The shots would be the first vaccines available against a respiratory virus that kills thousands and leads to many more hospitalizations each year.The NewsThe Food and Drug Administration on Wednesday approved GSK’s vaccine for the respiratory syncytial virus, or R.S.V., for adults who are 60 and older, the company said. The vaccine, to be sold as Arexvy, appears to be the first in the world approved for sale to protect older adults.An transmission electron microscopic image of R.S.V.Centers for Disease Control and PreventionWhy It Matters: R.S.V. can be lethalThe F.D.A. estimates that R.S.V. is associated with 6,000 to 10,000 deaths each year in adults 65 and older and at least 60,000 hospitalizations in that age group. It is a leading killer of children worldwide.This winter, R.S.V. contributed to the “tripledemic” also involving flu and Covid cases that swamped children’s hospitals and some I.C.U. wards.Background: Benefits and risks of the shotsOn March 1, an F.D.A. advisory panel reviewed data from trials for two vaccines aimed at older adults, one from GSK and one from Pfizer. The panel recommended that the agency approve both.The GSK vaccine was nearly 83 percent effective in preventing lower respiratory tract illness in adults 60 and older in a study of about 25,000 patients, according to data published in The New England Journal of Medicine. The virus can lead to pneumonia, which is far more worrisome for older adults and especially for those with underlying medical conditions like heart and lung disease or diabetes.Pfizer’s R.S.V. vaccine for older adults is also expected to receive F.D.A. approval this month. In a large study of that shot, it was found to be nearly 67 percent effective in preventing R.S.V.-related illness.The Pfizer and GSK vaccines were even more effective in treating older and sicker patients.The advisers did learn of some rare side effects from the vaccine trials. In the days after the shots were given, two recipients of the Pfizer vaccine and one recipient of the GSK shot developed cases of Guillain-Barré, a condition where the immune system attacks the nervous system (but not the spine or brain), according to data given to the F.D.A. panel.Moderna is also developing a vaccine for R.S.V. in older adults and said it expected authorization in the first half of this year. The company said a trial of 37,000 older adults showed 82 percent efficacy of the shot. The study was completed with “no safety concerns identified,” a Moderna news release said, though the company added that safety analyses were continuing.AstraZeneca and Sanofi are also seeking F.D.A. approval of a monoclonal antibody treatment meant to protect infants and toddlers up to 2 years old from R.S.V. infections. The companies reported findings from a major study indicating that the therapy reduced confirmedillnesses by 75 percent after one shot, according to AstraZeneca.Pfizer is seeking a separate approval for an R.S.V. vaccine given in the later stages of pregnancy to protect young infants.What’s Next: When will the vaccines be available?The Centers for Disease Control and Prevention is expected to follow the F.D.A.’s approval with a recommendation for use of the R.S.V. vaccines for older adults, possibly in June. The vaccine is expected to be available in the fall at local pharmacies, clinics and other health care settings.GSK executives have said that supplies of the vaccine, which is manufactured mainly at a plant in Belgium, should be readily available once it’s approved for use. For Medicare patients with Part D drug coverage, the vaccine will be available with no out-of-pocket expense, Alison Hunt, a GSK spokeswoman, said. But the company has not released a price, although insurers typically cover vaccines.The company told investors this year that it hoped to gain approval from the European Union for its R.S.V. vaccine, and later in China. Last week, the European Medicines Agency did recommend approval of GSK’s vaccine for adults 60 and older.

The Academies accepted millions of dollars from members of the Sackler family — including some who led Purdue Pharma, makers of OxyContin — even while advising federal officials on opioid policy.More than 75 members of the National Academies of Sciences, Engineering and Medicine demanded on Thursday that the organization explain why it has for years failed to return or repurpose millions of dollars donated by the Sackler family, including some who led Purdue Pharma.The company’s drug, OxyContin, helped set in motion a prescription opioid crisis that has claimed hundreds of thousands of lives. The New York Times reported this month that even as the Academies advised the government on opioid policy, the organization accepted $19 million from the Sackler family and appointed influential members to its committees who had financial ties to Purdue Pharma.One report issued by the Academies claimed that 100 million, or 40 percent of Americans, were in chronic pain. The figure, later found to be inflated, was cited by drugmakers to convince doctors to write large numbers of opioid prescriptions.In a letter delivered to Marcia McNutt, president of the National Academies of Sciences, scientists and economists called on the organization to clarify how research committee members who ran nonprofits heavily funded by Purdue were chosen to provide guidance to federal authorities on opioid policy: “How did the system fail in the past?” the letter asked.“The academy was looking like it had been morally asleep for the last 30 years,” Robert Putnam, an author of the letter and Harvard public policy professor, said in an interview.“We of course take the concerns of National Academy of Sciences members seriously, and their concerns were in part what prompted very serious conversations here about returning or repurposing the funds, to which the N.A.S. remains committed,” the organization said in a statement on Friday.The National Academies was chartered in 1863 by Abraham Lincoln to advise the nation on scientific and medical questions. The institution elects new members each year — elite scientists and physicians — and delivers influential advice to the White House, Congress and federal agencies.Though about 70 percent of the National Academies budget comes from federal funds, it also raises private donations from individuals, nonprofits and companies, including Chevron, Google, Merck and Medtronic.“If they begin to see the problem — that is, this huge influx of private money, and private money often comes with implicit strings — they will see it’s a threat to the core principles of the Academies,” Dr. Putnam said of the National Academies’ current leadership.Signatories of the letter include eight Nobel Prize winners. Two authors are National Academies of Sciences members who in 2017 urged top officials to distance the organization from the Sacklers.Robert M. Hauser, a prominent social scientist, wrote in an October 2017 email to two top Academies officials: “I have been thinking about the willingness of the N.A.S. to accept support from the Sackler family and to produce events and awards — lectures, forums, colloquia, prizes — however meritorious, in their name.”He and another Academies member had concluded “that the N.A.S. should disassociate itself from the Sacklers.” The other member was Angus Deaton, a Nobel Laureate and co-author of a book about surging deaths tied to substance use and suicide among members of the white working class.Dr. Deaton said in an interview that he and Dr. Hauser had asked for a call with top officials about the Sacklers’ involvement.“We wanted more than anything to warn them that there was a lot of trouble ahead down this route, and that tens of thousands of people were dying and the Sacklers were giving them money,” Dr. Deaton recalled in an interview.The organization accepted $19 million from the Sackler family and appointed influential members to its committees who had financial ties to Purdue Pharma.Eric Baradat/Agence France-Presse — Getty ImagesDr. Hauser, who worked at the National Academies from 2010 to 2016, referenced an in-depth New Yorker article about the Sackler family’s “ruthless” marketing of OxyContin in the email, which was sent to Bruce Darling, then the executive officer, and James Hinchman, then the chief operating officer.“Sooner or later I thought this was going to blow up in their faces,” Dr. Hauser said in an interview. “And it would really besmirch the reputation of the Academies, which I felt strongly about defending.”Four minutes after Dr. Hauser’s initial request was emailed, he received a reply from Mr. Darling: “We had a conversation at the N.A.S. Council this past summer on the very issue that you raise, and we made a decision that I would be pleased to discuss with you.”Mr. Darling and Mr. Hinchman did not respond to messages requesting comment.Dr. Hauser recalled that Mr. Darling summarized the Sacklers’ donations as something that had been discussed and required no new action. Dr. Deaton and Dr. Hauser felt their concerns had been dismissed.Two National Academies reports on opioids have faced criticism from experts. One published in 2011 included two panelists with significant financial ties to Purdue and concluded that 100 million Americans were in chronic pain, a number that proved to be greatly inflated. (The Centers for Disease Control and Prevention later estimated that roughly 52 million adults suffered from chronic pain, and more than 17 million U.S. adults experience high-impact or more severe chronic pain.)Still, the report armed drug companies with a talking point that proved influential with Food and Drug Administration officials who oversaw opioid approvals. It was also cited by Purdue Pharma attorneys in their response to a Senate inquiry.Another Academies committee on opioid policy was singled out by Senator Ron Wyden, Democrat of Oregon, because of some members’ links to Purdue. That panel, formed in 2016, went forward with a study after four members were replaced.Articles in The Progressive and in The BMJ, or the British Medical Journal, have also noted the Sacklers’ ties to the Academies and identified additional committee members with links to Purdue.The letter on Friday asked for “clear answers” to what procedures are in place to “ensure that advisory committee members are properly vetted,” among other questions.The Academies told The Times that beginning in 2019 Sackler family donations were no longer used for science-related events, research and awards, the purposes for which they were intended. The funds “were never used to support any advisory activities on the use of opioids,” Megan Lowry, a spokeswoman, said.The donations amounted to roughly $19 million and, as invested funds in the institution’s endowment, were worth about $31 million in late 2021, the most recent accounting available. Universities that accepted Sackler funds, including Tufts and Brown, have reallocated some of the money to addiction prevention and treatment efforts.Members of the Sackler family who were active in running Purdue Pharma began donating in 2008 to the National Academies of Sciences. The money was used to sponsor forums and studies.In 2015, family members donated $10 million to launch the Raymond and Beverly Sackler Prize in Convergence Research, according to reports by the organization’s treasurer. Dr. and Ms. Sackler died in 2017 and 2019. An attorney for the family said those donations had “nothing at all to do with pain, medications or anything related to the company.”Dame Jillian Sackler, whose husband, Arthur, died years before OxyContin arrived on the market, began giving to the Academies in 2000, and donated $5 million by 2017, Academies reports show.A day after The Times’s report ran, the National Academies issued a statement saying it had explored returning or repurposing the funds. “Doing so in an ethical and transparent manner will be the most important consideration,” the organization said.A perceived lack of urgency in the statement helped prompt the new letter from Academies members. “It’s another brushoff the way we read it,” Dr. Hauser said.He added: “We wrote our letter to tell them, ‘You guys have to be serious, prompt and sufficient about this.’”

Even as the nation’s drug crisis mounted, the National Academies of Sciences, Engineering and Medicine continued to accept funds from some members of the Sackler family, including those involved with Purdue Pharma.For the past decade, the White House and Congress have relied on the National Academies of Sciences, Engineering and Medicine, a renowned advisory group, to help shape the federal response to the opioid crisis, whether by convening expert panels or delivering policy recommendations and reports.Yet officials with the National Academies have kept quiet about one thing: their decision to accept roughly $19 million in donations from members of the Sackler family, the owners of Purdue Pharma, the maker of the drug OxyContin that is notorious for fueling the opioid epidemic.The opioid crisis has led to hundreds of thousands of overdose deaths, spawned lawsuits and forced other institutions to publicly distance themselves from Sackler money or to acknowledge potential conflicts of interest from ties to Purdue Pharma. The National Academies has largely avoided such scrutiny as it continues to advise the government on painkillers.“I didn’t know they were taking private money,” Michael Von Korff, a prominent pain care researcher, said. “It sounds like insanity to take money from principals of drug companies and then do reports related to opioids. I am really shocked.”Unlike the World Health Organization, which was accused of being manipulated by Purdue and later retracted two opioid policy reports, the National Academies has not conducted a public review to determine if the Sackler donations influenced its policymaking, despite issuing two major reports that influenced national opioid policy.One of those reports, released in 2011 and now largely discredited, claimed that 100 million Americans suffered from chronic pain — an estimate that proved to be highly inflated. Still, it gave drugmakers another talking point for aggressive sales campaigns, primed doctors to prescribe opioids at an accelerating rate and influenced the Food and Drug Administration to approve at least one highly potent opioid.Another problem arose in 2016, months after the National Academies received a $10 million Sackler family donation. The F.D.A. had tapped the institution to form a committee to issue new recommendations on opioids. But one senator took exception to some of the members selected by the Academies, complaining they had “substantial ties” to opioid makers, including Purdue. Before work began, four people were removed from the panel.The headquarters of Purdue Pharma in Stamford, Conn., in 2018.George Etheredge for The New York TimesThe National Academies is a nongovernmental institution, chartered by Abraham Lincoln in 1863, to serve as an independent adviser to the nation on science and medicine. Members of the Academies are elected each year — a career-capping honor for scientists and doctors.In recent years, though, the advisory group has come under criticism for lapses over disclosing conflicts of interest in reports on biotechnology, genetically modified food and pharmaceutical pricing. Lisa Bero, chief scientist at the University of Colorado Center for Bioethics and Humanities, said the group’s longtime failure to disclose financial ties between committee members and industry placed the Academies in the “dark ages” of research integrity.Accepting millions of dollars from the Sackler family while advising the federal government on pain policy “would be considered a conflict of interest under almost any conflict-of-interest policy I’ve ever seen,” Dr. Bero said.Lawmakers and others have issued investigations into the business practices of members of the Sackler family and lavish spending by Purdue that amplified the voices of doctors and medical organizations wanting more opioid prescriptions despite soaring overdose deaths.Yet aside from an article in a medical journal in 2019, the National Academies has not drawn public attention. After internal meetings, it quietly removed the Sackler name from the conferences and awards the family once helped sponsor.Megan Lowry, a spokeswoman for the National Academies, said in a statement that the Sackler donations “were never used to support any advisory activities on the use of opioids or on efforts to counter the opioid crisis.” Ms. Lowry added that the organization had been prevented from returning the Sackler money because of legal restrictions and “donor unwillingness to accept returned funds.” The Academies declined to make senior officials available for interviews.The Sackler donations emerged as an internal issue for the advisory group in 2019, when members of the governing council were briefed about the money. Sylvester Gates, known as Jim, a prominent Brown University physicist on the council, said members were “outraged” and wanted to ensure the funds did not influence the work of the Academies. But returning the money, Dr. Gates said, “was more complicated than the string theory I studied.”The Lincoln SocietyRaymond and Beverly Sackler in 2004. The family branch’s donations to the National Academies began in 2008.Taco van der Eb/Hollandse Hoogte, via Redux PicturesThe National Academies receives 70 percent of its budget from federal funding, with the remainder from its endowment and private donors, including corporations that sell fossil fuels, chemicals and myriad prescription drugs. Members of the Sackler family who were among the most heavily involved in running Purdue Pharma made their first donations to the National Academies in 2008, when Dr. Raymond Sackler, and his wife, Beverly Sackler, and the couple’s foundation, started contributing, according to Academy treasurer reports. Dr. and Ms. Sackler died in 2017 and 2019, respectively.Daniel S. Connolly, a lawyer for the Raymond and Beverly Sackler branch of the family, said the couple gave $13.1 million, which differs slightly from the $14 million listed in the National Academies treasurer reports. The donations were intended to support the National Academy of Sciences “in ways that are clearly described publicly as having nothing at all to do with pain, medications or anything related to the company,” Mr. Connolly said.The reports from the National Academies treasurer describe science-related events, prizes and studies supported by Raymond and Beverly Sackler. Donations from Dame Jillian Sackler, whose husband, Arthur, died years before OxyContin arrived on the market, began in 2000 in amounts that by 2017 reached $5 million, reports show. Those donations funded a series of scientific meetings, the treasurer reports say. The gifts qualified the Sackler donors for the institution’s Lincoln Society, consisting of top givers who enhance the Academies’ “impact as advisers to the nation,” according to the 2021 treasurer report. The Academies invested the funds, which grew to more than $31 million by the end of 2021, the most recent accounting available.A Flawed ReportA worker removed the Sackler name from the Tufts Medical Center campus in Boston in 2019.Cody O’Loughlin for The New York TimesAs the Sackler donations grew, a Purdue Pharma lobbyist was trying to make inroads with the Academies, according to records released in lawsuits against opioid makers. The Pain Care Forum, a group co-founded by Burt Rosen, the Purdue lobbyist, pushed for legislation introduced in 2007 and 2009 that included calling for a National Academies report to “increase the recognition of pain as a significant public health problem.”Soon after the measure passed in a 2010 law, Mr. Rosen convened the Pain Care Forum at a 10 p.m. gathering to focus on “meetings with the Institute of Medicine,” the former name for the National Academy of Medicine, and for “membership on I.O.M. Committee.”At the same time, the National Academies was forming the committee that would produce its 2011 opioids report, which included the estimate that about 100 million or 42 percent of American adults were in pain, a figure that other researchers later found to be significantly inflated. The report described chronic pain that limited function and cost the nation billions of dollars in lost salary and wages. Later estimates from the Centers for Disease Control and Prevention defined chronic pain by different categories of severity, saying the condition affects 7 percent to 21 percent of Americans.The report did not disclose any conflicts of interest for committee members nor did it disclose the Sackler funds. A spokeswoman for the National Academies said it did not release members’ conflict statements.But among the panelists chosen, Dr. Richard Payne was president of the American Pain Society, a physicians group, in 2003 and 2004, which at the time drew more than $900,000 from Purdue. Dr. Payne died in 2019.Another panelist, Myra Christopher, was swapping emails in 2007 with Purdue staff about “talking points” to respond to a news broadcast critical of opioids, records released in a Senate Finance Committee investigation in 2020 show.At the time that the 2011 report was written, Ms. Christopher was president of the Center for Practical Bioethics, a nonprofit based in Kansas City, Mo. Purdue gave $934,770 to the organization that year. Asked about the funding, John Carney, a former chief executive at the center, sent an opinion article that stated the group’s donors did not dictate any of its work. Ms. Christopher declined to comment.The 2011 report, which allowed pharmaceutical companies to argue that doctors should prescribe more opioids, came out even as the White House announced a very different message — that the nation was facing an opioid addiction crisis.Soon after the National Academies report was issued, Dr. Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing, emailed the institution and asked whether it would disclose that Ms. Christopher’s organization had received funds from Purdue.“No, sorry, can’t do that,” Clyde Behney, an official with the Academies replied in an email in August 2011 reviewed by The New York Times. “Keep in mind that the report is done and released, so the future is more important than the past.”Mr. Behney declined to comment. In a statement, the National Academies said it published an article in JAMA to explain how the committee arrived at the estimate that 100 million Americans were in pain. And the article, by Dr. Victor Dzau, president of the National Academy of Medicine, said that “conflict of interest is not an issue for the authors of the report,” who he said were carefully vetted. The JAMA article made no mention of Sackler family donations.Dr. Dzau later wrote a letter to JAMA clarifying that he should have disclosed — in that article and others — conflicts of his own, including funds he received from Medtronic, which made a device to infuse pain medication.The outsize pain figure was invoked routinely over the years — including in 2012 by Purdue’s own lawyers, who described the figure as evidence of pain that was “untreated or under-treated” in response to a Senate inquiry. Federal officials also highlighted the statistic. In 2014, Dr. Margaret Hamburg, the F.D.A. commissioner at the time, cited the figure of 100 million people “living with severe chronic pain” to explain why the agency approved a controversial and potent opioid called Zohydro.Another Panel QuestionedDr. Robert Califf, the F.D.A. commissioner, in April convened a meeting of experts to review study methods for evaluating long-term use of opioids.Anna Rose Layden for The New York TimesBy 2016, a new set of National Academies committee members would face scrutiny.Opioid overdose deaths were soaring that year and would soon overtake car crashes as the leading cause of death in the United States. Dr. Robert Califf, then the acting commissioner of the F.D.A., was under pressure from Congress to do something.He turned to the National Academies. Citing the 100 million people in pain, Dr. Califf and other top F.D.A. officials wrote in an article in The New England Journal of Medicine that the institution “brings an unbiased and highly respected perspective on these issues that can help us revise our framework.” (Dr. Califf was elected to be a member of the Academies later that year.)Soon after, names were floated to sit on the committee, leading Senator Ron Wyden, a Democrat of Oregon, to raise concerns about “potential conflicts of interest and bias” in a letter to Dr. Dzau, the National Academy of Medicine president. One person’s work, funded by Purdue, used the term “pseudoaddiction” to downplay the lure of opioids, the senator noted.The National Academies then replaced four panelists. The committee’s final report was widely respected and remains a key document for the F.D.A., which said it had consulted a variety of sources to address the drug crisis. Dr. Califf continues to rely on the report, which called for a “fundamental shift” in the nation’s approach to prescribing opioids.Shannon Hatch, an agency spokeswoman, said that the F.D.A. was not aware that the Sackler family donated to the Academies and that the 2017 report speaks for itself.Two members of the panel — Richard Bonnie, chairman of the committee and director of the University of Virginia Institute of Law, Psychiatry and Public Policy, and Dr. Aaron Kesselheim, a Harvard Medical School professor — said they were not aware of the Sackler family donations until asked about it by The Times. “I certainly didn’t feel any influence or pressure or expectations of what we would say from anyone at the National Academies,” Dr. Kesselheim said.Two years after that report was released, The BMJ examined the potential conflicts of Dr. Dzau and of members of yet another Academies committee convened to examine opioid-prescribing guidelines.Since then, the Justice Department announced an $8 billion civil and criminal settlement with Purdue Pharma and a civil settlement with members of the Sackler family. Those Sackler family members agreed to pay $225 million to resolve civil claims, and said they acted “ethically and lawfully.” Members of the family have not faced criminal charges.A bankruptcy plan to reorganize Purdue and resolve thousands of opioid cases was challenged over the Sacklers’ proposed conditions and is under appellate review.Purdue Pharma was asked by The Times to respond to a list of questions about its contacts with the Academies. But Michele Sharp, a Purdue spokeswoman, did not respond directly to any of those issues. Instead, she said the company was focused on its bankruptcy and settlement proceedings. “The settlement would deliver over $10 billion of value for opioid crisis abatement, overdose rescue medicines, and victim compensation,” she said.Institutions that more publicly examined their use of Sackler donations include Tufts University, which released a review of possible conflicts of interest related to pain research education funded by Purdue Pharma. Concerns noted in the report included a senior Purdue executive’s delivering lectures to students each semester.The World Health Organization in 2019 retracted two guidance documents on opioid policy after lawmakers aired concerns about ties to opioid makers, including a Purdue subsidiary, among report authors and funders.Going forward, experts in nonprofit law said the National Academies was in the unusual position of having millions of dollars with no plans for their use.Some universities, including Brown and Tufts, have dedicated their respective funds from the Sacklers to address the prevention or treatment of addiction.Given the devastation of the opioid crisis, Michael West, senior vice president of the New York Council of Nonprofits, said that it would be worth the effort for the Academies to follow their lead.“This would be a way,” he said, “of trying to make it right.”Alain Delaquérière

The NewsThe Food and Drug Administration on Tuesday authorized an additional round of bivalent booster shots for adults who are 65 and over as well as people with compromised immune systems. The effort is to ensure ongoing protection against Covid, which is still claiming more than 1,300 lives each week.The bivalent shots target Omicron variants of the coronavirus. The agency said people who are 65 and older who have not had a bivalent booster shot in at least four months may get another one. For those who are immunocompromised, additional doses of the bivalent vaccine can be given two months after the last shot. Those who are unvaccinated can get a single dose of the bivalent booster, the agency said.“Covid-19 continues to be a very real risk for many people,” Dr. Peter Marks, the F.D.A. vaccine chief, said. “The available data continue to demonstrate that vaccines prevent the most serious outcomes of Covid-19, which are severe illness, hospitalization and death.”The Food and Drug Administration on Tuesday approved an additional round of bivalent booster shots to ensure ongoing protection against Covid. Rosem Morton for The New York TimesWhy It MattersAlthough levels of the virus are dipping as the summer months approach, it is still being linked to 1,300 deaths each week, according to data from the Centers for Disease Control and Prevention.C.D.C. data also show that only 43 percent of people over 65 have received an Omicron booster shot, and just 20 percent of those 18 and older.BackgroundThe spring booster approval was for the same formula that was released to protect people from the Omicron variant of the virus. An updated vaccine is expected later this year. (The agency on Tuesday also rescinded authorization for the original monovalent vaccines that Americans received in the first mass-vaccination campaign.)The decision to offer the booster to the most vulnerable this spring is sound for two reasons, said Dr. Daniel Griffin, an infectious disease specialist at Columbia University.“One is the traditional reason — it protects people from severe disease,” he said. “But there is what I call the superpower where for a matter of three or four months, you get an extra benefit of reducing your risk of even getting infected.”What’s NextThe C.D.C. typically endorses updated vaccine schedules after F.D.A. authorizations.The F.D.A. said it intended to make decisions about the recommended vaccine schedule for people younger than 65 after a June advisory meeting. The agency said its advisers would make their recommendations based on whatever strain of the virus is circulating at that time.The F.D.A. said it expected to make updated formulations of the vaccines for this fall “once the specific strains are selected for the Covid-19 vaccines.”

A Senate homeland security committee examined growing health care shortages amid reports of rationing within hospitals.An increase in shortages of inexpensive yet critical medications is forcing hospitals to make “horrible” choices and is amounting to a national security threat, according to a report and testimony at a Senate homeland security hearing on Wednesday.A report prepared for the hearing found that drug shortages increased by nearly 30 percent last year compared with 2021, with an average shortage lasting 18 months and some spanning 15 years. They include common antibiotics, anesthetics and sterile fluids used to keep intravenous drug tubes clean.The problems were pegged to economic drivers, an opaque supply chain and the fact that as much as 80 to 90 percent of certain products are made overseas, said Senator Gary Peters, a Democrat of Michigan and chairman of the Senate Committee on Homeland Security and Government Affairs.“Taken together, these underlying causes not only present serious concerns about providing adequate care to patients, they also represent serious national security threats,” Mr. Peters said.Dr. Andrew Shuman, a cancer surgeon in Michigan, told senators at the hearing that shortages in his field have come to “represent a tragedy that’s happening in slow motion.”Dr. Shuman, who holds leadership roles at the University of Michigan hospital system and the Veterans Affairs Ann Arbor Healthcare System, said one cheap and established cancer drug called etoposide was recently in scarce supply. He had to weigh which patients, young and old, with lung, brain and testicular cancer, should receive the limited number of doses.“As a doctor who has devoted my life to fighting cancer, it’s hard to express how horrible that is,” Dr. Shuman said.The hospital pharmacist managed to stretch the supply on hand, but “our pharmacists should not be desperately trying to squeeze out a few last drops when a life may be on the line,” Dr. Shuman said.One expert outlined the efforts of the U.S. Pharmacopeia, a nonprofit focused on a safe drug supply, to map the dynamics and causes of shortages. That group found that there is a higher risk of shortages for drugs with a low price, complex manufacturing process or quality problems marked by a history of recalls, said Vimala Raghavendran, vice president of informatics product development for the U.S.P.Those factors can add up in interesting ways: Many of the cheapest products tend to be manufactured in regions of India and China where they are inexpensive to produce, but the concentration of facilities creates an extra layer of vulnerability to problems such as natural disasters or political unrest.Ms. Raghavendran said efforts to diversify the locations for production were important, but warned that bringing the manufacturing to the United States would not be the only way to fix the issue. She noted the recent bankruptcy of a U.S. generic drugmaker. The abrupt closure of Akorn Pharmaceuticals last month has been linked to the worsening of an albuterol shortage.Witnesses also emphasized the need for more transparency into drug supplies. Policymakers are “flying blind” when it comes to the sources of critical ingredients, often referred to as A.P.I., or active pharmaceutical ingredients, Ms. Raghavendran said.While the Food and Drug Administration gets some data on those active ingredients, the agency acknowledged to Senate staff that the data was not kept in a usable format, but rather “buried in PDFs within individual drug applications,” the Senate report says.Erin Fox, an expert at the University of Utah who tracks drug shortages, said another gap in information was critical, as well: There is no data on drugmaker quality. Such information might be used to reward the most scrupulous suppliers and help them expand production. Yet while the F.D.A. “sees really clear quality differences between products and manufacturing sites,” the information is confidential and not available to drug buyers.“There’s really no incentive for one company to do a better job,” Dr. Fox said. “If one company did do a better job, we have no way of knowing that.”The matter deserves attention, she said: “Unlike other products, people’s lives are at stake.”Dr. Shuman, the cancer surgeon, cited other troubling shortages, including of eye drops that “literally keep people from going blind that cost a few dollars a month.” He said patients with glaucoma who do not get the drops could be faced with surgery instead.Those critical but cheap treatments in short supply point to a need for incentives or subsidies to companies that make them, Dr. Shuman said, given that “drug pricing structures are not always reflective of their value to patients.”

Pfizer’s treatment applies an approach that is different from some other products, which doctors say may make it safer for people at risk of heart attacks or stroke.The Food and Drug Administration has approved a Pfizer nasal spray for treatment of migraines that uses a different therapy from other nasal products on the market for severe headache pain, the company said on Friday.The fast-acting treatment, which is called zavegepant and will be sold as Zavzpret, performed better than a placebo in relieving pain and patients’ most bothersome symptoms, according to clinical trial results published in the journal Lancet Neurology. Participants in the trial who took the medication were more likely to report returning to normal function 30 minutes to two hours after taking it.The gains, though, were not significant for every patient. A study tracked the experience of 1,269 patients — half on the drug and half on a placebo — focusing on how they reported feeling two hours after using either substance. About 24 percent on the medication reported freedom from pain, compared to about 15 percent who took a placebo, according to the study.Dr. Timothy A. Collins, chief of the headache division at Duke University Medical Center’s neurology department, said the product gave doctors a new option in a nasal spray format that patients with migraines tended to appreciate. He said the condition often comes with nausea, so swallowing a pill can be unpleasant. He also said the drug presented few side effects, like drowsiness, that had been reported with other products.“We’ve been waiting for this medication to come out,” Dr. Collins said. “It’s a really helpful addition to migraine management.”One additional upside of the medication is that it’s safe for patients who have had a heart attack or a stroke, he added.Pfizer said the medication would be available in pharmacies in July, but did not disclose the estimated price of the new spray. The company estimated that nearly 40 million people in the United States suffered from migraines each year.Calling the F.D.A.’s approval a “significant breakthrough,” Pfizer described the medication as the first and only nasal spray for migraines using a migraine inhibitor that attempts to block the release of proteins called calcitonin gene-related peptides, which studies have shown are present in greater volume during an attack and that can cause inflammation and pain. Some other nasal products use triptans, which are a class of drugs aimed at serotonin receptors but are generally not recommended for people with vascular diseases.Dr. Rashmi Halker Singh, an associate professor of neurology at the Mayo Clinic who cares for patients with migraines, said the new medication built on a discovery about the role of calcitonin gene-related peptides that was decades in the making.“And I think that discovery has been really groundbreaking in helping us to better understand what happens when someone is having a migraine attack,” she said.While medications in the class exist in pill form, nasal sprays are absorbed more quickly, another benefit of Pfizer’s new treatment.“Hopefully this will help us help more people,” Dr. Halker Singh said. “That’s the bottom line, right?”The major study of the drug also measured the trial participants’ freedom from their most bothersome symptoms two hours after taking the medicine. Forty percent of those taking it reported an improvement. Among those on a placebo, the result was 31 percent.Some side effects were reported by trial participants. About one-fifth of those who took the medication reported an altered sense of taste. Others experienced nasal discomfort and nausea.The authors concluded that “additional trials are needed to establish the long-term safety and consistency of effect across attacks.”

The F.D.A. seemed poised to rescind approval of Makena, after studies over time indicated the treatment did not halt early childbirth for many women.The company that makes Makena, the only drug aimed at preventing preterm birth, announced on Tuesday that it was voluntarily pulling the medication off the market after advisers for the Food and Drug Administration concluded that the treatment did not help pregnant women at all.Makena’s drugmaker, the Covis Pharma Group, said its decision had been made in deference to an F.D.A. advisory committee that agreed unanimously in October that a large study had showed that the drug offered no benefit to newborns.Makena had been cited by critics as a flawed example of the F.D.A.’s accelerated drug approval program because the agency’s original green light for sale was based on indications that the drug would be effective. But a succession of manufacturers could not provide convincing proof after years of study that the drug halted sometimes dangerous preterm births.Makena is now owned by Covis Pharma Group, a private-equity-backed company based in Switzerland.“While we stand by Makena’s favorable benefit-risk profile, including its efficacy in women at highest risk of preterm birth, we are seeking to voluntarily withdraw the product and work with the F.D.A. to effectuate an orderly wind-down,” Raghav Chari, chief innovation officer at Covis, said.The drug’s removal means that many women who have had an early birth will have no evidence-backed therapy to use during another pregnancy. While the drug was criticized for giving women false hope, patients and doctors who favored further study in the highest-risk populations spoke up in its defense at recent agency meetings.Despite dismal study results of late, Makena was the only resort for a health risk that disproportionately affects Black women and children who have higher risks of disability or death with premature birth. The initial study of the drug that led to its accelerated approval in 2011 showed signs of promise, but a far larger trial that concluded in 2019 showed no benefit for mothers or babies.The road to removing the drug from the market has been lengthy. The F.D.A. first proposed taking the drug off the market in October 2020. The drug’s sponsor appealed the decision, setting up a lengthy process leading to a hearing last fall.By October of last year, 15 F.D.A. advisers voted unanimously that the lengthy so-called confirmatory study had showed no benefit to babies. All but one agreed that the drug should be withdrawn from the market.Covis’s decision on Tuesday followed the recommendation made this past January by Dr. Celia Witten, an agency official and the presiding officer at the October hearing, that the drug be removed from the market. Still, Dr. Witten said she agreed with an advisory panel member who had acknowledged that officials could feel an imperative to “do something” when faced with a patient in need.“I think that when we leave something on the market that hasn’t been shown to be effective, we lose out on other investigations that might be pursued,” Dr. Anjali Kaimal, an obstetrician and administrator at the University of South Florida, said during the October hearing. “And the last thing I would say is that, again, faced with that powerless feeling: Is false hope really any hope at all?”In its news release on Tuesday, Covis said it had outlined a plan for voluntary withdrawal that included a wind-down period allowing patients using the medication to complete their courses and for the company to use its remaining inventory.But the F.D.A. “was not in agreement with the proposal,” Covis said, and let the process advance to Dr. Witten’s recommendation.The F.D.A.’s “accelerated approval” program is intended to grant rapid approval to a drug targeted at a serious, unmet medical need if it shows promise in delivering a benefit to patients. The program has sped about 300 drugs to the market in 30 years. It drew fierce criticism over the approval of the Alzheimer’s drug Aduhelm, an expensive drug that many experts criticized as risky and ineffective.Congressional efforts to alter the accelerated approval process culminated last year with minor changes, including the speeding up of follow-up studies to confirm whether a drug benefits patients.The F.D.A. should seek even more authority to improve the program, said Dr. Michael Carome, director of health research at Public Citizen, a consumer advocacy group. He said the agency advisers should be reviewing a drug seeking fast-tracked approval before an initial OK is granted. The F.D.A. should also seek authority to pull a drug from the market rapidly when the follow-up study shows no benefit, Dr. Carome said.“Makena is a classic example,” he said, “where the clock has dragged out too long.”

The shots, if approved by the agency, would be the first vaccines publicly available against a respiratory virus that kills thousands a year. Some advisers did cite a small but identifiable health risk.After hours of deliberation over safety concerns, a Food and Drug Administration advisory panel on Wednesday recommended approval of a second vaccine for the respiratory syncytial virus in older adults, advancing the first shots against an illness that can be deadly for the very young and the very old.Over two days this week, the panel debated and then voted in favor of two vaccines, one by Pfizer and one by GSK (GlaxoSmithKline), that would become available for adults 60 and older.The panels made their recommendations to the agency, which typically abides by advisory committee decisions and could grant formal approval within months.The F.D.A. estimates that R.S.V. is associated with 6,000 to 10,000 deaths each year in adults 65 and older and at least 60,000 hospitalizations in that group. It is a leading killer of children worldwide. This winter, R.S.V. contributed to the tripledemic also involving flu and Covid cases that swamped children’s hospitals and some I.C.U. wards. The caseloads have eased off recently.In addition to the vaccine candidates reviewed by the panel this week, AstraZeneca and Sanofi are seeking F.D.A. approval of a monoclonal antibody treatment aimed at protecting infants and toddlers up to 2 years old from R.S.V. infections. The companies reported findings from a major study indicating that the therapy reduced “medically attended” illnesses by 75 percent after one infusion, according to AstraZeneca.Pfizer is seeking separate approval for an R.S.V. vaccine given in the later stages of pregnancy to protect the youngest. It was 82 percent effective in keeping infants from developing severe R.S.V. in the first 90 days after they were born, the company said, though the effect fell to 69 percent by the time the infants were six months old.During two days of meetings this week, the F.D.A. advisers examining data on the proposed vaccines for older adults were not viewing the process as a simple pathway to approval. They debated the benefits of a vaccine for R.S.V. patients who overwhelmingly avoided hospitalization against the very few, but concerning, reports of autoimmune conditions like Guillain-Barré syndrome that emerged shortly after the shots were administered.On Tuesday, the panel voted in favor of the Pfizer vaccine by 7 to 4, with one abstention, on its safety and efficacy. On Wednesday, it voted 10 to 2 in favor of the GSK vaccine’s safety and unanimously on the shot’s efficacy.About 34,000 patients were studied in Pfizer’s trial, with half getting a placebo, according to an F.D.A. summary of the data. The vaccine was deemed nearly 67 percent effective in preventing R.S.V.-related lower respiratory tract illness, which can lead to pneumonia. That vaccine was nearly 86 percent effective in treating the disease with three or more symptoms, according to the data.The GSK vaccine was nearly 83 percent effective in lower respiratory tract illness in a study of about 25,000 patients — half on the vaccine and half on a placebo, according to data the company provided to the F.D.A. No R.S.V. deaths were reported among the patients in the GSK or Pfizer studies.Several panel members expressed concerns about side effects reported with each vaccine. After seven days, one patient who received the Pfizer vaccine developed Guillain-Barré syndrome, a condition where the immune system attacks the nervous system (but not the spine or brain). The case was considered life-threatening, F.D.A. records show, though a “potentially confounding factor” was that the patient had suffered a heart attack the day before the condition developed.Another Pfizer vaccine recipient developed Miller Fisher syndrome, which is considered to be a type of Guillain-Barré, eight days after getting the shot. That patient, from Japan, reported double vision and a tingling or burning feeling in her palms and the soles of her feet. Her symptoms were mostly resolved within 41 days, the F.D.A. records said.The two cases in the Pfizer study put the rate of the condition at about one in 9,000, even though it is typically about one in 100,000, according to Dr. Hana El Sahly, chairwoman of the vaccine advisory committee and a professor of virology at Baylor College of Medicine. “So this is major,” Dr. El Sahly said.Dr. Marie Griffin, a health policy professor at Vanderbilt University, said the Pfizer vaccine was difficult to evaluate given the low incidence of severe infections among those in the trial.“I think the benefit for relatively healthy, older people — you have to consider that — is not that great,” Dr. Griffin said. “Compared to a possible high risk of a very severe outcome.”One recipient of the GSK vaccine, who was 78 and from Japan, also developed Guillain-Barré nine days after getting the vaccine; she went on to spend six months in a rehabilitation hospital. The company and the F.D.A. considered the case to be related to the vaccine.Two recipients of the GSK vaccine, both 71 and from South Africa, developed acute disseminated encephalomyelitis, a neurological disorder with symptoms including weakness and loss of vision. One case resulted in death. The company and the F.D.A. considered the cases “possibly related” to the vaccine, noting that both patients also received a flu vaccine at the same time as the R.S.V. shot.Watching the safety of the vaccines after they are approved will be important, said Dr. Henry Bernstein of the Zucker School of Medicine at Hofstra University, and should be considered against the background that the effort to create an R.S.V. vaccine has gone on for years.“I don’t know that there’s a rush to get this to market if we’re going to take two steps forward, and three steps back as far as public health and optimizing vaccination rates,” Dr. Bernstein said.Pfizer and GSK said they would conduct continuing safety monitoring of the vaccines if they were approved by the F.D.A.Moderna is developing an mRNA-based vaccine for R.S.V. in older people, and said it plans to submit favorable data from a major trial to the F.D.A. for approval in the first half of this year. Janssen and Bavarian Nordic have also announced studies that are underway for their R.S.V. vaccines.Vaccine experts from the Centers for Disease Control and Prevention examined the Pfizer and GSK study data and determined that in one year, more than 21,000 people 65 and older would need to take the GSK vaccine to prevent one R.S.V. death; the number was nearly 25,000 for the Pfizer shot. They concluded that the data supported use of the vaccines for patients in that age group (but not in patients 60 and older).A C.D.C. survey of nearly 600 people who were 60 and older reported that 68 percent would “definitely” or “probably” get an R.S.V. vaccine if an option approved by the F.D.A. were available. Nearly 10 percent more said they would get the shot if a health care provider recommended it.

The problem begins at the farm where plants draw toxins from the soil. There’s no washing them away.The Food and Drug Administration’s new plan to keep high levels of lead out of baby foods like mashed sweet potatoes, apple sauce and dry cereal is part of a larger effort to eliminate heavy metals from the foods the youngest children eat.The push follows years of studies by public health, consumer and government experts revealing concerning levels of arsenic in rice cereal and other items fed to infants, including big-name brands like Gerber and organic staples like Earth’s Best.This problem is not confined to baby-food factories, though. Metals like cadmium and mercury often get into crops as the plants burrow into the ground, drawing in nutrients from contaminated soil — or from naturally occurring compounds. Here are some possible answers to how these heavy metals get into food, what growers can do to keep it out — and how parents of the tiniest diners can steer clear of tainted food.How do heavy metals get into foods in the first place?Rain washes pollutants from factories, landfills, animal feed lots or from roadway auto emissions into lakes, rivers and streams. These pollutants can travel through groundwater or irrigation streams and contaminate crops or soil, according to Laurie Beyranevand, director of the Center for Agriculture and Food Systems at Vermont Law and Graduate School.Some of the metals occur naturally in the soil. Others can get added by certain fertilizers and insecticides, said Arthur Villordon, a professor at Louisiana State University who specializes in sweet potato farming.As plants grow, some, like leafy greens, are particularly efficient at drawing in heavy metals and storing them in their leaves, roots or fruit.Why do these metals get into baby foods?Beyond contamination because of absorption from the soil, heavy metals can also find their way into baby food through additives like fortified vitamin mixes, said Evelyn Rusli, co-chief executive of Yumi, a baby food company that does extensive testing of its ingredients and finished products.Why is that a particular concern for babies?Heavy metals are not healthy for adults, but they are particularly bad for babies. Infants and toddlers grow rapidly, developing key body systems and laying the foundation for lifelong cardiovascular, immune and brain health. Because they are far smaller than adults, a small dose of any toxin can be harmful. They may also be less efficient at metabolizing toxins than adults. Small amounts of lead, for instance, have been found to affect behavior, I.Q. and academic achievement, according to the American Academy of Pediatrics.What products should I avoid if I’m feeding a baby?Rice, used in baby cereal and snack puffs, is consistently identified in studies as the food with the highest levels of arsenic, which is associated with cancer. The problem is believed to stem from rice farming in fields that are flooded year after year with water that can contaminate the soil. (Scientists are working on ways to minimize the problem.)Dry rice cereal is often one of the first foods parents are urged to mix with breast milk or formula when a baby begins the transition from a liquid diet to solid food. Dry oatmeal cereal is a better alternative, according to a report by Healthy Babies Bright Futures, an advocacy group.Other foods found to have the lowest levels of heavy metals include peas, green beans, butternut squash and bananas. Beans, eggs and soft meat in traditional baby food or prepared at home are low-metal forms of protein, the report says. Serving a wide variety of fruits and vegetables — instead of relying heavily on carrots and sweet potatoes — can help reduce overall exposure to heavy metals.Why aren’t the foods tested before they get on the market?While some food companies monitor toxin levels, they are not required to report the results to the public or to list them on product labels. The F.D.A. has broad mandates that food makers ensure their products are safe, but there are few actual limits for specific toxins. The F.D.A. has set an “action limit” for inorganic arsenic in rice cereal marketed for babies and has proposed one for lead in juice.These limits — like those proposed for lead in baby food — do not set a strict bar. Rather, they create guidelines for food makers to voluntarily follow. If the F.D.A. finds that a company exceeds the levels, it can pursue enforcement action, which can lead to a product recall, seizure or a recommendation for criminal prosecution.What can be done to remove metals from foods?Washing produce will not help. But there are agricultural techniques that can reduce the levels seeping into crops. Farmers can test soil and use contaminated fields for crops that do not tend to pick up the metals, like beans. They can also use fields with suboptimal soil to grow lavender or other crops that might not be eaten, Ms. Beyranevand, of Vermont Law, said. Farmers are also trying to reduce toxins by growing crops — such as sunflowers and poplar trees — that are efficient at drawing impurities out of the soil and then disposing of the plants.Agriculture experts are studying hundreds of varieties of plants that people eat to determine which are the least likely to harbor heavy metals, according to the Healthy Babies Bright Futures report.What can food companies do?Ms. Rusli, of Yumi, said her company reviewed soil content data from the Environmental Protection Agency to buy produce for its baby food from regions with lower levels of contamination. It also conducts testing before entering into contracts with farmers and tests finished products to ensure that metals aren’t added during processing.

The agency estimated that the guidelines could reduce young children’s dietary exposure to lead by about 25 percent.The Food and Drug Administration on Tuesday proposed maximum limits for the amount of lead in baby foods like mashed fruits and vegetables and dry cereals, after years of studies revealed that many processed products contained levels known to pose a risk of neurological and developmental impairment.The agency issued draft guidance, which would not be mandatory for food manufacturers to abide by. The guidelines, if adopted, would allow the agency to take enforcement action against companies that produced foods that exceeded the new limits.“This is really important progress for babies,” said Scott Faber, vice president of public affairs for the Environmental Working Group, a nonprofit organization that had urged the agency to take action to remove metals from foods. “We were grateful that F.D.A. has and the Biden administration has made reducing toxic metals in baby food a priority.”The new limits, aimed at foods for children under 2, do not address grain-based snacks that have also been found to contain high levels of heavy metals. And they do not limit other metals, like cadmium, that the agency and many consumer groups have detected in infant foods in previous years.Jane Houlihan, research director for Healthy Babies Bright Futures, a nonprofit, called the guidelines disappointing. “It doesn’t go far enough to protect babies from neurodevelopmental damage from lead exposures,” she said. “Lead is in almost every baby food we’ve tested, and the action levels that F.D.A. has set will influence almost none of that food.”She said the limits would address some of the highest levels they had found but more broadly appeared to “codify the status quo.”The Centers for Disease Control and Prevention has said there is no safe level of lead for children, who more readily absorb the heavy metal. The F.D.A. proposed setting a lead level lower than10 parts per billion in yogurts, fruits or vegetables and no more than 20 parts per billion in root vegetables and in dry infant cereals.The limits “would result in significant reductions in exposures to lead from food while ensuring availability of nutritious foods,” according to an F.D.A. news release. The move is part of the agency’s Closer to Zero initiative, which is aimed at reducing the exposure of young children to toxins such as lead, arsenic, cadmium and mercury.The changes “will result in long-term, meaningful and sustainable reductions in the exposure to this contaminant from foods,” said Dr. Robert M. Califf, the commissioner of the F.D.A. The guideline would allow the agency to identify foods as “adulterated” if they contained levels beyond the limits, and to then seek a recall, seize products or recommend a criminal prosecution.The agency estimated that the proposed levels could reduce the dietary exposure to lead for some young children by about 25 percent. According to the F.D.A., low levels of lead exposure in children can lead to “learning disabilities, behavior difficulties and lowered I.Q.” as well as immunological and cardiovascular effects.In 2020, the F.D.A. set limits for inorganic arsenic in rice cereal for infants and in April of last year, it proposed maximum levels for lead in juice.In comments submitted to the F.D.A. on its broader plan, Gerber wrote in 2021 that reducing toxins was difficult because plants absorbed them from the soil as they grew.“Actions that result in removing baby foods from the diet, whether intentional or not, do not change exposure if these foods are replaced with other sources of the same fruits, vegetables and grains that are prone to having heavy metals,” the company wrote.A Gerber spokeswoman said on Tuesday that the company was reviewing the F.D.A.’s proposal, and planned to work with the agency “to advance this important effort to continue to reduce the levels of heavy metals in infant and toddler foods.”Walmart and Hain Celestial, which produces Earth’s Best Organic foods, did not respond to requests for comment on the proposal. Beech-Nut Nutrition Company said in a statement that it was reviewing the guidance and would work with the F.D.A. on “the establishment of science-based regulatory” limits for “naturally occurring heavy metals.”Attorneys general from New York, Illinois, Pennsylvania, Michigan and other states had weighed in on the overall plan, urging the F.D.A. to post the results of its tests for multiple metals in baby food on its website.Lead is ubiquitous in the environment from decades of unregulated use in gasoline for cars, farm machinery, aircraft and paint, said Tracey Woodruff, a scientist at the University of California, San Francisco, who studies exposure to toxins.She applauded the F.D.A.’s goals, but said a strict limit would be more effective because the voluntary guideline would require monitoring for possible enforcement.“Corporations are innovative and know how to tweak what they need to do to meet legal standards and make a profit,” she said.Representative Raja Krishnamoorthi, Democrat of Illinois, has been a leading voice calling for reductions of heavy metals in baby foods. He and other lawmakers issued a report in 2021 showing that baby foods like carrots and sweet potatoes were contaminated with heavy metals.On Tuesday, Representative Krishnamoorthi said in a statement that he has been pressing the F.D.A. to ensure baby food is safe. He said he remained concerned that the “lead levels announced today are considerably more lenient than those specified in” legislation that he and other lawmakers introduced in March 2021.Months later, Consumer Reports released tests showing that arsenic remained present in rice cereal meant for babies even after the limit was issued. The group advised parents to favor dry oatmeal as a safer alternative.Mr. Faber, of the Environmental Working Group, said the new guideline would prompt food companies to encourage suppliers to alter their farming practices to reduce the lead levels in food.“I think that past history has shown that farmers and food companies are very quickly able to change how they grow and process these ingredients to meet tougher standards,” he said.