Florida is suing to find out

President Joe Biden took a victory lap on Labor Day 2022 claiming he had defeated Big Pharma. He was talking about the American Rescue Plan and how it caps Medicare drug costs per person at $2,000 per year, along with the ability of the government to negotiate down drug prices for the country’s 6 million Medicare recipients. But nowhere does it say that American patients can buy imported drugs from Canada — a proposal that’s been discussed since the 1990s.

Back in July 2019, before the Ukraine phone call impeachment and the Covid-19 pandemic, President Trump was moving forward on a way to allow the import of pharmaceuticals from Canada — widely used medicines such as EpiPen and synthroid.

Elite media begrudgingly gave us the straight story, with the Associated Press suggesting that Trump was looking to beef up his reelection as he looked to fulfill a campaign promise.

President Barack Obama had campaigned on the same promise, only to be unable to include it in the final version of the Affordable Care Act. Clearly the pharmaceutical industry, which spends hundreds of millions to get what they want in Congress, is threatened by the idea of Americans buying their drugs prepared for a foreign market.

Importing cheaper drugs from Canada has been a popular proposal for voters from both sides of the political spectrum since Bill Clinton was in office and famously gutted the exact same type of proposal after signing it into law. HHS Secretary Donna Shalala at the time said she could not guarantee that the importation program would “pose no additional risk to the public’s health and safety,” or that it would result in measurable cost reduction to the American consumer.

Last-minute switcheroos are common in the Canada importation proposals: who can forget the outcry from progressives when in early January 2017, Cory Booker and several other Democrats voted against Sen. Bernie Sanders’ amendment (co-sponsored with Sen. Amy Klobuchar) to the lame-duck budget resolution that would have “establish a deficit-neutral reserve fund relating to lower prescription drug prices for Americans by importing drugs from Canada.”

Big Pharma legislation often makes for some strange bedfellows. Thirteen Democrats voted against Bernie’s amendment, while 12 Republicans voted for it. Sen. Cory Booker famously had to defend himself on Twitter for opposing the amendment by using the same trope used by Dr. Shalala: that the public safety of the program could not be guaranteed.

Against the backdrop of pre-impeachment, pre-pandemic hope and prosperity, Trump signed an executive order directing HHS Secretary Alex Azar to move forward with a rule that would allow — yet again — for the importation of pharmaceutical drugs from Canada to the United States.

This time, Azar — a former pharma executive himself — said that the drug supply chain was now secure enough to allow for safe importation. The program is called SIP: Section 804 Importation Program (referring to section 804 of Medicare Part D, passed in 2003 under President George W. Bush but which was never activated due to those safety concerns.

“The landscape and the opportunities for safe linkage between drug supply chains has changed,” Azar said. “That is part of why, for the first time in HHS’s history, we are open to importation. We want to see proposals from states, distributors, and pharmacies that can help accomplish our shared goal of safe prescription drugs at lower prices.”

On July 24, 2020, President Trump signed the executive order that became the FDA’s “final rule,” entered into the federal register on October 1, 2020, to take effect November 30, 2020. The rule would allow the importation of drugs from Canada by states, tribal nations, pharmacists and wholesale distributors, from whom Azar welcomed proposals.

Someone finally got it done.

But so far, no jurisdiction has begun importing Canadian drugs. On August 31, 2022, Florida Gov. Ron de Santis held a press conference in front of massive empty shelves, part of the state’s proposal to inspect and relabel medicines bought from Canada. De Santis claimed that not only was Florida the first state to submit a proposal to the FDA, in late 2020, but he had actually suggested to President Trump to enact the rule in the first place.

But Florida’s proposal has languished in the Biden administration. And now, he is suing the FDA under the Freedom of Information Act to find out why after two years, the proposal still has not been approved.

“This isn’t Djibouti, it’s Canada,” he said, referring to speculation there might be continued concerns about safety of the drugs.

In July 2021, President Biden issued a sweeping executive order aimed at bringing down pharmaceutical drug costs, mentioning the Trump-era rule as part of the push.

“So Biden is saying he wants this for consumers, but yet his administration is not willing to act to be able to prove it, so that people have access to more affordable pharmaceuticals.”

A spokesperson for the FDA, in an e-mail to Back2Facts, said that the agency does not comment on pending litigation, and included a link that details the agency’s ongoing efforts to “implement a statutory pathway for the importation of certain drugs from Canada.” The agency also added to its web page titled “Human Drug Imports” a paragraph stating that they welcome states and other stakeholders to contact the Intergovernmental Affairs Division to “start the conversation.”

It sounds like Florida has been doing that, but so far they haven’t been able to fill the shelves of what the governor calls a “turnkey” operation ready to go.

“It’s hard to even meet with people at the FDA, you know very arrogant with how they’ve gone about this stuff, but our view is, we need to keep pressing forward so, after 630 days, 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.”

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Also in July 2020, President Trump signed an executive order directing the FDA to lower insulin and Epipen prices for those with no insurance, high deductibles or a high co-pay. On January 22, 2021, Joe Biden issued an executive order freezing all agency rules that had not yet been finalized.

In the end, the Trump insulin rule has been criticized as not designed to help enough people (35,000 people who make between 150% and 350% above the poverty level), and could be potentially harmful to the bottom line of Federally Qualified Health Centers where the rule was going to apply. Read the JAMA Network article supporting this view, which appears to be a veiled admission that middle class Americans with high copays and deductibles, or no insurance at all, are also paying a premium to help these federal health centers stay afloat.

Contrast that with the fanfare that NGOs have been praising Biden’s American Rescue Plan, which caps drug costs for Medicare recipients at $2,000 per year. There were no articles claiming this proposal didn’t help enough people. And nobody has bothered to point out the obvious, that $2,000 a year for medicine is still a lot for patients of any age.