Of course, PhRMA will sue. It will claim that FDA cannot allow “unsafe” medicines into the US market. But assuming the federal FDA laws and rules mean what they say, the FDA has the power to grant state government entities the ability to purchase non-US sourced prescription drugs and biologics. Afterall, these Canadian drugs in particular are made in US facilities, and just re-labeled and shipped to Canada.
In any event, Florida is the first through the gate — here, in 2024. But this is something Hillary Rodham Clinton’s 1994 Health Care initiative sought but was unable to achieve. An early draft of what became the ACA of 2010 — or Obamacare, also provided for reimportation. But it was dropped from the final bill, to garner enough votes to pass.
Personally, I have to wonder if… the silly strike suits, against HHS and CMS and the VA, claiming that drug companies like Merck need not negotiate on price… have led to this moment at FDA. That and the endless price increases, on even very old medicines. Mr. Davis likely has only himself to blame for the idea that next, his lawyers will be fighting in local Florida courts to prevent that state from buying the very same drugs in Canada as roll off the line in New Jersey… albeit with a new label plastered on the side of the vials. So it goes. Here is the latest, from The NYT, this morning:
…The Food and Drug Administration has allowed 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.
The approval, issued in a letter to Florida Friday, 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 rein 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….”
Dr. Robert Califf, the F.D.A. commissioner, said in a statement that the agency will be vetting additional state applications to be sure they live up to the program’s goals.
“These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs,” Dr. Califf said….
This is — indeed — a sea change. And more good news for consumers, here early in 2024. Though it may be late 2025, before the suits are put to bed, and Canadian inventory reaches state medical aid providers’ shelves — for seniors, and low income Americans.
Pharma will also likely try to end contracts with some Canadian sources, claiming breach — but this is going to be the “new normal”… all because pharma won’t negotiate in good faith on prices, inside the US. Onward.
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