Amid soaring drug prices, FDA reverses stance and cracks down on cheap imports

“We’ve been doing this for 15 years, and we are not hiding anything,” store owner said.

The agency sent in criminal investigation agents with search warrants for computer files and any paperwork related to sales of foreign drugs. The agents also took files on customers and the stores’ financial records. They left behind a letter for store owners to sign, acknowledging that the practice of importing foreign medicines is illegal.

Although none of the stores has closed due to the activity, the owners are spooked by the turn of events—and puzzled by the timing.

Bill Hepscher, co-owner of Canadian MedStore, which owns six of the nine raided storefronts, said that the FDA’s actions “worr[y]” him. For years, his stores have helped patients with valid prescriptions order the medicines they need at steeply discounted prices compared with those in the States. The stores don’t dispense the drugs, rather they simply arrange for the medicines to be delivered directly to the customers’ homes. Hepscher estimates that he has about 10,000 customers a year.

He emphasized that the stores only rely on foreign pharmacies that have been certified by the nonprofit pharmacychecker.com or verified by the Canadian International Pharmacy Association. And many of the imported drugs are manufactured at the same facilities as those found in the US.

Until now, the FDA has generally been lax or patchy in its enforcement of illegally imported medicines—and it has ignored stores like Hepscher’s. But the raids suggest that the agency has reversed its “non-enforcement” policy, Hepscher said.

“We’ve been doing this for 15 years, and we are not hiding anything,” he said. “We are not in the shadows.”

Hepscher was stumped as to why the stores were suddenly targeted, particularly after President Donald Trump had indicated that he wanted to help lower prescription drug prices.

A spokesperson for the FDA would not comment on whether an investigation was ongoing or a policy had changed. The spokesperson simply told KHN that:

“The FDA is concerned about the safety risks associated with the importation of unapproved prescription drugs from foreign countries. 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.”

But in a speech this month, FDA Commissioner Scott Gottlieb did note that the agency would crack down on illegal imports of unapproved drugs.

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