reynolds, said in a statement that the F.D.A.’s latest ruling “flies in the face of proven science.” The company said it would fight the decision in court, which could allow Reynolds to keep the disputed Vuse products on the market indefinitely.Juul and other e-cigarette makers that are appealing similar agency decisions have been permitted to keep their vaping products on the shelves during litigation.If the F.D.A. were to succeed in court against Reynolds, the company would be dealt a severe financial blow. Market data analyzed by Goldman Sachs indicates that the menthol variety is the top seller of Vuse products, and those menthol vapes make up about 29 percent of the U.S. e-cigarette market, representing $1.6 billion in sales. Overall, Vuse products, including tobacco-flavored products, comprise 40 percent of the market.The F.D.A. has had the authority to determine the sale of e-cigarettes since 2016. It has denied millions of applications either for products to stay on the market or for the sale of new vaping devices. The agency has pledged to decide every application by the end of this year.Antismoking groups and others have urged the F.D.A. to more tightly regulate the e-cigarette market, and noted that a recent survey of middle and high school students showed that Vuse vapes were a popular choice among those who used e-cigarettes.Reynolds has tried to position its products to regulators as legitimate alternatives for adults in an e-cigarette space flooded with illicit products. The company volunteered to stop selling its mixed berry flavor, which was also denied marketing authorization by the F.D.A. on Thursday.“Central to the efficacy of any regulated market is the rule of law — where good behavior is encouraged, and bad behavior punished,” Kingsley Wheaton, a British American Tobacco executive, said in the company’s statement. “We also remain deeply concerned that the F.D.A. continues to allow the proliferation of youth-appealing vapor products like Cotton Candy and Peanut Butter Cookie, which are flooding U.S. retail shelves. Companies in open defiance of the agency must be held accountable.”But Reynolds is contesting other restrictions. It has filed suit in California against the state’s new ban on flavored tobacco, after the state attorney general warned the company and another about marketing products that were said to have a “cooling” flavor.Yolonda Richardson, president of the Campaign for Tobacco-Free Kids, applauded the F.D.A.’s decision on Vuse, saying it was “one of the strongest actions the F.D.A. has taken to rid the market of illegal, flavored e-cigarettes and is a necessary step toward ending the youth e-cigarette crisis in the United States.”Alex Liber, a Georgetown University assistant professor and tobacco control policy researcher, recently worked on a paper linking flavored-vape bans to an increase in cigarette sales.He said the F.D.A. appeared to be on a path of authorizing only vapes that taste like a cigarette. The agency has rejected other menthol e-cigarette applications, deeming them too alluring to adolescents to outweigh the benefit to adults.“Whatever that bar and evidence is, I don’t think anyone has hit it,” Dr. Liber said. “I don’t know if F.D.A. knows what it looks like. I don’t know what that would be.”

Some vapes are appearing with increasing nicotine levels that approach those in a carton of cigarettes. U.S. regulators did not authorize them, but have failed to keep them off shelves.Juul was once the cool vape, blamed for hooking teenagers on e-cigarettes, and it is set to pay billions of dollars in legal settlements.Then came Puff Bar, which was hot in high schools until federal officials began impounding those vapes. Elf Bar stepped in, and its products have been seized at the border. A parade of facsimiles is moving in right behind them: Virtue Bar, Juicy Bar, Lost Mary, Lost Vape and many more.The latest flood of illicit e-cigarettes is arriving from China in Barbiecore colors and fruit, ice cream and slushy flavors, and accounts for a major share of the estimated $5.5 billion e-cigarette market in the United States.The never-ending influx of vapes, some offering 5,000 or more puffs per device or escalating nicotine levels, has exposed a gaping lapse in enforcement by the Food and Drug Administration, which has authorized only a handful of the hundreds of options that line convenience store walls nationwide. Members of Congress, two dozen state attorneys general and even the Big Tobacco companies have stepped up their calls for the agency to get the situation under control.Granted, the latest pleas by the tobacco industry are viewed by antismoking groups as a cringe-worthy effort to lock down market share, but some others interpret the addition of these odd bedfellows as a sign of a market run amok.The F.D.A. “has been dealt a very difficult hand, and a lot of which includes putting the genie back — or stuffing the genie back — in the bottle,” said Erika Sward, assistant vice president of advocacy for the American Lung Association. “And I don’t envy them for that.”Agency officials said they had used every tool within their authority to crack down on e-cigarette outlaws. Yet recent fines issued by the agency topped out at about $19,000 per violation and largely targeted a few products sold at each store. The agency’s orders telling six manufacturers to stop selling certain products were directed at U.S. stores, some of which were in small cities.And though the F.D.A. has fired off hundreds of warning letters, the effect is barely felt: Flavored vape sales have surged 60 percent over the past three years, to 18 million vaping products a month in June from 11 million a month in early 2020, according to the C.D.C. Foundation.“The F.D.A. should not be having any of these flavored e-cigarettes on the market,” said Yolonda Richardson, president of the Campaign for Tobacco-Free Kids. “And so it just needs to do its job.”When the F.D.A. received expanded authority to regulate e-cigarettes in 2016, the objective was to draw a new line in public health: Smokers would have an alternative to traditional cigarettes, and tobacco use among minors would remain at historic lows.Seven years on, nearly 40 percent of e-cigarette users are 25 or younger, according to the Centers for Disease Control and Prevention. And of the 2,000 or so vaping and e-cigarette products on the market, the agency has only given the green light to about two dozen of them, and it still has to deal with a backlog of applications, according to research on the industry.There are few places where the problem feels more pressing than in high school bathrooms, where students crowd the stalls between classes to get a nicotine fix.Kyle Wimmer, an art teacher at Mountain Range High School in Westminster, Colo., helps students quit vaping through creating artwork out of relinquished vape pens.Kevin Mohatt for The New York TimesTeenage vaping rates have fallen roughly by half since their height during the Juul craze of 2019, to about 14 percent of high school students last year from nearly 28 percent at their peak, federal surveys show. Those rates were based on survey responses in which students said whether they had vaped within the past 30 days.Kyle Wimmer, an art teacher at Mountain Range High School, north of Denver, frequently hears from students dealing with nicotine addiction from e-cigarette use.He accepts discarded vapes and helps young people turn them into art. And as a teacher who has been open about his past struggles with alcohol, he’s also there to listen.“It’s hard to tell kids not to do this when they’re hooked because they can’t just stop,” Mr. Wimmer said, adding: “They’re having troubles. They’re struggling.”A vape-inspired piece at Mountain Range High School. “It’s hard to tell kids not to do this when they’re hooked because they can’t just stop,” Mr. Wimmer said.Kevin Mohatt for The New York TimesA growing body of research shows that while vapes may not be as toxic as cigarettes, they are far from healthy, particularly for adolescents who become addicted to nicotine while their brains are still developing.The American Heart Association has raised the alarm about possible cardiovascular effects from e-cigarettes and called for more research. One recent meta-analysis reported higher heart attack risks in e-cigarette users than in those who did not vape or smoke anything. (Cigarette smokers had the highest risk.)In recent years, the market has begun to move toward high-volume vapes advertising 5,000 to 6,000 puffs — with about as much addictive nicotine as is in a carton of cigarettes. The devices come in flavors that could appeal to younger adolescents such as birthday shake, gummy bear and watermelon ice, and they have higher concentrations of nicotine than were found before. The prices have also dropped, said Barbara Schillo, chief research officer for the Truth Initiative, who documented the trend in a recent study.“In other words, these disposable devices are getting bigger, stronger and cheaper,” Dr. Schillo said.Calls for change have only grown louder. In a letter sent in late August, 30 state attorneys general urged the F.D.A. to do more to deter youth vaping and to ban all but tobacco flavored e-cigarettes.Lawmakers, including Senator Richard J. Durbin, Democrat of Illinois and a leading opponent of e-cigarettes, have pushed for action. His office discovered nearly two dozen types of vapes being sold online even after the F.D.A. had denied their marketing applications and sent them warning letters.“I just don’t understand it,” Senator Durbin said in a floor speech last month, adding that the F.D.A. “is cowardly, refusing to use its full arsenal of enforcement tools — fines, injunctions — for even these most flagrant cases.”Even R.J. Reynolds, the maker of Newport and Camel cigarettes and the best-selling Vuse vapes, has invoked public health in a petition lodged with the F.D.A. seeking official action. It asked the agency to prioritize enforcement of flavored, disposable vapes.Luis Pinto, a spokesman for the company, said that devices aimed at young people and minors threatened the efforts of Reynolds and others to convert adult smokers to e-cigarette users. “The whole category is in peril,” he said.Reynolds’s Vuse e-cigarettes led vaping sales for a year ending in August, Goldman Sachs data shows, with $2.2 billion in sales. The “other” category, which included flavored imports, trailed with $1.6 billion in sales, with Juul close behind.Brian King, the F.D.A.’s tobacco center chief, said that the agency had ramped up warnings, fines and injunctions on illicit vape makers, sellers and distributors. He rebutted some of the criticism from “the cheap seats” and said enforcement efforts needed to be strategic and methodical.“It’s a very complex chess match, not a game of tic-tac-toe,” Dr. King said. “And we need to ensure that the actions we take are both scientifically and legally defensible.”The F.D.A. has been working with border authorities to seize imports of Elf Bar and Esco Bar products from China.Andrew Harnik/Associated PressF.D.A. officials meet regularly with Justice Department prosecutors, Dr. King said, describing them as critical partners. The agency has also worked with border authorities to seize imports of Elf Bar and Esco Bar products, he added. In addition, the agency has received funding to begin an effort to closely track the rapidly morphing vape marketplace.“Nothing’s off the table when it comes to enforcement,” he said.In late September, the F.D.A. announced 22 fines of $19,192 each against gas stations that received warning letters but did not stop selling Elf Bar products.The F.D.A. has required e-cigarette makers to file applications to sell their products and to submit proof that the products would be likely to compel cigarette smokers to switch — but not to attract new users. The agency has denied millions of applications and let some top-selling products remain on market pending decisions.Two years have passed since a court-imposed deadline required the F.D.A. to respond to all applications. Dr. King said it would finalize decisions, including on some Vuse and Juul vapes, by the year’s end.The lengthy, opaque approval process, marked with legal challenges and defiance of the F.D.A.’s decrees, has opened the door to the shape-shifting influx of unauthorized vapes that come by air, land and sea from factories in China (where flavored vapes are outlawed).The confusing mix of product statuses has prompted the Energy Marketers of America, an organization representing retailers, including convenience stores linked to gas stations, to file a petition with the F.D.A. seeking clarity about which e-cigarettes the stores can legally sell.Stores are “well positioned to aid in the fight against illegal and dangerous products by keeping them off their shelves,” according to the petition.

Genetic testing that reveals potential cancer risks or other maladies with no regulatory oversight is among the targets of the agency’s proposed review.The Food and Drug Administration said on Friday that it was moving to close what has widely been viewed as a loophole allowing certain lab tests — like those that determine the profile of a tumor or the genetic health of a fetus — to bypass review with virtually no tracking or oversight.The agency proposed a rule that would bring the tests under its regulatory authority, requiring laboratories conducting them to provide data on test accuracy. Hundreds of tests on the market have very little oversight and may be misleading to the public and patients seeking to learn whether they have Lyme disease, Alzheimer’s or will develop cancer.The proliferation of these tests “leaves Americans vulnerable to making important health care choices based on potentially faulty or inaccurate test results,” Dr. Robert Califf, the F.D.A. commissioner, said in a news briefing on Friday.The tests, which included the first ones to detect Covid-19, have been subject to agency concern for 30 years and have been a perennial — yet essentially untouchable — target by lawmakers dating back to former Senators Edward Kennedy and Barack Obama and as recently as this year.Academic medical centers that include labs operating the tests have opposed changes, citing the importance of being nimble in the face of a rapidly changing, pandemic-prone world.Though renewed attention about the tests’ accuracy may be unsettling to patients, there have been few clues available to them — or even to their doctors — about whether the tests were vetted or received thorough F.D.A. oversight, according to Jeff Allen, president of the Friends of Cancer Research, a nonprofit partly funded by pharmaceutical companies.“A rule like this is getting to it at the front end to be sure each test out there meets reliable accuracy standards — so those questions don’t need to be asked,” he said.Mr. Allen said the pathology lab in a hospital may know the origins of a test, but that information is rarely passed on to doctors and patients. He said that his organization was concerned about the accuracy of tests administered to glean the genetic profile of a tumor that led to decisions on treatment.An investigation by The New York Times found that prenatal genetic screening tests were frequently wrong, with many false-positive results.Academic researchers, physicians and the F.D.A. have criticized other, similar tests, as well. Those include tests that are meant to calculate a person’s so-called genetic propensity for developing diabetes or becoming an elite athlete.Doctors have also raised concerns about tests meant to predict the chances of developing Alzheimer’s disease. In 2015, the F.D.A. issued a report about 20 tests of concern, including one to detect ovarian cancer and another for Lyme disease. A longstanding concern about the tests is whether they have misled patients facing decisions about aborting a fetus with a possible genetic abnormality or getting a mastectomy or hysterectomy based on cancer screenings.Opponents of additional F.D.A. oversight say the agency does not have the resources to review and oversee tests for emerging health concerns.Susan Van Meter, president of the American Clinical Laboratory Association, which represents lab companies and test makers, said in a statement that billions of tests were run each year that influence a majority of the decisions made by health providers.The association noted that the only test now available to detect fentanyl mixed with a dangerous animal tranquilizer, xylazine — a combination known as “tranq dope” — is one that would be subject to the new layer of oversight.“F.D.A. seriously risks falling behind on its current public health priorities,” according to the association’s statement released on Friday. The association said it planned to ask the agency to withdraw the proposed rule and said it would continue to work with Congress on the matter.An effort to update oversight of lab tests failed late last year in Congress after advocacy groups spent countless hours on a compromise. Called the Valid Act, the measure was expected to pass in an omnibus budget bill, but ultimately was not included. It was reintroduced earlier this year.The regulatory paths for lab tests generally depend on who is analyzing the test. Tests manufactured by a company and performed by a consumer or health care provider tend to be regulated by the F.D.A., which requires the test maker to evaluate and report on its accuracy.The less regulated tests, known as “lab-developed” tests, tend to be processed at a central location with results transmitted back to consumers or health care providers. Those tests may be overseen by lab experts for Medicare and may also be accredited by the College of American Pathologists.The F.D.A. is not even sure how many lab-developed tests exist.“No one truly knows how many of these tests are out there, or who makes which one, let alone which tests have a track record of inadequate results and problems and which don’t,” said Dr. Jeffrey Shuren, the head of the F.D.A.’s medical device and diagnostics division, during the briefing on Friday.The proposed rule will be open for public comment and likely will be challenged in court, said Jeffrey Shapiro, a lawyer at King & Spalding who represents some labs that have developed tests.He said the lab-developed tests are services or procedures that are already regulated by Medicare officials.“This proposed rule is nothing new, it’s the same dispute that F.D.A. has been having with industry for 30 years,” Mr. Shapiro said. “Major economic questions like this one affecting the health of millions should be decided by Congress, not F.D.A.”The agency also noted how long the debate over these unregulated tests has dragged on, with Dr. Califf acknowledging on Friday that the agency had to deal with how prolific the tests had become.“Laboratory-developed tests play a central role in U.S. health care, and many are similar to other tests that come in to the F.D.A. for review,” Dr. Califf said. “This approach no longer makes sense and puts U.S. patients at risk.”

Pharmacists affiliated with the University of Florida have spent decades nudging the agency to pull a decongestant from over-the-counter medicines.Dr. Leslie Hendeles began prodding the Food and Drug Administration to reject a decongestant in cold medicines when he had a mop of curly red hair and Bill Clinton had just become president.By the time opposition to the drug had coalesced, Dr. Hendeles was appearing, at age 80, as an expert to testify before the agency’s advisers, his hair white and his overview of the ingredient spanning 50 years.His advocacy culminated in the advisory panel’s unanimous vote on Tuesday, when it concluded that the decongestant, a common ingredient in cold and flu remedies, is ineffective.Prompted by the news, consumers threw open their medicine cabinets upon learning that the decongestant, phenylephrine, was listed in more than 250 of their go-to drugs for congestion like some versions of DayQuil, Sudafed, Tylenol and Theraflu. And the decision has caused some confusion — experts say the ingredient still works in nasal sprays, just not when taken orally in pill or liquid form.Given that the drug is considered safe, experts say there is no need to throw away the products, which contain other ingredients that do work.Nothing will change immediately. F.D.A. officials have to review the panel’s decision, solicit public comments and most likely will give drug makers some time to adjust or swap out ingredients rather than face a decision to strip store shelves of so many consumer staples. Other delays could occur if the companies contest the actions in court. And some experts, notably Dr. Scott Gottlieb, a former F.D.A. commissioner, have long maintained that phenylephrine does work, to some extent. Some defenders of the drug may try to oppose any action that banishes the decongestant altogether.But how phenylephrine stayed on the market this long despite decades of studies and questions is a tangled story involving old drug standards dating back to a law signed by President Kennedy, the proliferation of meth labs using everyday cold remedies in the 1990s, and even the pandemic.Like other federal agencies, the F.D.A. can move glacially, at times hampered by antiquated rules and a morass of regulatory procedures.“There is no question that regulation of over-the-counter medications was broken for many years,” said Dr. Joshua Sharfstein, a former agency official and vice dean at the Bloomberg School of Public Health at Johns Hopkins. The latest moves, he said, indicate that the “agency is only now getting its handcuffs off.”One could argue the process of dissecting phenylephrine — a drug used for dilating eyes and calming hemorrhoids — took roughly six decades. The Kennedy era had ushered in a new law that required the F.D.A. to evaluate a drug’s effectiveness in addition to existing safety standards.President Kennedy gave a pen to Frances Oldham Kelsey of the F.D.A. after signing the Drug Industry Act of 1962, which required companies to demonstrate a drug’s safety and effectiveness before marketing it.Abbie Rowe/White House Photographs, John F. Kennedy Presidential Library and Museum, BostonIt wasn’t until 1976 that the F.D.A. began reviews of over-the-counter cold medicines, like phenylephrine, as a class of drugs.But by the early 1990s, the decongestant still hadn’t received a full approval, and the lengthy delays had attracted the attention of Dr. Hendeles and a group of pharmacy professors at the University of Florida.They would become the one constant in the last 30 years of phenylephrine’s history by putting pressure on the F.D.A. to do something.Dr. Hendeles published his first critique of the drug in 1993, noting that the agency had oversight of two more popular decongestants that were effective and a third that was not: phenylephrine. The medication was meant to constrict blood vessels and clear congestion in the nose. But it was destroyed in the stomach, he wrote in a medical journal. That meant most of the medication didn’t make it to the bloodstream — much less to the nose.By the 2000s, what would seem like an unrelated problem was surging: Illegal methamphetamine labs in rural areas on the West Coast were exploding, as was abuse of the illicit drug.Meth cooks’ ingredient of choice was one of the most common decongestants on the market at the time, pseudoephedrine, which could be found at any drugstore.By then, it was one of two decongestants available for congestion relief; a third had been pulled in 2000 after studies tied it to strokes.The meth crisis prompted the passage of state and federal laws to restrict sales of products containing pseudoephedrine, and consumers had to show identification and sign a ledger to buy it from behind the counter or a locked cabinet of a pharmacy.Concerned about losing sales, companies with medicines containing the popular meth additive turned to the last option authorized by the F.D.A.: phenylephrine.Dr. Hendeles said he was dismayed to see the ingredient in medicines lining pharmacy shelves, knowing patients were complaining that the replacement didn’t help them at all.He teamed up with a colleague, Dr. Randall Hatton, and they dug deeper, plumbing the data used in the 1970s for the drug’s initial approval.Dr. Hatton unearthed memos to the F.D.A. from the 1960s and 1970s that had not been peer-reviewed. He and colleagues ran the data in modern analysis software and concluded that the drug was no better than a placebo.As their research progressed, Dr. Hendeles tried to reach the F.D.A., where he had once been a visiting scientist. He was not breaking through, he said. So he turned to the office of U.S. Representative Henry Waxman, a crusading California lawmaker, for help.Dr. Leslie Hendeles, left, and Dr. Randall Hatton worked together to urge the F.D.A. to review the effectiveness of phenylephrine.UF News ServiceMr. Waxman fired off four letters, citing the professors’ findings and imploring the agency to act. “F.D.A. has a duty to arm Americans with the information they need so that they don’t waste their hard-earned money on medicines that do not work,” he wrote in a letter in 2006.The F.D.A. replied that same year, restating the findings of its 1976 decision. The letter suggested that if a consumer did not get relief from phenylephrine, “they have the option of not purchasing it.”Dr. Hendeles, the letter said, was free to petition the agency.And he did. Dr. Hendeles requested a dosing review and examination of use of the drug for children. That led to a public F.D.A. advisory hearing in 2007. There, the Consumer Healthcare Products Association, the business trade group that represents the makers of over-the-counter medicine, maintained that the drug worked.Dr. Hendeles recalled what he considered show-stopper testimony. Representatives for Schering Plough, at the time the maker of Claritin-D, which contained the restricted decongestant pseuodoephedrine, told advisers that they had studied its rival, phenylephrine, and found it had no effect. The company’s newspaper ads touted its “bold move” to keep the “powerful formula” for Claritin-D, a letter by Mr. Waxman noted.Still, the advisory committee voted 11 to 1 that “evidence is supportive” that phenylephrine “may be effective,” and called for more research.Eight years passed.Then Dr. Hendeles and colleagues pounced on a study that emerged from Merck, which had acquired Schering Plough. The company examined the drug at the authorized dose and at a dose four times as high, and again found it did not relieve symptoms. Merck also funded a study on a slow-release formula.But that stubborn head complaint — congestion — did not budge.(In 2014, Merck sold Claritin-D, which still contains pseudoephedrine, to Bayer.)The Florida pharmacists petitioned the agency for a ban, using the latest study as ammunition. But their efforts were stymied by what many former agency officials described as a beleaguered over-the-counter division, which had 31 staff members in 2018.The staff had to follow “an arcane process that handcuffed the agency and provided insufficient resources to clear a backlog,” said Dr. Peter Lurie, who was an associate commissioner at the agency through 2017.Dr. Scott Gottlieb called the advisory panel’s decision “a shame.”Eric Thayer for The New York TimesThe Florida team ran into other hurdles throughout the years.After this week’s vote, in posts on X, formerly known as Twitter, Dr. Gottlieb, who was the agency’s commissioner from 2017 to early 2019, called the panel’s decision “a shame.” He recalled that phenylephrine “was believed to be weakly active when we looked at this question around 2005/06. Now there may be no good, cheap, accessible options for consumers to get incremental relief.”In an interview on Friday, Dr. Gottlieb said he thought more study of the ingredient was needed. “I think it’s premature to say that it doesn’t work,” he said.Interest in the decongestant was renewed after pandemic legislation expanded agency staffing and overhauled the F.D.A.’s procedures for over-the-counter drugs so that decisions would be more aligned with those in its prescription drug division.Soon after, the F.D.A. team took up the longstanding issues with the decongestant, producing a painstaking, 89-page review of phenylephrine that the advisory panel combed as the basis for its decision. (The agency’s report confirmed the findings of Dr. Hendeles and his colleagues, and also noted apparent bias in some of the 1970s data that led to the drug’s initial acceptance.)“It was a joy to read,” Dr. Hendeles said.When he testified before the panel earlier this week, Dr. Hendeles talked about a study from 1971 involving modified scuba masks to measure nasal congestion — the first finding phenylephrine to be a dud.Other organizations including Public Citizen, the American College of Clinical Pharmacy and the National Center for Health Research also urged the panel to dispense with the ingredient. The industry association argued that the ingredient was effective and that low levels in the blood did not negate its effect. A statement from Kenvue, a spinoff of Johnson & Johnson, said products with phenylephrine are a small part of its business and it sells cold products without it.When agency advisers cast their 16-to-0 vote, Dr. Hendeles was thrilled. “Nothing was as exciting and exhilarating as the vote,” he said.Lawyers representing people who purchased cold and flu medicines containing phenylephrine are already announcing lawsuits against the drug makers, claiming the companies knew the decongestant was useless.For now, the products remain on the shelves. “We feel vindicated for something that we worked on for a long time,” Dr. Hatton said. “But it’s not over.”

The F.D.A. is expected to approve a new round of shots by Pfizer and Moderna as early as Monday to prepare Americans for the fall and winter season when infections usually tick upward.The latest Covid boosters are expected to be approved by the Food and Drug Administration as early as Monday, arriving alongside the seasonal flu vaccine and shots to protect infants and older adults from R.S.V., a potentially lethal respiratory virus.The Centers for Disease Control and Prevention is expected to follow up on Tuesday with an advisory meeting to discuss who should get the new shots, by Pfizer-BioNTech and Moderna. After a final decision by the C.D.C.’s director, millions of doses will be shipped to pharmacies, clinics and health systems nationwide within days.As Covid cases creep up, the prevention measures could portend the first winter of the decade without a crush of patients pushing hospitals beyond capacity. But a healthy winter is far from a lock: Last year, the updated Covid vaccine made it into the arms of only 20 percent of adults in the United States.Some experts view that statistic with little alarm because the number of Covid deaths slowed over the last year, thanks to an increasingly immune population and higher vaccine rates among older Americans. Others see this year as an opportunity to protect more vulnerable people from severe illness or death.“We now have some really good tools,” said Dr. Marcus Plescia, chief medical officer of the Association of State and Territorial Health Officials, a public health group. “It’s just — what is it going to take to get people comfortable with using them?”Federal officials have been retreating from labeling the new formulation as boosters to previous shots, preferring to recast them as an annual immunization effort akin to the flu vaccine. That shift may reflect concern over the fatigue that some Americans have expressed about yet another round of shots against the virus.The vaccine campaign will also be the first since the end of the public health emergency, which expired in May. In previous years, the U.S. government bought hundreds of millions of vaccine doses and distributed them for free. This year, private insurance and government payers like Medicare that cover the vast majority of Americans are expected to provide the vaccines to people for no fee.But the question remains whether the private market of hospitals, clinics and pharmacies will be able to calibrate their vaccine orders to stock a realistic supply. Experts are uncertain how much demand there will be for the latest shots.“There could be a period in here where things are a little bit chaotic, and that’s never a good situation,” Dr. Plescia said.Packing the Moderna vaccine at a distribution center in Mississippi in 2020. This year, vaccine makers are expected to donate doses for the uninsured.Paul Sancya/Agence France-Presse — Getty ImagesAlso of concern in the handoff to the private market: the nation’s 23 million adults with no health insurance. The Biden administration has made plans to cover costs and offer the Covid vaccine through local clinics and major pharmacies, but some experts are worried about whether people who lack insurance will be aware of the new shots — or where to get them.“They don’t have an insurer sending them leaflets — they may not have a usual source of care,” said Anthony Wright, executive director of Health Access, a California advocacy group. “And so the trusted messenger of their health plan, their doctor, their clinic, is not there saying, ‘It’s no cost. It’s really easy.’”Vaccine manufacturers are expected to donate doses for the uninsured. Kelly Cunningham, a spokeswoman for Moderna, said the company had no cap on the number of Covid vaccine doses it planned to donate.The latest shots are becoming available as Covid hospitalizations and deaths are rising slightly, albeit not to the levels of past years. In the week ending Aug. 26, there were 17,400 people admitted to the hospital — more than about 6,000 at a low point this summer. Deaths were also up to about 600 a week last month, though far lower than the weekly average of 14,000 deaths of 2021.Once the vaccines are approved and the C.D.C. signs off, the Biden administration plans to urge the public to get their Covid and flu shots at the same time, a practice that has been studied and deemed safe, an administration official said. It’s a messaging effort they expect to share with major vaccine makers, which will be marketing the Covid doses commercially for the first time.Walgreens and CVS said they both already have the updated flu and R.S.V. shots available in stores. Once Covid vaccine approvals are in place, Dr. Kevin Ban, Walgreens’ chief medical officer, said the chain would have the new shots on hand “as soon as possible.” A CVS spokesperson said doses could be arriving later this week. Representatives of both chains said the Covid shot would be available at no cost to all who are eligible under the C.D.C. guidelines expected Tuesday.Targeted populations most certainly will include people 65 and older as well as those who are immunocompromised or have serious underlying medical conditions that leave them more susceptible to severe illness from the virus.Nursing homes, some of which were host to inoculation teams from the major drugstore chains when vaccines first became available, are now relying on their usual long-term-care pharmacies to supply most vaccines. But many homes have fallen behind on booster rates: Recent Medicare data show that about 62 percent of residents are up-to-date on their shots even though older adults are among the most vulnerable to severe disease and death from the virus.The new Covid vaccines target the XBB.1.5 variant, which was dominant when vaccine makers began to formulate and test a new version. Though the virus has had a rotating cast of variants, experts say the new Covid jab should fortify protections against severe infection.Recent fears that one newer, highly mutated variant would escape the vaccine proved unfounded by reputable independent labs, said Fikadu Tafesse, an associate professor of molecular microbiology and immunology at Oregon Health & Science University. The C.D.C. also reviewed studies on the matter and confirmed Friday that the vaccine was holding strong.“We were really getting ready for no response at all, but the data is very, very promising,” Dr. Tafesse said.A production line of Pfizer’s Covid vaccine in Michigan. As with previous shots, the latest vaccine won’t eliminate the chances of getting the disease, but is expected to reduce the chances of severe illness, hospitalization or death.Pfizer, via Associated PressAs with earlier shots, the updated ones are not expected to eliminate the chances of contracting a mild case of Covid. Instead, they are expected to reduce the chances of severe illness, hospitalization or death. The first Covid vaccines, given in early 2021 and targeting the initial form of the virus that emerged in Wuhan, had an efficacy rate of about 95 percent, meaning that far fewer vaccinated people became sick than those who were not immunized.As the first vaccine’s potency waned with newer Omicron variants, a bivalent booster was approved in August 2022 that targeted the initial virus and BA.5, which was dominant at the time. That shot led to fewer people with Covid being hospitalized, dropping over several months to 25 percent from 60 percent..The latest mRNA vaccines by Pfizer and Moderna is called a monovalent because it was aimed at one variant of Omicron, XBB.1.5., and unlike earlier boosters does not include protection against the original virus that caused widespread infections in China more than three years ago. But experts and researchers say that it should provide protection against many of Omicron’s variants.Pfizer and Moderna reported that their vaccines had a potent response to the newest circulating variants, though only Moderna posted its initial data on Thursday. But researchers continue to discuss how well it will stand up to new variants. The F.D.A. has mainly reviewed results submitted by the companies of animal or smaller human studies of immune response.Jerica Pitts, a spokeswoman for Pfizer, said the data submitted by the company to the F.D.A. in June involved tests in animals. Trials following people who received the shot are continuing, she said.Moderna submitted data to the F.D.A. on the immune response of 100 people to the new shots, which the company said in June “robustly elicit neutralizing antibodies” against XBB variants.John Moore, a professor of virology and immunology at Weill Cornell Medicine, said he was not impressed with the latest results. He said the new shot showed an immune response similar to last fall’s booster. That means that although the new shot will be worth getting, “it’s nothing remotely like a game changer.”Regulators are also considering whether to authorize a booster dose from Novavax, which employs a different but widely used technology for its coronavirus vaccine. That shot could be authorized in the coming weeks, giving some Americans who may prefer Novavax’s formulation as an alternative to the vaccines offered by Moderna and Pfizer-BioNTech.Dr. Daniel Griffin, an infectious disease physician at Columbia University in New York, said getting the Covid shot in late October would provide robust protection at a time when people gather for holidays, and would help stop the virus’s spread to the most vulnerable, including older adults, pregnant people and those with compromised immune systems.And while many might be weary of the social-protection argument, he said they could lessen their own odds of a more serious outcome.“So a younger individual may say, ‘I’m not going to get a booster for the public health,’” Dr. Griffin said, “‘but I am going to get a booster because if I can reduce my chance of getting Covid, I can reduce my chance of long Covid.’”Noah Weiland and Carl Zimmer contributed to this report.

The manufacturer, Philips Respironics, said it would compensate users of CPAP machines and other flawed devices that were recalled after they blew bits of foam into consumers’ mouths and lungs.Philips Respironics has agreed to a $479 million partial settlement on claims over flaws in the company’s breathing machines that spewed gases and flecks of foam into the airways of consumers and that spawned recalls involving millions of the devices, lawyers for plaintiffs in the lawsuit announced on Thursday.As one segment of continuing class-action lawsuits over the devices, the agreement covers only monetary reimbursements to users of the devices and vendors who might have financed replacements for consumers, according to the lawyers. The economic claims amount is uncapped, which will permit other device users to apply for compensation.This tentative settlement, which is subject to federal court approval, does not address other significant claims in the plaintiffs’ cases involving personal injury or the cost of medical care related to use of the breathing machines. Philips did not admit wrongdoing or liability as part of the proposed deal.The company has faced a multiyear setback, after beginning recalls in the United States of about five million of its breathing machines, which are intended for people with sleep apnea and other maladies. The lawsuits have claimed that flaking foam and gasses emitted from the machines were linked to health issues including respiratory illnesses, lung cancer and death. The foam was used in the machines to reduce noise and vibration.In June 2021, the Food and Drug Administration announced a recall of Philips machines that also included BiPAP devices and ventilators made since 2009, warning that foam deterioration in the products could cause “serious injury” to users. Philips initially released a memo to doctors saying the foam breakdown posed risks of “toxic carcinogenic effects,” but the company has since released updates reporting a far lower level of concern.“We are confident in these claims and we look forward to holding Philips accountable for the physical harms they caused patients,” the plaintiffs’ lawyers said in a statement.Millions of people suffer from sleep apnea, a condition associated with interrupted breathing that carries a number of risks, including strokes, heart attacks and possible cognitive decline from decreased oxygen supply.The spate of recalls in the last few years frustrated doctors and device users, who anguished over whether to continue using the machines and face potential health hazards, or forgo any treatment. Rival companies were hard-pressed to fill orders from those seeking replacements, leaving many consumers with no options.The agreement announced on Thursday would provide compensation ranging from about $50 to $1,500 to each consumer, in addition to $100 for each device returned to Philips. The company said it replaced and delivered nearly 2.5 million devices for U.S. consumers and suppliers.“Patient safety and quality are our top priorities, and we want patients to feel confident when using their Philips Respironics devices,” the company said in a statement.The F.D.A. and some experts have criticized Philips for not notifying consumers when it first learned of potential flaws with some of its devices. Agency and court records show that concerns at Philips emerged in 2015. More than 105,000 injuries and 385 reports of deaths that were possibly related to the foam breakdown in Philips machines have been reported to the F.D.A.The U.S. Department of Justice has been in touch with Philips about a possible consent decree to address problems related with the recall process, the company said in an earnings disclosure in July. Under a subpoena issued in April 2022 as part of another investigation into the events leading up to the recall, Philips continued to supply information, the July report said.

The NewsPulse oximeters routinely overestimated levels of oxygen in the blood in darker-skinned Covid patients, leading to delays in treatment and hospital readmissions, according to a research article published on Thursday.The research focused on the first years of the coronavirus pandemic, when patients overwhelmed hospitals. At the time,blood-oxygen levels were a key factor in deciding which patients wound up in limited hospital beds and received treatment.Researchers from Baylor College, Johns Hopkins University and HCA Healthcare reviewed the cases of about 24,500 patients whose blood-oxygen levels were first measured with a pulse oximeter via a fingertip and whose blood was then drawn and tested to further examine those levels.These researchers and other experts have raised concerns that the pulse oximeter readings via fingertip of people with darker skin pigment often show flawed results. The issue has already led to reviews by federal regulators, with some efforts underway to determine how to produce more accurate readings.iStock/GettyWhy It Matters: The readings influence patient care.Pulse oximeter readings are used routinely and help inform doctors in shaping medical care for any number of illnesses, including heart failure, sleep apnea and respiratory conditions. A normal reading for a patient in good health should be an oxygen saturation level in the blood of about 95 percent or higher. If the readings are falsely high, patients may look fine on paper — but they may not get the level of care they need.The patients in the study released Thursday in JAMA Network Open were the ones researchers would have expected to have fared the best: Their doctors saw the need to take a more precise measure of their blood-oxygen levels. (Most patients’ fingertip reading is never double-checked with a blood draw.)Patients with a fingertip pulse-oximeter reading of 94 percent or more but whose blood tests showed lower levels were deemed to have an unrecognized need for Covid therapy. Black patients were found to be nearly 50 percent more likely than white patients to have their condition go undetected. Hispanic patients were 18 percent more likely than white patients to have an unrecognized need.Patients with unrecognized needs, regardless of race, experienced delays of roughly an hour that translated into a 10 percent higher risk of delayed Covid treatment. They were also more than twice as likely to be readmitted to the hospital.The new study did not include patients whose oxygen levels might have mistakenly appeared normal via the pulse oximeter but had no follow-up blood test, and perhaps were sent home even though they may have been seriously ill.“That’s the patient population that we’re really truly concerned about,” said Dr. Ashraf Fawzy, a study author who is a Johns Hopkins assistant professor and intensive care physician.Background: Flaws could lead to great health disparities.The Food and Drug Administration approves the type of fingertip pulse oximeter used in hospitals and sold by prescription. The agency issued a safety communication about the flaws in early 2021. And it held a hearing in the fall before an expert panel, with researchers outlining studies pointing to the role the device might have in deepening health disparities for patients with darker skin tone.The agency approved those devices through its so-called 510(k) program, which clears devices that are similar to existing ones — with some additional scrutiny. The program has been criticized over the years because the standards for clearing devices are typically lower than those for the agency’s approval of new drugs.During the hearing in November, the F.D.A. noted that the pulse oximeters sold over the counter are subject to even less oversight, prompting agency advisers to call for warnings to consumers who use the devices to gauge their own respiratory health.What’s Next: The F.D.A. promises further review.The F.D.A. has not announced a major change in how it oversees pulse oximeters, but it said on Thursday that it planned to publish a discussion paper to get feedback on the issue and convene another meeting with experts to discuss potential approaches.“It is a high priority for the agency to ensure that oximetry device performance is equitable and accurate for all U.S. patients,” the agency said in a statement.Some work has also begun to design a better pulse oximeter.For now, though, Dr. Fawzy said doctors should trust their overall impression of a patient’s condition when taking a pulse-oximeter reading into account.“It’s important for us to recognize that this device may lead to clinical decisions that are inaccurate,” he said, “or that we may be under-treating certain people or under-recognizing their needs.”

The LatestA tornado that ripped apart a vast Pfizer drug warehouse in North Carolina last week will probably lead to disrupted supplies of crucial drugs used in surgery and critical care, according to estimates made by an independent nonprofit.The tornado, which reached wind speeds of 150 miles per hour and snapped trees at the base, primarily hit a storage center where Pfizer kept raw materials, packing supplies and finished medications. The production plant at the site did not have “major damage,” the company said, noting that it’s working to restart operations soon.Pfizer released a list of drugs that could go into shortage — or in some cases, a deeper state of shortage. They include common I.V. pain relievers like fentanyl and morphine, as well as lidocaine, used in local anesthesia, and heparin, used to treat or prevent blood clots.The tornado-damaged Pfizer pharmaceutical factory in Rocky Mount, N.C.Sean Rayford/Getty ImagesWhy It Matters: Some of these medicine are not widely produced.The U.S. Pharmacopeia, a nonprofit that examines the drug supply chain, took a close look at the likely effect of the tornado damage. The nonprofit assigns “vulnerability scores” to medications, accounting for factors linked to shortages, like low prices, quality problems at production sites and the number of companies that make the drug.The painkiller infusions had a high vulnerability score, as did I.V. electrolytes like potassium chloride and magnesium sulfate that are made at the plant and listed by Pfizer as potentially affected by the tornado. These medications help patients with severe dehydration or diabetes complications, among other conditions.One unexpected upside to the deepening shortages of some medications is that, under federal rules, specialized pharmacies are allowed to make the drugs on an emergency basis. That policy “will come in handy at a time like this when you have an unexpected shock to the system,” said Vimala Raghavendran, a shortage expert at the U.S. Pharmacopeia.Last Time This Happened: Cancer drug shortage threatened patient care.This disaster struck as the last drug shortage crisis began to ease. For weeks this spring and summer, doctors were running out of two inexpensive, generic chemotherapy drugs that are the best shot at a cure for patients with testicular, ovarian and other cancers.Doctors predicted heightened death rates as patients arrived for treatment only to discover they would not be getting the most potent drug in the combination used to treat them. The Food and Drug Administration has since begun to allow shipments of the drugs from China that were not expressly approved for the United States market.Now, “it seems better,” Dr. Lucio Gordan, president of Florida Cancer Specialists, said in an email on Tuesday, noting that his centers have a month’s supply of the drugs, which are called cisplatin and carboplatin.What We Don’t Know: Will Congress or the White House act?Medication shortages are not new. But the cancer drug crisis started a widespread conversation about its root causes and solutions. Some proposals have come from Medicare, which unveiled a plan to incentivize hospitals to stockpile essential drugs. A key Senate health committee advanced a pandemic-funding bill that would give the F.D.A. more data to head off shortages.Leaders in the generic drug industry and other experts cite the pressure from intermediary companies that award the lowest-price bidder with access to millions of customers. The “race to the bottom” in prices, they say, destabilizes the industry and rewards those who might cut corners or operate overseas, often in India, where labor costs are lowest. House Republicans have been examining some of those dynamics but have not issued proposals.