The agency plans to authorize Florida to purchase medicines directly from wholesalers in Canada, where prices are far cheaper. Pharmaceutical companies oppose the plan.The Food and Drug Administration has decided to allow Florida to import millions of dollars worth of medications from Canada at far lower prices than in the United States, overriding fierce decades-long objections from the pharmaceutical industry, according to a senior administration official.The approval is a major policy shift for the United States, and supporters hope it will be a significant step forward in the long and largely unsuccessful effort to reign in drug prices. Individuals in the United States are allowed to buy directly from Canadian pharmacies, but states have long wanted to be able to purchase medicines in bulk for their Medicaid programs, government clinics and prisons from Canadian wholesalers.Florida has estimated that it could save up to $150 million in its first year of the program, importing medicines that treat H.I.V., AIDS, diabetes, hepatitis C and psychiatric conditions. Other states have applied to the F.D.A. to set up similar programs.But significant hurdles remain. The pharmaceutical industry’s major lobbying organization, the Pharmaceutical Research and Manufacturers of America, or PhRMA, which has sued over previous importation efforts, is expected to file suit to prevent the Florida plan from going into effect. Some drug manufacturers have agreements with Canadian wholesalers not to export their medicines, and the Canadian government has already taken steps to block the export of prescription drugs that are in short supply.“Canada’s drug supply is too small to meet the demands of both American and Canadian consumers,” Maryse Durette, a spokeswoman for Health Canada, wrote in an email message. “Bulk importation will not provide an effective solution to the problem of high drug prices in the U.S.”Congress passed a law allowing drug importation two decades ago, but federal health officials delayed implementing it for years, citing safety concerns, one of the main arguments drug companies have used against it. In 2020, President Donald J. Trump pushed the law forward, announcing that states could submit importation proposals to the F.D.A. for review and authorization. President Biden added momentum the following year, instructing federal officials to keep working with states on importation plans.Florida applied and later sued the F.D.A., accusing the agency of what Gov. Ron DeSantis called a “reckless delay” in approving the request. Friday’s announcement grew out of that lawsuit; a federal judge had set a Jan. 5 deadline for the F.D.A. to act on the state’s application.Eight other states — Colorado, Maine, New Hampshire, New Mexico, North Dakota, Texas, Vermont and Wisconsin — have laws allowing for a state drug importation program, and many are seeking, or planning to seek, F.D.A. approval.Colorado’s application is pending with the F.D.A. New Hampshire’s application was rejected last year. Vermont’s was deemed incomplete; a spokeswoman said the state was waiting to see how the F.D.A. handled the applications by other states before resubmitting.Colorado officials have signaled that states may face challenges to their importation plans from drugmakers in Canada, among them familiar names like Pfizer, Merck and AstraZeneca. Some drugmakers have written contracts with drug-shipping companies prohibiting deliveries to the United States, Colorado officials said in a report.Drug importation has broad political and public support. A 2019 poll by KFF, a nonprofit health research group, found that nearly 80 percent of respondents favored importation from licensed Canadian pharmacies.“Importation is an idea that resonates with people,” Meredith Freed, a senior policy analyst with KFF, said. “They don’t fully understand why they pay more for the same drug than people in other countries.”With the 2024 presidential election on the horizon, candidates are looking to claim credit for efforts to reduce drug prices. President Biden is spotlighting the Inflation Reduction Act, which empowers Medicare to negotiate prices directly with drugmakers for the first time, but only for a limited number of high cost medicines. Mr. DeSantis, who is challenging Mr. Trump for the Republican nomination, is touting his import plan.Several experts in pharmaceutical policy said that importation from Canada would not address the root cause of high drug prices: the ability of pharmaceutical makers to fend off generic competition by gaming the patent system, and the federal government’s broad failure to negotiate directly with drugmakers over cost.“Seems like political theater to me, where everyone wants to say they did something to drive down the price of prescription drugs,” Nicholas Bagley, a health law expert at the University of Michigan Law School, said of Florida’s plan.Both Mr. Bagley and Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, said that the Inflation Reduction Act is a more direct path to lowering prices; the law’s price negotiation provisions are expected to save the federal government an estimated $98.5 billion over a decade. Drugmakers are suing to block those provisions from taking effect.A protest outside the Pharmaceutical Research and Manufacturers of America in Washington in 2021. PhRMA is likely to file suit to prevent any plan from going into effect.Saul Loeb/Agence France-Presse — Getty ImagesWith its approval in hand, Florida has more work to do. Before it can distribute Canadian drugs, the state must send the F.D.A. details on those it plans to import. The state has to ensure that the drugs are potent and not counterfeit. It also must put F.D.A.-approved labels on medications instead of those used in Canada.The F.D.A. said it would be watching to see if the state upholds safety rules — such as the reporting of any drug side effects — and delivers significant cost savings to consumers. Florida’s approval to import lasts for two years from the date of the first drug shipment.In Canada, health officials have been casting a wary eye on the push to import from their country. In November 2020, shortly after the Trump administration announced that states could submit importation proposals, the Canadian government published its own rule to prevent manufacturers and wholesalers from exporting some drugs that are in short supply.The Canadian government is likely to further restrict exports if they begin to affect Canadians, said Amir Attaran, a law professor at the University of Ottawa. He said the numbers don’t work out for a nation of nearly 40 million to supply medications for a state with 22 million people, much less for 49 other U.S. states.“If all of a sudden Florida is able to extend a vacuum cleaner hose into this country to take what’s in the medicine chest, the supply disruption will be a completely different category,” he said. Dr. Kesselheim, of Harvard, said the F.D.A.’s authorization was unlikely to make a difference in the price of very expensive brand-name drugs, because manufacturers would block wholesalers from exporting the medicines.“I think it’s going to be hard for states to import drugs like that in any kind of scale that would make a difference in terms of lowering prices for patients,” Dr. Kesselheim said. Even so, he said, the F.D.A.’s announcement is significant because it puts to rest the notion that drug importation cannot be accomplished safely.Mr. Bagley of the University of Michigan said there was a simpler solution to high drug prices than patchwork state importation programs: Having the U.S. government negotiate with drug companies over prices, just as many other nations, including Canada, do.“This whole thing is a jerry-rigged, complicated approach to a problem that’s amenable to a pretty straightforward solution, which is that you empower the government to bargain over the price for drugs,” he said. “So instead, we’re sort of trying to exploit the machinery that Canada has created and that we were too timid to create.”

The proposal has elicited mounting opposition from tobacco companies, Black activists worried about police enforcement and small businesses, as President Biden moves into an election year.The Biden administration is delaying a decision on whether to ban menthol cigarettes amid intense lobbying from tobacco companies, convenience stores and industry-backed groups that contend that billions of dollars in sales and jobs will be lost, a senior administration official confirmed on Wednesday.The proposal has also generated concerns that Black smokers will become the targets of aggressive police tactics, although some Black leaders, top lawmakers and government officials dispute that and say that tobacco companies are financing and fueling those fears.The plan to eliminate menthol cigarettes has been years in the making. The Food and Drug Administration formally proposed an official rule last year, aimed at reducing health disparities, citing statistics that an estimated 85 percent of Black smokers prefer menthol brands. Black men especially face outsize health risks, including high rates of smoking-related lung cancer and death.In recent months, dozens of groups have had appointments with administration officials to discuss the proposal. Tobacco companies and convenience store groups fighting the ban have aligned with the National Action Network, founded by the Rev. Al Sharpton, to advance the argument about the potential for racial targeting by the police. The group attended a large meeting with tobacco lobbyists and top administration officials on Nov. 20.Many other Black organizations, including a majority of the Congressional Black Caucus, have dismissed the policing argument, calling it a cynical attempt to exploit trauma and distract from the harm of cigarettes.“What we’re seeing now,” said Patrice Willoughby, vice president of policy and legislative affairs at the N.A.A.C.P., “is the reaction of a very well-organized industry that has been peddling death to the Black community.”The F.D.A. has said it would like to see the proposal finalized this year, and Michael Felberbaum, an agency spokesman, said on Wednesday that it remained committed to issuing the rule “as expeditiously as possible.” The White House timetable for a decision on the ban had been shifting as months passed, against the backdrop of President Biden’s tough re-election bid next year.President Biden returned to the White House after pardoning a turkey on Nov. 20, when tobacco lobbyists, Black civil rights leaders, senior White House officials and the heads of the F.D.A. and U.S. Health and Human Services department all met.Erin Schaff/The New York Times In recent weeks, public health groups have increasingly expressed concerns about the delays, urging administration officials to act quickly. The Washington Post earlier reported that the Biden administration would postpone any action on the proposal until the spring.Senator Richard J. Durbin, the Democratic majority whip from Illinois, addressed the rumors of political motivations for the delay on the Senate floor on Wednesday, saying concerns that Black people would vote against the president in the next election because of the ban were “greatly exaggerated.”“And I want to make it clear,” he said, “they’re peddling stories — Big Tobacco is — that we’re going to go out and arrest African Americans if they use menthol cigarettes. But that’s not the case at all.”The F.D.A. has said that the ban will be enforced at the manufacturers’ level, and not against individuals.The largest U.S. tobacco companies have considerable financial stakes in the menthol cigarette market, which the Federal Trade Commission estimates is a little more than one-third of all U.S. cigarette sales. Menthol cigarette sales for Reynolds American, which makes the top-selling Newport brand, total about $7 billion a year, research by Goldman Sachs shows.Reynolds has vowed to fight the ban all the way to the Supreme Court, a battle that could postpone implementation of the final prohibition rule for years. Both Altria, which makes menthol Marlboros, and Reynolds have attempted to soften their public image in recent years with pledges of a smoke-free future, marketing e-cigarettes like NJOY and the popular Vuse products. Yet cigarettes still make up three-quarters of the $76 billion U.S. tobacco market, with alternatives like vapes trailing far behind, according to Goldman Sachs estimates.Convenience store, gas station and wholesaler groups have stacked the White House meeting calendar, too, predicting a loss of $34 billion in sales from menthol cigarettes and snacks and drinks purchased by customers, and from flavored cigars that would be banned under a companion proposal. The menthol ban would not cover the sale of menthol e-cigarettes.The old R.J. Reynolds Tobacco Company factory sits just blocks away from its current headquarters in Winston Salem, N.C.Caitlin Penna for The New York TimesMr. Biden’s administration has called the effort a “critical piece” of his Cancer Moonshot initiative, noting that about 30 percent of all cancer deaths are caused by smoking. The F.D.A. has estimated that the menthol ban could reduce smoking by 15 percent in 40 years. Studies project that as many as 650,000 smoking-related deaths could be avoided.The agency proposed the ban more than a year ago and forwarded it to the White House in October. Public health groups have been at the edge of their seats watching the White House calendar fill with meetings, mostly from opponents of the ban.“Each day we wait is another day for Big Tobacco to hook new users and target communities with menthol cigarettes and flavored cigars,” Nancy Brown, chief executive of the American Heart Association, said in a statement. “By prohibiting the sale of menthol cigarettes and flavored cigars, the administration would make historic progress in saving lives from tobacco use.”About 18.5 million smokers choose a menthol brand. Researchers say the cooling sensation of the menthol flavor makes it easier to start smoking and harder to quit. Public opinion polls have shown that about 60 percent of Americans favor banning menthol cigarettes.Tobacco companies have been criticized for decades for targeting Black communities, with studies documenting industry marketing for menthol cigarettes in magazines like Essence and Ebony, and with billboards and discounts targeted at Black neighborhoods.Researchers have documented decades of tobacco industry marketing for menthol cigarettes in magazines like Essence and Ebony, and with billboards and discounts targeted at Black neighborhoods.via American Heart AssociationLobbying over the ban has been intense, with Reynolds and Altria donating millions of dollars in recent years to Republican-controlled super PACs and also spending millions lobbying in Congress.Some Republican lawmakers have opposed the ban, including Senator Marco Rubio of Florida, who is supported by a PAC that received $10,000 from Reynolds late in 2022. He wrote letters in July warning that the ban could give Mexican drug cartels a new illegal substance to traffic.A spokesman for Mr. Rubio said two Democrats signed a similar letter and that supporters backed the senator because they agreed with his agenda, not the other way around.Some House Republicans have also sent letters to the administration warning that the ban could have a disastrous effect on small businesses and that it could encourage cigarette smuggling that would benefit terrorist groups.In June, a House appropriations bill included a provision that would have prohibited any spending on imposing the ban. Representative Andy Harris, a Republican and doctor from Maryland, argued that a ban would “take products out of the legal system and put them into illicit markets,” helping criminals and straining law enforcement.Representative Debbie Wasserman Schultz, Democrat of Florida, introduced a measure to protect the ban, telling fellow House members that they had “succumbed to Big Tobacco yet again” and urging them to protect future generations. “We have to prevent more death,” she said.The bill stalled on the House floor and is said to have little chance of passing.Opponents of the ban demonstrated last month in front of the Manhattan office of Senator Chuck Schumer, the Democratic majority leader.Gwen Carr, the mother of Eric Garner, who died after a police officer placed him in a chokehold, warned at the protest that a menthol ban would increase police encounters. “This will create more havoc in the Black and brown communities,” she said.In an interview, Ms. Carr said she had not received money from tobacco companies. “I can’t be bought,” she said.Gwen Carr, the mother of Eric Garner, at a rally outside New York City Hall in March, calling in part for legislators to oppose a menthol ban.Michael M. Santiago/Getty ImagesEbonie Riley, a senior vice president at the National Action Network, acknowledged the group had received money from tobacco companies but declined to say how much. She said the group’s opposition to the menthol ban was not related to those donations.“We don’t endorse smoking of any kind, but we do endorse adult decisions,” Ms. Riley said.Ms. Riley also attended one of the largest White House meetings about the ban late last month. Attendees included senior White House officials; Dr. Robert Califf, the F.D.A. commissioner; and Xavier Becerra, the secretary of Health and Human Services. The National Organization of Black Law Enforcement Executives, which for years listed Reynolds as a sponsor and has received funding from Altria, was also there.Opponents to the ban supplied White House officials with a report issued by a task force in Massachusetts, where flavored tobacco has been banned for years, that recommended criminal charges for possession or sale of banned products. Tobacco companies have argued that such a provision would lead to the use of more force by the police in minority communities.Reynolds representatives also met twice with White House officials in November, said Luis Pinto, a company spokesman. He said the company argued that bans were not effective and that the F.D.A. had vastly underestimated the cost of keeping illegal menthol cigarettes out of the country.Mr. Pinto said White House officials had inquired about the matter, and Reynolds followed up with an F.D.A. report estimating that enforcement would cost about $659,000 a year for the work of five employees.“The illicit cigarette market is already thriving; and a menthol ban will only fuel the size, scope and span of that market, as millions of menthol cigarette smokers will look for a replacement,” according to a follow-up letter Reynolds sent on Nov. 14. David Sutton, an Altria spokesman, said the company was also concerned about illicit sales as well as lost tax revenue and jobs.“We believe equitable harm reduction, not prohibition, is the better path forward, and that the F.D.A. should authorize smoke-free products and encourage adult smokers to transition to a smoke-free future,” Mr. Sutton said in an email.David A. Fahrenthold