Florida sues FDA over slow approval of Canadian drug imports

  • Florida is suing the FDA for not approving its prescription drug reduction plan.
  • The state wanted to import cheaper prescriptions from Canada.
  • President Joe Biden supported importing drugs when he was a candidate.

Florida is suing the Food and Drug Administration for failing to approve a plan by Republican Gov. Ron DeSantis to import cheaper prescription drugs from Canada.

The governor on Wednesday accused the FDA of “illegally withholding” and “unreasonably delaying” approval of Florida’s program, saying “we believe this violates federal law.” He is suing for a federal judge to order an end to the delay.

“It’s hard to even come across people from the FDA, very dismissive, very arrogant about how they did it,” DeSantis said at a press conference at a pharmaceutical distribution warehouse in Lakeland, Florida. “But our view is that we need to keep moving forward. After 630 days we are still waiting for an answer and so we believe we have waited long enough. Today we are taking action.”

DeSantis’ office calculates that importing cheaper drugs from Canada could save the Florida government up to $150 million a year. Imported drugs are said to include treatments for HIV/AIDS, diabetes and asthma.

The plan would primarily save money for Florida’s Medicaid program and reduce the amount the state pays for drugs it provides to people in correctional facilities. Medicaid covers health costs for low-income people, pregnancy and childbirth, and people with disabilities.

Florida was the first state under former President Donald Trump to take advantage of a 2003 federal law that allows states to have drug import plans approved.

Trump ordered the Department of Health and Human Services to establish safety rules for the programs, then the Florida Legislature passed an importation law in 2019.

From there, state officials worked with the Trump administration for more than a year to create their plan. They deposit for federal approval shortly after Trump’s re-election loss. Other states are also working on plans, including Vermont, New Mexico, Colorado, Maine and New Hampshire.

Biden promised during the 2020 campaign that he would authorize drug imports as part of a broader plan to reduce prescription costs, and signed an executive order in July 2021 that would allow it. DeSantis said when Florida officials saw the executive order, they thought they would get the green light soon.

But Florida’s plan remains in limbo.

“It’s been a frustrating process from macro to micro,” Simone Marstiller, secretary of the Florida Agency for Health Care Administration, said at the Lakeland press conference. “My team and I had so many meetings with the FDA it’s not even funny. But all we got was word salad, bureaucracy, blockages, raids and stall tactics.

The United States pays several times more for prescription drugs than neighboring Canada to the north because Canada has a panel that negotiates drug prices by linking them to prices of those in similar countries. Although the Government of Canada funds more health services than the United States, many Canadians must purchase additional private insurance to help pay for prescription drugs.

However, the prices are lowest in Canada. The United States spent an average of $1,310 per person on prescription drugs in 2021, compared to $868 per person in Canada, according to the Organization for Economic Co-operation and Development.

The FDA did not immediately respond to Insider’s request for comment.

Rejecting the proposal could backfire on Biden and allow Republicans to accuse the president of political motivations even if his aides cite security or other concerns for their decision.

DeSantis has hinted that he thinks politics or pharmaceutical lobbying may be at play, though it’s unclear what’s behind the delay. Florida filed a public information request with the FDA to find out what the internal discussions were regarding their plan, but received no response.

“Are they putting politics before patients? Are they putting the interests of Big Pharma before the interests of Floridians and average taxpayers? That’s what we need to find out,” said DeSantis.

Biden signed the Cut Inflation Act Aug. 16, and it contains several provisions for drug savings for the Medicare program — which primarily covers adults over 65. But part of the bill fixing the price of prescription drugs would only apply to to 10 drugs from 2026.

Trump and DeSantis have stood up to their party by pushing for the importation of prescription drugs, which was originally championed by Sen. Bernie Sanders, an independent from Vermont.

The idea of ​​allowing cheaper drugs to be imported is popular with voters, with 78% of respondents in a Kaiser Family Foundation poll saying they supported him. But the pharmaceutical industry is a powerful interest in Washington and state capitals with political action committees pouring donations on politicians of both parties.

Pharmaceutical industry groups oppose the importation, which they say could lead to dangerous drugs entering the United States. Some outside experts have also been skeptical that the import plans would save consumers money, and Canadian officials raised concerns that the import would cause shortages there.

Last year Sanders told Insider he thought the Biden administration should approve Florida’s plan and that it should be taken up nationally.

“I think we should do it for the whole country,” he said. “If we can develop a security protocol – which we absolutely can – then of course we should go ahead with the re-importation.”

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