Especially for Black patients, inaccurate readings have imperiled care and may have contributed to deaths during the pandemic, experts told an advisory panel.Researchers warned an expert panel of the Food and Drug Administration on Tuesday that flawed readings on devices measuring oxygen levels in the blood — especially among Black and dark-skinned patients — might have contributed to deaths during the coronavirus pandemic. Panelists, in turn, urged the federal agency to raise accuracy standards and to alert doctors and consumers of the potential risks.The devices that measure blood oxygen typically on the fingertip, known as pulse oximeters, can be cheap, small products sold over the counter or medical devices used in hospitals and clinics.Decades before the pandemic, studies showed that they were less accurate on darker skin, often giving a healthy reading when blood tests showed more concerning levels.But in recent years, experts said the flawed readings might have driven some of the racial and ethnic disparities exposed in studies reviewing access to Covid treatments. Authors of the studies emphasized that blood-oxygen levels were often a key factor in deciding who would receive certain medicines, oxygen therapies and even hospital beds at times when all were in short supply.Dr. Amal Jubran, a pulmonary critical care doctor at Loyola Medicine in Chicago, one of the first physicians to identify the problem in 1990, testified on Tuesday that flawed readings were “hazardous” during the height of the pandemic.They “most likely contributed to the several-fold greater number of deaths in Covid-19 in ethnic minority patients than in white patients,” Dr. Jubran told the panel.The F.D.A. reviews prescription pulse oximeters and those used in hospitals under its so-called 510K program, which clears devices that are similar to existing ones — with some additional scrutiny. The over-the-counter versions are deemed “wellness” devices and are subject to virtually no agency oversight.Read More on the Coronavirus PandemicWarnings of a ‘Tripledemic’: An expected winter rise in Covid cases appears poised to collide with a resurgent flu season and a third pathogen straining pediatric hospitals in some states.Updated Boosters for Kids: The Food and Drug Administration broadened access to updated Covid booster shots to include children as young as 5.A Decline Among Seniors: Americans over 65 remain the demographic most likely to have received the original series of Covid vaccinations. But fewer are getting booster shots, surveys indicate.Personality Changes: New research suggests that Covid’s disruption of social rituals and rites of passage have made people less extroverted, creative, agreeable and conscientious.The accuracy concerns, which the agency flagged in 2021, led to a 10-hour meeting Tuesday of an F.D.A. advisory panel involving doctors and advisers. They did not formally vote on specific ways that the agency might address the issue, but several suggested measures like adding warnings to product labels and raising the bar manufacturers need to reach — in terms of correct readings — to get new devices approved. Doctors testifying to the panel also said studies gauging device performance on people with a range of skin tones and chronic medical conditions were needed.Veverly Edwards, a community representative and the only African American on the panel of mainly white male doctors, called for manufacturers to be held accountable. She said Black people should have a sustained voice on the matter that also affects people of many ethnicities with dark skin.“I guess my fear is that historically that the disparity in health care is like it never stops,” said Ms. Edwards, who is an assistant professor at the University of Memphis. “When you lump African Americans in with everyone else, we end up on the short end — because this started 30 years ago and here we are today addressing it.”During the hearing, F.D.A. officials said the pulse oximeters used in hospitals were marketed based on studies of as few as 10 healthy people. And the devices that people buy online or at retail pharmacies are not scrutinized by the F.D.A.Panelists agreed that the current rules were too lax for devices that had become a key driver of patient-care decisions, such as prescribing or ending the use of supplemental oxygen.“That should be held to a very different standard,” said Dr. Hugh Cassiere, an adviser and critical care chief at North Shore University Hospital in New York. “We really need to tighten that up.”Doctors who appeared before the panel cited a series of studies that showed how inaccurate readings from the devices used in hospitals affected people with darker skin during the pandemic and were associated with inadequate medical care.One University of Michigan study found that the devices that squeeze the finger gave elevated readings in Black people when a blood test showed a lower rate, suggesting “hidden” hypoxemia, or significantly low blood oxygen. The discrepancy was found in nearly 12 percent of Black people and in nearly four percent of white people.Dr. Ian Wong, a Duke University researcher, confirmed elevated levels of hidden hypoxemia in Black and Hispanic patients. He also told the panel that he found that all patients who had hidden hypoxemia had a risk of in-hospital death that was 70 percent higher than those with accurate readings.Doctors at the Johns Hopkins University School of Medicine confirmed the disparity again and noted the result: Black and Hispanic patients were 29 and 23 percent less likely to be recognized as candidates for Covid treatments.The studies were largely based on self-identified race, and researchers are still looking into the degree that melanin in the skin — which lends the darker pigmentation — affects pulse oximeter performance.The findings underscore the importance of testing the devices on sick patients and those with a range of skin tones, said Dr. Eric Gartman, a Brown University assistant professor testifying for the American College of Chest Physicians. Currently those devices are tested in healthy people in a lab.“We wouldn’t tolerate that in a medicine,” he said, “so I’m not sure we should tolerate that in a device, either.”Dr. Jesse Ehrenfeld, president-elect of the American Medical Association and an anesthesiologist, testified that he wondered if the pulse oximeter he used on a patient Tuesday morning was going to be accurate.“We need to take appropriate steps to remove the growing uncertainty around these devices and ensure the health and safety of the public,” he said.Dr. Ehrenfeld said the F.D.A. should put specific warnings on devices that produce biased readings, make health providers aware of the limitations and increase testing of devices that were already cleared by the agency.For the oximeters that people buy online or from retail stores, the lack of regulation is troubling, said one agency adviser, Dr. Murad Alam, a medicine professor at Northwestern University. People use them, he noted, to monitor oxygen levels at home and decide if they need urgent medical attention.“This is a misclassification problem,” Dr. Alam said. “I don’t know how it happened, but this is not shampoo. So F.D.A. will need to find a way to regulate these.”Advisers urged the agency to provide prominent warnings that the retail devices are not for medical use and are not approved by the F.D.A. The agency said it was working with researchers from Stanford and the University of California, San Francisco, on real-world studies of device performance.

The agency cited Teva’s continuing supply problems as well as those of other drug makers struggling to fill the gap.The Food and Drug Administration has declared a nationwide shortage of Adderall, a medication used to treat A.D.H.D. that has had surging demand in recent years.The F.D.A. noted that one maker of the drug, Teva Pharmaceuticals, has had continuing manufacturing delays, and other manufacturers of generic versions or alternatives have also reported periodic problems with meeting demand.The agency recommended that patients taking Adderall talk to their doctors to find alternative treatments.Adderall, which contains the stimulant amphetamine, is a controlled substance and highly regulated, so it is difficult for pharmacies to quickly pivot and carry new brands, analysts said. Further muddying the picture is the recent popularity of telehealth services. A crop of telehealth start-up companies flourished during the pandemic, with some prescribing Adderall and other drugs to patients in unknown quantities.The number of Adderall and generic-equivalent prescriptions has been rising in recent years, according to figures from IQVIA, a data analytics company. Total prescriptions rose by about 16 percent, to 41.2 million last year from 35.5 million in 2019.Over the years, concerns have been raised about the overprescribing of Adderall for children and young adults with A.D.H.D., and about its abuse as a study aid among college students. The teenage mental health crisis that exploded during the pandemic put a spotlight on sharp increases in some prescriptions, like Adderall.Dr. David Goodman, director of the Adult Attention Deficit Disorder Center of Maryland, said about 4 percent of adults and 8 percent of children have attention deficit hyperactivity disorder, and large numbers of them go untreated — roughly 70 percent of adults and 40 percent of children. He said growing awareness about the condition appears to be leading to a surge in demand for medications.In addition, he said, the telehealth start-ups made it cheaper and less time-consuming to get a diagnosis, although he questioned whether all of those were accurate.“I can understand why there are shortages, because there’s an increased demand of people who are seeking these medications,” said Dr. Goodman, who is also an assistant professor of psychiatry at Johns Hopkins University School of Medicine. He received $18,000 in 2021 as a consultant for drug companies.While a number of companies make Adderall and generic versions, pharmacies may find it difficult to pivot to other suppliers because of amphetamine’s status as a controlled substance that typically includes restrictions on its use and monitoring of prescription orders. Any given pharmacy might risk raising red flags with the Drug Enforcement Administration by doubling its supply, said Erin Fox, an expert on drug shortages at the University of Utah.“With a controlled substance, it’s harder for patients to call around and find a pharmacy that has product for them,” Ms. Fox said.Dr. Goodman said patients report almost every day that they are unable to get prescriptions filled. He said his office has had to reissue them in different dosages to help patients receive treatment. Even then, some come up short and, without their medications, may miss deadlines or forget important tasks if they are working in a high-pressure situation.There is little data on start-up telehealth companies that have drawn criticism for rapidly prescribing a variety of medications, including Adderall.One such company is Cerebral, which is based in San Francisco. A former vice president of Cerebral, Matthew Truebe, filed a wrongful termination suit against his former employer, claiming that a company goal was to prescribe stimulants to 100 percent of the company’s A.D.H.D. patients, something he considered “not safe or legal,” according to court records. Mr. Truebe also claimed the company had duplicate patients in its database, suggesting that some were seeking prescriptions to resell.Cerebral, valued at over $1.2 billion this summer, said in a court filing that Mr. Truebe was not fired as an act of retaliation, but because he was a “poor performer.” The company has received a subpoena from federal investigators reviewing its compliance with the Controlled Substances Act. A Cerebral rival, called Done, is also facing Drug Enforcement Administration scrutiny, The Wall Street Journal reported.Chris Savarese, a spokesman for Cerebral, said the company had ceased prescribing controlled substances to new patients and had not been accused by any government agency of wrongdoing.

While use among youths has fallen since the peaks of 2018-19, resumption of in-school classes this year shows students still have access to flavored, disposable vapes.High school students resumed taking the annual National Youth Tobacco Survey in school this year and 14 percent of them reported using e-cigarettes, underscoring how an upstart industry is dodging regulators’ efforts to spare a generation from nicotine addiction.The number shows a slight change from 11 percent last year, but researchers cautioned against drawing comparisons to 2021’s survey, which was conducted differently because it took place when many schools were closed during the pandemic. The latest results were released by the Centers for Disease Control and Prevention on Thursday.Though the age-old force of peer pressure may still be encouraging use, the percent of high school students who reported vaping in the last 30 days was still far lower than record-high levels reached in 2019 of nearly 28 percent.Overall, the survey found that 2.5 million middle and high school students, or about 9 percent, used e-cigarettes in the last 30 days. That puts their overall rate of use several times higher than that of adults, which is estimated at about 3 percent.In the survey, which was conducted from January through May of this year, high school students reported strongly favoring fruit- and candy-flavored vapes. Some mentioned PuffBar, Vuse and Juul as their favorite brand among those on the survey’s list.Read More on Smoking, Vaping and E-CigarettesThe Business of Addiction: McKinsey’s ties to opioid makers are well known, but for decades the consulting giant worked with Big Tobacco and has also advised Juul.Youth Vaping Settlement: Juul tentatively agreed to pay $438.5 million to settle an investigation by nearly three dozen states over marketing and sales practices that they contend set off the teen vaping crisis.Ban Suspension: The Food and Drug Administration ordered Juul to stop selling e-cigarettes on the U.S. market, though it later suspended the ban citing “scientific issues” that warrant a review of the decision.Nicotine Levels: The F.D.A. is planning to require tobacco companies to slash the amount of nicotine in their cigarettes. But experts warn that drastic cuts could prove disruptive and fuel underground markets.But many said their favored e-cigarette brand was not one of the 13 listed. That finding highlights how nimble the industry has been in stamping an array of brand names on vapes with flavors like strawberry ice cream and fresh vanilla that are largely made in China and shipped from warehouses to corner stores and into e-commerce.“What that shows is that playing Whac-A-Mole with a few products is not going to solve the problem,” said Vince Willmore, a spokesman for the Campaign for Tobacco-Free Kids. “As long as any flavored products are still on the market, kids are going to shift to them. To solve the problem, you have to clear the market of all flavored products.”One stark finding was that one in four of the high school students who were e-cigarette users reported vaping every day. Groups opposed to e-cigarettes and tobacco products were particularly troubled by one other result that reflected the highest frequency-of-use to date: Nearly half of the high school students who were vaping said they were doing so 20 to 30 days a month.“That’s a real signal of addiction and setting up young people for a lifetime of addiction which they don’t want, they didn’t choose and they don’t like,” said Robin Koval, president of the Truth Initiative, a nonprofit organization aimed at eliminating youth tobacco use.The Food and Drug Administration considers e-cigarettes to be generally beneficial, because they can provide an alternative to adult users of traditional cigarettes, which coat the lungs in tar. The agency’s hope for health gains, though, has existed in the shadow of a youth vaping crisis that exploded in 2018-19, prompting an outcry from parents, schools, lawmakers and public health experts.The F.D.A. began to crack down on vape makers in 2019, banning many flavors and ordering manufacturers to apply for marketing authorization to keep their products on the market — an ongoing process. That effort has been challenged by e-cigarette makers who saw a loophole in making e-cigarettes with synthetic nicotine and jumped into the market with blueberry, kiwi and candy-flavored vapes.This spring Congress gave the F.D.A. the authority to rein in those devices. The agency said it was reviewing about one million applications to sell synthetic nicotine products. In July, the agency gained authority to remove unauthorized nontobacco products from the market but has said it needs to move methodically as it enforces the law.The consequences for teens who develop a nicotine addiction are just beginning to be understood. Dr. Rose Marie Robertson, science and medicine officer with the American Heart Association, said scientists were seeing toxic effects from the inhaled flavoring ingredients. She said researchers were also detecting signs of e-cigarette use on the heart and lungs.“It took us 40 years to show that women would develop lung cancer more readily if they smoked,” Dr. Robertson said. “The fact that we’re seeing any effects at an early stage is very worrisome.”The persistent rate of e-cigarette use among teenagers also concerns experts who were thrilled to see youth cigarette smoking rates fall steadily for years.“To have decades of progress wiped away by e-cigarettes has been astonishing to us who’ve been there all along,” Dr. Robertson said.

The pharmaceutical industry finances about 75 percent of the agency’s drug division, through a controversial program that Congress must reauthorize by the end of this month.Every five years, top officials of the Food and Drug Administration go behind closed doors to negotiate the terms of its core budget — about $3 billion this year.But the F.D.A. is not at the table with members of Congress or with White House officials. Instead, it’s in dozens of meetings with representatives of the giant pharmaceutical companies whose products the agency regulates. The negotiations are a piece of the “user fee” program in which drug, device and biotech companies make payments to the agency partly to seek product approvals. The fees have soared since the program’s inception three decades ago and now make up nearly half of the F.D.A.’s budget and finance 6,500 jobs at the agency.The pharmaceutical industry funding alone has become so dominant that last year it accounted for three-quarters — or $1.1 billion — of the agency’s drug division budget.Details of the program are being debated in Congress as a Sept. 30 deadline for reauthorization nears. The powerful pharmaceutical lobby says its role in funding the agency has helped speed approvals of lifesaving drugs to the market by providing it with the resources to do the work. But advocates for patients and doctors say the agreements have enabled the industry to weaken the approval process meant to ensure that drugs are safe and effective.“It’s kind of like a devil’s bargain,” said Dr. Joseph Ross, a professor at the Yale School of Medicine who has studied F.D.A. policies, “that I think is not in the best interest of the agency, because it turns this every-five-year cycle into the F.D.A. essentially asking industry, ‘What can we do to secure this money?’ ”In recent weeks, the user fee bill in Congress became snagged by added provisions, including over an effort to speed approval of generic drugs that could cut into the big companies’ profits and make the drugs less expensive for consumers and insurers. A key Republican senator and the major pharmaceutical lobby opposed that provision.Versions of the bills in the House and Senate also included a raft of extra proposals that would require annual inspections of infant formula makers and increase oversight of cosmetics, diagnostic tests, dietary supplements and food packaging.Those measures may not survive final haggling over reauthorizing the program in Congress, where the drug and device industries spend hundreds of millions on lobbying and campaign contributions. Senator Richard Burr, Republican of North Carolina and the leading member of the main Senate committee overseeing the agency, opposed the amendment that would allow the F.D.A. to help generic drug makers replicate an off-patent drug with specifics on the ingredients, which for years had tended to be more of a guessing game.The Congressional Budget Office estimated that the generic drug measure could save taxpayers $546 million over 10 years by speeding those versions to market. But Mr. Burr argued that it would hamper innovation and, objecting to another amendment limiting drug exclusivity, voted against the bill in June. In July, he introduced a stripped-down user fee bill to reset negotiations.Senator Richard Burr of North Carolina, a leading member of the Senate committee that oversees the F.D.A., voted against a user fee bill in June.Al Drago for The New York TimesSenator Patty Murray, Democrat of Washington and chairwoman of the Senate committee that oversees the F.D.A., issued a statement Wednesday underscoring the urgency of the moment.“At every single phase in this process, I‘m laser focused on patients—and making sure F.D.A. works for families, not pharmaceutical companies’ bottom lines,” Ms. Murray said. “We absolutely can’t let Congressional inaction force F.D.A. to send out pink slips. But we also can’t, and I won’t, stop pushing for the kind of reforms families need to see from the drug industry and this critical agency.”In committee hearings this summer, senators debated the merits of the user fee program.Senator Bernie Sanders, an independent of Vermont and a longtime critic of the drug industry, suggested that the pharmaceutical companies’ tendency to charge “outrageous” prices was related to their significant role in funding and advancing policy goals of the F.D.A.’s drug division.“So the industry, in a sense, is regulating itself,” Mr. Sanders said during a hearing on June 14 of the Senate Health, Education, Labor & Pensions Committee. “May make sense to somebody — but not to me.”Mr. Burr, a business-focused conservative, complained that the program burdens companies with negotiating with the agency over the fees, which he predicted would rise even higher. He has also complained about how the high costs of the program limit opportunity for small businesses; new-drug application fees are $1.5 million to $3.1 million.“In a perfect world, I hope we would all be here lobbying that there are going to be no user fees paid to the F.D.A. by anybody,” he said during the hearing. Ultimately, the White House and Congress have final say over the agency’s priorities.Even Dr. Robert Califf, the F.D.A. commissioner, acknowledged in a news briefing this summer that the program was not ideal. “Philosophically, I wish the taxpayer paid for all the F.D.A. and there weren’t user fees,” he said.A spokeswoman for the F.D.A. said agency policy prohibited officials from commenting on pending legislation.The user fee program traces its roots to 1992, when AIDS activists pressed the F.D.A. to hasten drug approvals. About a decade later, drugs moved through the pipeline more quickly, averaging about 10 months from roughly 19 months.Over the years, the program’s scope and funding grew. Annual “performance reports” detail the F.D.A.’s efforts to make quick decisions, hold routine meetings with drug companies and approve products under fast-track pathways.User fees were added for medical devices, generic drugs and biologics, which include vaccines and gene therapies. (The tobacco division and its 1,200 employees are entirely user-fee funded, though the industry has no say in how the dollars are spent.) By 2012, drug companies accounted for half of the F.D.A. drug division budget, through fees for new-drug applications and annual payments for approved drugs.“Philosophically, I wish the taxpayer paid for all the F.D.A. and there weren’t user fees,” said Dr. Robert Califf, the F.D.A. commissioner.Anna Rose Layden for The New York TimesDr. Aaron Mitchell, an oncologist and researcher at Memorial Sloan Kettering Cancer Center, recently wrote that the fee program’s policy changes had “favored industry through decreasing regulatory standards, shortening approval times and increasing industry involvement in F.D.A. decision making.”He said he was surprised that user fee negotiations in 1997 led to reducing the number of clinical trials for drug approval to one, from the longtime standard of two trials. He said it was also notable that the 2012 user fee law allowed “fewer, smaller or shorter clinical trials” for therapies for life-threatening conditions.“The faster you’re rushing to approval and the less clinical evidence that you’re requiring,” Dr. Mitchell said, “the greater the chances that you’re going to miss something” that could harm patients.Some F.D.A. drug approvals based on uncertain evidence have proved highly controversial. Medicare refused to routinely pay for the Alzheimer’s drug Aduhelm, citing little evidence of benefit and serious safety risks. Another approval of a medication for a deadly muscle disease — over the objections of agency experts — drew scrutiny when insurers refused to pay for it, calling the therapy “investigational.” The agency issued those approvals on the condition that further study prove a benefit, though such reviews take years to complete.For its part, the F.D.A. said the user fee process had given it authority to improve public health by expanding oversight of foreign drugmakers, allowing hearing aids to be sold over the counter and monitoring drug shortages.The user fee process “revolutionized” the F.D.A.’s drug approval process, Dr. Peter Marks, director of the agency vaccine and gene therapy division, told a Senate panel in April.“It’s not an understatement to say that there are many people with us today who would not be here without the program, which has dramatically reshaped drug development and approval in the United States,” Dr. Marks said.Those testifying from industry groups PhRMA, AdvaMed and BIO, which represents the biotech industry, have noted the program’s value in ensuring the F.D.A. has the staff and technology to review a growing number of rapidly changing gene and cell therapies, novel medical devices and rare-disease therapies. The Pharmaceutical Research Manufacturers of America, known as PhRMA, called the program a “success” and said the funding made the F.D.A. a global leader in approving three-fourths of new medicines before any other nation.The growth of the program “reflects the robust innovation and timely access to safe and effective medicines required for an appropriately staffed and funded F.D.A.,” Priscilla VanderVeer, PhRMA vice president of public affairs, said in a statement.“It’s a great example of a meaningful public, private collaboration to get patients the products that they need,” said Scott Whitaker, president of AdvaMed, which represents medical device makers.Dr. Reshma Ramachandran, a professor of medicine at Yale University, said doctors often don’t recognize the pressure the drug industry exerts over the F.D.A.Christopher Capozziello for The New York TimesThe pace of approvals often appears too hasty for Dr. Sanket Dhruva, a cardiologist and an assistant professor of medicine at the University of California, San Francisco. One cardiac device he recently encountered was approved after a study followed patients for only 30 days and offered no comparison against the standard treatment. It was not enough information for him to use the device on the patients he treats, he said.Generally, he said that doctors could earn more money by adopting the newest technologies and that hospitals liked to advertise them, though clear evidence of safety and effectiveness was often lacking.“What we end up going on is hype,” Dr. Dhruva said.Dr. Mitchell expressed concern that new cancer drugs had been approved using tests that compared a new treatment with a placebo, a practice that F.D.A. guidance has deemed unethical, instead of testing them against standard therapies. That leaves him uncertain whether the new drugs for the cancer patients he treats are better than the old ones.Dr. Reshma Ramachandran, co-director of the Yale Collaboration for Research Integrity and Transparency, said that doctors were not trained to sift through F.D.A. records to scrutinize the quality of the studies that led to approvals. Nor do many recognize the pressure the drug industry exerts on the F.D.A. to meet approval decision deadlines.“And that just seems like the wrong metric to care about,” said Dr. Ramachandran, who has tracked the user fee process and testified to Congress for Doctors for America. “It should be: ‘Are patients healthier? Are patients safe?’ And that just seems like an afterthought.”The latest negotiation cycle over prescription drug user fees involved about 100 meetings between the F.D.A. and drug company representatives and six meetings with groups like Dr. Ramachandran’s.The concerns expressed about the imbalance of access — that the drug and device industries hold outsize sway compared with patient groups and public-interest advocates — have led to calls for Congress to find a way to fully fund the agency through a tax on sales or by federal appropriations.While few see that change as likely, Dr. Mikkael Sekeres, a former F.D.A. oncology adviser who is a professor of medicine at the University of Miami, said that the F.D.A. should match its brisk pace of approvals with a system that could identify problems just as quickly.“They don’t have a good mechanism to monitor the side effects of these drugs once they’re on the market,” said Dr. Sekeres, who recently wrote a book about the F.D.A. “So the post-marketing approval surveillance mechanism isn’t as good as it should be to guarantee the safety of the public.”

The agency issued a final rule that took years to complete and opens the door to cheaper, more accessible devices without a prescription or medical exam.The Food and Drug Administration moved today to make hearing aids available over the counter and without a prescription to adults, a long-sought wish of consumers frustrated by expensive exams and devices.As soon as mid-October, consumers with mild to moderate hearing loss should be able to buy hearing aids over the counter online and in retail stores, without being required to see a doctor for an exam to get a prescription.The F.D.A. cited studies estimating that about 30 million Americans experience hearing loss, but only about one-fifth of them get help. The changes could upend the market, which is dominated by a relatively small number of manufacturers, and make it a broader field with less costly, and perhaps, more innovative designs. Current costs for hearing aids, which tend to include visits with an audiologist, range from about $1,400 at Costco to roughly $4,700 elsewhere.“This could fundamentally change technology,” said Nicholas Reed, an audiologist at the Department of Epidemiology at Johns Hopkins Bloomberg School of Public Health. “We don’t know what these companies might come up with. We may literally see new ways hearing aids work, how they look.”The F.D.A.’s final rule takes effect in 60 days. Industry representatives say device makers are largely ready to launch new products, though some may need time to update labeling and packaging or to comply with technical details in the rule.Dr. Robert Califf, the F.D.A. commissioner, tweeted Tuesday that the rule tackles a “critical public health issue” that affects millions.“Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective and affordable hearing aids from their neighborhood store or online,” he said.Hearing loss is associated with cognitive decline, depression, isolation and other health problems in older adults. Yet the barriers to getting hearing help have included costs that are not covered by Medicare. There is also stigma — such as appearing “old” — that comes with use.Appreciation for the importance of sharp hearing is for adults is also off-kilter: A recent survey found that people aged 50 to 80 were twice as likely to plan on taking their pet to the veterinarian in the coming year than to get their hearing checked.“It breaks my heart a little bit,” said Sarah Sydlowski, associate chief improvement officer of the Cleveland Clinic Head and Neck Institute and lead author of the study. “I think our biggest challenge as a profession and as a health care system is to make sure that people understand that hearing is incredibly important. It deserves their attention, it deserves their action.”The change has been percolating for years. In 2016, a proposal for the F.D.A. to approve over-the-counter hearing aids for adults with mild to moderate hearing loss came out in a National Academies report. The following year, Senators Chuck Grassley, a Republican of Iowa, and Elizabeth Warren, a Democrat of Massachusetts, introduced a bill enabling the agency to make the change that was signed into law.The process to finalize regulations has moved slowly since then, with some conflict over details, like how the federal rule would interact with state laws on hearing aid returns or warrantee policies and how much the devices should amplify sound.President Biden issued an executive order last July calling for greater competition in the economy, which included a call for the rule “to promote the wide availability of low-cost hearing aids” to be published.That rule came out in the fall, followed by a period of public comment. The Hearing Industries Association, an industry group, submitted a 45-page comment letter warning the F.D.A. about companies that had come on the market in 2018, after the initial law passed, selling hearing aids that “were ineffective, of poor quality, and in some cases, dangerous.” The organization offered detailed advice on how to avoid a repeat scenario.“We applaud the action to increase access to care for persons who have difficulty and encourage them to seek a professional,” to help navigate their options and the fitting process, said Kate Carr, president of the trade group. Other organizations raised concerns that the F.D.A. would be creating a safety issue by allowing new hearing aid makers to make devices that allow users to hear loud sounds.Senators Warren and Grassley had released a joint report accusing the “dominant hearing aid” makers of engaging in an “astroturf lobbying” effort by flooding the F.D.A. with repetitive comments steering the agency toward a new generation of hearing aids that would be “less effective, protecting manufacturers’ existing market share and locking in their competitive advantage.”“The logic is simple: The less effective an O.T.C. hearing aid is, the more likely consumers will be forced to abandon these options and instead opt for more expensive, prescription devices sold by the manufacturers that dominate this line of business,” the senators’ investigative report said.

The agency official headed an office that plays a key role in deciding whether to approve e-cigarettes and other products aimed at reducing smoking.A Food and Drug Administration official with considerable power over authorization decisions for e-cigarettes and products aimed at curbing smoking resigned on Tuesday to work for Philip Morris International, the global tobacco conglomerate and maker of Marlboros.The official, Matt Holman, was chief of the office of science in the agency’s Center for Tobacco Products. In a memo to the staff on Tuesday, Brian King, the center’s director, wrote that Dr. Holman had announced that he would be leaving — effective immediately — to join Philip Morris. The memo said Dr. Holman had been on leave and, consistent with agency ethics policies, had recused himself from all tobacco center work “while exploring career opportunities outside of government.”Mr. King lauded Dr. Holman’s 20 years of work at the F.D.A., where he has in recent years been “preparing for and overseeing review” of marketing applications for e-cigarettes and other nicotine-delivery products. Dr. Holman said in an interview on Wednesday that his exact role at Philip Morris had so far been broadly defined but added that he would work on tobacco harm-reduction efforts and provide some input on regulatory submissions to the agency.His resignation adds further turmoil to the agency’s tobacco control division, which is undergoing a review ordered by Dr. Robert Califf, the agency’s commissioner. The division also lost its longtime director, Mitch Zeller, who retired in April.To critics, Dr. Holman’s move is a particularly concerning example of the “revolving door” between federal officials and the industries they regulate, in this case, one that has garnered a high degree of public distrust. It has also raised questions about agency approvals, including that of Philip Morris’s IQOS, a “heat-not-burn” tobacco device, which some researchers have found troubling. IQOS is not sold on the U.S. market now because of patent litigation, but if those were resolved, the device would face fresh F.D.A. reviews.Federal rules governing “revolving door” career moves do not prevent an official from overseeing regulatory matters one week and joining a corporation with products under review the next.“This is legal. That’s the bottom line,” said Dr. Michael Carome, director of the Public Citizen health research group. “It’s this type of revolving door move that really undermines public confidence in the agency.”The federal rules do ban Dr. Holman from appearing before the F.D.A. on matters in which he “participated personally and substantially during government service.”Dr. HolmanU.S. Food and Drug AdministrationDr. Holman said that he consulted with agency ethics lawyers before starting job discussions earlier this month. He said he was drawn to Philip Morris because he viewed the company as being committed to the goal of moving cigarette smokers to noncombustible and less harmful products.“They are taking the actions that I think would align with such a goal,” Dr. Holman said. “And that’s what really drew my attention to P.M.I. I’m going there not to help them sell more cigarettes, but the opposite.”He brushed off “revolving door” criticisms, saying that if that were his motivation, he could have left the agency for industry many years ago. But lawmakers and some public health experts criticized Dr. Holman’s choice and its effect on the F.D.A.’s decision-making.“It is embarrassing for the F.D.A., which sees itself as a public health agency, to have its employees go to a company that is a leading manufacturer of death,” said Micah Berman, an associate professor of public health and law at Ohio State University.Representative Raja Krishnamoorthi, a Democrat of Illinois, was equally critical. “The revolving door between F.D.A. and the industries it is tasked with regulating is extremely disturbing,” he said in a statement. “While some, including P.M.I., may argue that their hire is evidence of P.M.I.’s alleged commitment to taking the health impacts of its products more seriously, I won’t hold my breath.”As head of the F.D.A. science office, Dr. Holman played a key role in approvals of electronic cigarettes and similar devices, which manufacturers have had to submit for review to stay on the market in recent years.IQOS, the Philip Morris product that Altria has a license to distribute in the United States, was one of the approved products. It is sold in Korea, Japan and other countries. A company spokesman said U.S. sales were expected to resume next year, but it must undergo new agency reviews before that.Critics of the IQOS approval include Stanton Glantz, a retired professor of medicine, and his colleagues at the University of California, San Francisco, who published a study saying the device contained toxins, some potentially carcinogenic and some at higher levels than in combustible cigarettes. The agency’s approval “disregarded valid scientific evidence and misapplied the public health standard mandated by law,” the study in the journal Tobacco Control concluded.Dr. Glantz said on Wednesday that Dr. Holman ignored another major study showing that e-cigarette use — outside of controlled studies of quitting efforts — was not associated with reduced rates of smoking. He said approvals have done little to deal with the problem of dual-use, or using cigarettes and e-cigarettes, which is worse for overall health. Of Dr. Holman’s departure, Dr. Glantz said, “good riddance.”“He’s the one who signed off on these approvals,” he said. “They deal with all of these issues by ignoring it, by relying on out-of-date studies.”Among the F.D.A.’s recent controversies was the decision in June to deny marketing authorization to Juul Labs’ e-cigarettes. Since then, the agency has relented, announcing a review of its decision.In a court filing, Juul cited the authorization granted to Philip Morris as a reason it would likely prevail, saying IQOS was approved even though a dozen chemicals in IQOS aerosols were “‘potentially genotoxic and/or carcinogenic’ and were ‘present in higher concentration[s]’ than in combustible cigarette smoke.”Dr. Holman said many agency decisions have their critics, but he believed IQOS authorization was warranted on a full review of the data.Philip Morris said in a statement that Dr. Holman “is committed to helping existing adult smokers access scientifically substantiated smoke-free alternatives while protecting youth. We are looking forward to him joining our team as we continue to pursue a smoke free future.”The company also recently hired Keagan Lenihan, a former F.D.A. chief of staff, as a vice president of government affairs.

The agency’s commissioner asked an external foundation to examine its operations in the wake of the baby formula and vaping crises.The Food and Drug Administration has commissioned a review of its food and tobacco programs following public outrage over baby formula shortages and concerns about flavored nicotine products.Dr. Robert Califf, the head of the F.D.A., said the agency had confronted issues that “have tested our regulatory frameworks and stressed the agency’s operations,” prompting the review announced on Tuesday.The review will be conducted by the Reagan-Udall Foundation, a nonprofit affiliated with the agency. Its directors include nonprofit, academic, corporate and trade association leaders.Congressional lawmakers have hammered the agency for its handling of the infant formula shortage, saying it was slow to heed a whistle-blower’s warning about the troubled plant and did not place a priority on food safety. For several years now, the agency has also been under scrutiny for what some have viewed as an inability to curb the teenage vaping crisis.At a congressional hearing on Wednesday, Dr. Califf defended the agency but said there was still room to examine the structure, funding and leadership of its food safety division that had oversight authority of consumer goods like infant formula.“We have the safest food in the world,” Dr. Califf told members of the Senate Appropriations subcommittee. “Every expert I’ve talked with — the C.D.C. monitors this carefully — said that our food is as safe as it’s ever been. So to say it’s not working is, in my view, just incorrect. That doesn’t mean it can’t be a lot better and that there aren’t major problems. So, you know, that’s why we’re doing this top-down review and plan to make significant changes.”Dr. Califf said that the country’s food system was being challenged by supply chain problems and climate change and that it could better embrace the revolution in technology.The agency is also seeking an examination of its tobacco division and enforcement operations as it faces “an increasing number of novel products that could potentially have significant consequences for public health,” according to an statement. They included highly potent cannabis products, including vapes, that are being tied to addiction and psychosis in teens.Lawmakers and the public have been pressuring the F.D.A. to take action against makers of flavored synthetic nicotine e-cigarettes in flavors that appeal to young people. Congress gave the agency the authority to remove such products from the market in April, and enforcement powers kicked in earlier this month.Yet, the agency has said it was reviewing the marketing applications of about one million applicants submitted by about 200 companies. It issued warnings to two companies, which were selling about 10,000 types of vape products without authorization.Lawmakers and a group of physicians have urged the agency to act faster, though, with a group of Massachusetts General Hospital pediatricians and others calling for “swift action” as more teenagers become addicted to high-nicotine e-cigarettes.The F.D.A. was caught off guard by baby formula shortages spurred earlier this year after it shut down a baby formula factory over quality and safety concerns. The agency had discovered a deadly bacteria called cronobacter sakazakii inside the plant, as reports began to emerge of infant deaths possibly tied to the bacteria.Although the deaths were not definitively linked to the bacteria at the plant, the F.D.A. and the Justice Department entered into a consent decree with the manufacturer, Abbott Nutrition, to oversee process improvements at its Michigan formula plant.Dr. Califf acknowledged that the F.D.A. had limited infant formula supply chain insight during Congressional hearings over the matter. The shortages frightened parents of young children and led to hospitalization of some children who were dependent on formula. Since then, the agency has allowed some foreign formula imports and announced changes to help overseas manufacturers gain access to the U.S. market.Dr. Califf has promised a thorough review of the steps that led to the formula shortage.The external review by the Reagan-Udall Foundation is expected to take two months.

Agency inspectors found a leaking roof, standing water and cracked production equipment before a facility shutdown that led to major shortages.The Abbott Nutrition plant in Michigan that was shut down in February, sparking a widespread baby formula shortage crisis, had a leaking roof, water pooled on the floor and cracks in key production equipment that allowed bacteria to get in and persist, Dr. Robert Califf, the head of the Food and Drug Administration, told a House panel on Wednesday.He detailed “egregiously unsanitary” conditions in the Sturgis, Mich., plant to lawmakers during a hearing, but he also acknowledged that his agency’s response was too slow in addressing problems at the plant.“Frankly, the inspection results were shocking,” Dr. Califf told members of the House Energy and Commerce Subcommittee on Oversight and Investigations. “We had no confidence in integrity of the quality program at the facility,” noting the agency worked with Justice Department officials to dictate steps the company needed to take to turn the facility around.That effort is expected to result in the plant reopening on June 4, Jonathon Hamilton, an Abbott spokesman, said, with some formula expected to begin rolling out June 20. Officials hope new shipments will reach store shelves within six to eight weeks, although resumption of full production at the plant will take longer.Abbott has replaced the leaking roof at the plant as well as the floor, Dr. Califf said.House panel members sharply questioned the commissioner and other agency officials at the hearing. They also demanded answers from an Abbott executive about the plant’s troubled history as well as to how the company would correct glaring deficiencies and ease shortages that have agonized families across the country.Christopher Calamari, an Abbott Nutrition senior vice president, offered little explanation for conditions at the Michigan factory but said he was “deeply, deeply sorry” about the shortages. He said the company was coordinating 50 flights a week from its formula plant in Ireland to a dozen U.S. airports to increase supplies.“We are committed to ensuring that this never happens again,” Mr. Calamari said.Representative Gary Palmer, a Republican of Alabama, pressed Mr. Calamari for specifics about why the company did not fix problems at the plant before the F.D.A. forced its hand.“We prioritize safety and compliance in our plants,” Mr. Calamari said. “And we’re committed to doing so and getting better coming out of this event.”Mr. Palmer replied that he was not satisfied with that response.Committee members pushed back against F.D.A. and Biden administration assertions that it was difficult to recognize in real time the extent of the contamination and the resulting nationwide breakdown in the supply chain. The Abbott plant had produced one-fourth of the nation’s infant formula, including tailored formulas for people with specialized nutritional needs.“There was a life-and-death crisis in front of the F.D.A., but they failed to see the severity of the situations,” said Representative Cathy McMorris Rodgers, a Republican of Washington. “We must solve the immediate issue and also ensure that we are taking action so this situation never happens again.”Read More on the Baby Formula ShortageUnderstand the Shortage: With just a handful of companies making infant formula for the U.S. market, the shutdown of an Abbott Laboratories plant had an outsize effect.Missing Safeguards: The shortage has revealed regulation gaps that make it hard to monitor the deadly bacterium that led to a recall.A Desperate Search: As the United States faces a baby formula shortage, some parents are rationing supplies, or driving for hours in search of them.An Emotional Toll: The shortage is forcing many new mothers to push themselves harder to breastfeed, with some even looking for ways to start again after having stopped.The agency had discovered a battery of problems at the plant last fall. At the same time, reports began emerging of babies who had been hospitalized with a rare bacteria. Cronobacter sakazakii, which can be deadly to infants, was found in four babies who had consumed formula from the plant, according to the Centers for Disease Control and Prevention.Testimony during the hearing made it clear that the F.D.A. took months to try to match the bacteria that sickened the first baby to bacteria that was later found throughout the plant.Dr. Califf testified to the House Oversight Committee about the Abbott Nutrition plant virtually on Wednesday.Brendan Smialowski/Agence France-Presse — Getty ImagesCronobacter strains related to two of the babies did not match samples of the bacteria later found at the plant, although Dr. Califf said the agency considered those results “inconclusive” given shortcomings with genome sequencing.The illnesses set the recall in motion this year. The plant shutdown began Feb. 17 and exacerbated shortages that had been intermittent during the height of the pandemic. Empty shelves have left parents struggling, driving hundreds of miles to find baby formula and, at times, improvising to feed hungry infants.Dr. Califf also acknowledged several ways that the F.D.A. had erred in addressing this problem: Its follow-up inspection in January should have started sooner, he said, adding that the agency took too long to circulate a whistleblower report that arrived in October but did not reach top officials until February.“It was too slow, and there were decisions that were suboptimal along the way,” Dr. Califf said.He told lawmakers that the agency did not receive an immediate notice when a formula plant found the deadly Cronobacter bacteria. Nor does the agency have access to the supply chain information that each of the three main U.S. baby formula manufacturers have in-house.The report of an anonymous whistleblower who said he worked in the Sturgis plant came up repeatedly during the hearing. The whistleblower alleged that safety staff there “celebrated” the F.D.A. overlooking problems after a 2019 inspection and did not destroy enough product when it found Cronobacter in finished products. That top agency officials did not see those claims until February “is stunning to me,” Mr. Palmer said.Details in the report suggested there was “corruption” at the plant, Representative Kim Schrier, Democrat of Washington, charged. Dr. Califf said he could neither confirm nor deny whether there might be criminal proceedings in the future.Mr. Calamari emphasized that the whistleblower’s claims had not been proven. “That’s an open investigation,” he said. “And it’s ongoing.”The report’s allegations resonated with panel members of both parties, including Representative Larry Bucshon, Republican of Indiana, who described himself as a “private-sector guy.”“It seems like that facility’s culture is a problem,” Mr. Bucshon said. “It seems to me that the company needs to do better with oversight.”Mr. Calamari contended that Abbott had invested tens of millions of dollars toward quality and maintenance, and he praised the dedication of employees at the 700,000-square-foot facility, which he visited last week.“I saw the team members there,” he said. “They are empowered to speak up and they are passionate about what they make and they make those products as it was for their own family.”Several panel members called for stricter agency oversight of food safety and more frequent inspections of troubled plants.Navigating the Baby Formula Shortage in the U.S.Card 1 of 6A growing problem.