Marco Rubio prods FDA to greenlight Gov. DeSantis’ Canadian drug plan

Florida Republicans have a plan to lower prescription drug prices, if only the federal government would clear the way.

That’s the contention of U.S. Sen. Marco Rubio, who is leading a letter to the Food and Drug Administration (FDA) in support of a Gov. Ron DeSantis’ plan to import pharmaceuticals from other countries, with the hopes of cost savings for consumers.

Rubio was joined by Florida Republican U.S. Reps. Gus Bilirakis, Mario Díaz-Balart, Neal Dunn, Brian Mast and John Rutherford on a letter Wednesday to FDA Commissioner Robert Califf pushing for the long-awaited approval.

“The (Joe) Biden Administration, which wants to lower drug costs for Americans, especially its older citizens, continues to delay the approval of Florida’s proposal intending to do exactly that,” the Republican legislators contend.

Also at issue: an FDA failure to provide a “substantive update since November 2021,” with communication completely stalled since May 2022 between the feds and the Agency for Health Care Administration (AHCA).

“If the Biden Administration is serious about lowering the cost of prescription drugs, then the FDA must do its job and follow through with the State of Florida’s drug importation plan,” the legislators insist.

The prodding is the latest attempt to accelerate a process first conceptualized before the pandemic.

In 2019, the Legislature approved Florida’s Prescription Drug Importation Program, fulfilling a promise in DeSantis’ first State of the State message.

Upon submitting the concept paper to the federal Department of Health and Human Services, DeSantis announced “our state is one step closer to realizing true cost savings on safe, high-quality prescription drugs from Canada.”

HB 23 establishes an intergovernmental structure: administered by AHCA, pills from Health Canada would be brought in via the program, which will be administered by a vendor.

A second prong of the program would allow imports from other countries deemed to be safe by the Food and Drug Administration.

The Governor lauded President Donald Trump for “commitment to this effort and his clear direction to the U.S. Department of Health and Human Services to expedite a pathway for the safe importation of prescription drugs.”

The state submitted its Section 804 Importation Proposal (SIP) to the U.S. Department of Health and Human Services (HHS) for Florida’s Canadian Prescription Drug Importation Program in November 2020.

However, Trump left the White House without the program moving forward, leaving it to the somewhat more adversarial Biden administration to address, but progress has been too slow for Tallahassee’s liking.

“With the issuance of this new executive order directing the FDA to work with states, I expect no further delay in the approval of Florida’s plan to import safe and effective prescription drugs. While Big Pharma and federal bureaucracy have continued to stand in the way, it’s past time Florida taxpayers realized savings on these drugs,” DeSantis insisted in July 2021.

The state has since filed suit to compel the FDA to accept its importation proposal.

“Gov. DeSantis and I are fighting to lower prescription drug costs, but Washington bureaucrats are blocking our efforts,” said Attorney General Ashley Moody in August.