FDA to Issue First Approval for Mass Drug Imports to States from Canada

FDA to Issue First Approval for Mass Drug Imports to States from Canada

The Food and Drug Administration has allowed Florida to import millions of dollars’ worth of drugs from Canada at prices far lower than those in the United States, ignoring decades-long fierce objections from the pharmaceutical industry.

Approvalissued in a letter in Florida on Friday constitutes a major policy shift for the United States, and one its supporters hope will be a significant step forward in long and largely unsuccessful efforts to rein in drug prices. In the United States, individuals are allowed to purchase directly from Canadian pharmacies, but states have long wanted to be able to purchase 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 to treat HIV, AIDS, diabetes, hepatitis C and psychiatric disorders. Other states have asked the FDA to establish similar programs.

But significant obstacles remain. Some drug manufacturers have agreements with Canadian wholesalers so that they do not export their drugs, and the Canadian government has already taken steps to block the export of prescription drugs that are in short supply.

“The supply of drugs in Canada is too limited to meet the demand of American and Canadian consumers,” wrote Maryse Durette, spokesperson for Health Canada, in an email message. “Massive imports will not be an effective solution to the problem of high drug prices in the United States”

The pharmaceutical industry’s main lobbying organization, the Pharmaceutical Research and Manufacturers of America, or PhRMA, which sued over previous importation efforts, is expected to sue to block Florida’s plan . In a statement Friday morning, PhRMA called the FDA’s decision “reckless” and warned that it was “considering all options” to prevent it from taking effect.

Congress passed a law allowing drug importation two decades ago, but federal health officials delayed its implementation for years, citing safety concerns, one of the main arguments cited by pharmaceutical companies to oppose it. In 2020, President Donald J. Trump advanced the law, announcing that states could submit importation proposals to the FDA for review and authorization. President Biden added momentum the following year, give instructions to federal officials continue to work with states on import plans.

Florida applied and then sued the FDA, accusing the agency of what Gov. Ron DeSantis called a “reckless delay” in approving the request. Friday’s announcement stems from that lawsuit; a federal judge had set a January 5 deadline for the FDA to act on the state’s request.

Dr. Robert Califf, FDA commissioner, said in a statement that the agency will review states’ additional requests to ensure they meet the program’s goals.

“These proposals must demonstrate that the programs would result in significant savings for consumers without adding risk of exposure to unsafe or ineffective medications,” Dr. Califf said.

Eight other states – Colorado, Maine, New Hampshire, New Mexico, North Dakota, Texas, Vermont and Wisconsin – have laws authorizing a national drug importation program, and many are seeking or plan to seek FDA approval.

Colorado request is pending with the FDA New Hampshire’s request was denied Last year. Vermont’s was deemed incomplete; a spokeswoman said the state was waiting to see how the FDA handled other states’ requests before resubmitting them.

Colorado officials have signaled that states could face challenges from drugmakers in Canada, including household names like Pfizer, Merck and AstraZeneca. Some drugmakers have signed contracts with drug shipping companies barring shipments into the United States, Colorado officials said in a report.

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

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

As the 2024 presidential election approaches, candidates are seeking to take credit for efforts to reduce drug prices. President Biden is promoting the Inflation Reduction Act, which for the first time allows Medicare to negotiate prices directly with drug manufacturers, but only for a limited number of high-cost drugs. Mr. DeSantis, who is challenging Mr. Trump for the Republican nomination, is touting his import plan.

“We have a warehouse ready to go and the state will save hundreds of millions of dollars because I can buy the same drug there at a fraction of the price and then it will be relabeled in Florida and then it will go out of there.” DeSantis said Friday during a campaign stop in Iowa.

Several drug policy experts said importing from Canada would not address the root cause of high drug prices: the ability of pharmaceutical manufacturers to fend off generic competition by gaming the patent system and he widespread failure of the federal government to negotiate directly with drug manufacturers over costs. .

“It seems like political theater to me, where everyone wants to say they did something to lower the price of prescription drugs,” said Nicholas Bagley, a health law expert at the University of Texas Law School. the University of Michigan, regarding the Florida plan.

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 lower prices; the provisions of the law on price negotiation should save the federal government from estimated at $98.5 billion over a decade. Drugmakers are suing to prevent these provisions from taking effect.

With approval in hand, Florida still has work to do. Before it can distribute Canadian drugs, the state must send the FDA details of those it plans to import. The state must guarantee that medicines are potent and not counterfeit. It must also put FDA-approved labels on drugs rather than those used in Canada.

The FDA said it would monitor whether the state followed safety rules — such as reporting any drug side effects — and provided consumers with significant savings. Florida’s import approval lasts two years from the date of the first drug shipment.

In Canada, health officials are wary of pressure on imports from their country. In November 2020, shortly after the Trump administration announced that states could submit import proposals, the Canadian government released its own rule to prevent manufacturers and wholesalers from exporting certain medicines that are in insufficient supply.

The Canadian government is likely to further restrict exports if they start to affect Canadians, said Amir Attaran, a law professor at the University of Ottawa. He said the numbers aren’t enough for a country of nearly 40 million people to provide medicine to a state of 22 million people, let alone 49 other U.S. states.

“If all of a sudden Florida is able to extend a vacuum hose into this country to take what’s in the pharmacy, the disruption in supply will be in a whole different category,” he said. he declared.

Harvard’s Dr. Kesselheim said FDA approval was 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’s going to be difficult for states to import drugs like that on any scale that would make a difference in terms of lowering prices for patients,” Dr. Kesselheim said. Still, he said, the FDA’s announcement is important because it puts to rest the notion that drug importation cannot be done safely.

Mr. Bagley, of the University of Michigan, said there was a simpler solution to high drug prices than disparate state importation programs: asking the U.S. government to negotiate prices with drug companies, all as do many other countries, including Canada.

“This is all a complicated, complicated approach to a problem that lends itself to a fairly simple solution, which is to give the government the power to negotiate on drug prices,” he said. “Instead, we’re sort of trying to exploit the machinery that Canada created that we were too timid to create.”

Molly Longman contributed reporting from Cumming, Iowa.

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Eric D. Eilerman

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