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New Prescription Drug Rules Being Considered


After years of American patients clandestinely going to Canada and purchasing their prescription drugs to save money, a proposed federal rule change could bring them in from the cold.

Governor Ron DeSantis and Health and Human Services Secretary Alex Azar announced Wednesday in Tallahassee, a plan to allow prescription drug importation from Canada to multiple states -- including Florida.

“We look to figure out what options do we have to do this; prescriptions drugs is [sic] heavily regulated by the federal government,” DeSantis said. “But we were able to identify a law that was passed almost 20 years ago that did provide an avenue for the importation of safe and affordable drugs from Canada.”

DeSantis signed a state law earlier this year, which created a program to import Food and Drug Administration-approved prescription drugs from abroad. Under the new rule, imported drugs would need to be relabeled, tested for authenticity and be available at reduced costs.

“This is only one step and I’ve always said there’s no silver bullet with this,” said the Governor. “But this is a step that no one’s been willing to take for almost 20 years. All the way back to 2003 you’ve had presidents of both parties; you’ve had [HHS] secretaries of both parties and yet, until now, we haven’t done it.”

The governor says the state will be engaged in the rulemaking process going forward, but he cautions Floridians there’s still a lot of work to be done before the shipments begin heading south.

“And some people are like, ‘Oh wow, when is this going to happen?’ This is not easy stuff, and for them to be here now they’ve worked really hard on this. So we’re really excited,” said DeSantis.

“We know this is a real challenge for many Americans, including many Floridians,” said HHS Sec. Alex Azar.

The announcement also marks an about-face from Azar, who just last year called drug importation a “gimmick.” He’s issued a notice of proposed rulemaking and draft guidance for the plan.

“Premiums for Medicare Part-D prescription drug plans have dropped steadily; but the average Floridian on Medicare is still paying $367 a year out-of-pocket for the drugs that they need,” Azar said.

Nearly 240,000 Florida residents, says Azar, have drug spending that pushes them into the catastrophic phase of Medicare Part-D; meaning they could be shelling out up to $5,000 or more out-of-pocket to fill needed prescriptions.

Azar announced two actions:

“First – the FDA is proposing to authorize states to develop programs that would allow importation of certain prescription drugs from Canada,” said Azar. “Second – we’re publishing a draft guidance that drug manufacturers can follow to facilitate importation of FDA-approved drugs into the United States.”

Credit Florida Governor's Office
Gov. Ron DeSantis signs into law a bill that allows imports of prescription drugs from Canada.

Governor DeSantis announced in August that the Florida Agency for Health Care Administration (ACHA) had submitted its concept paper to HHS, outlining a plan for the wholesale importation from Canada.

“My folks were working with Sec. Azar’s folks to try to figure out what would this look like if we go forward,” said DeSantis. “Today, the [proposed] draft rule has been issued, there will obviously be a comment period, but [HHS] worked closely with my administration to kind of get a good template.”

HHS Secretary Alex Azar says his agency will continue to explore ways to reduce drug prices, while protecting incentives for innovation and maintaining standards for safety, effectiveness, and quality.

“We’re also driving competition to historic levels of generic drug and bio-similar approvals,” said Azar. “We’ve banned pharmacy gag clauses and we’ve allowed Medicare advantage plans to negotiate more effectively against drug companies.”

There appears to be some strings attached. Canadian officials have expressed skepticism of the plan, and are concerned that it might lead to drug shortages or higher prices in their country.  Also, any cost savings for American consumers could be months, or even years down the road.