US FDA to allow Florida to import cheaper drugs from Canada (updated)

Alliance Pharma

05/01/2024 15:56

(Adds PhRMA response in paragraph 5 and 6, background in
paragraph 3, details from FDA's letter in paragraphs 8 and 9)
    By Khushi Mandowara
       Jan 5 (Reuters) - The U.S. Food and Drug Administration
(FDA) on Friday authorized Florida to directly import
prescription drugs from Canada, making it the first state to get
approval for a plan aimed at bringing cheaper medicines to
Americans.
    Drug costs in the United States are higher than any other
nation in the world by two to three times. 
    Supporters of importation policy, which has been considered
for years, have said buying drugs from another country could
help lower costs in the United States. 
    The pharmaceutical industry has opposed the plans and said
it will not lead to lower costs for consumers and put the safety
of the U.S. drug supply at risk. 
    The industry's major lobbying organization, the
Pharmaceutical Research and Manufacturers of America (PhRMA),
said it was "deeply concerned with the FDA's reckless decision
to approve Florida's state importation plan" and considering
"all options to prevent the policy from harming patients." 
    "The importation of unapproved medicines, whether from
Canada or elsewhere in the world, poses a serious danger to
public health," PhRMA CEO Stephen Ubl said in an emailed
statement. 
    Former U.S. President Donald Trump in 2020 finalized a plan
that included a measure allowing states to submit import
proposals to the FDA. The Biden administration subsequently
followed with an order for the FDA to work with states on the
plans. 
    The regulator said on Friday it was committed to working
with other states seeking to gain similar approvals. 
    FDA Commissioner Robert Califf said proposals from other
states "must demonstrate the programs would result in
significant cost savings to consumers without adding risk of
exposure to unsafe or ineffective drugs." 
    Before Florida can import drugs, it needs to submit more
drug-specific information for the FDA's review and approval, and
evidence that the drugs it seeks to import have been tested to
comply with FDA's standards, the agency said. 
    Florida's administration will also be required to submit a
quarterly report that includes information about the imported
drugs, cost savings and any potential safety and quality issues,
the FDA said.     

    

 (Reporting by Khushi Mandowara in Bengaluru; Editing by
Shinjini Ganguli)
 ((Khushi.Mandowara@thomsonreuters.com;))