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FDA finally clears Florida to import prescription drugs from Canada


The FDA said Florida’s program will be authorized for two years. Approval comes after months of wrangling that led to the state filing two lawsuits against the agency.

Almost five years after Florida began pursuing the idea, the U.S. Food and Drug Administration on Friday approved a plan that will allow the state to import cheaper prescription drugs from Canada.

The federal agency approved the importation program for two years, saying Florida had met requirements to show that it “will significantly reduce the cost of covered products to the American consumer without posing additional risk to the public’s health and safety.”

The plan is designed to make imported drugs available in government programs such as Medicaid, the prison system and facilities run by the Department of Children & Families. At least initially, the state wants to import drugs to treat conditions such as HIV and AIDS and mental illness.

Gov. Ron DeSantis' office said an analysis showed the program could save up to $183 million a year when it is fully in place.

Friday’s approval came after lengthy wrangling about the plan and the state filing two lawsuits against the FDA. In one of the lawsuits, the state blamed the delays, in part, on “the FDA’s longstanding symbiotic relationship with big pharmaceutical companies,” which the federal agency has denied.

On Friday, DeSantis said in a statement: “After years of federal bureaucrats dragging their feet, Florida will now be able to import low-cost, life-saving prescription drugs. It’s about time that the FDA put patients over politics and the interests of Floridians over Big Pharma.”

Florida's plan, the first in the nation, is a long-sought approach to accessing cheaper medications after decades of frustration with U.S. drug prices.

Democratic President Joe Biden has backed such importation programs as a way to lower drug costs, signing an executive order in 2021 that directed the FDA to work with states on imports.

That policy change represented a seismic shift after decades of lobbying by the pharmaceutical industry, which said imports would expose U.S. patients to risks of counterfeit or adulterated drugs. The FDA also previously warned of the difficulties of assuring the safety of drugs originating from outside the U.S.

But the politics have shifted in recent years, with both parties — including former President Donald Trump — doubling down on the import approach.

The pharmaceutical industry has pushed back on Florida's plan and is expected to sue.

"We are deeply concerned with the FDA's reckless decision to approve Florida's state importation plan," Stephen Ubl, president and CEO of the drug industry trade group PhRMA, said in a statement. "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. Politicians need to stop getting between Americans and their health care.”

DeSantis and then-Florida House Speaker Jose Oliva, R-Miami Lakes, made the importation issue a priority in 2019, with lawmakers approving the idea. The state submitted a proposal in November 2020 to the FDA.

That touched off a review process that included the FDA seeking revisions to the plan. The state filed a revised proposal in October to try to address the federal agency’s concerns, according to court documents.

As an example of issues that emerged during the back-and-forth, the FDA in an Aug. 14 letter pointed to Florida’s proposal lacking a secured warehouse within 30 miles of an “authorized port of entry” for prescription drugs in Canadian importation programs. The only authorized port of entry was Detroit, while Florida planned to store shipments at a facility in Whitestown, Ind.

Last month, Florida Agency for Health Care Administration Secretary Jason Weida told a state House panel that the FDA “set up a number of hoops” and “we have jumped through them all.”

As the FDA review continued in 2022, the state filed a lawsuit alleging violations of the federal Administrative Procedure Act and the Freedom of Information Act. The Administrative Procedure Act allegations centered on delays in the decision-making, while the Freedom of Information Act allegations involved records that the state sought from the FDA.

The state filed another Freedom of Information Act lawsuit in 2023. Both cases remain pending in federal court in Tampa.

“Florida has won many legal battles against the Biden administration, and I am pleased they finally decided to back down and stop standing between Florida and lower prescription drug prices,” state Attorney General Ashley Moody said in a statement.

A news release posted on the FDA website described the approval as a “first step on this pathway toward Florida facilitating importation of certain prescription drugs from Canada.”

Before importation can start, the Agency for Health Care Administration has to meet conditions, such as submitting additional “drug-specific information” for FDA approval, the news release said.

Also, the news release said AHCA will have to ensure “that the drugs Florida seeks to import have been tested for, among other things, authenticity and compliance with the FDA-approved drugs’ specifications and standards.”

The state must also provide a quarterly report to the FDA on the types of drugs imported, cost savings and any potential safety and quality issues.

“These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs,” FDA Commissioner Dr. Robert Califf said in a statement.

The state said it will begin by providing prescription drugs in a small number of classes that will include maintenance medications for people with chronic conditions such as HIV/AIDS, mental illness, prostate cancer and urea cycle disorder.

The medications would be only for certain patients, including foster children, people with disabilities, inmates, certain elderly patients and — eventually — Medicaid recipients.

“After three long years of waiting for FDA approval, we are excited to finally have the opportunity to see this vision come to fruition and provide Floridians access to safe and affordable prescription drugs,” Weida said in a statement. “As we move forward, we will continue to work every day to find ways to lower costs for Florida’s vulnerable populations.”

Like most developed nations, Canada sets limits on the prices drugmakers can charge if they wish to enter the market. Health officials there previously have suggested their country’s prescription drug market is too small to have any real impact on U.S. prices.

The U.S. has long had the highest prescription drug prices in the world, with essentially no government limits on what companies can charge. Only in 2022 did Congress pass a law allowing the federal government to negotiate prices for a small number of medications used by seniors in the Medicare program. The first such negotiations are set to take place later this year.

Information from the Associated Press was used in this report.

Jim Saunders is the Executive Editor of The News Service Of Florida.