DeSantis announces lawsuit over Canada drug import delays from FDA

LAKELAND, Fla. (WFLA) — Gov. Ron DeSantis spoke in Lakeland at LifeScience Logistics Distribution Center. Signage at the event read “Lower Drug Prices.” The governor was in Lakeland to discuss efforts to provide access to lower cost medication to Florida residents.

DeSantis said the Florida effort to get cheaper medications predated “Bidenflation” and that the high costs pinched not only patients but the state budget as well.

“Now you see, particularly over the last year and a half, you’ve seen big increases in groceries, big increases in energy, utilities, rent, all of these different things with the Bidenflation,” DeSantis said. “I think that drugs, and being able to give some relief there, now more than ever is something very important.”

The governor said it was a goal of his since first taking office, even when Donald Trump was president. He said the state’s options were limited.

“A lot of this is controlled by the federal government, obviously big Pharma is very powerful in Congress and with different people in Washington, and they’re able to structure this a lot of times in ways that benefit them over the average American,” DeSantis said. “We found there was a provision of a law from 2003 that said states could apply to HHS to purchase drugs from Canada.”

DeSantis said they were the same drugs bought in America but they were “80% cheaper” in countries like Canada.

“It’s all because basically American consumers underwrite the entire pharmaceutical industry, they basically get cheaper prices everywhere else outside the United States, and then we basically fund all of the research and development for everything that goes into producing these,” DeSantis said. The governor said the state had wanted to make use of the 2003 provision, and that in 2019 he had met with President Trump, and staff at the U.S. Department of Health and Human Services, but had gotten some pushback.

“They were saying no, no, no, and tried to say it was a safety issue. But you know, people use drugs in Canada, this isn’t Djibouti, it’s a safe country,” DeSantis said. “You can get drugs, and do. It does involve relabeling and making sure everything is accurate, and making sure they’re bonafide and not counterfeit, but it’s attainable.”

DeSantis said Trump ended up approving of the idea, but the application had not been approved officially at the end of 2020, and that now under President Biden, the application has remained stalled.

“He actually said last summer, he signed an executive order saying that he wants to approve these plans for states,” DeSantis said. “I think he did that in like June or July of 2021. But here we are now, our application has been, we were the first state to do this, other states have followed Florida’s model, it’s just been sitting at FDA for months and months and months, probably over a year, a year and a half. And no action. Biden is saying he wants this for consumers, but yet his administration is not willing to act to be able approve this, so people have access to more affordable pharmaceuticals.”

The governor said when Biden had signed the executive order, the state had hoped for progress on the application, and to get an answer, but had yet to see any and that meeting with Food and Drug Administration staff was frustrating and difficult.

“After 630 days, we still sit here waiting here for an answer,” DeSantis said. “It’s our view that we have waited long enough, so today we are taking action. The state of Florida has filed a lawsuit against the FDA, they have unlawfully withheld and delayed approval of Florida’s program, and we think this violates federal law, so we are asking a federal judge to order the FDA to end the delay and approve Florida’s program.”

The lawsuit, according to DeSantis, includes violations of the federal Freedom of Information Act, saying that despite the long time waiting for a response to the FOIA request, no answers were forthcoming.

“You won’t be too surprised, we still have not received a response to our request. So the clock’s been ticking. We have a right to know what the FDA has been doing the last two years,” DeSantis said. “Are they putting politics over patients, are they putting the interests of big Pharma over average Floridians, over taxpayers? That’s what we need to find out.”

He said they were at LifeScience because it was a distribution center and that it was “a turnkey” and it was ready to perform the service, if the FDA approves the state’s application, saying it’s been “ready to go for a long time.”

DeSantis was joined in Lakeland by Attorney General Ashley Moody, Surgeon General Dr. Joseph Ladapo, and Agency for Health Care Administration Secretary Simone Marstiller, as well as multiple state legislators and residents affected by prescription drug prices.

“We think this is urgent, we think we deserve a response very quickly,” DeSantis said. “This is yet another way we are innovating and leading the country. No one was talking about this until we stepped forward, passed our legislation several years ago, submitted our plan, a very well thought out plan to the Trump administration, and have been waiting now under the Biden administration.” He said multiple states had followed suit. “I’d hate to think the Biden administration would not approve it just because it’s Florida, because it has issues with Florida, you know, politically. On issues like this, this would benefit people of all walks of life, regardless of any political persuasion. We just hope they’ll do the right thing.”

After the governor spoke, Moody discussed the legal effort.

“This is such an incredibly important issue,” Moody said, praising DeSantis’ efforts to improve the cost and access to medication for Floridians, calling him an innovator for progress for Florida. “As you heard him say, this law’s been on the books for a while. Why are we not doing this? The drugs are over 200% more costly to Americans when we can just get them at a cheaper savings from Canada. This seems like we would’ve figured this out before.”

Moody said DeSantis was a governor who “drills down” on the details, and that Floridians could save thousands of dollars per year if the imported drug plan is approved.

“Florida was the first” to file, “Right before Biden took office,” Moody said. “We’ve been waiting, and waiting, and waiting, and when he came out and said ‘This is important’ and demanded that the FDA work with the states to get this done, maybe he meant ‘except Florida?’ We were the first, we have all of our ducks in a row, we have all of our facilities, we’ve dedicated funding, we’re ready to help Floridians, because of this governor and great leadership in our legislature.”

Moody said she’d like to say it’s due to the application sitting on a desk, but “we all know this administration is not quick to act to get things done for Florida,” saying she was frustrated by how common this plea was becoming.

“Washington, Biden administration, do something!” Moody said. “Do something, on the border, do something. Stop fentanyl. Do something, lower prescription drug costs for Americans. Do something. It has become the do nothing administration.”

She told those gathered to compare the president to DeSantis, saying that the governor was more quick to act, rather than the “do-nothing” administration of Biden.

The surgeon general spoke next, talking about the “interesting issue” that he said overlapped with other topics spoken about with the governor.

“The facts are clear,” Ladapo said. “I have the Department of Health, we have county health departments, we prescribe medications for diabetes, for COPD, for asthma, for HIV, for other chronic conditions. Florida went through the process, first took the initiative of this 20 year old law, that provides this much room that allows states to be able to get drugs from Canada for lower prices, and it’s this narrow, that’s why it took 20 years and a governor who actually cares about people and about what he thinks matters, to take it up and move it forward.”

Ladapo said Florida took a detailed plan for how to enact the provision and import drugs, chemically analyze them to ensure they’re not counterfeit and that the drugs are safe and distributed only within Florida.

“I looked at this report, it’s like 200 pages long or something, it’s very detailed, and all of these pieces are in place, we start the process under the governor’s leadership,” Ladapo said. “And almost two years later, the FDA has not responded to our request to move forward. And what’s behind this? I will tell what I think is behind this, based on my assessment of the evidence. The pharmaceutical industry is going to do what they do. What they do is they lobby for laws that keep their profits as high as possible. It’s not about you and me, sick people, that’s not what it’s about. Lobbying for laws that keep their profits high, that’s how they’ve behaved.”

Ladapo said leaders in the federal government and the Biden administration have put industry interests over the needs of Americans by keeping costs up. After the surgeon general, Sec. Marstiller spoke.

“All we’ve gotten,” from the FDA, Marstiller said, “is word salad. Bureaucracy, stonewalling, stiff-arming, and stall tactics. This thing has been sitting on somebody’s desk for well over 600 days. This is not what government is supposed to do. Government is supposed to serve you.”

She said they are “here to do what is right for the state of Florida,” and was “appalled” that Florida had to sue the FDA for it to do its job.

“We know there are reasons for this, be they political, be they corporate, whatever the case may be, we don’t have time for that,” Marstiller said. “Gov. DeSantis has been steadfast in developing healthcare policy that is good for the state of Florida, and if other states follow his lead, good for the entire country. We know that we need in healthcare today is transparency, some aspect of consumerism, we need to disrupt the process in the industry.”

Marstiller said in addition to the Canadian import program, the state wanted to also “not rest” until look at pharmacy benefit managers, the “middlemen” between doctors and pharmacies that were adding to costs to consumers for prescription drugs.

DeSantis returned to the podium after Marstiller. He said pricing was an intentional issue, that policies over the years have brought Americans to the current situation, with laws “designed to artificially keep your profits high,” in a way that “wasn’t free market.”

Then he introduced a patient to speak about drug pricing issues.

Bob Lavallee, a Navy veteran from Marion County, spoke about the medical needs of himself and his wife, and how high prices and some work related misfortune had put their health needs potentially in jeopardy.

“I’m 69 years old, my wife is 65, and we both have life-saving medicines that we need,” Lavallee said. “In 2015, I suffered a stroke. By the grace of God and my doctors, I’m okay, except for a little bit of word stuff. I have to have a medicine called Eliquis, and my wife has to have a medicine called Advair. And next month, I will be making a decision, because next month I’m going to have to have a refill for 90-days supply, that I’ve been using since 2015. The cost of this medicine is going to be about north of $500 for a 90-day supply. My wife is going, it’s going to cost, the Advair, north of $300 for a 90-day supply. I used to work, after the stroke I was okay and I could work, I was able to supplement the food and the medicine. Due to unfortunate circumstances, I lost my job, therefore I lost my income, therefore I lost means to get the medicine. This next month in September, we’re going to have to decide, either it’s going to be medicine or food.”

Lavallee stopped briefly.

“It’s a big decision, we have to do it, or we’re not going to be able to pay our bills,” Lavallee said. “I just want you to know that I really appreciate the governor and all that’s involved for doing this. It’s going to be a lifesaver in itself. So please support whatever you can to this effort, and I really really really appreciate it from the bottom of my heart.”

DeSantis spoke again, saying that those stories were not uncommon.

“If he and his wife were just in one of these other countries, this wouldn’t be a problem,” DeSantis said. “The crunch is really, just in our country, because of the way these laws are. We’re doing our part.”

DeSantis said they were working to provide relief to the people of Florida, and that while he had told people it wouldn’t happen overnight, he didn’t anticipate having an administration in Washington that delayed for months even when they say they’re supportive.

During a subsequent question and answer session, DeSantis spoke about members of Congress, and how the law had already existed. The state was exploiting the provision to help Floridians, and that members of U.S. Congress should do things in the interest of the people, not to help the pharmaceutical industry. While research is necessary for advancement and improvement, DeSantis said “I think that that could be done in a way that’s not putting almost the entire burden of that on American consumers and patients.”

He said it was obvious that the current Congress wouldn’t fix the problem.

“You wonder. I mean drug prices have gone on for so long. Pelosi’s been in office for 30 years, I mean she’s a great example of why we need term limits for members of Congress,” DeSantis said. “But I do think there’s more of a window now, because I think a lot of people have seen how Big Pharma has handled these COVID vaxxes, and you know there was a push to get them out and I get that, but there hasn’t been a push for transparency that I think consumers deserve when it comes to this.”

The governor said Ladapo was looking at transparency issues with pharmaceuticals and studies into myocarditis risks for young men who take the COVID-19 vaccines. He, as at a previous event, criticized the banning of Djokovic from tennis competitions over his lack of vaccination, even though he had already contracted and recovered from the virus.

“When you combine a lack of transparency with the heavy hand of government, I think that caused a lot of people to say ‘whoa, what is this all about?'” DeSantis said. “I’m happy in Florida. From the very beginning, we said that there would be no mandates. We made sure that school districts couldn’t mandate it on students to go,” and mentioned how in the District of Columbia, vaccination mandates for schools had been postponed until January to, in his words, avoid affecting November’s elections, and saying they wanted to “push jabs on six-month-old babies.”

The Q&A continued, with Ladapo, Moody, and Marstiller answering questions on drug prices, the state’s examination process for the drug price data, and other efforts and rules regarding what medications could be included in the import program, once approved.

Then DeSantis answered a question about the arrests for felons who could not vote, voting and then being arrested for voter fraud in the 2020 election.

“At the end of the day, there are issues with ‘have you completed the terms of your sentence, have you paid the restitution, any fines and fees,’ that is required, that can be an issue,” DeSantis said. “But on the 20 arrests we did, those are people who are categorically ineligible to vote. Those are people who have been convicted of sex assault, and people who have been convicted of homicide. There has never been any law or constitutional amendment enacted in Florida that provides them with the right to vote.”

DeSantis said those convicts could apply for clemency, but they would not get a very “good hearing from” himself or the attorney general, but the right to apply for clemency is available. None of the arrested individuals had applied, according to the governor.

He said under no circumstances were convicted rapists or murderers allowed to vote in Florida.

On the topic of penalties to doctors who say things that state governments determine to be “misinformation,” DeSantis said policies of that nature in places like California were wrong. He referred back to how he’d been accused of COVID-19 misinformation during the state’s policy changes to reopen schools and businesses during the pandemic.

DeSantis accused some government agencies of putting out misinformation for saying vaccines would fully prevent COVID infection and later being proven wrong, while “pillorying” doctors who disagreed, like Ladapo.

“They dissented from the medical establishment, and they were pilloried. I mean Joe has been attacked,” DeSantis said about Ladapo. “It cuts against orthodoxy, it cuts against the narrative, they’re going to come after you. He doesn’t care, he’s fine to do that. What we’re going to do though, and we should have done in the last legislative session, we had some hiccups with a couple of people in the legislature, but we’re going to do the opposite of California. Not only are we going to not do things where someone get penalized for what the government says is misinformation, but we’re going to protect people’s right to practice with evidence-based medicine. Just because some woke association is saying one thing doesn’t mean that you are bound by that when you have the evidence and the data supporting you on the other side.”

A final question DeSantis responded to was regarding vaccination safety and fraud over how the vaccines were promoted.

“It’s one thing if you say, you know, it’s experimental, emergency use, no mandate but if you wanna take it,” DeSantis said. “But I do think there were people making these representations saying ‘oh no, pregnant women it’s fine, we know it’s safe,’ and they really didn’t know that. So, they’re saying these things and anyone that had any concerns would basically be telling, you know you’re anti-science, but this thing hadn’t been around long enough to really know. It’s one thing to say ‘hey we’re in a pandemic, let’s just make this available, we don’t necessarily know every answer.’ But they went beyond that, higher-ups said it’s been conclusively proven…”

DeSantis brought Ladapo back up to the podium to discuss it, mentioning studies to do with vaccine effect on menstrual cycles during COVID-19.

“As a scientist, I struggle with this, because I went into medicine, I felt it was a noble profession,” Ladapo said. “There have been a lot of things that have not been noble done by my profession, wittingly or unwittingly, over the last two years. One of these things the governor brought up, menstrual cycles. Pardon me, I don’t have menstrual cycles. But you know, menstrual cycles as an example, that’s an example, that many women noted after taking the mRNA vaccine, noted a change in. You know, you remember early on, anytime someone said something, they had a chest pain or a fever or they couldn’t go back to work the next day, it was always pushed away, silenced, or dismissed. It hasn’t been acknowledged. Even in its acknowledgement, it’s been minimized. The official response now from NIH is that ‘yes it can happen,’ but the menstrual cycles return to normal usually after one or two months, it’s fine. But anyone after who said ‘But why is it changing’ is…why is the administration of this vaccine leading to menstrual changes.”

Ladapo said there were a “number of adverse events” that have not yet been investigated, and have been minimized by health authorities. He said DeSantis had “given him some latitude to pry” into the different health questions about the safety of vaccines.

Regarding criminal investigations of potential fraud, Moody said part of her job included educating about where to submit information about potential criminal activity should be given to the Florida Department of Law Enforcement.

She said that while there are investigators to look at false or deceptive or fraudulent statements about consumer products, they do operate in some civil settings to address those needs.

News Channel 8 reached out to the Biden Administration for comment but we have not yet heard back.