Florida Sues the FDA over Lack of Response on Program to Lower Drug Prices

The state of Florida is suing the Food and Drug Administration (FDA) over records requests regarding a program designed to import cheaper drugs from Canada.

The lawsuit, filed Monday, followed the agency’s failure to properly respond to a July 6 Freedom of Information Act request and overall delay in reviewing the request for the program.

“FOIA (the Freedom of Information Act) requires the FDA (Food and Drug Administration) to process records requests and promptly provide the requested records or the reasonably segregable portion of records not subject to a FOIA exemption,” the lawsuit reads in part, explaining that the agency “has neither provided AHCA (the Agency for Health Care Administration) any responsive documents in response to its request, nor has the FDA claimed that any responsive records are exempt from disclosure.”

“Therefore, the FDA’s failure to produce requested records or claim applicable exemptions violates FOIA,” it states.

Gov. Ron DeSantis (R), flanked by other prominent state officials including state Attorney General Ashley Moody, said on Wednesday that lowering prescription drug prices has remained a priority of his administration since taking office.

The DeSantis administration filed a lawsuit in Tampa federal court claiming the U.S. Food and Drug Administration has not complied with a public-records request about the state’s proposed program to import cheaper prescription drugs from Canada.https://t.co/x0L9esmJbP

— WUSF (@wusf) August 31, 2022

“This was something that continues to really pinch people’s budgets, and it pinches the state of Florida’s budget because in our programs, when we do with health programs, it causes the cost of those to go up dramatically,” he said, explaining that Bidenflation is not helping.

“I think the drugs and being able to give some relief there now more than ever is something that’s very, very important. But back in 2019, my first year in office, we wanted to find ways, so we’re limited as the state because a lot of this is controlled by the federal government,” he explained.

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“We found there was a provision of the law from 2003 that said states could apply to HHS to purchase drugs from Canada. And so these are the same drugs that you purchase here, they’re just like you know 80 percent cheaper or 75 percent cheaper,” he said:

And it’s all because you know, basically American consumers underwrite the entire pharmaceutical industry. They get cheaper prices everywhere else outside the United States and then we basically fund all the research and development and everything that goes into producing these. And so it’s definitely inequitable and so we said if we can use this program and be able to contract — even if we just started with state agencies contracting —  we’d be able to save you know $100 million, 200 million for taxpayers and then obviously, you know that will trickle down to consumers and we would be able to expand this. So I went up to Washington, I met with President Trump. I told them this is something that’s really good and a lot of people were telling them no because you had–  pharma doesn’t like it.

Despite that, Trump approved and the legislature passed a law “saying Florida needs to develop a plan”:

We created this this plan and it took it took a long time to be able to get that just right. We sent it up to Washington during the Trump administration for approval from the FDA. So this was in the latter part of 2020, almost two years ago that they’ve had this. … So after 630 days, you know, we still sit here waiting for an answer, and so it’s our view that we’ve waited long enough.

“And so today we’re taking action, the state of Florida has now filed a lawsuit against the FDA. They have unlawfully withheld and unreasonably delayed approval of Florida’s program, and we think this violates federal law,” he said, explaining that they are 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 claims under the Federal Freedom of Information Act.”

“Are they putting the interests of big pharma over the interest of average Floridians and taxpayers?” DeSantis said of the FDA. “And that’s what we need to find out. So we’ve been continuing to push for transparency.”