Late last month, the Food and Drug Administration raided nine stores in Central Florida that helped customers illegally order affordable prescription drugs from verified pharmacies abroad, particularly those in Canada, according to a report by Kaiser health news.
The agency sent detectives with search warrants for computer files and all papers related to the sale of foreign drugs. The agents also took files on customers and the stores’ financial records. They left a letter for the shop owners to sign acknowledging that importing foreign medicines is illegal.
While none of the stores have closed due to the activity, the owners are shocked by the turn of events – and puzzled by the timing.
Bill Hepscher, co-owner of Canada’s MedStore, which owns six of its nine storefronts, said the FDA’s actions[y]him. For years, his stores have helped patients with valid prescriptions order the drugs they need at deeply discounted prices compared to those in the United States. Hepscher estimates that he has about 10,000 customers a year.
He stressed that the stores rely only on foreign pharmacies certified by the nonprofit Pharmachecker.com or verified by the Canadian International Pharmacy Association. And many of the imported drugs are manufactured in the same facilities as those in the US.
Until now, the FDA has generally been lax or patchy in its enforcement of illegally imported drugs — ignoring stores like Hepscher’s. But the raids suggest the agency has reversed its “non-enforcement” policy, Hepscher said.
“We’ve been doing this for 15 years and we’re not hiding anything,” he said. “We are not in the shadows.”
Hepscher was puzzled why the stores were suddenly targeted, especially after President Donald Trump indicated he wanted to help lower prescription drug prices.
An FDA spokesperson would not say whether an investigation is ongoing or whether policy has changed. The spokesman simply said it KHN That:
“The FDA is concerned about the safety risks associated with importing unapproved prescription drugs from abroad. Drugs that come from unknown or foreign sources may not be regulated or subject to less oversight than U.S. requirements. These unknowns endanger the health of patients.”
But in a speech this month, FDA Commissioner Scott Gottlieb noted that the agency would crack down on the illegal importation of unapproved drugs, with a focus on illicit opioids.
This story has been updated to clarify that Gottlieb’s comments were directed at opioid drugs.