FDA Gives First Approval for Mass Import of Drugs to States from Canada

The Food and Drug Administration has decided to allow Florida to import millions of dollars worth of drugs from Canada at much lower prices than in the United States, overriding the pharmaceutical industry’s fierce decades-long objections, according to a report. senior government official.

The approval marks a major policy change for the United States, and supporters hope it will be a significant step forward in the long and largely failed effort to control drug prices. Individuals in the United States are allowed to buy directly from Canadian pharmacies, but states have long wanted to be able to buy drugs in bulk for their Medicaid programs, government clinics and prisons from Canadian wholesalers.

Florida estimated that it could save up to $150 million in the first year of the program by importing drugs that treat HIV, AIDS, diabetes, hepatitis C and psychiatric conditions. Other states have applied to the FDA to establish similar programs.

But significant hurdles remain. The pharmaceutical industry’s main lobbying organization, the Pharmaceutical Research and Manufacturers of America, or PhRMA, which has sued over previous import efforts, is expected to sue to prevent the Florida plan from taking effect. Some drug manufacturers have similarities with Canadian wholesalers not to export their drugs, and the Canadian government has already taken steps to block the export of prescription drugs that are in short supply.

“Canadian drug supply is too small to meet the demand of both U.S. and Canadian consumers,” Maryse Durette, spokeswoman for Health Canada, wrote in an email message. “Bulk imports will not provide an effective solution to the problem of high drug prices in the US”

Congress passed a law allowing drug imports 20 years ago, but federal health officials have delayed its implementation 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 import proposals to the FDA for review and authorization. President Biden added momentum the following year, instructing federal officials to continue to work with states on import plans.

Florida has signed up and later sued the FDA, accusing the agency of what Gov. Ron DeSantis called a “reckless delay” in approving the request. Friday’s announcement came out of that lawsuit; a federal judge had set a Jan. 5 deadline for the FDA to respond to the state’s request.

Eight other states — Colorado, Maine, New Hampshire, New Mexico, North Dakota, Texas, Vermont and Wisconsin — have laws allowing a state drug importation program, and many are seeking or planning to seek FDA approval.

Colorado’s application is pending with the FDA New Hampshire’s application was denied last year. Vermont’s was considered incomplete; a spokeswoman said the state was waiting to see how the FDA handled other states’ applications before resubmitting them.

Colorado officials have indicated that states could face challenges in their import plans from drugmakers in Canada, including household names such as Pfizer, Merck and AstraZeneca. Some drugmakers have written contracts with drug shipping companies that ban deliveries to the United States, Colorado officials said in a report.

The importation of drugs enjoys broad political and public support. A 2019 poll from KFF, a nonprofit health research group, found that nearly 80 percent of respondents supported importing from licensed Canadian pharmacies.

“Importation is an idea that resonates with people,” said Meredith Freed, senior policy analyst at KFF. “They don’t fully understand why they pay more for the same medicine than people in other countries.”

With the 2024 presidential election looming, candidates want to take credit for efforts to lower drug prices. President Biden is highlighting the Inflation Reduction Act, which gives Medicare the authority to negotiate prices directly with drugmakers for the first time, but only for a limited number of expensive drugs. Mr. DeSantis, who is challenging Mr. Trump for the Republican nomination, is touting his import plan.

Several pharmaceutical policy experts said imports from Canada would not address the root cause of high drug prices: the ability of pharmaceutical makers to fend off competition from generics by gaming the patent system, and the broad inability of the federal government to negotiate costs directly with drug manufacturers. .

“Sounds like political theater to me, where everyone wants to say they’ve done something to bring down the price of prescription drugs,” Nicholas Bagley, a health law expert at the University of Michigan Law School, said of the plan. Florida.

Both Mr. Bagley and Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, said the Inflation Reduction Act is a more direct path to lowering prices; The law’s provisions on price negotiations are expected to save the federal government estimated at $98.5 billion well over a decade. Drug manufacturers have filed suit to prevent these provisions from taking effect.

Now that approval is in hand, Florida has more work to do. Before the state can distribute Canadian drugs, it must send the FDA details of the drugs it plans to import. The state must ensure that the drugs are potent and not counterfeit. It must also put FDA-approved labels on medications instead of those used in Canada.

The FDA said it would monitor whether the state is enforcing safety rules — such as reporting any side effects from medications — and delivering significant cost savings to consumers. Florida’s approval to import lasts two years from the date of the first shipment of medications.

In Canada, health officials are closely monitoring the push to import products from their country. In November 2020, shortly after the Trump administration announced that states could submit import proposals, the Canadian government published its own rule to prevent manufacturers and wholesalers from exporting certain medicines that are in short supply.

The Canadian government will likely further restrict exports if they start to impact Canadians, said Amir Attaran, a law professor at the University of Ottawa. He said the numbers don’t add up for a country of nearly 40 million to supply medicines to a state of 22 million, let alone 49 other US states.

“If Florida can suddenly extend a vacuum hose to this country to catch what’s in the medicine chest, the supply disruption will be in a whole different category,” he said.

Dr. Harvard’s Kesselheim said the FDA’s approval is unlikely to make a difference in the price of very expensive brand-name drugs because manufacturers would prevent wholesalers from exporting the drugs.

“I think it will be difficult for states to import these types of drugs on any scale that would make a difference in terms of lowering prices for patients,” said Dr. Kesselheim. Still, he said, the FDA’s announcement is important because it challenges the idea that drug imports cannot be accomplished safely.

Mr. Bagley of the University of Michigan said there is a simpler solution to high drug prices than patchwork state import programs: let the U.S. government negotiate prices with pharmaceutical companies, as many other countries, including Canada, do doing.

“This whole thing is a complicated, complicated approach to a problem that’s amenable to a pretty simple solution, which is you give the government the power to negotiate the price of drugs,” he said. “So instead we’re trying to exploit the machinery that Canada created and that we were too timid to do.”