“Florida has proven that [the drug importation plan] significantly reduce the cost of [drugs] can be made available to U.S. consumers without posing additional risks to the public health and safety,” the FDA said in its report.
Letter approving the Florida Plan.
Before importing drugs, the Florida Department of Health Services must submit certain 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 warning from former FDA leaders, including Biden's current FDA chief, that importing drugs is a “dangerous approach” that is “likely to harm patients.” It was conducted.
In 2017, FDA Commissioner Robert Califf and three former FDA leaders, Margaret Hamburg, Mark McClellan, and Andrew von Eschenbach. told parliament Such efforts could “undermine U.S. confidence in a system that has proven to be highly successful in ensuring drug safety.”
President Joe Biden has increasingly touted his administration's efforts to lower prescription drug prices in recent months, highlighting implementation of the first-ever Medicare drug price negotiations and other anti-inflation law policies at a number of events. There is.
“For too long, Americans have been forced to pay some of the highest prescription drug prices of any industrialized nation in the world,” White House press secretary Kelly Scully said in a statement. “Today's FDA action is a step in the right direction that could help other states apply for import plans.”
Pharmaceutical companies objected: The pharmaceutical industry is expected to sue to block drug imports from Canada, which it says poses a “significant risk to public health.”
Asked whether the industry group would file a lawsuit, PhRMA spokeswoman Nicole Longo said, “As always, we consider all options when a policy is passed, and we will do so again.” Stated.
Another citizen petition from PhRMA seeking to block Florida's plan to import drugs from Canada is expected to be denied on Friday, according to a government official granted anonymity to discuss the FDA's plan.
“We are deeply concerned about FDA's reckless decision to approve Florida's import plan,” PhRMA CEO Stephen Uble said in a statement. “Ensuring patients have access to the medicines they need is important, but the importation of unapproved medicines, whether from Canada or elsewhere in the world, poses a serious risk to public health. .”
What's next: Khalif said his agency works with states and American Indian tribes that want to implement drug importation programs.
“These proposals must demonstrate that the program provides significant cost savings to consumers without increasing the risk of exposure to unsafe or ineffective drugs,” Khalif said in a press release.
Colorado is working on a similar application with the FDA, a government official said.
“Colorado is in the process, but it's even further behind than Florida,” the official said. “New Hampshire, they're on pause, but others are interested.”
In Florida, the state's application for drug imports from Canada has been a top priority for DeSantis, who ultimately pushed former President Donald Trump to give final approval to enact a federal plan in 2020. I worked hard. DeSantis also slammed the Biden administration for not approving the state's plan. He filed earlier and even sued the FDA for records related to the decision-making process.
