Pharmacist Thomas Jensen checks a prescription at Rock Canyon Pharmacy in Provo, Utah, on 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 measure that could reduce costs for Americans, but faces fierce opposition from the pharmaceutical industry.
The regulator also said it was committed to working with other states looking to import drugs from Canada.
The FDA’s approval of Florida’s plan is an important step forward in a broader, years-long effort to control drug costs in the U.S. Patients pay much more for drugs than in Canada and some other countries.
Drug importation could open up a new, cheaper source of drugs beyond the retail and mail-order pharmacies that Americans typically rely on to fill their prescriptions.
Along with Florida, other states such as Colorado, North Dakota and Vermont have their own major drug plans, which will require FDA approval. 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 takes effect, including potential lawsuits from the pharmaceutical industry.
Drug makers have long argued that importation can introduce counterfeit drugs into the U.S. supply chain and harm patients, a concern the FDA previously raised because the agency cannot guarantee the safety of those drugs. .
However, Friday’s FDA approval appears to have barriers aimed at mitigating potential safety concerns.
Before Florida can distribute Canadian drugs, the state must send the FDA details about the drugs it plans to import, ensure those treatments are not counterfeit or ineffective, and relabel those drugs to be consistent with FDA-approved labeling. FDA.
Florida must also submit quarterly reports to the agency on cost savings and potential safety issues, among other obligations. The FDA approval allows Florida to import medications for two years from the date of the first shipment of medications.
“These proposals must demonstrate that the programs would produce 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 rejected the FDA’s action 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 consumers.” patients.”
“Ensuring patients have access to needed medications is critical, but the importation of unapproved medications, whether from Canada or anywhere else in the world, poses a serious danger to public health,” said CEO Stephen Ubl. from PhRMA. “Politicians must stop standing between Americans and their health care.”
The group sued the FDA in 2020 over a Trump administration plan to import Canadian drugs, but that 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 plans to import drugs from Canada.
