
FDA Approves Florida’s Drug Importation Plan
1/19/2024 | 26m 46sVideo has Closed Captions
Canada raises concerns over Florida’s approved plan to import lower-cost medications.
The U.S. Food and Drug Administration approves a Florida program allowing the state to import certain prescription medicines from Canada to help reduce costs for consumers. But Canada says the move could negatively impact its own supply of pharmaceuticals. Plus, lawmakers debate ways to add capacity to Florida’s health care industry whilst ruling out Medicaid expansion in the state.
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NewsNight is a local public television program presented by WUCF

FDA Approves Florida’s Drug Importation Plan
1/19/2024 | 26m 46sVideo has Closed Captions
The U.S. Food and Drug Administration approves a Florida program allowing the state to import certain prescription medicines from Canada to help reduce costs for consumers. But Canada says the move could negatively impact its own supply of pharmaceuticals. Plus, lawmakers debate ways to add capacity to Florida’s health care industry whilst ruling out Medicaid expansion in the state.
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Learn Moreabout PBS online sponsorship>>This week on NewsNight, the US Food and Drug Administration greenlights a Florida program allowing the importation of prescription medicines from Canada.
Plus, lawmakers debate ways to add capacity to Florida's health care industry but rule out Medicaid expansion.
NewsNight starts now.
[MUSIC] Hello, I'm Steve Mort, and welcome to NewsNight where we take an in-depth look at the top stories and issues in central Florida and how they affect all of us.
We'll come to our main discussion in a moment.
But first, we wanted to mention the big political news of the week.
A reminder, we are recording the show on Thursday morning so things can change by airtime.
In the Iowa caucuses Donald Trump scored a runaway victory with Governor DeSantis placing a distant second round 30 points back just ahead of Nikki Haley and in the Florida House District 35 special election, the Democrats flipped the district from the Republicans.
I asked UCF political scientist Aubrey Jewett about both developments.
>>Usually finishing second in Iowa wouldn't be that bad, honestly, because Iowa, on the Republican side in particular, doesn't have a great track record of predicting not only who's going to get the nomination, but is actually going to win the presidency.
But otherwise, by traditional metrics, no, I don't think that DeSantis has a great shot.
But what does he have a possibility of if something happens to Trump?
Right.
There's these four different legal battles.
Maybe one or two of them actually proceed to trial.
Maybe Trump is found guilty of something maybe that really finally shakes up the race and convinces enough Republicans that they just even if they really like Trump, that he's not the person that could win.
So I think for that's realistically, DeSantis' only hope that he becomes the possible nominee.
>>Another big political development I wanted to talk about here in central Florida is Democrat Tom Kean's win in the Florida House District 35 special election, flipping the district from the Republicans despite a voter registration advantage for the GOP is this, as Florida Democratic Party Chair Nikki Fried suggests, another big loss for governor DeSantis?
>>I don't know that it's a big defeat for DeSantis, but it is a victory for the Democrats.
And the fact is, Democrats really, they got a great candidate.
They raised a lot of money and they were able to win a seat that Republicans held before and that's what they need to do.
I mean, before Democrats can start talking about upsets and these sorts of things, they need to actually win the competitive seats that they actually should be able to win if they really tried hard and everything goes their way.
And that's what happened this time.
So it does give Democrats some hope and perhaps will mobilize some other Democrats coming up in the 2024 elections, regular elections.
>>Aubrey Jewett there.
You can find our full conversation on our website.
It's all at wucf.org/newsnight.
Next tonight, the health care industry in Florida, starting with the importation of prescription drugs.
Early this month, the FDA approved a state plan to bring in certain medications from Canada, where drug prices are significantly lower than in the United States.
It's the first time the federal government has given approval to such a program.
After President Biden urged health officials to support state level importation efforts.
I spoke about the issue with Philip Galewitz.
A senior correspondent with KFF Health News.
>>Over 20 years ago, Congress passed a law that would allow us to break to import drugs from Canada, but only if the Health and Human Services Secretary certified that it could be done safely.
At the very end of the Trump administration in 2020, HHS Secretary Alex Azar made that certification.
It fell to Biden.
Biden didn't make any decisions until just now.
So the Biden administration hasn't really been rushing to do this.
But but now they have.
>>What's the position of the pharmaceutical companies here?
>>The drug industry opposes this.
They believe that if people import drugs from overseas, that that opens the door to bringing counterfeit drugs.
Other people look at that argument and raise their eyebrows, say that's a red herring and believe that the real reason the drug industry doesn't want this is because this would lower their profits.
>>Will consumers see a difference?
>>It's not going to help the average Joe walk into a pharmacy and buy a lower priced drug.
The plan Florida was they they want to initially help out their state agencies which buy drugs to help people corrections.
This would also at some point help the Medicaid program.
The state health departments its initially helped to save the money for the state agencies.
The money they spent on drugs.
>>Phil Galewitz there from KFF Health News.
Well, let's bring in our panel now to break it all down.
Joining us in the studio this week, Caroline Catherman for the first time from the Orlando Sentinel.
Thanks so much for coming in, Caroline.
>>Yeah, thanks for having me.
>>Joe Mario Pedersen covers health for 90.7 WMFE News.
Thanks for being here.
>>Glad to be here.
>>And Beth Kassab, editor of The Winter Park Voice, once again, thanks for being here, Beth.
>>Always good to be here.
>>Good to see you guys here today.
Caroline, let me start with you on this one, if I could.
What do we know about why the Biden administration kind of changed tack here?
Right.
They'd been kind of dragging their feet a little bit on on approving a program like this.
Why did they go ahead and do it in the end?
>>Yeah.
So Biden has said, you know, since he was elected to office that his priority is lowering drug prices because the US obviously has prescription drug prices way higher than most countries.
I know that in I think in 2020 or 2021 he did.
He expressed support for a Canada importation plan, but like you said, has sort of been dragging his feet in terms of actually approving Florida.
The FDA said that was because there were just a few parts of Florida's plan that they wanted more specificity on some tweaks to.
DeSantis, though, obviously sued and, you know, sort of is alleging some sort of ulterior motive.
But, you know, they finally did approve it.
And the rationale, obviously, behind approving it is lowering drug prices for, you know, Floridians and the state.
>>Joe Mario, the governor says that this could save consumers about $150 million in the first year.
Do we know much about how consumers will experience this?
>>So, you know, looking at it, supporters say that they estimate that this will have two different kinds of effects.
And the first being, like Caroline said, that, you know, introducing competition, introducing more generics into the market should drive down prices hypothetically.
Right.
But the other thing that it accomplishes is by introducing these generics and that competition, there is a hope that it will demystify this idea that drugs that are made here in the country have a higher quality and therefore are of a higher price.
>>They're often the same drugs, right, manufactured by the same companies?
>>Yes, very much so.
So they want to bring light to that as well.
Again, demystifying that.
>>I mean, Beth what about some of the hurdles here?
I mean, presumably I mean, this is the government.
It's prescription drugs.
There's going to be a lot of hoops and regulations that Florida's got to jump through.
It's not like they can just open the spigot and the drugs arrive from Canada, presumably.
>>Yeah, right.
So the press release came out and this long awaited decision.
But this is not going to be an overnight situation.
Florida does still have some hoops to jump through, as you said.
They've got to provide more information to the FDA about the specific drugs they want to import.
They also have to figure out a way to test the drugs, you know, the quality control that Joe Mario was alluding to.
And there's also some some kind of labeling hurdles, some bureaucratic stuff that they're going to have to work out.
>>I mean, essentially, I mean, individuals themselves have been for many years have been going to Canada to get prescription drugs.
This is just now state stepping into essentially the same thing.
There is a possibility of a of a legal challenge from the pharmaceutical industry.
And broadly, what's been the response of pharma to the FDA's approval?
>>So pharma has raised concerns about the safety and quality of drugs from Canada.
Now, the FDA has said these drugs are going to have to go through the same rigor of approval that drugs from the US would go through.
And they're going to have to be individually approved by the FDA.
But the pharmaceutical industry has alluded to the possibility of legal action, saying they are exploring avenues by which to challenge this decision.
So that might be something we see in the coming months.
>>Could this have an impact on Canada, though?
I mean, presumably this is going to have an impact on on on Canada's drug supply, right?
I mean, and is it is it is it so that they're even going to allow exports to happen?
>>Right.
So it's been widely reported so far that the reaction in Canada has not been positive.
There are already concerns there about drug shortages and accessibility for people who live in Canada.
And they're saying, hey, not so fast, Florida.
We have our own issues and we're not so sure we're on board with this plan.
So again, not an overnight fix.
And I think it's also important to keep in mind that even if all these hurdles are accomplished, the number of people who would take part in this is is pretty small.
We're talking about people on prescriptions, certain prescriptions who are getting care through state agencies.
>>Very interesting.
Well, we'll keep an eye on it all.
It could be a while before this starts to happen, but it'll be certainly something that we watch here on the program.
Meanwhile be sure to join the conversation on social media we're at WUCFTV on Facebook, X, and also on Instagram.
Okay.
Next tonight, some rare bipartisanship in Tallahassee.
Live Healthy, a package of bills championed by Senate President Kathleen Passidomo aims to give a shot in the arm to Florida's health care industry.
The voluminous bills making their way rapidly through the legislature include SB 7016, which aims to keep more doctors in the state and SB 7018, which would fund health innovation programs.
Both have companion legislation in the House, but despite bipartisan support, Democrats are also calling for Medicaid expansion in Florida.
While Republicans say that's not on the table.
>>There are over 800,000 uninsured Floridians who would gain access to health insurance and care through the expansion of Medicaid.
And expanding Medicaid would also mean that the state of Florida, over a five year period, would have access to $14.3 billion in federal money.
>>What's the point if you don't have enough health care providers, whether it's nurses, doctors, technicians, soup to nuts you, it doesn't mean anything.
And when was the last time you tried to get an appointment with your your primary care doctor, if you have one?
You know, six months, eight months, a year.
And a lot of these doctors don't take Medicaid.
So at this point, what we need to do is get our health care workers here to provide the health care that our citizens need.
>>Kathleen Passidomo there, before her Geraldine Thompson okay, Beth, let me come to you first on this one and before we get to what's in that that package that lawmakers are considering, what we know about Florida's existing infrastructure and its capacity to handle the growing population that we're seeing here.
>>Right.
So we do know that Florida's population is growing really rapidly.
It's already one of the biggest states in the country.
It's likely to hold that and eve We also know that there are shortages in the health care industry when it comes to certain types of providers.
Primary care physicians is is one of those.
I don't agree with the wait times we just heard from the Senate president.
That is not something that I have personally seen or heard a lot about from folks in terms of that length of time.
But there are some shortages.
We know that.
And so the workforce concerns are very real.
However, you know, there are pipelines in place, there are incentives in place.
And I think there are if you look at the industry situation, Medicaid expansion would make a huge difference financially and perhaps the large hospital systems, other big networks would be able to meet some of these demands through hiring.
>>I want to talk a little bit about Medicaid expansion in a moment.
But Joe Mario I mean, one of the interesting things watching these bills go through the committees is sort of the ideas that are in them.
And one of them that was sort of a little bit controversial in one of the committee hearings that I watched was this plan to allow some foreign trained physicians to to skip residency, to practice in Florida.
Tell us about that.
>>Yeah, it's the idea of bringing in foreign physicians from outside the country, bringing in-- >>To meet some of that demand.
Right.
>>Exactly.
Some of the shortages that Beth had actually brought up and a shortage that experts believe could be exacerbated by this aging medical population that we have.
Right.
There are studies that say that I think there is like 30 between 30 and 40% of medical staff physicians within Florida that are 60 years of age or older.
And about one in ten of them are planning on retiring in the next five years.
So we need some solutions.
This is possibly one of them.
Right.
So the idea here is to bring in these physicians.
They have to have, according to one of the proposals right now, is they have to have a medical license from whatever country they're coming from at least four years of practice.
And they would have needed to have completed their residency or post-grad in that country.
>>Well, how much is it going to cost?
Caroline?
I mean, do it do we have an idea about the numbers here and where that money's going?
>>The estimates right now are around $800 million, give or take.
50 million and either direction, of course, that may change.
And the bulk of that is actually going to be going towards an increasing Medicaid reimbursement rates for some of these practitioners and fields where we are seeing shortages.
I think it's over $500 million of that is going towards Medicaid reimbursement rate increases.
>>But as we've heard, you know, Democrats are critical.
There's no mention of Medicaid expansion.
Right.
I mean, what are the the concerns from Democrats and and how do Republicans respond to those those calls for Medicaid expansion?
>>Well, what I'm seeing from a lot of Democrats is kind of the argument that the Florida Republicans are trying to hold up sort of like this new shiny object, like, hey, look at this, look at our new plan when really what they are saying is that this solution exists and has existed for some time, but because of bruised egos and hurt feelings over the political polarization, over the expansion of Medicaid here in Florida and in a handful of other states, the Republican Party has been unwilling to go in that direction when in fact, that is a very logical solution to many of these problems that are on the table.
By not doing that, Florida is leaving a lot of federal funds on the table.
And, you know, the hospitals are going to feel that other providers are going to feel it.
And of course, the people who are uninsured, Florida's under-insured and uninsured rates are astronomical compared to other states.
So people are feeling this every single day.
>>What do you guys hear from your sources about Medicaid expansion and sort of this sort of reluctance, I guess, to join the 40 odd other states that have expanded coverage?
>>Yeah, I think it's especially relevant right now because pandemic protections that would not allow states to take people off of Medicaid have now ended.
I think Florida has removed it's something like over 800,000.
It was 800,000 last I checked.
It's probably more now.
People have been removed from Medicaid in Florida since the unwinding of these pandemic era protections began last spring.
So especially right now, it's becoming more and more relevant and more part of the conversation because there's records of record numbers of people without insurance right now.
And Florida has been receiving rebukes from the federal government, from activist groups criticizing its process of removing people from these Medicaid rolls and pointing out that, you know, more people would be able to stay if Florida expanded Medicaid.
>>Yeah.
Very interesting point.
Just finally, Joe Mario, I mean, we talked about the two main pieces of legislation there at the top, but there are a lot of bills that tackle health care related issues in this session.
Right.
I mean, there's one that stuck out to me that aims to expand HIV treatment availability.
>>Yeah, I'm really happy we're talking about this.
I'm really excited about this proposal.
So as as Caroline knows from her reporting on this subject, this is something that's really needed.
What this would do is expand treatment and testing with pharmacies throughout Florida.
So this would give more accessibility to people throughout the state to come in, get tested, see if they have HIV, and then go through what treatment plans are available to them, whether that's PAP or prep.
You know, this is how we can tackle this problem.
Right.
And one of the bigger things that I'm excited about for this proposal is really, you know, talking to advocates or any expert who's dedicated to try and decrease HIV diagnoses, that is, you have to destigmatize HIV.
And one of the ways that we do that is trying to normalize it, getting to getting people to talk about it more, seeing it more.
So if we can see it more in these pharmacies, that's one way to make it not so scary to normalize the idea of coming in and getting tested and getting ahead of this problem.
>>You've covered this.
What what do you make of the proposal?
>>I think that I mean, well, first of all, I want to say Florida has one of the highest rates of HIV of any state.
Central Florida in particular, is a hotspot.
And there are thousands of people who have it and don't know they have it because they haven't gotten tested and they haven't gotten the diagnosis.
So that is contributing a good bit to the spread, is people spreading it without knowing it.
There are thousands of new HIV diagnoses in the state each year.
Florida is behind other states in terms of its emphasis on testing programs.
So I think that any efforts to increase testing are very needed based on conversations with people that work in this area.
And I you know, I think that that's a fantastic step in a good direction.
>>Interesting.
Well, we'll keep an eye on that as well.
Just a reminder, we're recording the show on Thursday morning.
So as legislation works its way through the Florida House and Senate, things can change by air time.
>>In the meantime, you can find links to two of the main Live Healthy Senate bills and much more on Florida's drug importation program as well on our website, wucf.org/newsnight.
Okay.
Finally tonight, the Florida surgeon general's decision to up the ante in his criticism of mRNA COVID 19 vaccines.
Joseph Ladipo is demanding a halt to the vaccines, claiming DNA fragments in them could integrate with human DNA.
He says that might put recipients at risk of side effects such as cancer.
But the FDA doesn't agree.
Krystal Knowles reports.
>>Back in 2021, the FDA approved mRNA COVID 19 vaccinations, with state agencies keen to quickly getting shots in arms.
But in Florida, that's changed.
>>We're the leaders-- >>Florida Surgeon General Dr. Joseph Ladipo sent a letter to the FDA calling to halt the use of mRNA vaccines contradicting federal health agencies.
In part, the letter reads Lipid nanoparticles are an efficient vehicle for delivery of the mRNA in the COVID 19 vaccines into human cells and may therefore be an equally efficient vehicle for delivering contaminant DNA into human cells.
The FDA has fired back standing behind the safety of these vaccines.
Its rebuttal letter reads in part, It is quite implausible for the residual small DNA fragments located in the cytosol could find their way into the nucleus through the nuclear membrane, present in intact cells, and then be incorporated into chromosomal DNA.
Dr. Celine Gounder is an infectious disease specialist and epidemiologist at NYU and Bellevue Hospitals.
Dr. Gounder says it is highly unusual for states to contradict guidelines from the federal government, especially when it comes to the issues of public health.
>>There are two main claims, one, that the mRNA in mRNA vaccines, like the COVID vaccines, can somehow integrate into human DNA.
And this shows a real lack of understanding of basic molecular biology and how DNA and mRNA work.
It is not biologically plausible or possible for mRNA to integrate into DNA.
The other claim is that somehow the mRNA vaccines can cause, quote, turbo cancer.
First of all, turbo cancer does not exist.
And so for someone to claim that mRNA vaccines which have only been around now for a couple of years would be causing a rash of turbo cancers when we've never seen any kind of exposure really lead to cancers at that rate, that quickly is also just not plausible.
>>Dr.
Gounder says it is highly unusual for a state to contradict guidelines from the federal government, especially when it comes to the issues of public health.
So she says what's happening in Florida could put the population at risk.
>>The average person doesn't study molecular biology and genetics and vaccine science and so on.
And so how are they to know what's right or wrong?
How are they to know that their own surgeon general of the state may not be giving them the best information possible?
>>And let's break all this down, Joe Mario.
Dr. Ladipo wrote to the FDA last year, I think to make these sort of most recent claims about DNA is the response.
We heard that from the FDA sort of broadly what you would expect.
>>Yeah, I think so.
I mean, the surgeon general's had a few concerns, but the major one being, you know, was there testing for DNA integration.
And the FDA's letter went over why that is why his concerns for this are implausible.
And what they went through really was in his concerns, he appeared to be ignoring something called the central dogma of molecular biology, which is our understanding of like the flow of life.
Right.
So DNA in the nucleus creates RNA in the cytoplasm, which creates proteins.
The mRNA vaccine interacts with RNA, which tells it to create proteins.
Right.
He suggesting that these small fragments of DNA enter the cytoplasm and then travel upstream into the DNA to create cancerous mutations, which we know cannot happen because of that dogma.
That's just not how it works.
>>You and I, Caroline, have been talking about mRNA vaccines, it seems, since early on in the pandemic.
And Dr. Ladipo, as we know, has expressed this skepticism, you know, since he joined the DeSantis Administration.
From your contacts, what has been the sort of the broader response from the health care community this time?
And will the surgeon general's position actually change the availability of vaccines in Florida?
>>Yeah.
So his position is not going to change the ability, the availability of vaccines in Florida in the health care community at large really disagrees with what he's saying.
These concerns that, you know, especially this theory about DNA integration, are not new.
For decades, this is the rhetoric that anti-vaxxers have been using.
And, you know, from what I understand, it's this idea of DNA integration is highly theoretical.
And what he's asking for, it would be like going and saying we should test spiders to see if like, if they bit us, would we turn into Spider-Man?
Like, it's just highly implausible from what I'm talking or from what I'm hearing from experts.
And this is just, you know, for a very long time, he's sort of espoused this anti-vaccine rhetoric.
This is an escalation of that.
One thing the experts are very clear on is that vaccination is crucial.
COVID 19 can be a deadly disease.
And it's important to note that he is Ladipo is only expressing concerns about RNA vaccines.
There is a non mRNA vaccine for COVID 19.
Yes.
From Novavax.
So everyone should get vaccinated.
He's not speaking out against COVID vaccines, just the mRNA ones.
>>Certainly a controversy that's likely to continue here in Florida, especially when it comes to mRNA vaccines.
A reminder you can always find more on the stories you see on NewsNight including all those you've seen tonight on our website, wucf.org/newsnight along the bottom of your screen.
That is all the time we have for this week.
My thanks to Caroline Catherman from the Orlando Sentinel.
Thanks for being here, Joe Mario Pedersen, 90.7 WMFE News, and Beth Kassab from the Winter Park Voice.
Thank you guys so much for being here today.
Really appreciate your time.
We'll see you next Friday night at 8:30 here on WUCF.
In the meantime, for all of us here at NewsNight, take care and have a great week.
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