The Food and Drug Administration final month despatched legal investigation brokers with search warrants into 9 storefronts throughout Central Florida that assist prospects order medicine from pharmacies in Canada and abroad at massive reductions.
The brokers notified the shop homeowners that importing medicine from overseas nations is prohibited and that these serving to to “administer” such medicines may face fines or jail time.
None of the shops has closed, however their homeowners are scared the Trump administration has reversed a long-standing “non-enforcement” coverage in opposition to the shops. Some of them have been open for practically 15 years.
“It worries me,” stated Bill Hepscher, co-owner of Canadian MedStore, which owns six of the 9 storefronts visited by the FDA in late October. His shops are within the Tampa Bay and Orlando areas.
FDA spokeswoman Lyndsay Meyer wouldn’t affirm or deny that any investigation was occurring. Nor would she reply whether or not the FDA has modified its coverage.
“The FDA is concerned about the safety risks associated with the importation of unapproved prescription drugs from foreign countries,” she stated. “Drug products that come from unknown or foreign sources may be unregulated or subject to less oversight than U.S. requirements. These unknowns put patients’ health at risk.”
In a speech Nov. 14, FDA Commissioner Scott Gottlieb stated the company could be stepping up its work to stop the importation of medicine into the United States, together with tripling the employees at worldwide mail services who examine packages suspected of containing medicine.
Hepscher stated the search warrants have been for computer systems, paperwork pertaining to gross sales of overseas medicine and any medicine themselves. The brokers didn’t take away computer systems, he stated, however they appeared to make copies of recordsdata. They additionally took prospects’ paper recordsdata and the shops’ monetary and financial institution data.
The storefronts primarily serve seniors preferring in-person help with shopping for medicines from Canada and different nations, reasonably than utilizing an web website. Hepscher stated his shops assist about 10,000 individuals a yr, and he estimates Florida has about 20 such storefronts.
That’s only a small fraction of the two p.c of American adults who say they buy drugs from outside the United States — both over the web or throughout travels to Canada or abroad.
The Florida shops do not dispense any drugs. Instead, pharmacies in Canada and different nations ship the medication on to prospects’ properties. Consumers want a sound prescription earlier than they’ll place an order.
Hepscher stated he and most different storefronts use solely overseas pharmacies licensed by the nonprofit firm pharmacychecker.com or the Canadian International Pharmacy Association, which verifies the pharmacies as protected. The medicine from overseas pharmacies typically are made in the identical manufacturing vegetation all over the world as medicine bought in U.S. pharmacies.
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Hepscher stated he doesn’t know what prompted the FDA motion. He refused to signal a letter the FDA brokers left with him acknowledging that he was conscious the reimportation apply is prohibited.
“We’ve been doing this for 15 years and we are not hiding anything,” he stated. “We are not in the shadows.”
Hepscher stated he discovered the timing attention-grabbing since President Donald Trump has been promising to assist decrease the worth of medicine for Americans.
Roger Bate, a well being economist with the American Enterprise Institute, a conservative suppose tank, stated the crackdown on storefronts may have critical penalties for his or her prospects.
“It’s a shame because this will drive people who are not competent using the Internet to buy from rogue websites,” Bate stated.
The concept of permitting Americans to purchase medicine from Canada has been pushed by some Republicans and Democrats for years. But it has been bitterly opposed by the pharmaceutical business, which has cited security considerations that the medicine may not meet U.S. requirements.
KHN’s protection of prescription drug improvement, prices and pricing is supported by the Laura and John Arnold Foundation.
Phil Galewitz: firstname.lastname@example.org”>email@example.com, @philgalewitz