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Gov. Ron DeSantis' proposed wholesale prescription drug importation program secured a key preliminary nod Monday when it was approved by the 40-member House Appropriations Committee in a partisan vote.

House Bill 19, sponsored by Rep. Tom Leek, R-Ormond Beach, calls for the state to contract with pharmaceutical exporters in Canada and elsewhere to import FDA-approved, lower-cost prescription drugs to Florida.

HB 19 now only needs a successful hearing before the House Health & Human Services Committee before it can be presented for a House floor vote.

Monday’s hearing before the Appropriations Committee cleared a procedural hurdle but also exposed nettlesome vagaries in the plan – such as offering no guarantees it would deliver savings envisioned and no capacity to ensure what patients pay for is what they get from providers beyond the state’s capacity to regulate or hold them accountable.

The fact that the proposal is likely illegal under Canadian law is another stickler lawmakers will have to contend with.

In addition, a formidable new foe emerged – Partnership for Safe Medicines, a nonprofit with ties to “Big Pharma’s” lobbying group, the Pharmaceutical Research and Manufacturers of America (PhRMA), made its first formal appearance in opposing HB 19.

Partnership for Safe Medicines maintains the measure would lead to importation of counterfeit or contaminated drugs and endanger peoples’ lives.

George Karavetsos, a former director of the Food & Drug Administration's Office of Criminal Investigations and ex-federal prosecutor in Miami, said under HB 19, state residents will have no idea what medicines they’re taking and where they come from.

“You will attempt to license a non-U.S. wholesaler that is not ‘regulate-able’ and lack legal authority to make manufacturers liable and accountable,” Karavetsos said. “You will have to take their word for it that what they are sending is what they say it is.”

"This importation program cannot be made safe," he added. "People will be severely injured and even die."

Partnership for Safe Medicines Executive Director Shabbir Safdar said cost savings are exaggerated, noting of “the last seven states that have passed importation programs, none of them are in existence now, all of them failed” because Canada’s drug market is too small to translate its price-controlled benefit to a larger consumer base.

“To really cut costs,” he said, lawmakers should look at (pharmaceutical benefit management) “PBM regulation, co-pay restrictions,” and requiring more generic medications be made available.

Chris Ward, a former Ontario lawmaker, said Canadian pharmacies are dealing with “crisis level” shortages of more than 170 prescription drugs.

“You need a willing seller,” Ward said. “There is no support for this in Canada. Canadian wholesalers are on record opposing plans such as Florida’s” and want Canadian lawmakers “to take steps to stop this.”

“I’m kind of blown away by some of what you’ve said,” Rep. Carlos Guillermo-Smith, D-Orlando, told Ward. “Are you telling the members of this committee that if we were to enact” the bill “the Canadian government would enforce their law and block Florida from importing” Canada drugs?"

“I am very confident the Canadian government would take whatever steps are necessary to prevent the operability of this program,” Ward replied.

Ward also suggested lawmakers lower costs by addressing “middle men” – PBMs and insurers.

“Our costs are lower for a variety of reasons,” he said. “Price controls play a part; the elimination of middle men plays a very significant role. We don’t have PBMs taking a cut. We don’t have insurance companies taking a cut.”

The committee rejected six amendments submitted by Rep. Barbara Watson, D-Miami Gardens, including one to exempt senior citizens, inmates and pregnant women because “prescription drugs from outside of the United States” carry “an unknown danger and risk of death or harm.”

According to 39-page HB 19’s 22-page staff analysis, the U.S. spends about $333 billion annually on prescription drugs, or about $10,739 per person. U.S. drug prices are between 30 to 190 percent more than in other developed countries, it states.

“We have allowed our government to build a regulatory scheme that is so complex,” Leeks said in introducing the bill. “Today we have a chance to win one for the consumer.”

Leek said 90 percent of active ingredients in pharmaceuticals are manufactured outside the U.S. and that “there are 340,000 foreign-owned facilities licensed to manufacture drugs in this country.”

“If you came in here with the premise that the drugs that would come in under this program are any less safe than those that are domestically available, your premise is incorrect,” he said.

It is uncertain if DeSantis’ proposal, if adopted, will be approved by the federal government. Health & Human Services Secretary Alex Azar last year called state wholesale drug importation proposals “a gimmick.”

In introducing his proposal in February, DeSantis suggested a provision in the 2003 Medicare Modernization Act allows for state drug importation programs. He said President Donald Trump was “enthusiastic” about the proposal.