Fate of Billions for Opioid Victims From Sacklers Rests With Supreme Court

The court will decide whether Purdue’s owners can gain permanent immunity from future opioid lawsuits in exchange for payments up to $6 billion.In 2014, when the first opioid lawsuits were filed against Purdue Pharma, Tiffinee Scott’s daughter was still years away from her fatal overdose from addictive prescription painkillers, including Purdue’s OxyContin, which she was taking to manage sickle cell pain.That year, Dede Yoder’s teenage son was struggling with an addiction that began with an OxyContin prescription for a sports injury. He would die from an overdose in 2017, after attempting rehab eight times.It would be years before Gary Carter’s son, who had been filching his grandparents’ OxyContin, would die from an overdose of fentanyl, an illicit opioid that many people who became addicted to prescription painkillers eventually turned to over the past decade.The three families and others who have ended up suing Purdue shared their stories in letters to the Supreme Court, which will hear oral argument Monday on the remaining sticking point in the yearslong effort to settle litigation that has ballooned into nearly 3,000 cases. A multi-billion-dollar agreement is at stake.A ruling upholding the disputed provision would finally start the flow of payments from the company and its owners — members of the billionaire Sackler family — to cities, states, tribes and individuals to help them cope with the costs of the ongoing opioid crisis. It would also allow Purdue to emerge from bankruptcy restructuring as a public benefit company.A ruling against the measure could blow up the painstakingly negotiated settlement, leaving the fate of the company and the urgently sought payments up in the air.The court will consider the legality of a condition demanded by the Sacklers and approved by a bankruptcy judge: In exchange for paying up to $6 billion, the Sacklers insist on being shielded from civil lawsuits that anyone else might want to bring against them involving Purdue and opioids.That liability shield is standard for businesses that file for bankruptcy, as Purdue has done. But the Sacklers have not filed for bankruptcy. Still, they argue that because the Purdue settlement relies on their personal contributions, Purdue’s liability protection should also extend to them.The situation has created an agonizing irony for many who have lost loved ones to opioids. Desperate for funds to pay off their debts and address the addiction crisis, many support giving the Sacklers the sweeping legal pass.“NO ONE wants to see the Sacklers pay the full price more than me,” Cheryl Juaire, who organized grieving parents, wrote to the court. “I lost TWO SONS as a result of their actions. But the only thing that will make my personal tragedy worse is to know that others will suffer the way I do every day.”The Stamford, Conn., headquarters of Purdue Pharma, which is awaiting a Supreme Court ruling on whether nearly 3,000 opioid lawsuits against it can be settled.Frank Franklin II/Associated PressAn overwhelming majority of claimants reached that conclusion more than two years ago, voting in favor of the settlement plan, including liability immunity for the Sacklers. They said they feared that protracted litigation would devour money that they have long needed.But an arm of the Justice Department that monitors bankruptcy proceedings objected, along with a handful of other parties, arguing that precluding people from having their day in court was both unconstitutional and outside the power of a bankruptcy court.Last summer, after a federal appeals court upheld the Sackler shields, the Justice Department division, the U.S. Trustee Program, petitioned the Supreme Court to take up the matter.The speed with which the court scheduled the case may reflect its awareness of the opioid problem. But legal experts said its ruling would be unlikely to dwell on the public health crisis. The court, they said, will focus narrowly on the liability shield, an increasingly popular, though contentious, bankruptcy tactic.“I’m sure, though, that even if the opioid crisis doesn’t show up anywhere in the opinion, the court has to be bearing in mind that cities, states and individuals have been desperately waiting for these funds. They need to know the answer to this question so they can figure out what to do next,” said Adam Zimmerman, who teaches mass tort law at the University of Southern California’s Gould School of Law.Though numerous pharmaceutical companies have been sued for their roles in the opioid epidemic, the Sacklers and Purdue loom large in the story of the complex, decades-old crisis. Their signature drug, OxyContin, approved by the Food and Drug Administration in late 1995, became a game changer in a new market hungry for prescription painkillers. To the medical establishment that was then beginning to recognize pain as a “fifth vital sign,” long-acting OxyContin looked like a wondrous medication.Purdue became known for lavish sales conferences, at which pain medicine physicians, trained and hired by the company, would falsely claim that the risk of addiction to OxyContin was extremely low. By 2007, Purdue and three of its top executives had paid fines of $634.5 million and pleaded guilty to federal criminal charges for misleading regulators, doctors and patients about the drug’s potential for abuse.The steep fines did little to deter Purdue from continuing to aggressively market OxyContin.Eventually, attention became focused on the Sacklers themselves, some of whom served as Purdue board members and made large charitable donations to medical schools and museums. In exchange, the institutions renamed buildings after the Sacklers. But as the family saga became featured in books, television series and documentaries and their notoriety grew, most stripped the Sackler name from their properties and dissociated themselves from Purdue’s owners.The size of the Sacklers’ fortune from OxyContin has long been a mystery. An independent audit commissioned by Purdue for the bankruptcy court found that the Sacklers withdrew about $10.5 billion from Purdue between 2008 and 2017, of which they paid more than 40 percent in taxes. The $6 billion settlement offer, the Sacklers say, represents most of the profit from the drug during that period.As lawsuits against Purdue and the Sacklers rapidly accrued, in 2019 Purdue sought restructuring in bankruptcy court, a move that automatically suspended all lawsuits against the company. The tactic was the first step on the path leading toward the Supreme Court.Dan A. Polster, a federal judge in Cleveland, was assigned to manage thousands of opioid cases nationwide.Maddie McGarvey for The New York TimesMost other companies that have been sued over their role in the opioid crisis — drug manufacturers, distributors and retailers — have reached settlements and are starting to make payments. But the opioid tragedy has not receded. Though production of prescription painkillers slowed, cheap heroin and then fentanyl rushed in to fuel an ever-growing demand. During a 12-month period ending in June, overdose fatalities from opioids and other drugs, including cocaine and methamphetamine, were predicted to surpass 111,000, according to provisional federal data.Whether the billions of dollars in the Purdue settlement and others will have a meaningful impact on addiction and overdose fatality rates remains to be seen. In January 2018, Dan A. Polster, a federal judge in Cleveland assigned to oversee nationwide opioid settlements, asked whether a court was, in fact, the proper place to grapple with a public health crisis that had passed through the hands of federal and state regulators, physicians, hospitals and insurers as well as the pharmaceutical industry.“The federal court is probably the least likely branch of government to try and tackle this, but candidly, the other branches of government, federal and state, have punted,” he said.Now, nearly six years after his remarks, with the Supreme Court about to wade in, the national opioid litigation may be edging toward conclusion. But many health and legal experts believe it will not resolve the addiction crisis that it was intended to address.“It’s easy for people to think, ‘Hey, we’ll go to court, and we’ll solve the problem,’ but that also assumes that the way you solve a public health crisis is just by handing out money,” said Abbe R. Gluck, a Yale Law School professor and an author of a forthcoming article on unorthodox uses of bankruptcy.Congress and oversight agencies need to step up, Ms. Gluck said. “When it comes to opioids,” she added, “there’s a lot more that has to happen that litigation can’t touch.”

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Opioid Settlement Money Is Being Spent on Police Cars and Overtime

As states and counties spend the first wave of billions of dollars from the pharmaceutical industry, public health groups are challenging how some funds are being used.After years of litigation to hold the pharmaceutical industry accountable for the deadly abuse of prescription painkillers, payments from what could amount to more than $50 billion in court settlements have started to flow to states and communities to address the nation’s continuing opioid crisis.But though the payments come with stacks of guidance outlining core strategies for drug prevention and addiction treatment, the first wave of awards is setting off heated debates over the best use of the money, including the role that law enforcement should play in grappling with a public health disaster.States and local governments are designating millions of dollars for overdose reversal drugs, addiction treatment medication, and wound care vans for people with infections from injecting drugs. But law enforcement departments are receiving opioid settlement money for policing resources like new cruisers, overtime pay for narcotics investigators, phone-hacking equipment, body scanners to detect drugs on inmates and restraint devices.“I have a great deal of ambivalence towards the use of the opioid money for that purpose,” said Chester Cedars, chairman of Louisiana’s advisory opioid task force and president of St. Martin Parish. The state’s directives say only “law enforcement expenditures related to the opioid epidemic,” added Mr. Cedars, a retired prosecutor. “That is wide open as to what that exactly means.”On Monday, 133 addiction medicine specialists, legal aid groups, street outreach groups and other organizations released a list of suggested priorities for the funds. Their recommendations include housing for people in recovery and expanding access to syringe exchange programs, personal use testing strips for fentanyl and xylazine, and medication that treats addiction.They expressly stated that no funds “should be spent on law enforcement personnel, overtime or equipment.”“Law enforcement already gets a lot of funding, and I’m sure they would say it’s never enough,” said Tricia Christensen, an author of the proposed priorities, who is the policy director at Community Education Group, which has been tracking opioid settlement money across Appalachia. But the opioid money, she said, “is really unique.”Law enforcement departments have been receiving opioid settlement money for policing resources like new cruisers, overtime pay, phone-hacking equipment, body scanners and restraint devices.Whitney Curtis for The New York TimesGroups that monitor opioid settlements use various criteria to estimate the total payout. But even employing the most conservative tabulation, the final amount could well be north of $50 billion when pending lawsuits are resolved, notably the multibillion-dollar Purdue bankruptcy plan, which the Supreme Court temporarily paused last week.At first glance, that looks like a fabulous trove of money. In reality, it will be parceled out over 18 years and is already dwarfed by the behemoth dimensions of the opioid crisis, now dominated by illicit fentanyl and other drugs.The spectacle of states as well as thousands of cities, counties and towns all struggling to determine the most effective uses of these desperately needed funds is raising many questions.Underlying the wrangling is a push for greater transparency in awarding the money and a determination not to repeat the mistakes of the Big Tobacco settlement 25 years ago. State governments have used most of the $246 billion from tobacco companies to plug budget holes and pay for other projects, and reserved relatively little to redress nicotine-related problems.Now, states and local governments have committees to determine appropriate allocation of the opioid money. Sheriffs and police officials comprise less than a fifth of the members on those task forces, according to a recent analysis by KFF Health News, Johns Hopkins University and Shatterproof, a national nonprofit that focuses on addiction.But public sentiment in many communities favors ridding the streets of drug dealers as a means of abating the crisis.When Samuel Sanguedolce, the district attorney of Luzerne County in Pennsylvania, presented his budget to the County Council in November, he made a pitch for some of the county’s settlement money, about $3.4 million so far.“With 10 more detectives, I could arrest those cases around the clock,” he said, referring to drug dealers. “I think this is a good way to use money that resulted from this opioid crisis to assist those detectives without putting it on the taxpayers.”“And I’ve asked not just for detectives,” he continued. “But hiring people, of course, costs money, in the way that they need guns and vests and computers and cars.”In many areas of the country, the lines between law enforcement and health care can be somewhat blurred: Police and sheriffs’ departments are also emergency responders, trained to administer overdose reversal drugs. Louisiana is dedicating 20 percent of its opioid money to parish sheriffs.OnPoint NYC, an overdose prevention center and safe injection site.Seth Wenig/Associated PressSheriff K.P. Gibson of Acadia Parish, who represents sheriffs on Louisiana’s opioid task force, said that he intended to use the $100,000 his department is set to receive for “medical needs” of people in the jail, including various opioid treatments and counseling. The goal, he said, is to help inmates become “productive citizens within our community,” once they are released.Public health officials and addiction treatment specialists are also concerned about another use of the money: grants for faith-based rehab programs that prohibit federally approved medications like Suboxone and methadone, which blunt cravings for opioids.“I would be open to a faith-based cancer program, but not one that doesn’t let you take effective medicines to treat the cancer,” said Dr. Joshua Sharfstein, a professor at Johns Hopkins Bloomberg School of Public Health, which has released its own guidance principles for the settlement funds.Throughout the years of negotiating opioid settlements, lawyers for states, tribes and local governments and those defending drug distributors, manufacturers and pharmacy chains struggled to avoid the pitfalls that emerged from the Big Tobacco litigation.This time, local governments have struck agreements with state attorneys general over the allocation of the money. Legislatures are largely excluded from most of the funds.Johns Hopkins praised Rock County, Wis., as a jurisdiction that strove to get a full picture of local needs for the money: It put together a working group to review evidence-based literature and conducted surveys and meetings to elicit community suggestions.In North Carolina, county governments receive 85 percent of the funds, which have reached nearly $161 million so far. Having signed onto the core principles worked up with the attorney general, the counties have great discretion in spending their allotments.“When you look at who addresses the issues of the opioid epidemic, it’s addressed locally by E.M.S., social services and jails. Those are all county functions in North Carolina, so that’s why it made sense for them to get the bulk of the resources,” said Josh Stein, the North Carolina attorney general, who helped negotiate the national opioid settlements.Dressing a skin wound in the Kensington neighborhood of Philadelphia.Matt Rourke/Associated PressEach county is establishing its own priorities. Stanly County, he said, is setting up teams to reach people who have just survived overdoses, hoping to connect them with services. Mecklenburg County has directed some of its funding for post-recovery education and job-training programs.Such uses can help to lift a community stricken by addiction, said Ms. Christensen, whose group monitors opioid settlements for 13 states. “I really subscribe to the idea that overdoses are often ‘deaths of despair’ — that the reason many folks spiral into chaotic drug use has a lot to do with what has happened to them and their lack of opportunities,” she said. “So how can we invest in the community to prevent that from happening generation after generation? That’s why I think community input is so important in this process.”The groups that released the new set of priorities cited examples of promising use of the funds. Michigan’s plans include adding rooms in hospitals so that new mothers can stay with infants born with neonatal abstinence syndrome. Kentucky is giving $1 million to four legal aid groups to represent people with opioid-related cases.“I was blown away by that,” said Shameka Parrish-Wright, executive director of VOCAL-KY, a community group that worked on the priorities documents. Ms. Parrish-Wright, a former candidate for Louisville mayor who had been addicted to drugs, homeless and incarcerated, added: “Those legal entities are really helpful in making sure we deal with paraphernalia charges and evictions. People coming out of treatment are sometimes discriminated against because of those charges and can’t get housing or jobs.”VOCAL-KY has not applied for settlement money but works closely with groups that do. Its members attend meetings held by Kentucky’s opioid task force. “Knowing that Black and brown and poor white communities are dealing with it the worst, we pushed them to have another town hall in those communities,” Ms. Parrish-Wright said.With Big Tobacco’s cautionary tale shadowing these debates, the issue of accountability looms. Who ensures that grantees spend their money appropriately? What sanctions will befall those who color outside the lines of their grants?So far, the answers remain to be seen. Christine Minhee, a lawyer who runs the Opioid Settlement Tracker, which analyzes state approaches to spending the funds, noted that on that question, the voluminous legal agreements could be opaque.“But between the lines, the settlement agreements themselves imply that the political process, rather than the courts, will bear the actual enforcement burden,” she said. “This means that the task of enforcing the spirit of the agreement — making sure that settlements are spent in ways that maximize lives saved — is left to the rest of us.”

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Should Opioid Settlement Money Be Spent on Law Enforcement?

As states and counties spend the first wave of billions of dollars from the pharmaceutical industry, public health groups are challenging how some funds are being used.After years of litigation to hold the pharmaceutical industry accountable for the deadly abuse of prescription painkillers, payments from what could amount to more than $50 billion in court settlements have started to flow to states and communities to address the nation’s continuing opioid crisis.But though the payments come with stacks of guidance outlining core strategies for drug prevention and addiction treatment, the first wave of awards is setting off heated debates over the best use of the money, including the role that law enforcement should play in grappling with a public health disaster.States and local governments are designating millions of dollars for overdose reversal drugs, addiction treatment medication, and wound care vans for people with infections from injecting drugs. But law enforcement departments are receiving opioid settlement money for policing resources like new cruisers, overtime pay for narcotics investigators, phone-hacking equipment, body scanners to detect drugs on inmates and restraint devices.“I have a great deal of ambivalence towards the use of the opioid money for that purpose,” said Chester Cedars, chairman of Louisiana’s advisory opioid task force and president of St. Martin Parish. The state’s directives say only “law enforcement expenditures related to the opioid epidemic,” added Mr. Cedars, a retired prosecutor. “That is wide open as to what that exactly means.”On Monday, 133 addiction medicine specialists, legal aid groups, street outreach groups and other organizations released a list of suggested priorities for the funds. Their recommendations include housing for people in recovery and expanding access to syringe exchange programs, personal use testing strips for fentanyl and xylazine, and medication that treats addiction.They expressly stated that no funds “should be spent on law enforcement personnel, overtime or equipment.”“Law enforcement already gets a lot of funding, and I’m sure they would say it’s never enough,” said Tricia Christensen, an author of the proposed priorities, who is the policy director at Community Education Group, which has been tracking opioid settlement money across Appalachia. But the opioid money, she said, “is really unique.”Law enforcement departments have been receiving opioid settlement money for policing resources like new cruisers, overtime pay, phone-hacking equipment, body scanners and restraint devices.Whitney Curtis for The New York Times Groups that monitor opioid settlements use various criteria to estimate the total payout. But even employing the most conservative tabulation, the final amount could well be north of $50 billion when pending lawsuits are resolved, notably the multibillion-dollar Purdue bankruptcy plan, which the Supreme Court temporarily paused last week. At first glance, that looks like a fabulous trove of money. In reality, it will be parceled out over 18 years and is already dwarfed by the behemoth dimensions of the opioid crisis, now dominated by illicit fentanyl and other drugs.The spectacle of states as well as thousands of cities, counties and towns all struggling to determine the most effective uses of these desperately needed funds is raising many questions.Underlying the wrangling is a push for greater transparency in awarding the money and a determination not to repeat the mistakes of the Big Tobacco settlement 25 years ago. State governments have used most of the $246 billion from tobacco companies to plug budget holes and pay for other projects, and reserved relatively little to redress nicotine-related problems.Now, states and local governments have committees to determine appropriate allocation of the opioid money. Sheriffs and police officials comprise less than a fifth of the members on those task forces, according to a recent analysis by KFF Health News, Johns Hopkins University and Shatterproof, a national nonprofit that focuses on addiction.But public sentiment in many communities favors ridding the streets of drug dealers as a means of abating the crisis.When Samuel Sanguedolce, the district attorney of Luzerne County in Pennsylvania, presented his budget to the County Council in November, he made a pitch for some of the county’s settlement money, about $3.4 million so far.“With 10 more detectives, I could arrest those cases around the clock,” he said, referring to drug dealers. “I think this is a good way to use money that resulted from this opioid crisis to assist those detectives without putting it on the taxpayers.”“And I’ve asked not just for detectives,” he continued. “But hiring people, of course, costs money, in the way that they need guns and vests and computers and cars.”In many areas of the country, the lines between law enforcement and health care can be somewhat blurred: Police and sheriffs’ departments are also emergency responders, trained to administer overdose reversal drugs. Louisiana is dedicating 20 percent of its opioid money to parish sheriffs.OnPoint NYC, an overdose prevention center and safe injection site.Seth Wenig/Associated PressSheriff K.P. Gibson of Acadia Parish, who represents sheriffs on Louisiana’s opioid task force, said that he intended to use the $100,000 his department is set to receive for “medical needs” of people in the jail, including various opioid treatments and counseling. The goal, he said, is to help inmates become “productive citizens within our community,” once they are released.Public health officials and addiction treatment specialists are also concerned about another use of the money: grants for faith-based rehab programs that prohibit federally approved medications like Suboxone and methadone, which blunt cravings for opioids.“I would be open to a faith-based cancer program, but not one that doesn’t let you take effective medicines to treat the cancer,” said Dr. Joshua Sharfstein, a professor at Johns Hopkins Bloomberg School of Public Health, which has released its own guidance principles for the settlement funds.Throughout the years of negotiating opioid settlements, lawyers for states, tribes and local governments and those defending drug distributors, manufacturers and pharmacy chains struggled to avoid the pitfalls that emerged from the Big Tobacco litigation.This time, local governments have struck agreements with state attorneys general over the allocation of the money. Legislatures are largely excluded from most of the funds.Johns Hopkins praised Rock County, Wis., as a jurisdiction that strove to get a full picture of local needs for the money: It put together a working group to review evidence-based literature and conducted surveys and meetings to elicit community suggestions.In North Carolina, county governments receive 85 percent of the funds, which have reached nearly $161 million so far. Having signed onto the core principles worked up with the attorney general, the counties have great discretion in spending their allotments.“When you look at who addresses the issues of the opioid epidemic, it’s addressed locally by E.M.S., social services and jails. Those are all county functions in North Carolina, so that’s why it made sense for them to get the bulk of the resources,” said Josh Stein, the North Carolina attorney general, who helped negotiate the national opioid settlements.Dressing a skin wound in the Kensington neighborhood of Philadelphia.Matt Rourke/Associated PressEach county is establishing its own priorities. Stanly County, he said, is setting up teams to reach people who have just survived overdoses, hoping to connect them with services. Mecklenburg County has directed some of its funding for post-recovery education and job-training programs.Such uses can help to lift a community stricken by addiction, said Ms. Christensen, whose group monitors opioid settlements for 13 states. “I really subscribe to the idea that overdoses are often ‘deaths of despair’ — that the reason many folks spiral into chaotic drug use has a lot to do with what has happened to them and their lack of opportunities,” she said. “So how can we invest in the community to prevent that from happening generation after generation? That’s why I think community input is so important in this process.”The groups that released the new set of priorities cited examples of promising use of the funds. Michigan’s plans include adding rooms in hospitals so that new mothers can stay with infants born with neonatal abstinence syndrome. Kentucky is giving $1 million to four legal aid groups to represent people with opioid-related cases.“I was blown away by that,” said Shameka Parrish-Wright, executive director of VOCAL-KY, a community group that worked on the priorities documents. Ms. Parrish-Wright, a former candidate for Louisville mayor who had been addicted to drugs, homeless and incarcerated, added: “Those legal entities are really helpful in making sure we deal with paraphernalia charges and evictions. People coming out of treatment are sometimes discriminated against because of those charges and can’t get housing or jobs.”VOCAL-KY has not applied for settlement money but works closely with groups that do. Its members attend meetings held by Kentucky’s opioid task force. “Knowing that Black and brown and poor white communities are dealing with it the worst, we pushed them to have another town hall in those communities,” Ms. Parrish-Wright said.With Big Tobacco’s cautionary tale shadowing these debates, the issue of accountability looms. Who ensures that grantees spend their money appropriately? What sanctions will befall those who color outside the lines of their grants?So far, the answers remain to be seen. Christine Minhee, a lawyer who runs the Opioid Settlement Tracker, which analyzes state approaches to spending the funds, noted that on that question, the voluminous legal agreements could be opaque.“But between the lines, the settlement agreements themselves imply that the political process, rather than the courts, will bear the actual enforcement burden,” she said. “This means that the task of enforcing the spirit of the agreement — making sure that settlements are spent in ways that maximize lives saved — is left to the rest of us.”

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New Fentanyl Laws Ignite Debate Over Combating Overdose Crisis

Critics say a fierce law-and-order approach could undermine public health goals and advances in addiction treatment.Three teenage girls were found slumped in a car in the parking lot of a rural Tennessee high school last month, hours before graduation ceremonies. Two were dead from fentanyl overdoses. The third, a 17-year-old, was rushed to the hospital in critical condition. Two days later, she was charged with the girls’ murders.Listen to This ArticleFor more audio journalism and storytelling,

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Sacklers Can Be Shielded From Opioid Liability, Appeals Court Rules

The decision gives the Purdue Pharma owners long-sought protection, but it will release billions of dollars from their fortune to states and communities to help cope with the costs of addiction.Members of the Sackler family, the billionaire owners of Purdue Pharma, will receive full immunity from all civil legal claims — current and future — over their role in the company’s prescription opioids business, a federal appeals court panel ruled on Tuesday.The ruling gives the family the sweeping protection that it has been demanding for years, in exchange for payment of up to $6 billion of the family’s fortune to help address the ongoing ravages of the opioid crisis.That money, plus the company’s initial outlay of $500 million, can now begin to be dispensed to states and communities for addiction treatment and prevention programs, needs that soared during an epidemic that has grown far beyond abuse of Purdue’s signature prescription painkiller drug, OxyContin.Unless it is successfully appealed to the Supreme Court — an unlikely prospect, legal experts said — the new ruling will close the door on Purdue’s hotly contended bankruptcy restructuring, which began nearly four years ago. The bankruptcy is at the core of a plan intended to resolve thousands of opioid cases against the company nationwide, plus roughly 400 against individual Sackler family members.According to the plan, Purdue would be restructured into a new entity called Knoa Pharma that will manufacture medications for addiction reversal and treatment as well as continue to produce other drugs, including OxyContin. It will be overseen by a public board. Over time, Knoa Pharma is expected to contribute at least many hundreds of millions dollars more to plaintiffs.Some close observers of the Purdue case applauded the ruling, calling it a pragmatic reading that could now loosen up billions of dollars for states, local governments, tribes and individuals who sued Purdue for its early and aggressive role in marketing OxyContin as a nonaddictive pain treatment.“It’s time to put this bankruptcy behind us. Victims have been waiting for too long to recover,” said Ryan Hampton, an advocate for opioid victims who served as the co-chairman of the Purdue creditor’s committee.He added: “The system is far from perfect, but the true injustice will be if this victims’ settlement is held up any longer.”But others said the Sacklers had received a significant pass. “Bankruptcy was not meant to be an alternative justice system for powerful corporations and their superrich owners. But that is the effect and perception when courts read the law to provide extraordinary protections well beyond what Congress authorized,” said Melissa B. Jacoby, a law professor at the University of North Carolina at Chapel Hill.A bankruptcy filing typically puts a temporary halt on a company’s creditors, including on lawsuits. The major issue in this case was that even though Purdue had filed for bankruptcy, the Sacklers, as individuals, had not. As a result, plaintiffs who fought the plan contended, the Sacklers should not receive the benefit of their company’s liability protection.The Sacklers stepped down from Purdue’s board of directors in 2018 and have had no direct involvement in the company since then.Judge Eunice C. Lee of the United States Court of Appeals for the Second Circuit, who wrote Tuesday’s opinion for a three-judge panel, found that the bankruptcy code permits corporate owners who haven’t filed for personal bankruptcy to receive liability protection under certain circumstances.“Bankruptcy is inherently a creature of competing interests, compromises, and less than perfect outcomes,” she wrote. “Because of these defining characteristics, total satisfaction of all that is owed — whether in money or in justice — rarely occurs.”Quoting from a bankruptcy ruling in a 2019 case that did not involve Purdue, Judge Lee also stressed that the releases granted to the Sacklers “ ‘are not a merit badge that somebody gets in return for making a positive contribution to a restructuring,’ nor are they ‘a participation trophy’ or a ‘gold star for doing a good job.’ ”The Sacklers’ liability protection does not extend to criminal prosecutions, should any ever be filed.Purdue filed for bankruptcy in September 2019, as the rising opioid cases against the company turned into a torrent.Tuesday’s ruling came more than a year after oral arguments before the Second Circuit panel. As months passed, thousands of litigants expressed growing frustration that the case remained unresolved, with promised payments held in abeyance even as the opioid epidemic itself, now marked by fentanyl use, continued to surge.The ruling was a win for Purdue, which appealed a decision by a federal district judge, who overturned a settlement that had originally been approved by a bankruptcy court judge in 2021. But most of the parties that had appealed the 2021 plan eventually wound up dropping their objections, after the Sacklers increased their payout offer by roughly $1.73 billion.The only objectors who remain include several Canadian municipalities, a few individuals and the U.S. Trustee, a Justice Department program that is the watchdog of the bankruptcy system. Ms. Jacoby, the North Carolina law professor, said that because the last objecting states had agreed to the Purdue plan, the U.S. Trustee’s argument for pursuing the case would not be robust.The U.S. Trustee declined to comment on Tuesday’s ruling.In a statement after the ruling was issued, Purdue called the decision “a victory for Purdue’s creditors, including the states, local governments and victims who overwhelmingly support the plan of reorganization.”“Our focus going forward is to deliver billions of dollars of value for victim compensation, opioid crisis abatement and overdose rescue medicines,” the statement continued. “Our creditors understand the plan is the best option to help those who need it most, the most fair and expeditious way to resolve the litigation and the only way to deliver billions of dollars in value specifically to fund opioid crisis abatement efforts.”The families of the two founding brothers of Purdue, Dr. Mortimer Sackler and Dr. Raymond Sackler, both deceased, said in a joint statement: “The Sackler families believe the long-awaited implementation of this resolution is critical to providing substantial resources for people and communities in need. We are pleased with the Court’s decision to allow the agreement to move forward and look forward to it taking effect as soon as possible.”

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The Drug in ‘Tranq Dope’ Is Great for Horses but Horrific for Humans

Drug dealers are mixing xylazine, an animal tranquilizer relied on by veterinarians, into fentanyl, with deadly results. But controlling it is tricky.Penny, a 3-year-old sorrel mare with a white blaze, had been slobbering her feed and fighting her bit, signs of a likely toothache. An exam confirmed that she needed two wolf teeth extracted and the sharp edges of some molars ground down, procedures that required propping her jaws open with a speculum.To protect Penny from pain, and protect himself from the kick of a horse who outweighed him tenfold, Boyd Spratling, Penny’s veterinarian, gave her a shot of xylazine, a common animal tranquilizer. Within moments, her long neck drooped and her eyelids fluttered at half-mast. Forty-five minutes later, dental surgery done, Penny sauntered out of the clinic in rural Nevada and into her trailer.To Dr. Spratling, xylazine is a vital analgesic and sedative, which he also occasionally uses in cattle, for procedures like C-sections in cows and penile injury repairs in bulls. It’s a staple for zoo veterinarians, too. But in the last few years, the drug has also turned into something else: a cheap, addictive adulterant to illicit fentanyl that is contributing to the rise in overdose deaths around the country. The xylazine-fentanyl combo, known in the drug trade as “tranq dope,” is a life-threatening mix that depresses breathing, heart rate and blood pressure, and can cause blackened, chemical burn-like flesh wounds that can lead to amputation.In a xylazine alert in March, the Drug Enforcement Administration said that in 2022, it had detected the drug in nearly a quarter of the confiscated fentanyl samples in 48 states.Last week, the White House’s Office of National Drug Control Policy designated the drug mix as an “emerging drug threat,” a classification that requires the office to devise a governmentwide intervention plan. But addressing the threat is proving to be a tricky balancing act involving stakeholders in areas as disparate as addiction medicine, commercial livestock and law enforcement. The challenge is to walk a careful line by managing a drug that is essential for veterinarians but is fueling a public health crisis.Law enforcement agents are pressing for xylazine to be listed as a controlled substance, which would criminalize distribution for human use. Currently, the police can’t arrest a person for sales or distribution of xylazine. Their resources to track down its production are modest. A controlled-substance designation would make a crucial difference, law enforcement officials said.But veterinarians fear that if that happened, their access to the medicine would be heavily regulated. They would have to maintain separate logbooks for federal inspection. More worrisome: Production of a classified drug would require additional quality control and security measures so costly that a manufacturer could raise the drug’s price or just stop making it altogether.“When we first starting seeing on the news that xylazine was being mixed with fentanyl, we were horrified,” said Dr. Spratling, who keeps his xylazine in a double-locked container.But, he added, “let’s not shoot from the hip because then the people who really pay the price, regulatory-wise, are the ones who have been using it in a responsible manner all along.”Some addiction medicine specialists and harm reduction groups have different worries. They fear that new tough restrictions could set off a domino effect of the sort that contributed to the fentanyl crisis, including criminal charges against people with substance use disorders.Dr. Spratling gave a dose of xylazine to a horse before setting to work to clean out a puncture wound.Kim Raff for The New York TimesAuthorizing a drug to be listed as a federal controlled substance can be done either by Congress or jointly by the Food and Drug Administration and the D.E.A.A state can also list the drug. On Tuesday, Gov. Josh Shapiro of Pennsylvania, where the Philadelphia neighborhood of Kensington is ground zero for tranq dope, announced that his administration was doing so.A spokesman for the governor, Manuel Bonder, said Mr. Shapiro had decided to move ahead with the designation “rather than wait for any future possibilities in D.C.”Xylazine was approved by the F.D.A. for veterinary procedures in 1972. Since then, it has been used for procedures on sheep, deer, elk and even cats and dogs, as well as on horses and cattle. Earlier trials in humans had been shut down because the drug led to respiratory depression, so manufacturers never sought approval for human use. Until now, there has been insufficient incentive to research its impact on people. Its causal relationship to the flesh wounds that can result from its use is not understood. And unlike the protocols for opioids, those for reversing tranq dope withdrawal or managing rehabilitation have not been standardized.Last month, a bipartisan bill introduced in both chambers of Congress by members from rural states — including Nevada, Iowa, New Hampshire, California, Florida, Texas and Colorado — offered a compromise. Rather than listing xylazine as a controlled substance, the bill proposes that a person who employs it for “illicit” purposes — sales or distribution for human use — would face the same penalties as if it were listed as a Schedule III drug, including fines up to $500,000 and a first-offense sentence of up to 10 years in prison.Controlled substances are classified according to medical need and potential for abuse and addiction. Schedule III includes buprenorphine, the medication used to treat opioid use disorder. By comparison, Schedule I includes heroin and L.S.D. Schedule II includes oxycodone and fentanyl, which can be prescribed for pain.Legislators said this path represented a hard-fought middle ground for bipartisan buy-in and, they hope, a fast track to passage.“We need to make sure that we make it illegal for human use because of the devastating impact we see, but I also know, working with cattlemen and the ranchers in my state, that they need to be able to treat their horses and large animals with this drug,” said Sen. Catherine Cortez Masto, a Nevada Democrat, who introduced the bill with Sen. Chuck Grassley, an Iowa Republican, and Sen. Maggie Hassan, a New Hampshire Democrat.Their bill has been endorsed by veterinary, rancher and police associations. If enacted, it would require manufacturers to enhance xylazine record-keeping and send tracking reports to a D.E.A. database. Law enforcement agents could pursue dealers.But it exempts the legal use of xylazine for “administration to nonhuman species.” With that carve out, veterinarians would not face the restrictions of a controlled substance.Outreach workers attended to a man who they believed had just injected tranq dope, in the Kensington section of Philadelphia.Hilary Swift for The New York TimesTypically, domestic, veterinary-grade xylazine comes as liquid in a vial while bulk xylazine shows up as a cheaper powder, possibly imported. The F.D.A. already announced it was ramping up surveillance of imported xylazine.Beau Kilmer, the co-director of the RAND Drug Policy Research Center, said, “It’s important to know where xylazine is being mixed. The D.E.A. reports finding empty xylazine bottles at U.S. stash houses, so some mixing is happening here, but does mixing in the U.S. account for the majority or minority of cases?” But at this stage, he said, it was unclear what impact scheduling would actually have on human consumption and health.Many harm reduction groups and drug policy experts question the long-term efficacy of scheduling xylazine.The recent history of efforts to tighten controls on prescription painkillers highlights some of their concerns. As federal and state agencies imposed strict controls on prescription opioids, drug dealers and people who use drugs shifted to using illegal opioids — heroin, counterfeit pills and illicit fentanyl. Many people arrested as sellers are themselves dependent on those drugs.Maritza Perez Medina, the federal affairs director of the Drug Policy Alliance, a nonprofit harm reduction organization, said she worried that criminalizing xylazine would not substantially address its problems. “Simply put: Crackdowns put us in a game of whack-a-mole. When we try to eradicate one drug, a new one comes up.”Xylazine began appearing sporadically as an addictive substitute for heroin in the 2000s: In 2011, a study observed that people in farming areas of Puerto Rico were injecting horse anesthesia and developing serious lesions.Around 2006, the drug was found in Kensington, the Philadelphia neighborhood, which has a substantial Puerto Rican population. Its use there began escalating around 2018, after which it spread throughout the Northeast, following the path of fentanyl.Addiction medicine experts said their chief concern was abating the health dangers created by xylazine. They urged that newly introduced xylazine test strips, which people can use to check the drugs they buy, be as widely distributed as fentanyl test strips.But Dr. Joseph D’Orazio, the head of medical toxicology and addiction medicine at Temple University Hospital in Philadelphia, which has treated hundreds of patients for the effects of tranq dope, says that street drugs are mixed with so many different additives that even test strips fall short of what is needed to save lives.He said the immediate focus should be on developing better treatments to manage acute withdrawal from xylazine. “So many patients avoid or abandon treatment because our current medications are not adequate to combat the dose of fentanyl and xylazine found on the street.”For his part, Dr. Spratling remains aghast at the wildfire that xylazine has become. “I’ve been using xylazine for 45 years, and I’ve never seen the skin ulcerations and lesions on a horse that people are getting. It’s terrible. I’m dumbfounded,” he said.Penny, the young mare, not only sprang back from her xylazine shot but also quickly recovered from her dental surgery. Her spirits and mouth healed, she performed well a few weeks ago at a local county stock horse competition.But Dr. Spratling, who uses xylazine at least a half-dozen times a week for procedures, is uneasy. He said that if the government were to regulate the drug for him and his colleagues, many veterinarians would have a simple response. “They’ll just stop using it,” he said.Kim Raff for The New York Times

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White House Designates Animal Sedative as an ‘Emerging Drug Threat’

Officials said the formal designation was a sign of the grave danger posed by xylazine, which can cause horrific wounds and, when mixed with fentanyl, increase the likelihood of overdose.The White House on Wednesday designated a common animal tranquilizer that is increasingly mixed into street fentanyl as an “emerging drug threat,” a formal move that requires the administration to create strategies to enhance law enforcement efforts, health interventions and data collection to combat it.This is the first time that the White House’s Office of National Drug Control Policy has ever identified a substance for that designation, a mark of the gravity of the danger that it considers to be posed by the drug, xylazine.Xylazine was approved for veterinary procedures, primarily in cattle and horses, 50 years ago but has never been sanctioned for medical use in humans. Known popularly as tranq or tranq dope, it is a powerful and addictive sedative that slows breathing and heart rate, increases the risk of fatal overdose and often produces severe skin ulcers and abscesses that have led to amputations. “Many communities are not even aware of the threat in their backyard,” Dr. Rahul Gupta, the head of the drug control office, who is often referred to as the national drug czar, said in a briefing with reporters.According to a 2018 directive from Congress that established the emerging threat designation, the administration must now lay out plans within 90 days to coordinate a national response to xylazine. That could include creating protocols for treatment, withdrawal and wound care therapies, expanding testing for the drug’s presence and scheduling it as a controlled substance, which would give federal law enforcement agents authority to pursue its illicit use.Dr. Gupta said that xylazine withdrawal could lead to symptoms so intense — such as migraines, double vision and body-rattling anxiety — “that persons may leave medical treatment, including drug treatment, against medical advice.”But it is sought out by dealers and drug users because it is relatively cheap, with its own addictive properties, whether consumed on its own or mixed with opioids or even amphetamines. Like fentanyl, xylazine first appeared as an adulterant in the illicit drug supply in the Northeast, predominantly in Philadelphia, and then rapidly spread west and south. Citing data compiled by the Drug Enforcement Administration and the Department of Justice, Dr. Gupta noted that in the two-year period from 2020 through 2021, detection of xylazine in forensic labs grew 112 percent in the West and 193 percent in the South.Currently, the supplies of xylazine are thought to come from China and possibly Mexico, India and Russia, but they could also be coming from some domestic manufacturers who sell to veterinarians.Wednesday’s announcement follows a crescendo of recent alerts from local health authorities and warnings from other federal agencies. In a xylazine alert in March, the D.E.A. said it had detected the drug in 23 percent of confiscatedfentanyl samples in 48 states in 2022. Last November, the Food and Drug Administration, which approved xylazine decades ago for veterinary procedures, issued a nationwide warning to health care providers, and in February, it announced it would monitor imported xylazine for illegal diversion.Xylazine differs from fentanyl in major ways, which contributed to administration’s decision to declare it an emerging threat. Unlike fentanyl, heroin or the prescription painkiller oxycodone, xylazine is not an opioid. That means conventional methods for reversing an opioid overdose, like naloxone injections or nasal sprays, may not succeed in fully reviving a person who has used it.Xylazine withdrawal symptoms must be managed differently from those of an opioid, and rehabilitation protocols are not yet established. And unlike opioids or, for that matter, amphetamines, xylazine is not listed as a controlled substance, which would make it subject to greater law enforcement scrutiny.Dr. Rahul Gupta, the Biden administration’s drug czar. Designating xylazine as an emerging drug threat gives the administration further powers for drug detection and deterrence and for designing strategies to manage withdrawal and rehabilitation.Sophie Park for The New York TimesWednesday’s White House announcement had long been awaited by many community outreach groups and clinics, anxious for direction on how to combat xylazine. Dr. Joseph D’Orazio, chief of medical toxicology and addiction medicine at Temple University Hospital in Philadelphia, which has had perhaps the country’s largest influx of patients afflicted by xylazine, said that research about how the drug works in humans would be critical.“We still don’t know what causes the wounds, just a lot of conjecture,” he said. “Once that’s understood, maybe we can work up strategies on how to avoid the wounds or treat them better. And we need to understand the withdrawal so we can figure out how to treat it better.”Dr. Gupta noted that managing xylazine’s licit and illicit uses would be challenging. It is frequently used as a sedative and an analgesic in large-animal medicine, as veterinarians suture wounds, grind down sharpened molars and treated infected hooves. Preserving the drug’s status and access for veterinarians while shutting down supplies to dealers is a topic already under deep discussion.And Dr. Gupta was candid about the fact that getting a better grip on xylazine, while urgent, would be only a step in long, painful journey. His office is also pressing this effort, he said, in part to look ahead “to what potentially comes after xylazine, as an additive to fentanyl, in order to get in front of the next additive in the drug supply.”

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¿Cómo usar el Narcan, el aerosol para revertir sobredosis?

Esta versión de la naloxona, el fármaco que bloquea el efecto de los opiáceos en el cerebro, puede salvar vidas. Este es el modo de usarlo correctamente.Narcan, un atomizador nasal que puede revertir rápidamente una sobredosis de opioides, ha recibido la aprobación federal para ser vendido sin receta médica en Estados Unidos. A finales del verano, debería estar ampliamente disponible, no solo en las farmacias, sino también en tiendas de conveniencia, grandes cadenas y, posiblemente, a través de minoristas en línea.Si se utiliza a tiempo, Narcan, una versión del fármaco naloxona, que bloquea el efecto de los opiáceos en el cerebro, puede salvar la vida de alguien que tome opiáceos, como oxicodona, heroína o fentanilo.Piensa en Narcan o en cualquier atomizador nasal de naloxona como en un extintor de incendios, dijo Corey Davis, director del Proyecto Legal de Reducción de Daños de la Red para la Ley de Salud Pública. “Con suerte nunca lo necesitarás”, dijo. “Pero en algún momento puede que la cocina se incendie y no tengas tiempo de correr a la tienda por extintores”.Aquí encontrarás una guía para usar Narcan de forma correcta:¿Cómo sé si alguien tiene una sobredosis?Su respiración puede ser lenta, con gorgoteos o detenerse por completo. Sus pupilas pueden estrecharse hasta tener el tamaño de la punta de un alfiler, y sus labios o uñas pueden volverse azules o morados. La piel puede estar húmeda al tacto. Incluso sacudiéndolos y gritándoles, no los puedes despertar.¿Qué contiene la caja de Narcan?Una caja contiene dos dispositivos de atomizador nasal del tamaño de la palma de la mano, cada uno con cuatro miligramos de naloxona.¿Debo probar primero el atomizador para asegurarme de que funciona?No. Si aprietas el atomizador liberarás la dosis y la desperdiciarás.¿Cómo debo usarlo?Inclina suavemente hacia atrás la cabeza de la persona. Introduce la punta del atomizador en una fosa nasal hasta que ambos dedos estén contra la nariz. Empuja el atomizador para liberar la dosis completa.¿No debería llamar primero al 911?Llama al 911 después de utilizar el atomizador. Se trata de una emergencia, pero al avisar a un operador puedes perder minutos valiosos.¿Qué hago después de aplicar el atomizador y llamar al 911?Asegúrate de que las vías respiratorias de la persona están protegidas y despejadas. Coloca a la persona de lado, apoyando sus manos bajo su cabeza. Dóblale las rodillas para evitar que caiga boca abajo o boca arriba.Quédate con la persona unas horas o hasta que llegue el personal de emergencias.Los paquetes tienen dos dosis. ¿Debo emplear la segunda?Por lo general, una dosis es suficiente. Pero si la persona no ha empezado a despertarse al cabo de dos o tres minutos, aplica la segunda dosis en la otra fosa nasal, sobre todo si sabes que podría haber consumido un opioide más fuerte, como el fentanilo.¿Será perjudicial el atomizador si resulta que la persona no tenía una sobredosis de opioides?No. A menos que alguien sea alérgico a la naloxona, lo cual es poco frecuente, lo más seguro es utilizar el atomizador.¿Tiene efectos secundarios?El Narcan puede provocar síntomas de abstinencia, como vómitos. Hay que mantener abiertas las vías respiratorias para evitar el ahogamiento.Otros síntomas de abstinencia son: diarrea, dolores corporales, aumento del ritmo cardíaco, fiebre, piel de gallina, sudoración e irritabilidad. Recuerda que, aunque la abstinencia de opiáceos sea terrible, estás salvando una vida.¿Quién debe llevar consigo naloxona?Según informes de los Centros para el Control y la Prevención de Enfermedades, en 2021, en el 46 por ciento de las sobredosis mortales de opiáceos había transeúntes presentes. Si hubieran llevado naloxona y supieran cómo usarla, se podrían haber salvado vidas.Si conoces a personas que consumen drogas, aunque sea de forma ocasional, o si tú mismo consumes opiáceos, no hay ningún inconveniente en llevar Narcan. Si trabajas en una empresa que tiene un botiquín de primeros auxilios a mano, ¿por qué no guardar en él un aerosol de naloxona? Padres de adolescentes o adultos jóvenes, ¿qué tal una caja en su botiquín? ¿En las residencias universitarias? ¿En la enfermería del colegio? ¿En las bibliotecas?Piensa en el atomizador como si fuera un EpiPen para las alergias, un inhalador para el asma o, de hecho, un extintor de incendios.Jan Hoffman escribe sobre salud conductual y legislación sanitaria. Sus reportajes incluyen temas tan variados como los opioides, las tribus, los derechos reproductivos, la salud mental de los adolescentes y las dudas sobre las vacunas. @JanHoffmanNYT

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F.D.A. Approves Narcan for Over-the-Counter Sales

The nasal spray reverses opioid overdoses and public health officials hope that making it more widely available could save lives and reduce the nation’s high rates of drug fatalities.Narcan, a prescription nasal spray that reverses opioid overdoses, can now be sold over the counter, the Food and Drug Administration said on Wednesday, authorizing a move long-sought by public health officials and treatment experts, who hope wider availability of the medicine will reduce the nation’s alarmingly high drug fatality rates.By late summer, over-the-counter Narcan is expected to be for sale in big-box chains, supermarkets, convenience stores, gas stations and online retailers. New York City plans to install Narcan vending machines later this year.The commissioner of the F.D.A., Dr. Robert M. Califf, said in a statement that the over-the-counter authorization was meant to address a “dire public health need.”“Today’s approval of O.T.C. naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country,” Dr. Califf said. “We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”Narcan is a nasal spray version of naloxone, a drug that blocks an opioid’s effect on the brain. As the overdose crisis has worsened, with more than 100,000 drug-related deaths in the United States for each of the last two years, millions of doses have been administered by outreach workers, health care providers and emergency responders.But for people who use drugs, as well as for their friends and relatives, ready access to the prescription medication has been elusive.Naloxone access laws in every state allow pharmacists to have a standing prescription so they can dispense Narcan or a generic brand to anyone who requests it. But many pharmacies choose not to do so, preferring not to engage customers around illicit drug use, especially without a doctor’s oversight. Of the nearly 17 million naloxone doses distributed in 2021, only 2.64 million were from pharmacies, according to a recent report.Public health officials were quick to hail the F.D.A.’s authorization, the first time that an overdose reversal spray has been deemed safe for over-the-counter sales. With overdoses and overdose fatalities occurring in college dorms, public libraries, households, night clubs and restaurants, public health advocates hope that naloxone nasal sprays will soon become a staple of first-aid kits and family medicine cabinets.“Naloxone can mean the difference between life and death for someone experiencing an overdose and — as a city and a country — we have every reason to want people to have it in hand,” Dr. Ashwin Vasan, the health commissioner of New York City, said. “It is safe and effective, and with increasing fentanyl in our drug supply, we need it everywhere, to save lives.” The city provided more than 200,000 Narcan kits to community groups in 2022.One reason the F.D.A. approved Narcan for general sales is that it is easy to administer. Bystanders who see that a person slumped over is unresponsive to shaking and shouting, with slowed breathing — signs of a possible overdose — only have to unwrap the palm-size device, insert the tip into the person’s nostril and depress the plunger. In most situations, the medication revives the person within two or three minutes.Narcan will not work if the person has taken nonopioid drugs like methamphetamines or xylazine, an animal tranquilizer that has been infiltrating street drug supplies. But addiction experts note that because the supply of illegal drugs has become increasingly tainted with fentanyl, an opioid, there is no downside to using Narcan, regardless of what drug the person was believed to have taken.Although over-the-counter status will make Narcan more widely available, the cost of the medicine could be a deterrent to many.Currently, a two-dose pack of prescription Narcan is often free to people covered by Medicaid or private insurance, or has a co-pay of less than $10. But public and private insurance programs do not cover most over-the-counter medicines. Whether an exception will be made for Narcan could take months to resolve.This month, a big-box pharmacy in Manhattan was charging $98 for the two-dose box of prescription Narcan to customers without insurance. Another pharmacy chain in New Jersey charged $73.The company that makes Narcan, Emergent BioSolutions, declined to disclose the price it plans for an over-the-counter version, which will take several months to relabel and repackage. On Wednesday morning, after the F.D.A.’s announcement, the company released a statement that did not discuss cost.“We are dedicated to improving public health and assisting those working hard to end the opioid crisis — so now with leaders across government, retail and advocacy groups, we must work together to continue increasing access and availability, as well as educate the public on the risks of opioid overdoses and the value of being prepared with Narcan to help save a life,” Robert G. Kramer, the company’s chief executive officer, said in the statement.In its announcement of the authorization, the F.D.A. acknowledged the concern about price, urging other manufacturers of prescription naloxone to apply for over-the-counter approval, which could make pricing more competitive.“We will work with any sponsor seeking to market a nonprescription naloxone product,” said Dr. Patrizia Cavazzoni, director of the F.D.A.’s Center for Drug Evaluation and Research. She added that they were encouraging manufacturers “to contact the agency as early as possible to initiate discussions. ”The price of Narcan, or any naloxone nasal spray, can affect where the product is placed in a store. One intention behind making Narcan more widely available was to help consumers leapfrog awkward conversations with pharmacists and possible entanglements with insurance providers.But higher-priced items are vulnerable to shoplifting, so retailers may consign them to being secured behind a pharmacist’s counter, or in a locked glass box, both of which would require the customer to seek out a salesperson. Those placements, public health advocates said, could be a barrier to people who can afford Narcan, but may be too embarrassed to ask for it. Naloxone is also manufactured in vials of liquid that are accompanied with a syringe, which is substantially cheaper than the nasal spray and an option favored by many community outreach groups.“All naloxone should have been moved over the counter,” said Dennis Cauchon, president of Harm Reduction Ohio, a nonprofit group that distributes free naloxone doses. “Now you have the expensive version available without a prescription but the cheaper versions need a prescription. It’s important that brand name Narcan be priced much lower over the counter than it is now. The price needs to be less than $30 for a two-dose kit, preferably much lower.”

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How to Use Narcan, the Overdose-Reversing Nasal Spray

The F.D.A.’s decision to allow the overdose-reversing nasal spray to be sold over the counter means it will become much more widely available. Here is some guidance for using it correctly.Narcan, a nasal spray that can quickly reverse an opioid overdose, has now received federal approval to be sold over the counter. By late summer, it should be widely available — not just on pharmacy shelves but also at convenience stores, big box chains and possibly through online retailers.If used in time, Narcan, a version of the drug naloxone, which blocks the opioid’s effect on the brain, can be a lifesaver for someone taking opioids, including oxycodone, heroin or fentanyl.Think of Narcan or any naloxone nasal spray as a fire extinguisher, said Corey Davis, director of the Harm Reduction Legal Project at the Network for Public Health Law. “Hopefully you’ll never need it,” he said. “But at some point maybe the kitchen’s going to catch on fire and you won’t have time to run to the fire extinguisher store.”Here is some guidance for using Narcan correctly:How do I know if someone is overdosing?Their breathing may be slowed, with gurgling, or stopped altogether. Their pupils may be narrowed to a pinpoint, and their lips or fingernails may turn blue or purple. Their skin could be clammy to the touch. Even by shaking them and shouting loudly, you cannot wake them.What’s in the Narcan box?A box contains two palm-size nasal spray plunger devices, each with four milligrams of naloxone.Should I test the plunger first to make sure it’s working?No. If you prime the spray’s plunger you will release the dose and waste it.How should I use it?Gently tilt back the person’s head. Insert the spray tip into one nostril until both fingers are against the nose. Push the plunger to release the full dose.Shouldn’t I call 911 first?Call 911 after you use the spray. This is an emergency, but it can take precious minutes to alert a dispatcher. .What do I do after I’ve given the spray and called 911?Make sure the person’s airways are protected and clear. Roll the person on their side, propping their hands under their head. Bend their knees to prevent them from rolling over on their stomach or back.Please stay with the person for a few hours or until an emergency responder arrives.The kits have two doses. Should I use the second?Usually one dose will be sufficient. But if the person has not begun to wake up after two or three minutes, apply the second dose in the other nostril, particularly if you know a stronger opioid like fentanyl could have been involved.Will the spray be harmful if it turns out the person wasn’t overdosing on an opioid?No. Unless someone has an allergy to naloxone, which is rare, the safest bet is to use the spray.Are there side effects?Narcan may provoke withdrawal symptoms, including vomiting. The airways have to be kept open, to prevent choking.Other symptoms of withdrawal include: diarrhea, body aches, increased heart rate, fever, goose bumps, sweating and irritability. Remember that though opioid withdrawal is miserable, you are saving a life.Who should carry naloxone?According to reports by the Centers for Disease Control and Prevention, in 2021, bystanders were present at 46 percent of fatal opioid overdoses. If they had been carrying naloxone and knew how to use it, lives could have been saved.If you know people who use drugs even casually, or if you use opioids yourself, there is no downside to carrying Narcan. If you work at a business that has a first-aid kit on hand, why not keep a naloxone spray in it? Parents of teenagers or young adults, what about a box in your medicine cabinet? College dorms? The school nurse’s office? Libraries?Think of it much like an EpiPen for allergies, or an asthma inhaler — or, indeed, like a fire extinguisher.

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