The Biden administration will allow Florida to import cheaper prescription drugs from Canada, giving the green light to a plan put in motion by the state several years ago.

The Food and Drug Administration made the decision on Florida’s plan Friday, saying that the state’s health department must likewise provide quarterly reports to the agency, including information on cost savings and potential safety and quality issues.

FDA Commissioner Robert Califf said in a statement that the agency was “committed to working with states and Indian tribes” trying to develop importation proposals.

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

The FDA decision marks the latest turn in a back and forth between states and the federal government over importing cheaper drugs.

The pharmaceutical industry is already pushing back on the FDA’s announcement.

Stephen Ubl, president and CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA), called the FDA’s approval of Florida’s plan “reckless.”

“Ensuring patients have access to needed medicines is critical, but the importation of unapproved medicines, whether from Canada or elsewhere in the world, poses a serious danger to public health,” Ubl said in a statement. “Politicians need to stop getting between Americans and their health care.”

Ubl also noted that PhRMA “is considering all options for preventing this policy from harming patients.” The group had sued the FDA in 2020 over a Trump administration plan for importing Canadian drugs. The lawsuit was later dismissed.

President Joe Biden issued an executive order in July 2021 that included a call for the FDA to work with states on importing drugs from Canada.

In August 2022, however, Florida sued the FDA, claiming the agency was standing in the way of its drug importation plan.

In addition to Florida, states like Colorado, North Dakota and Vermont have laws that allow importation of drugs, according to the National Conference of State Legislatures. Over five of those states have asked the FDA for approval, the conference said.


U.S. allowing Florida to import drugs from

Canada, reviving fears of shortages



CBC
Fri, January 5, 2024 

Florida is one of a handful of states that have applied to import wholesale prescription drugs from Canada. (David Donnelly/CBC - image credit)

The U.S. Food and Drug Administration is allowing Florida to import what could amount to millions of dollars worth of prescription drugs from Canada — a move that could reignite worries about the drug supply north of the border.

Florida has estimated that purchasing prescription drugs from Canadian wholesalers to treat such conditions as HIV/AIDS, diabetes and hepatitis C could save the southern state $150 million US annually.

Marking a shift in U.S pharmaceutical policy, the FDA approved Florida's request. In a letter to the state government dated Friday, the director of the administration signed off on the proposal and said that importing medications from Canada could "significantly reduce the cost of covered products to the American consumer without posing additional risk to the public's health and safety."

The sunshine state is one of a handful that have applied for permission to import wholesale prescription drugs from Canada, meaning Friday's approval could be just the first of several.

Canada — which set up a federal regulatory agency decades ago to ensure patent drug prices are not excessive — has resisted such import plans for years.

In a media statement, federal Health Minister Mark Holland said Canada has regulations in place to protect its supply.

"I want to assure Canadians that they will continue to have access to medications they need when they need them," he said.

"Canadians can be confident that our government will continue to take all necessary measures to protect the drug supply in Canada."

Five provinces, including Quebec, allow pharmacists to prescribe Paxlovid directly to people who get sick with COVID-19. avoiding the need to see a doctor. 'It's really about getting the drug to the person as quickly as possible so they can start it and have the best possible outcome,' said Montreal pharmacist Daron Basmadjian.

The Canadian Pharmacists Association is urging Canadians not to rush out to stock up on their prescriptions in wake of the U.S. FDA's decision. (CBC/Radio-Canada)

Joel Lexchin, a retired emergency physician who studies pharmaceutical policy, said it's still not clear if Florida's plan will actually pan out.

"But if it goes ahead, then we should be worried," he said.

"Canada has 40 million people. Florida has more than half of that, so 22 million people. We can't supply Florida with the drugs that they may need without doing damage in Canada."

Lexchin said the U.S. is "attempting to use Canada to solve a relatively unique American problem.

"The U.S. government, amongst all the other OECD countries, doesn't allow price negotiations with manufacturers. So drug companies are free to set whatever prices they want. Here in Canada, we control prices so our prices for brand name drugs tend to be two and a half to three times lower than the U.S. prices."

Pharmacists' group calls for calm

Joelle Walker, vice president of public affairs for the Canadian Pharmacists Association, said the FDA's decision is "certainly not good news for Canadians" but she shares Lexchin's doubts about Florida starting bulk imports any time soon.

"Historically, we've had some pretty devastating drug shortages in Canada. And so the idea that they could import them from us is not really feasible," she said.

"I'm skeptical that it will actually come to fruition in its current form, but we want to make sure that we're diligent about reviewing it and making sure that we're not missing something."

Walker urged Canadians not to rush out to stock up on their prescriptions, which could trigger shortages.

"Don't be alarmed today. This certainly isn't happening tomorrow. This may never happen. So don't rush to your pharmacy, don't be concerned about it right now," she said.

"Hopefully, the measures that we have in place will help sort of restrict that flow from Canada to the United States."

This debate is not new. In 2019, then-U.S. president Donald Trump proposed a rule to allow wholesale bulk imports of prescription drugs, promising it would be a "game changer for American seniors."

Within months, the Canadian government blocked bulk exports of some prescription drugs to stave off the risk of shortages at home.

Health Canada issued a statement at the time saying approximately 10 to 15 per cent of drugs have been in short supply in Canada "at any given time" since 2017.

Lexchin said that while the Canadian government has brought in regulations to avoid mass exports, drug shortages — like the shortage of children's Tylenol in 2022 — can be hard to predict.

"If drugs are being made in a single plant, and there's a fire in the plant, or they discover there's contamination, that creates a shortage without any real warning," he said.

"So if we are committed to exporting large amounts of drugs, when a shortage comes up, then we may be on the short end of the stick."

Americans have been buying drugs from Canada for some time.

Pharmacists along the border have reported U.S. citizens making the trek to stock up on cheaper medicine, including insulin and Ozempic, a prescription diabetes treatment that has skyrocketed in popularity recently as an off-label drug for weight loss.

"People driving over the the border and coming and getting a little bit at a time, that wasn't really jeopardizing our supply," said Walker.

"But we've had recent examples in B.C., for example, where the importation of Ozempic was actually leading to a potential shortage because the numbers were so high."

Decision could harm Canadians, warns trade group

Innovative Medicines Canada, a trade group that represents about 50 pharma companies, said allowing Florida to import drugs meant for Canadians could "disrupt" Canada's health-care system.

"Canada simply can't supply drugs to Florida, or any other U.S. states, without significantly increasing the risk and severity of drug shortages nationwide," David Renwick, interim president of Innovative Medicines Canada, said in a statement.

"The U.S. market is nearly 10 times bigger than Canada's, and allowing drugs that were intended for Canadians to be exported to the U.S. would harm Canadian patients and disrupt our health-care system."

The head of Pharmaceutical Research and Manufacturers of America (PhRMA), one of the largest pharmaceutical industry lobby groups in the U.S., called the FDA's decision "reckless."

"Ensuring patients have access to needed medicines is critical, but the importation of unapproved medicines, whether from Canada or elsewhere in the world, poses a serious danger to public health," said PhRMA president Stephen Ubl in a media statement.

"PhRMA is considering all options for preventing this policy from harming patients."