Pharmacist Thomas Jensen, appears to be like over a prescription drug on the Rock Canyon pharmacy in Provo, Utah, May 9, 2019.
George Frey | Reuters
The Food and Drug Administration on Friday approved Florida’s plan to import cheaper prescription drugs from Canada, a first-in-the-nation transfer that would scale back prices for Americans however faces fierce opposition from the pharmaceutical trade.
The regulator additionally mentioned it was dedicated to working with other states looking for to import drugs from Canada.
The FDA’s approval of Florida’s plan is a major stride ahead in a broader, yearslong effort to rein in drug prices within the U.S. Patients shell out significantly more for medicines than they do in Canada and another international locations.
Drug importation might open up a brand new and cheaper supply of drugs past the retail and mail-order pharmacies that Americans sometimes depend on to fill prescriptions.
Along with Florida, different states resembling Colorado, North Dakota and Vermont have their very own drug vital plans in place, which would require FDA approvals. More than five states have requested the company to greenlight their applications, in accordance to the National Conference of State Legislatures.
But Florida’s newly accepted plan will possible face hurdles earlier than it takes impact, together with potential lawsuits from the pharmaceutical trade.
Drugmakers have lengthy argued that importation might introduce counterfeit medicines into the U.S. provide chain and hurt sufferers – a priority the FDA beforehand raised as a result of the company cannot assure the protection of these drugs.
However, the FDA’s Friday approval seems to have guardrails that goal to mitigate potential questions of safety.
Before Florida can distribute Canadian drugs, the state should ship the FDA particulars on the drugs it plans to import, be sure that these therapies should not counterfeit or ineffective and relabel these drugs to be in step with FDA-approved labeling.
Florida should additionally submit quarterly studies to the company about value financial savings and potential questions of safety, amongst different obligations. The FDA’s approval permits Florida to import drugs for 2 years from the date of the first drug cargo.
“These proposals should show the applications would lead to important value financial savings to customers with out including danger of publicity to unsafe or ineffective drugs,” FDA Commissioner Robert Califf mentioned in an announcement.
The pharmaceutical trade pushed again on the FDA’s transfer on Friday.
Pharmaceutical Research and Manufacturers of America, the trade’s largest lobbying group, known as the FDA’s approval of Florida’s plan “reckless” and mentioned it’s contemplating “all choices for stopping this coverage from harming sufferers.”
“Ensuring sufferers have entry to wanted medicines is vital, however the importation of unapproved medicines, whether or not from Canada or elsewhere on the planet, poses a critical hazard to public well being,” Stephen Ubl, the CEO of PhRMA, mentioned. “Politicians want to cease getting between Americans and their well being care.”
The group sued the FDA in 2020 over a Trump administration plan to import Canadian drugs, however that lawsuit was later dismissed.
President Joe Biden issued an executive order in July 2021 that included a name for the FDA to work with states on plans for importing drugs from Canada.