On Friday, the Food and Drug Administration gave the green light to Florida’s proposal to import drugs from Canada. This decision is a significant setback for pharmaceutical companies, who have expressed concerns about the potential for counterfeit medications entering the U.S. market and causing harm to patients. These companies may also experience financial consequences as a result of this approval.

The ruling is a significant victory for Florida’s Governor Ron DeSantis, as he aimed to establish his state as the first to bring in lower-cost prescription medications. The application was filed with the FDA over three years ago, and DeSantis, who is running for the Republican nomination for President, holds the Biden administration responsible for the lengthy delay.

DeSantis stated that he did not answer some phone calls, which could have been related to the topic at hand. He also expressed confidence that the state will see significant cost savings once the program is put into action. While on the campaign trail in Iowa, he informed reporters that the Biden administration had opposed the program for a considerable amount of time. However, he believed that the state was following the law and therefore continued to move forward.

The FDA declared in its letter approving the Florida plan that it will effectively lower the price of drugs for American consumers without compromising their health and safety.

Prior to importing drugs, Florida’s Agency for Health Care Administration must send particular medications to the FDA for evaluation and authorization. They must also verify that the drugs have been tested for legitimacy and safety.

Despite being cautioned by previous leaders of the FDA, including the current chief appointed by Biden, the decision was made to proceed with drug importation, a method deemed “risky” and potentially harmful to patients.

joined forces to launch a new independent, nonpartisan initiative called the Reagan-Udall Foundation.

In 2017, four individuals, including FDA Commissioner Robert Califf and three former agency leaders, Margaret Hamburg, Mark McClellan, and Andrew Von Eschenbach, collaborated to establish the Reagan-Udall Foundation. This initiative is independent and nonpartisan. told Congress

This action could potentially damage the trust of Americans in a well-established system that has effectively ensured the safety of pharmaceuticals.

In recent months, President Joe Biden has been emphasizing his administration’s actions to decrease the cost of prescription drugs. He has highlighted the introduction of Medicare drug price negotiations and other policies under the Inflation Reduction Act at various events.

Kelly Scully, spokesperson for the White House, stated that Americans have been paying excessively high prices for prescription drugs compared to other developed countries. She believes that the recent action taken by the FDA is a positive move that could potentially allow other states to implement importation plans.

The pharmaceutical sector is anticipated to take legal action in order to prevent the importation of drugs from Canada. They claim that this policy presents a significant threat to public health.

When asked if the trade group would file a lawsuit, PhRMA spokesperson Nicole Longo stated that they will once again carefully consider all possible courses of action, as they always do when a policy is implemented.

According to an anonymous senior administration official, a citizen petition submitted by PhRMA to prevent Florida from importing drugs from Canada will be rejected on Friday.

“We strongly object to the FDA’s irresponsible approval of Florida’s state importation plan,” stated Stephen Ubl, CEO of PhRMA. “While it is crucial for patients to have access to necessary medications, the importation of unapproved drugs, whether from Canada or any other country, presents a significant threat to public health.”

In the future, Califf stated that his agency will collaborate with states and American Indian tribes interested in implementing programs for importing drugs.

In a press release, Califf stated that these proposals need to show that the programs will lead to noticeable cost reductions for consumers and will not increase the likelihood of being exposed to dangerous or ineffective medications.

According to a high-ranking member of the administration, Colorado is collaborating with the FDA on a comparable submission.

According to a senior member of the administration, Colorado is currently going through that process, but they are not as far along as Florida. New Hampshire has temporarily stopped, while other states have shown interest.

Florida’s governor, DeSantis, has made it a major goal to import drugs from Canada. He strongly urged former President Trump to authorize the federal program in 2020. DeSantis has been critical of the Biden administration for not approving the state’s application faster and even took legal action against the FDA for information on their decision-making process.

This report was contributed to by Gary Fineout.