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Florida is keeping a close watch on the FDA these days. Here’s why.

You can’t spell Florida without “FDA.”
Maker Biogen was hopeful its drug aducanumab would be the first ever approved to treat the cognitive decline associated with Alzheimer's-- a major medical milestone.
Maker Biogen was hopeful its drug aducanumab would be the first ever approved to treat the cognitive decline associated with Alzheimer's-- a major medical milestone. [ DOMINICK REUTER | AFP ]
Published Jul. 22

The following first appeared in the Buzz political newsletter, a weekly dive into the power, politics and influence shaping Florida from Political Editor Steve Contorno and the Tampa Bay Times politics team. To subscribe and receive it in your email inbox each week, click here.

Florida is drowning in Red Tide, COVID-19 hospitalizations are up, and as recently as last week, multiple international crises were playing out in the streets of Miami.

What better time to talk about federal drug regulations?

The U.S. Food and Drug Administration either has or will soon make several decisions that affect every Floridian — whether they realize it or not. Let’s break three of them down.

1. Does this expensive Alzheimer’s treatment work?

Earlier this month, the agency approved aducanumab, a drug developed by Biogen as a treatment for Alzheimer’s. The drug is the first new treatment for the devastating neurological disease to hit the market in nearly two decades, a fact that is sure to give the families of the hundreds of thousands of Floridians who suffer from Alzheimer’s a great deal of hope.

There are three major issues, though. The drug costs $56,000 per patient per year, it’s unclear whether it works, and Congress is investigating whether the FDA was unduly influenced by the drug industry before it approved the treatment. So is the FDA’s inspector general.

“What disturbed us the most was the process the FDA had engaged in, in which they, in an unprecedented way, inappropriately collaborated with Biogen in reviewing the data from the clinical trials,” said Michael Carome, director of the health research group at the watchdog Public Citizen.

In response to questions, a Biogen spokesperson said “Biogen’s work with external stakeholders is conducted consistent with the principles of scientific research and legal and regulatory requirements.”

Tampa Bay-area congressional representatives have a front-row seat to the investigation. Reps. Kathy Castor, Gus Bilirakis and Scott Franklin all sit on U.S. House committees that plan to investigate reports that the FDA was in regular communication with Biogen officials throughout the approval process.

Spokespeople for the representatives said last week the elected officials are anxious to see what light is shed by the various investigations.

But no matter what is uncovered, it’s unlikely to change the fact that the drug has been approved to treat Alzheimer’s. If the federal government agrees to cover the treatment under Medicare, it could cost the taxpayer untold billions. Even if the feds don’t — and even with efforts by Biogen to drive down costs for consumers — the pricey drug could drive up insurance premiums across the board.

2. Is the agency fumbling COVID-19 vaccines?

With COVID-19 case rates spiking in Florida and vaccination rates plateauing, some have called on the FDA to give full approval to the coronavirus vaccinations that have been used by tens of millions of Americans.

Since America’s vaccination program started, the FDA has been allowing injections under the agency’s emergency use authorization. That doesn’t sit so comfortably with some: One woman surveyed by the Kaiser Family Foundation said she would “definitely not” get a vaccine because she didn’t want to use an “experimental drug.”

Another factor potentially contributing to vaccine hesitancy is the bureaucratic wrangling over the vaccines that are widely available.

Gov. Ron DeSantis on Wednesday re-upped his criticism of the FDA’s move to temporarily pause its approval of the vaccine offered by Johnson & Johnson in the spring: “We saw noticeable decline in J & J when they pulled it back...I think was a huge mistake,” he said Wednesday.

Even with the recent wave of cases, it’s unlikely that we’ll get full vaccine approvals in the next few months. A rushed process would be counterproductive, an FDA official wrote in a letter to the New York Times.

“Any vaccine approval without completion of the high-quality review and evaluation that Americans expect the agency to perform would ... do little to help combat vaccine hesitancy,” he wrote.

3. Is it finally time for Canadian drugs?

One of DeSantis’ signature health care pushes has been his attempt to allow Florida patients to import cheaper prescription drugs from Canada. President Joe Biden seemed to back the idea in a July 9 executive order.

But many obstacles remain in the way of Floridians benefiting from the less expensive drugs. (For instance, it’s not certain the drugs would wind up much cheaper for consumers at the end of the day.)

But the bigger question hanging over Florida: Will the FDA will approve Florida’s plan to import the drugs? We don’t know.