FDA approves Florida's plan to import cheaper drugs from Canada
Florida is one step closer to being able to import cheaper prescription drugs from Canada.
The Food and Drug Administration says it has authorized Florida's proposed program to import selected drugs.
Under federal law, any state or tribe can submit a proposal for importation, and a few have. The law allows importation of certain prescription drugs in bulk if doing so would save Americans money without adding safety risks. The FDA also has to give its blessing.
Florida's proposal, championed by Republican Gov. Ron DeSantis, is the first to be OK'd by the agency.
The state has to clear a lot more hurdles, however, before imports could begin. Among other things, it has to specify which drugs it wants to import, verify that they meet FDA's standards and relabel them.
While the FDA authorization is a major policy change, experts also say it alone won't solve the United States' problem with high-priced drugs.
Canada's drug supply is too small, and the country has already taken steps to protect it.
The pharmaceutical industry has pushed back and is expected to sue.
"We are deeply concerned with the FDA's reckless decision to approve Florida's state importation plan," says a statement from Stephen Ubl, president and CEO of the drug industry trade group PhRMA. "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. ... PhRMA is considering all options for preventing this policy from harming patients."
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Transcript
JUANA SUMMERS, HOST:
Prescription drugs are generally cheaper in Canada than they are here in the U.S., and now Florida is a step closer to being able to import them because of a shift in policy by the Food and Drug Administration. NPR pharmaceuticals correspondent Sydney Lupkin is here to talk with us about that. Hi, Sydney.
SYDNEY LUPKIN, BYLINE: Hi, Juana.
SUMMERS: So, Sydney, first, what exactly did the FDA do here?
LUPKIN: So the agency authorized Florida's proposal for a drug importation program that would allow the state to buy cheaper drugs from Canada. Under federal law, any state or tribe can submit one of these program proposals, and a few have. The law allows importation of certain prescription drugs in bulk if doing so would save Americans money without adding safety risks. It excludes some very expensive drugs. Florida's proposal is the first to be OK'd by the agency, but this is just a step. A lot more has to happen before Floridians, mainly those on the state Medicaid program, for instance, could benefit from Canada's lower drug prices.
SUMMERS: OK. I'm sensing there might be some hurdles here. What kind are we talking about?
LUPKIN: Oh, my gosh, all kinds of hurdles. So first, the FDA wants Florida to specify which drugs it wants to import. Florida also has to verify that the drugs meet FDA's quality standards and relabel those drugs. And that's a big undertaking. Here's Aaron Kesselheim, a professor at Harvard Medical School.
AARON KESSELHEIM: I think it's going to be very challenging for this sort of arrangement to make products available widely to patients at lower prices.
LUPKIN: Meanwhile, the drug industry is expected to put up a fight. The head of the trade group PhRMA has already called the FDA authorization reckless and said it is considering all options for preventing this policy from, quote, "harming patients." So the industry will likely sue. And Canada has been reluctant to play ball on this because this program could lead to drug shortages and increased prices in Canada.
SUMMERS: Right. I mean, Sydney, this is a popular idea here in the U.S. to import drugs from Canada and save money. But how could Florida actually do this without Canada being on board with it?
LUPKIN: Right. It seems like it couldn't. So one thing to keep in mind is that Canada has a lot fewer people than the U.S. does, only around 40 million, which is about the same size as California. When Canada buys drugs and negotiates their prices, something the U.S. doesn't do across the board, it's buying for that smaller population. So to have to supply Florida and other potential states with drugs through these importation programs, the math just doesn't work. And the industry can resist. Companies making branded drugs could try to limit their supply going into Canada so that it can't keep up with new demand from the U.S. And there won't be enough to send to Florida or whatever other state decides to do this.
SUMMERS: OK. So it does not sound to me like this is the wholesale solution to all of the drug price problems we're seeing here in the U.S.
LUPKIN: No, unfortunately, it's probably not. When I asked Kesselheim from Harvard how soon before Floridians might benefit from this program, he said, possibly never. That said, it's still a big step because the FDA is saying for the first time in years that, yes, drug importation like this can be done safely. I also spoke to Tricia Neuman, who directs the program on Medicare policy at KFF, a health policy nonprofit. She said importing cheaper drugs from Canada isn't any kind of comprehensive solution to America's drug price problem. Instead, the drug price negotiation that's begun in Medicare through the Inflation Reduction Act is a much better way to rein those high prices in. The administration is currently working on negotiations for its first 10 drugs. Those prices will be announced in the fall, and they could go into effect in 2026.
SUMMERS: NPR pharmaceuticals correspondent Sydney Lupkin. Thank you, Sydney.
LUPKIN: You bet. Transcript provided by NPR, Copyright NPR.
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