martes, 27 de agosto de 2019

Florida really wants to import drugs from Canada, but it’s got a long way to go

D.C. Diagnosis
Nicholas Florko

Florida really wants to import drugs from Canada, but it’s got a long way to go

Florida released a high-level plan Friday on how it believes it could safely import drugs from Canada — a major step that might well position the Sunshine State as the first in the U.S. to do just that. But, nonetheless, none of the experts I talked to — even those who support it — believe it’s ready for prime time. Here’s why:
HHS is in the process of writing regulations for how states can import drugs. There's a 2003 law already on the books that says that when it comes to drug importation, HHS has to certify that a state plan is both safe and would save significant money. The law says the agency also has to write regulations on how importing will work. The question, however, is which one comes first. HHS announced in late July it's starting in earnest on those regulations, so it seems unlikely the agency would greenlight Florida's new plan before those regulations are released. 
There’s a question of whether the plan could comply with existing laws. There's a 2013 law that requires drug makers to label all their products with a serial number so they can be tracked from factory to pharmacy. Drugs sent to Canada wouldn’t have that marker and thus couldn’t be brought into the U.S., experts tell me. 
Florida insists that repackagers, businesses that literally repackage drugs for drug companies, could fill this gap, but experts like Adam Fein, CEO of Drug Channels Institute, are skeptical. 
“The tough reality is that there is simply no way to alter the [law] to enable importation without undermining the purpose and value of this complex law,” Fein said.

Florida also need to find someone to sell them Canadian drugs. Florida would need to find a distributor in Canada that’s willing to sell the state drugs. That’s a big request, given Canadians are already up in arms about the U.S.’ plans to poach their medicines. Florida’s plan identifies 13 distributors they think might sell them drugs, but the state, curiously enough, says those companies “will be contacted to determine their interest in participating in the program." 
Read: Florida hasn’t even begun pitching them on the idea. The one Canadian company on Florida’s list that responded to my query confirmed that Florida had not contacted them about potentially participating in the program. And surprise, surprise: They aren't into it. "We are unfortunately not interested in the U.S. market and have not been in contact with any U.S. officials,” said Chantal Quirion, the director of business development for Distribution Pharmaplus.

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