DeSantis Sues FDA to Get Cheaper Drugs from Canada

Florida Gov. Ron DeSantis announced a lawsuit against U.S. Food and Drug Administration saying that they had not complied with a public-records request about the state’s proposed program to import cheaper prescription drugs from Canada.

The lawsuit was filed in federal court in Tampa, and on Wednesday, DeSantis made the formal announcement at a press conference in Lakeland.

The lawsuit came after state Agency for Health Care Administration Secretary Simone Marstiller submitted a Freedom of Information Act request on July 6 seeking numerous records about drug-importation proposals by Florida and other states.

“Big Pharma is very powerful in Congress and with different people in Washington. And so, they’re able to structure this a lot of times in ways that benefit them over the average American,” said DeSantis. “We found there was a provision of law from 2003 that said states could apply to HHS to purchase drugs from Canada, and these are the same drugs that you purchase here.”

“They’re just 80% cheaper or 75% cheaper,” said DeSantis.

At least initially, the state wants to import drugs to treat conditions such as HIV and AIDS, hepatitis C, diabetes, and mental illness, according to the lawsuit.

FDA officials would need to approve the importation program, and the state submitted a proposal in November 2020, the lawsuit said. The proposal has remained pending, with the state saying it has not received a timeline for a decision.

“We’re asking a federal judge to order the FDA to put an end to that delay, and to approve Florida’s program included in the lawsuit or claims,” said DeSantis. “I’d hate to think that, you know, the Biden administration would not approve it just because it’s Florida, because they have issues, with Florida politically.”

Former President Donald Trump’s administration approved a rule in 2020 to help clear the way for imports, but groups including the Pharmaceutical Research & Manufacturers of America launched a legal challenge that remains unresolved in federal court in Washington.

Marstiller’s July 6 request, in part, sought FDA records related to importation proposals by Florida, Colorado, New Mexico, New Hampshire, Vermont, and Maine.

Other examples from the request include records “relating to the Canadian drug importation program and private pharmaceutical stakeholders, including pharmaceutical companies, lobbying groups, and advocacy groups;” records about standards for laboratory testing; and records “relating to the ‘risk’ to the American public’s health and safety.”

Marstiller’s request, which was filed as an exhibit to the lawsuit, said the “records will shed light on the role of the FDA in implementing a program of great interest and importance to the people of Florida. The availability of essential, low-cost drugs is a matter of great public interest and concern in Florida and across America, especially because many vulnerable citizens need these drugs but cannot afford to pay for them. Moreover, the need for this information is urgent. Outpatient prescription drug prices have increased exponentially and continue to rise.”

The lawsuit briefly described steps Florida has taken to carry out the program but said it remains “stuck in the starting blocks” while waiting for an FDA decision.

“Florida is ready, willing, and able to begin operating the program immediately, having already built a refrigerated distribution facility and procured an approved importer and distributor currently being paid $1.2 million per month,” the lawsuit said.

“We’re ready to help Floridians because of this governor and the great leadership in our legislature,” said Florida Attorney General Ashley Moody. “This is the ‘get it done administration’ and compare that to the Washington and Biden.”

“(This is a) do nothing administration. And it is unfortunate that we are now a year and eight months into the administration, and we are now having to file suit to get them to do something. An agency of the administration cannot just sit on applications. They have to act with reasonable timeliness. They can’t unreasonably delay and it is sad again that we as Florida have had to bring suit against our own government in Washington to get them to do something.”

Reporting from The Free Press.