Pharmacist Thomas Jensen examines a prescription drug at Rock Canyon Pharmacy in Provo, Utah, on May 9, 2019.
George Frey | Reuters
The US Food and Drug Administration on Friday approved Florida’s plan to introduction of cheaper prescription drugs from Canada, a first move in the country that could reduce costs for Americans but they face fierce opposition from the pharmaceutical industry.
The regulator also said it was committed to working with other states seek to import drugs from Canada.
The FDA’s approval of Florida’s plan is an important step forward in a broader, multiyear effort to contain drug costs in the US. significantly more for drugs than in Canada and some other countries.
Drug importation could open up a new and cheaper source of drugs beyond the retail and mail-order pharmacies that Americans typically rely on to fill prescriptions.
Along with Florida, others states states such as Colorado, North Dakota and Vermont have their own drug importation plans, which will require FDA approvals. More than five states have asked the agency to greenlight their programs, according to the National Conference of State Legislatures.
But Florida’s newly approved plan will likely face hurdles before it goes into effect, including potential lawsuits from the pharmaceutical industry.
Pharmacists have long argued that the import could introduce counterfeit drugs into the U.S. supply chain and harm patients — a concern the FDA has previously raised because the agency cannot guarantee the safety of those drugs.
However, Friday’s FDA approval appears to have guardrails aimed at mitigating potential safety issues.
Before Florida can distribute Canadian drugs, the state must send the FDA details of the drugs it plans to import, ensure those treatments are not counterfeit or ineffective, and relabel those drugs to comply with the FDA-approved labeling.
Florida must also submit quarterly reports to the agency on cost savings and potential safety issues, among other obligations. FDA approval allows Florida to import drugs for two years from the date of the first drug shipment.
“These proposals must demonstrate that the programs would result in significant cost savings for consumers without adding risk of exposure to unsafe or ineffective drugs,” FDA Commissioner Robert Califf said in a statement.
The pharmaceutical industry pushed back against the FDA’s move on Friday.
Pharmaceutical Research and Manufacturers of America, the industry’s largest lobbying group, called the FDA’s approval of Florida’s plan “reckless” and said it is considering “all options to prevent this policy from harming patients.”
“Ensuring that patients have access to the medicines they need is critical, but the importation of unapproved medicines, whether from Canada or elsewhere in the world, poses a serious risk to public health,” said Stephen Ubl, CEO of PhRMA. “Politicians must stop coming between Americans and their health care.”
The team sued the FDA in 2020 over a Trump administration plan to import Canadian drugs, but that lawsuit was later dismissed.
President Joe Biden issued executive order in July 2021, which included a call for the FDA to work with states on plans to import drugs from Canada.
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