FDA approves first state request to import drugs from Canada

Jan 5, 2024, 8:30 PM | Updated: May 28, 2024, 10:27 am

The Food and Drug Administration has approved Florida's drug importation proposal. (Tetra images RF...

The Food and Drug Administration has approved Florida's drug importation proposal. (Tetra images RF/Getty Images)

(Tetra images RF/Getty Images)

Originally Published: 05 JAN 24 10:42 ET
Updated: 05 JAN 24 20:09 ET

(CNN) — The Food and Drug Administration on Friday approved Florida’s request to import certain drugs from Canada, marking the first time a state has been authorized to buy lower-cost medications in bulk from abroad.

Florida’s plan calls for importing medications for several illnesses for residents covered by certain public programs, including Medicaid enrollees and inmates.

The historic move is the latest salvo in the long-running battle to lower drug prices, one of Americans’ biggest health care headaches and a major element of President Joe Biden’s reelection campaign. Florida Gov. Ron DeSantis, who is seeking the Republican presidential nomination, is also highlighting his importation proposal as he seeks to curtail drug costs.

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

While US law allows drug importation, it never gained traction because of federal health officials’ concerns over safety and actual savings as well as fierce opposition from American drug manufacturers and Republican lawmakers.

Former President Donald Trump, however, made drug importation a centerpiece of his effort to reduce drug costs and pushed for federal approval of Florida’s proposal. In 2020, the Department of Health and Human Services issued a final rule establishing a path for states and certain other entities to set up drug importation programs. The next year, Biden issued an executive order directing the FDA commissioner to work with states that want to develop importation programs.

Though Biden, Trump and DeSantis are likely to take credit on the campaign trail for initiating drug importation in the US, major hurdles remain before Florida can actually start importing certain medications, and it could be a while before the state and its residents see savings. The drug industry is expected to continue its efforts to prevent the importation of drugs, and Canada has opposed the mass importation of its medications.

Florida’s proposal

Florida, which filed its proposal with the FDA in 2020, initially wants to import drugs to treat chronic health conditions such as HIV/AIDS, mental illness and prostate cancer, the governor’s office said in a press release Friday.

The state would make the imported drugs available to patients at county health departments managed by the state Department of Health, inmates at state correctional facilities and certain others served by state agencies. The program would then expand to Medicaid enrollees.

Florida expects to save up to $180 million in the first year and around $183 million annually once the program is fully implemented, the state said.

“We’re creating a system with importers and vendors that we as a state will import drugs from Canada, relabel them, get them to Florida and send them out through various state programs that way,” Florida’s Agency for Health Care Administration secretary, Jason Weida, told state lawmakers last month. “That guarantees safety. That guarantees cost savings.”

Seven other states, including Colorado, Maine and Texas, have passed laws that would allow them to create state drug importation programs. Some are in various stages of seeking FDA approval. New Hampshire’s application was rejected in 2022 because it did not identify a Canadian wholesaler.

Florida must meet certain FDA requirements before drugs can be imported. It must submit additional drug-specific information for the agency’s approval, ensure that the medications have been tested and comply with FDA standards, and relabel the medications consistent with FDA rules. In addition, the state must submit a quarterly report about the imported drugs, cost savings and 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,” said FDA Commissioner Robert Califf.

The state’s plan is authorized for two years from the date the FDA is notified of the first drug shipment.

The Pharmaceutical Research and Manufacturers of America, known as PhRMA, quickly issued a statement that said it is “considering all options for preventing this policy from harming patients.”

“We are deeply concerned with the FDA’s reckless decision to approve Florida’s state importation plan,” said Stephen Ubl, CEO of PhRMA, the main industry group. “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.”

The Canadian government, which is concerned about its own drug shortages, and independent experts have questioned whether importation would do much to help lower prices in the US since Canada’s drug market is relatively small. In 2020, Canada announced measures to protect its drug supply, including banning the distribution of certain drugs outside of the country that would cause or worsen a shortage. This includes all medications eligible for bulk importation to the US, according to Health Canada, which is responsible for national health policy.

“The Government of Canada is taking all necessary action to safeguard the drug supply and ensure Canadians have access to the prescription drugs they need and has been clear in its position: bulk importation will not provide an effective solution to the problem of high drug prices in the US,” Health Canada said in a statement Friday evening.

But others are more hopeful.

“This is a significant step in moving towards wholesale drug importation and residents of the United States accessing the same drugs at a lower cost,” said Maureen Hensley-Quinn, senior director of coverage, cost and value at the National Academy for State Health Policy, which developed drug importation model legislation that states can use.

This story has been updated with additional information.

™ & © 2024 Cable News Network, Inc., a Warner Bros. Discovery Company. All rights reserved.

We want to hear from you.

Have a story idea or tip? Send it to the KSL NewsRadio team here.


air quality in utah takes a hit as smog settles over the city...

Adam Small

Wildfire smoke moving into the Wasatch Front

Air quality in Utah could be unhealthy for sensitive groups in some areas due to wind bringing in wildfire smoke from the Pacific Northwest.

1 day ago

Health officials in eastern Utah are still investigating after a dozen swimmers got sick at the Ver...

Britt Johnson

Swimming pool at Vernal hotel still closed after acid leak

A dozen swimmers became sick and were hospitalized in Vernal on Saturday, later health officials discovered acid had leaked into the pool.

2 days ago

German Health Minister Karl Lauterbach receives a Covid booster vaccine on September 18, 2023.(Chri...

Alexandrea Bonilla

What’s a summer without a COVID spike?

COVID cases are surging once again this summer. The CDC says cases often rise due to the heat of the summer.

2 days ago


Mariah Maynes

Researchers reveal new findings in neurological origins of creativity

A team of researchers said that a new study shows creativity may be reliant on certain neurological functions.

2 days ago

Utah air quality is going down and it could get worse...

Josuee Sanchez

Utah air quality is deteriorating and could get worse

Utah is lacking of good air quality due to wildfires but it is mostly because of the hot weather.

4 days ago

Vehicles pass by a sign showing solidarity amid the COVID-19 pandemic in Murray on Sunday, April 12...

Heather Peterson

Youth mental health in Utah improving, post-pandemic

The latest Youth Risk Behavior Survey found that 37% of respondents reported feeling so sad or hopeless that they changed their usual activities.

6 days ago

Sponsored Articles

A young woman smiles while reading the menu at a lakeside restaurant, enjoying the panoramic view o...

Bear Lake Convention & Visitors Bureau

The best restaurants to try in Bear Lake

Save this guide to the best restaurants in Bear Lake when you need to find a place to dine during your next visit.

Female leg stepping on weigh scales. Healthy lifestyle, food and sport concept....

Health Utah

Sustainable weight loss: the science-backed way to achieve it

Learn more about Debbie's weight loss journey with Health Utah, who have a unique weight loss philosophy for success.

Underwater shot of the fisherman holding the fish...

Bear Lake Convention and Visitors Bureau

Your Bear Lake fishing guide

Bear Lake offers year-round fishing opportunities. By preparing ahead of time, you might go home with a big catch!

A group of people cut a purple ribbon...


Comcast announces major fiber network expansion in Utah

Comcast's commitment to delivering extensive coverage signifies a monumental leap toward a digitally empowered future for Utahns.

a doctor putting her hand on the chest of her patient...

Intermountain Health

Intermountain nurse-midwives launch new gynecology access clinic

An access clinic launched by Intermountain nurse-midwives provides women with comprehensive gynecology care.

Young couple hugging while a realtor in a suit hands them keys in a new home...

Utah Association of Realtors

Buying a home this spring? Avoid these 5 costly pitfalls

By avoiding these pitfalls when buying a home this spring, you can ensure your investment will be long-lasting and secure.

FDA approves first state request to import drugs from Canada