The FDA has also allowed Biden to use the Defense Production Act to address drug shortages. The Food and Drug Administration on Friday approved Florida’s plan to import drugs from Canada, a major blow to drugmakers who have warned that counterfeit drugs could be introduced into the U.S. supply chain and put patients at risk. could cause losses, and those who may see their income affected.
The decision is a major victory for Florida Governor Ron DeSantis, who wanted to make his state the first to import affordable prescription drugs. The state submitted its application with the FDA more than three years ago, and DeSantis, who is competing for the Republican presidential nomination, blames the Biden administration for the long wait.
“I missed a few calls, so maybe that’s what it was about,” said DeSantis, who predicted the program would save the state millions of dollars if implemented. He told reporters on the campaign trail in Iowa that the Biden administration “fought us on this for a really long time.” We felt we were in the right as far as the law is concerned, so we moved ahead.”
The FDA said in its letter authorizing the Florida plan, “Florida has demonstrated that [the drug importation plan] will significantly reduce the cost of [drugs] for US consumers without posing additional risks to the public’s health and safety.” Will give.”
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Before drugs can be imported, Florida’s Agency for Health Care Administration must submit specific drugs to the FDA for review and approval and ensure that they have been tested for authenticity and safety.
The decision comes despite years of warnings from former FDA leaders — including Biden’s current FDA chief — that drug importation is a “risky approach” that is “likely to harm patients.”
In 2017, FDA Commissioner Robert Califf and three former agency leaders – Margaret Hamburg, Mark McClellan and Andrew von Eschenbach – told Congress that such an effort “could undermine American confidence in what has proven to be a highly successful system for ensuring drug safety.” Is.”
President Joe Biden has praised his administration’s efforts to lower prescription drug prices in recent months, at several events highlighting Medicare drug price negotiations for the first time and the implementation of other Inflation Reduction Act policies.
“For too long, Americans have been forced to pay the highest prices for prescription drugs of any developed country in the world,” said White House spokeswoman Kelly Sculley. “Today’s FDA action is a step in the right direction that can help other states apply for importation plans.”
Pharma protests: The pharmaceutical industry is expected to sue to block drug imports from Canada – a policy it argues poses a “serious risk to public health.”
When asked if the trade group would sue, PhRMA spokeswoman Nicole Longo said, “As always when a policy is passed we consider all of our options, so we would do so again.”
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A separate civil petition from PhRMA seeking to block Florida’s plan to import drugs from Canada was rejected Friday, according to a senior administration official who granted anonymity to discuss the FDA’s plans. Will go.
“We are deeply concerned by the FDA’s reckless decision to approve Florida’s state importation plan,” PhRMA CEO Stephen Uble said in a statement. “Ensuring patients have access to essential medicines is important, but the importation of unapproved medicines, whether from Canada or elsewhere in the world, poses a serious threat to public health.”
“These proposals must demonstrate that the programs will result in significant cost savings without putting consumers at risk of exposure to unsafe or ineffective drugs,” Califf said in a press release. Colorado is working with the FDA on a similar application, according to a senior administration official.
“Colorado is in that process, but they’re farther behind Florida,” the senior administration official said. “New Hampshire, they’re on pause, others have expressed interest.”
In Florida, the state’s application to import drugs from Canada has been a top priority for DeSantis, who ultimately lobbied former President Donald Trump heavily to grant final authorization to enact the federal program in 2020. DeSantis also attacked the Biden administration for not approving the state’s proposal. Expedited applications, even suing the FDA for records related to the decision-making process.
