The U.S. government has stepped up seizures of drugs ordered by Americans from international sources through the mail—including cheaper, legal medications from legitimate pharmacies, Tarbell has found.
The interdiction is linked to new efforts by Food and Drug Administration and other parts of the federal government to block prohibited opiate deliveries. But the dragnet is catching increasing numbers of orders by individual Americans seeking medicines that are less costly or only available internationally—a practice that has not been the target of federal enforcement—until now.
“Something is really stupid. The government is supposed to help the American citizen, not hinder them,” said Francis Donnelly, an 85-year-old retiree in New Jersey.
Donnelly recently was notified by the FDA that it had intercepted his order of a drug called Asacol, which he’s been taking for decades to treat Crohn’s disease and ulcerative colitis. He has to get it overseas because its manufacturer stopped making it in the United States just before its patent expired in 2013. Donnelly said he and his doctor could not find alternatives that worked as well.
Interceptions on the Rise
The FDA began committing more money and staff to intercepting drugs at the nation’s nine international mail facilities in October 2017. In a recent post, the FDA noted that it intercepted 10,231 packages of drugs in the 2017 fiscal year. This year, the agency intends to quadruple that number to 40,000, and as soon as possible to 100,000 a year. It’s already expanded the team of investigators in mail facilities from eight to 22.
An FDA spokeswoman confirmed the pace is rising. In the first eight months of Fiscal Year 2018 (October 1, 2017 – May 31, 2018), a total of 19,318 FDA-regulated products, consisting primarily of drugs, offered for import through the international mail facilities were refused admission into the United States. 18,388 were returned to sender. 930 products (all drugs) were destroyed.
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That tally likely includes the seizure of Donnelly’s medication, which he learned of in early April. For that order, he used the online branch of a business called The Canadian MedStore that primarily serves people in Florida through a string of six storefronts. The business, according to founder William Hepscher, aims to help consumers gain safe access to overseas drugs by steering customers toward pharmacies that require prescriptions, are closely regulated in the countries where they are located, and ship genuine products.
Hepscher’s stores were raided in October 2017 just as the FDA was ramping up its efforts to block international shipments of medication.
Since then, Hepscher says he has gotten steady complaints from individual customers whose medication has been seized. Dozens of notices forwarded to Tarbell list treatments for asthma, blood pressure, multiple sclerosis, and diabetes, among others. In at least one instance in November, armed agents knocked on a retiree’s door and warned the man he could be arrested and prosecuted if he kept buying his less expensive medication, Hepscher said. The agent who interviewed that customer did not return a call seeking comment.
“People are feeling that their own federal government is threatening them,” said Hepscher. “For 15 years they’ve been allowing this, and now all of a sudden it’s as if they flipped a switch.”
On top of the government actions, Hepscher said he received notice in mid-May that two of his bank accounts were being closed. Both banks, PNC and Regions Bank, declined to explain what precipitated the closures, citing confidentiality. They also declined to explain the actions to Hepscher, he said. Banks can close accounts for any reason, but the simultaneous shuttering at least suggests a governmental impetus.
FDA spokeswoman Lyndsay Meyer declined to address any specifics about the MedStore cases, but pointed out that it is illegal to import drugs into the United States without FDA approval. The government generally looks the other way when individuals bring in their own drugs under the FDA’s personal importation policy. Yet the agency retains the discretion to intercept anyone’s drug shipment at the border or at the post office. The prime reason Meyer cited for enforcement against online pharmacies was safety. The position of the regulators—and pharmacy industry-backed safety groups—is that it is dangerous to allow imports from overseas because the FDA cannot ensure they would be held to adequate quality standards.
“The U.S. drug supply is among the safest in the world,” said Meyer. “The current protections in federal law create a closed drug distribution system that helps assure U.S. consumers that our nation’s drug supply is safe and secure.”
Hepscher said he has not gotten complaints from clients about bogus drugs. Indeed, much like Donnelly, several customers who had their medication intercepted told Tarbell they were more concerned about the FDA’s actions.
“I wouldn’t like it because I’m pretty much a free-market guy, but I understand they can do what they can do,” said Richard Knowles, a 57-year-old Floridian who takes the well-known drug Candesartan to control his high blood pressure. He supports himself through real estate and day-trading, and saves about $150 for a 90-day supply by buying internationally through the MedStore.
The FDA blocked his last order coming through Los Angeles.
No Clear Answers
Hepscher has asked repeatedly—through elected officials and directly—if there has been some change in the policy concerning personal importation that has led his business to be targeted after 15 years of facilitating shipments for individuals. Neither he nor the lawmakers have gotten much in the way of an explanation, he said.
Meyer said there “has been no change in policy regarding enforcement of the Personal Importation Policy,” and that decisions to block shipments are always made “based on the individual merits and facts of the case.”
Yet the FDA is devoting dramatically more resources to catching shipments of “unapproved” medicines like those ordered by Donnelly and Knowles.
Citing the opiate crisis, Gottleib asked Congress in March for greater authority to seize packages in the mail facilities. The authority would cover all medications, not just opioids, which are generally the province of the Drug Enforcement Administration. The FDA, again using opioids as the justification, also secured a last-second budget boost of $94 million in the so-called Omnibus government funding bill that President Trump signed in late March. The rationale that accompanied the legislation made clear the money is not meant just to catch opioid shipments.“Specifically, this funding is for the FDA to purchase equipment and information technology to identify unapproved and counterfeit pharmaceuticals, and to upgrade laboratory facilities used in this effort,” says the explanation.
It also explicitly mentions companies like Hepscher’s: “Additionally, funding is provided to better identify and target firms and organizations importing into the United States,” it says, adding that it would also “increase criminal investigation resources.”Even if those enhanced efforts, including the 10-fold jump in interdictions, primarily target facilitators like the Canadian MedStore, it could have sweeping impact. Millions of Americans order drugs from overseas every year, and growing numbers of local governments have been contracting with independent firms that do essentially what Hepscher does in sourcing prescriptions from reliable, cheaper international suppliers.
Meyer declined to say if the FDA’s dramatically enhanced enforcement would target imports linked to such local government efforts, or whether companies that serve local governments could run into the same sort of crackdown Hepscher is facing.
“We cannot speculate on any future compliance actions or criminal investigations,” Meyer said.
Meyer did allow that Hepscher’s customer who was visited by FDA criminal investigators didn’t have anything to worry about. “The FDA does not and would not prosecute an individual for buying medicines online for their personal use,” she said. “The product would be refused and no additional action would be taken against the individual.”
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That doesn’t help someone like Donnelly or Knowles if they can’t get or afford their medication.
“I guess I would probably start bleeding in my intestines,” Donnelly said. “What could I do about it? If I can’t get the medication to keep my ulcerative colitis and Crohn’s disease in check, then I’d have an uprising of Crohn’s and ulcerative colitis. And it’d be the government’s fault, and then I would die.”
Knowles summed up the choice facing anyone caught in a drug-price bind: “I’m worried about it, but it’s not something I’m going lose sleep over. If I can afford it, I take it. If I can’t afford it, I don’t take it. I know where I’m going to go when I die, so I’m not worried about that part of it either.”