The agency is asking the White House to move ahead with plans to drastically reduce the addictive substance in traditional tobacco cigarettes.In the final days of the Biden administration, the Food and Drug Administration is seeking White House approval to propose a drastic reduction in the amount of nicotine in cigarettes, a longstanding goal of public health experts that has faced stiff opposition from the powerful tobacco lobby.The F.D.A. submitted the proposal to the Office of Management and Budget only on Tuesday, a sign that the move was perhaps more wishful and symbolic than realistic for a White House juggling many late-term agenda items. And traditionally, the budget office’s review of agency proposals can take months.“I think it’s a milestone in progress toward the single most game-changing tobacco regulatory policy, in terms of lives that could be saved, that F.D.A. could ever do,” said Mitch Zeller, a former director of the agency’s tobacco center. “Having said that, it’s only a proposed rule, and we’re obviously in the waning days and weeks of an outgoing administration.”Even if the F.D.A. receives clearance from the White House to advance the proposal, whether it can survive once President-elect Donald Trump takes office in January is unclear given the sustained opposition from the industry. The tobacco lobby was also a significant donor to Mr. Trump’s campaign; the cigarette maker Reynolds American had given $8.5 million to his main super PAC by late October.Mr. Trump is known to personally oppose cigarette smoking, but has not weighed in recently on agency issues like nicotine levels in cigarettes. He has chosen Robert F. Kennedy Jr. as his likely nominee to run the nation’s top health agency, and Mr. Kennedy has railed against federal subsidies given to tobacco growers, saying they eclipse those sent to other farmers who grow fruits and vegetables. He listed the problem as evidence that “we are just poisoning” people and contributing to chronic disease.“It makes no sense if we want a healthy country,” he said in a speech in August.A World Health Organization study estimated in 2023 that the U.S. Agriculture Department allocated $437 million in subsidies to tobacco farmers from 2015 through 2020.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

President-elect Donald J. Trump announced on Friday that he would nominate Dr. Martin A. Makary, a Johns Hopkins University surgeon with a contrarian streak, to be commissioner of the Food and Drug Administration.In a post on social media, Mr. Trump said: “F.D.A. has lost the trust of Americans and lost sight of its primary goal as a regulator.” He said that Dr. Makary would work under Robert F. Kennedy Jr., the president-elect’s choice for the cabinet-level role as health secretary, to “properly evaluate harmful chemicals poisoning our nation’s food supply and drugs.”“I am confident that Dr. Makary, having dedicated his career to high-quality, lower-cost care will restore the F.D.A. to the gold standard of scientific research and cut the bureaucratic red tape at the agency to make sure Americans get the medical cures and treatments they deserve,” Mr. Trump said in a statement.Dr. Makary, 54, rose to prominence more than a decade ago as a critic of the medical establishment, speaking out about patient safety and working with hospitals to improve practices. He also gained attention during the pandemic, weighing in on herd immunity, vaccines and masks in 2021, roiling some doctors who were still contending with packed I.C.U.s and hundreds of deaths a week.As F.D.A. commissioner, Dr. Makary would lead an agency that has come under considerable fire from Mr. Kennedy Jr., who would be his boss if confirmed by the Senate to become secretary of the Department of Health and Human Services.Mr. Kennedy has been outspoken in his desire to overhaul the F.D.A., saying he would fire agency staff members whom he argued had “suppressed” disputed and sometimes harmful treatments; would gut an entire department; and would clamp down on the food and pharmaceutical industries. Mr. Kennedy has also criticized the so-called user fees from drug and medical device companies that pay for thousands of employees to review industry products and account for nearly half of the agency’s overall budget of $7.2 billion.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

Robert F. Kennedy Jr., one of President-elect Donald J. Trump’s advisers on health, is taking aim at the agency’s oversight on many fronts.Robert F. Kennedy Jr. has been unflinching in his attacks on the Food and Drug Administration in recent weeks, saying he wants to fire agency experts who have taken action against treatments that have sometimes harmed people or that teeter on the fringe of accepted health care practice.How much influence Mr. Kennedy will have in President-elect Donald J. Trump’s next administration remains unclear, with some suggesting that he could act as a White House czar for policy over several federal health agencies. Mr. Trump has voiced support for Mr. Kennedy in recent weeks, saying he will let him “go wild on health.” In his acceptance speech, Mr. Trump reiterated his support for Mr. Kennedy’s involvement on health matters.Some of Mr. Kennedy’s priorities are relatively standard, such as focusing on the health effects associated with ultraprocessed foods. Yet others threaten to undermine F.D.A. authority to rein in inappropriate medical treatments or to warn about products that can damage the public health.A spokeswoman for Mr. Kennedy did not respond to interview requests.Days before the election, in a post on X that has received 6.4 million views, Mr. Kennedy threatened to fire F.D.A. employees who have waged a “war on public health.” He listed some of the products that he claimed the F.D.A. had subjected to “aggressive suppression,” including ivermectin, raw milk, vitamins as well as therapies involving stem cells, and hyperbaric oxygen.Some items that he singled out had become flash points for conservative voters during the coronavirus pandemic, including ivermectin, which was found to be an ineffective treatment against Covid.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

It was added to cold and flu remedies in the 1990s when another ingredient went behind the counter over illicit meth lab concerns.The Food and Drug Administration on Thursday proposed removing a common ingredient in over-the-counter cold medicines that was found to have no effect on nasal congestion, despite its widespread use for decades.The proposal stems from a recommendation issued just over a year ago by a panel of experts who agreed unanimously that the ingredient, called phenylephrine, did not work when taken in liquid or pill form. It is still considered to be effective in nasal sprays.The ingredient has been used alone and in combination with other pain killers, cough suppressants and other agents meant to ease cold and flu symptoms in medications like Tylenol, Mucinex and Benadryl.“It is the F.D.A.’s role to ensure that drugs are safe and effective,” said Patrizia Cavazzoni, the director of the F.D.A.’s drug division. “Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant.”The agency emphasized that the ingredient was not considered unsafe.The move brings the agency one step closer to getting products containing the ingredient pulled from store shelves. In issuing the proposal, the F.D.A. also began seeking public comments. The F.D.A. said it would give companies additional time to reformulate their products if the proposal was finalized.Medical experts have said that patients who discover the ingredient in items in their medicine cabinet need not be concerned. They can safely take the rest of a combination product that includes phenylephrine if it contains other ingredients that are effective. Or they could throw out items that contain only phenylephrine.Getting the medication off the shelves has been a decades-long effort for Dr. Leslie Hendeles, a pharmacy professor emeritus at the University of Florida. He began raising concerns about the efficacy of the ingredient in the 1990s. It was added to cold and flu treatments as a stand-in for a more effective decongestant, pseudoephedrine, which was moved behind the counter after its use was noted in homegrown methamphetamine labs manufacturing illicit drugs.In 2007, Dr. Hendeles and a colleague filed an official petition with the F.D.A. asking them to remove the ingredient. Seventeen years later, on Thursday, Dr. Hendeles said that he was excited to see the process move forward.“It is amazing to me that it took this long, but it’s better than never,” he said.

The new director overseeing medical devices will confront criticisms about hasty approvals as she ushers in revolutionary technology.There are now artificial intelligence programs that scan M.R.I.s for signs of cancer, Apple AirPods that work as hearing aids and devices that decode the electrical blips of the brain to restore speech to those who have lost it.Medical device technology is now deeply entrenched in many patients’ health care and can have a stunning impact on their lives. As advancements become more tangible to millions of Americans, regulation of the devices has commanded increasing attention at the Food and Drug Administration.Dr. Michelle Tarver, a 15-year-veteran of the agency, is stepping into that spotlight at a critical time. She is taking the reins of the F.D.A.’s device division from Dr. Jeffrey Shuren, who forged deep ties with the device industry, sped up the pace of approvals and made the agency more approachable to companies. Some of those device makers were represented by Dr. Shuren’s wife and her law firm, posing ethical conflicts for him that continue to draw scrutiny.Dr. Michelle Tarver, an ophthalmologist and a 15-year veteran of the F.D.A.’s medical device division.U.S. Food and Drug AdministrationMore broadly, congressional lawmakers and consumer advocates have become increasingly concerned about the device industry’s influence over the sprawling division, which has a budget of about $790 million and a staff of 2,500. Device safety and standards for agency approvals of products as intimate as heart valves or neural implants will be at the forefront of the division’s mission in the coming years. Among the issues Dr. Tarver will encounter:Brains, computers and Elon MuskFew devices will require such intense oversight as one of the most breathtaking technologies in development: brain-computer interfaces that dip into the surface layers of the brain to decode its electrical noise — and return function to people who have lost it.Researchers from a number of teams have demonstrated the capability to restore the voice and speech of a California man with ALS, to enable a paralyzed man to walk and to help a man who is paralyzed below the neck to play Mario Kart by simply thinking about steering left or right.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

Patient advocates hope Dr. Michelle Tarver will lead the agency to focus more on safety and less on rapid approvals.The Food and Drug Administration on Tuesday announced that Dr. Michelle Tarver, an agency veteran, will be the new director of the medical device division.Dr. Tarver will face a slate of pressing tasks, that include addressing calls to strengthen standards to protect the public from issues like racial bias in artificial intelligence software and hastily authorized and faulty cardiac devices, like external defibrillators.She will also confront the challenge of restoring credibility to a division clouded by ethical lapses of Dr. Jeffrey Shuren, her predecessor, and of navigating her way in an agency with close ties to the industry.In addition, Dr. Tarver is assuming the position at a time of stunning technological advancement, overseeing research and potential approvals of devices meant to tap into brain signals to restore speech and movement.The division reviews thousands of medical products that are central to medical diagnosis and surgery, like DNA tests and surgical staplers. Other devices are implanted in the body for decades, including pacemakers and hip prostheses. The division has a budget of about $790 million and a staff of about 2,500.A 15-year veteran of the agency, Dr. Tarver is viewed by those inside the F.D.A. as a candidate who would sharpen the division’s focus on safety and quality. She is an ophthalmologist who continues to treat patients on the weekends, and she is also trained as an epidemiologist and has developed ways to measure patient preference in medical care.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

The Daytona Beach plant that makes nearly a quarter of the IV fluids used in the United States is intact in the wake of Hurricane Milton’s tear across Florida, according to a company spokeswoman.The site, operated by B Braun Medical, gained prominence this week as a backup source for IV solutions because Hurricane Helene had flooded a major producer of the fluids in North Carolina and left hospitals from California to Virginia with diminishing supplies.Company workers and officials from the federal Administration for Strategic Preparedness and Response took pre-emptive measures before Milton arrived, loading trucks full of finished IV medical products to ship them out of the storm’s reach through the night Tuesday. Allison Longenhagen, a company spokeswoman, said on Thursday that the manufacturing and distribution site at Daytona Beach was intact, and would reopen on Friday. She said a more complete update would be issued later Thursday.The threat to B Braun’s Florida plant worried officials, hospitals and people who rely on the fluids for nutrition, at-home dialysis and surgery because of the damage Hurricane Helene had done to a plant in Marion, N.C., run by Baxter, the nation’s leading maker of the products.Baxter ordinarily produces about 60 percent of the U.S. supply of IV products, or an estimated 1.5 million of the bags that are used each day, according to the American Hospital Association. Hospitals have begun canceling surgical procedures and rationing bags of the fluids while Baxter works to clean and restore its plant in Marion, which was extensively flooded.Early this week, Baxter provided hospital customers with just 40 percent of their usual deliveries of saline, dextrose and sterile water supplies. Baxter said Wednesday that it would increase deliveries to 60 percent.Other emergency measures were being taken to shore up gaps in the supply chain.On Wednesday, the Food and Drug Administration authorized temporary imports of Baxter fluids from Canada, Ireland, Britain and two plants in China. The company has not yet said when the imports would arrive, but said Thursday that trucks were shipping undamaged inventory from the North Carolina site.The patients most on edge about shortages are those who rely on a highly concentrated dextrose solution for nutrition. . Hospitals are conserving the fluids by giving some patients Pedialyte or Gatorade to drink, but those who rely on tube feeding for survival are less able to cut back.Beth Gore, chief executive of the Oley Foundation, which advocates for patients on long-term IV nutrition, said she had been hearing from dozens of families across the country who said they were told the supply for their children would be reduced or cut off.”We are all extremely concerned about the disproportionate harm that’s going to potentially happen to the home-care patients,” she said.

Officials are looking to foreign sources to ease shortages of IV bags caused by Hurricane Helene as hospitals begin rationing fluids to protect the sickest patients.U.S. officials are racing to approve airlifts of IV fluids from overseas manufacturing plants to ease shortages caused by Hurricane Helene that have forced hospitals to begin postponing surgeries as a way to ration supplies for the most fragile patients.The current shortage occurred when flooding coursed through western North Carolina and damaged a Baxter plant, which is now closed for cleaning. The plant makes about 60 percent of the United States’ supply of fluids used in IVs, for in-home dialysis and for people who rely on IV nutrition. They include premature babies in intensive care and patients who rely on tube feeding to survive.The situation could become even more dire now that Hurricane Milton is bearing down on Florida. On Tuesday, workers at B. Braun, makers of a fourth of the nation’s IV fluids, loaded trucks at the company’s plant in Daytona Beach with the medical bags and drove them north through the night to what they hoped would be a safer location.The Baxter plant, in Marion, N.C., and the B. Braun site in Daytona Beach manufacture about 85 percent of the nation’s supply of IV fluids. Experts on shortages have long pointed out the risk of such over-concentration of critical supplies, citing exposure to disasters like those now at hand. Even before the latest storm, supplies were tight and reflected a longstanding problem of how few companies are willing to produce crucial but low-cost and low-profit supplies.A spokeswoman for the B. Braun site in Florida said that the company was working with federal officials and that the plant’s staff would be off work Wednesday and planned to return on Friday once the hurricane had moved on.The supply crunch from flooding at the Baxter plant has led the company to limit hospital customers to 40 to 60 percent of their typical supplies this week. The American Hospital Association wrote to President Biden on Monday, seeking assistance to alleviate concerns about “substantial shortages of these lifesaving and life-supporting products.”We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

A top medical device regulator’s work overlapped at times with his wife’s legal representation of clients with business before the agency.Two members of Congress have asked an inspector general to investigate whether the top federal regulator for medical devices like pacemakers and artificial hips acted ethically in work that overlapped with that of his wife, a leading lawyer for device companies.The lawmakers cited an investigation by The New York Times that examined the intersection of the work of the regulator, Dr. Jeffrey Shuren of the Food and Drug Administration, and his wife, Allison Shuren, a co-chair of the drug and medical device practice at the prominent Washington office of Arnold & Porter.The two House Democrats who wrote a letter seeking an inquiry are Representatives Anna Eshoo, of California and ranking member of the health subcommittee, and Rosa DeLauro, of Connecticut and ranking member of the appropriations committee.The Times found several instances in which the couple’s work overlapped and could have posed conflicts of interest requiring Mr. Shuren’s recusal. The F.D.A. acknowledged ethics violations, saying that Dr. Shuren should have stepped aside or sought approval to be involved in two matters to “avoid any potential appearance of bias.”“In circumstances such as these,” the congresswomen’s letter to the inspector general, Christi Grimm, said, “the only way to get to the truth and be fair both to the public and Dr. Shuren is through an independent review of the matter to determine whether this is simply an appearance of impropriety or actual inappropriate and unethical conduct.”A spokeswoman for the inspector general’s office of the Health and Human Services Department said that the letter was received Tuesday and that “we are reviewing it for appropriate action.”We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

The F.D.A. authorized AstraZeneca to prescribe the treatment online for at-home use after a study showed it was feasible.The Food and Drug Administration on Friday authorized at-home use of FluMist, opening the door for needle-shy people to have easy access to a nasal spray vaccine that is potentially lifesaving.The approval will allow, for the first time, an alternative to the annual flu shot that parents and caregivers can give to children and that adults can use on their own outside of a health-care setting. It would still require a prescription and is expected to be available from an online pharmacy next fall.AstraZeneca, which makes the treatment, said it would start a FluMist Home website, where people can fill out a questionnaire that will be reviewed by a pharmacist before the treatment is shipped to a person’s home. The mist will remain available from prescribers as an in-office treatment. The current out-of-pocket cost for a dose is about $35 to $45, but may be less depending on insurance coverage.“Today’s approval of the first influenza vaccine for self- or caregiver-administration provides a new option for receiving a safe and effective seasonal influenza vaccine potentially with greater convenience, flexibility and accessibility for individuals and families,” said Dr. Peter Marks, director of the F.D.A.’s vaccine center, which authorized the at-home option.The agency required the company to study whether its instructions were clear and whether at-home administration was feasible. The agency concluded that it was, but advised caregivers to give the spray to those who are 2 to 17 years old.The flu takes a steep toll that varies greatly from year to year, according to an F.D.A. summary of data from the Centers for Disease Control and Prevention. From 2010 through 2023, hospitalizations have ranged from 100,000 to 700,000 each year, and from about 4,900 to 51,000 people have died.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.