For years, the FDA has defended its efforts to intercept prescription drugs coming from abroad by mail as necessary to keep out dangerous opioids, including fentanyl.
The pharmaceutical industry frequently cites such concerns in its battle to stymie numerous proposals in Washington to allow Americans to buy drugs from Canada and other countries where prices are almost always much lower.
But the agency's own data from recent years on its confiscation of packages containing drugs coming through international mail provides scant evidence that a significant number of opioids enters this way. In the two years for which KHN obtained data from the agency, only a tiny fraction of the drugs inspected contained opioids.
The overwhelming majority were uncontrolled prescription drugs that people had ordered, presumably because they can't afford the prices at home.
The FDA still stops those drugs, because they lack U.S. labeling and packaging, which federal authorities say ensure they were made under U.S. supervision and tracking.
FDA stated that 33 packages of opioids were found and no fentanyl was sent by mail in 2022, out of almost 53,000 drug shipments it inspectors looked at at international mail facilities. This is about 0.6% of all packages that were examined.
According to a detailed breakdown of drugs intercepted in 2020, the lion's share of what was intercepted — and most often destroyed — was pharmaceuticals. The No. 1 item was cheap erectile dysfunction pills, like generic Viagra. But there were also prescribed medicines to treat asthma, diabetes, cancer, and HIV.
FDA spokesperson Devin Koontz said the figures don't reflect the full picture because U.S. Customs and Border Protection is the primary screener at the mail facilities.
But data obtained from the customs agency shows it likewise found few opioids: Of more than 30,000 drugs it intercepted in 2022 at the international mail facilities, only 111 were fentanyl and 116 were other opioids.
On average, Americans pay more than twice the price for exactly the same drugs as people in other countries. In polling, 7% of U.S. adults say they do not take their medicines because they can't afford them. About 8% admit they or someone else in their household has ordered medicines from overseas to save money, though it is technically illegal in most cases. At least
— Florida, Colorado, New Hampshire, and New Mexico — have proposed programs that would allow residents to import drugs from Canada.
While the FDA has found only a relatively small number of opioids, including fentanyl, in international mail, Congress gave the agency a total of $10 million in 2022 and 2023 to expand efforts to interdict shipments of opioids and other unapproved drugs.
'Additional staffing coupled with improved analytical technology and data analytics techniques will allow us to not only examine more packages but will also increase our targeting abilities to ensure we are examining packages with a high probability of containing violative products,' said Dan Solis, assistant commissioner for import operations at the FDA.
But drug importation proponents worry the increased inspections targeting opioids will result in more uncontrolled substances being blocked in the mail.
'The FDA continues to ask for more and more taxpayer money to stop fentanyl and opioids at international mail facilities, but it appears to be using that money to refuse and destroy an increasing number of regular international prescription drug orders,' said Gabe Levitt, president of PharmacyChecker.com, which accredits foreign online pharmacies that sell medicines to customers in the U.S. and worldwide. 'The argument that importing drugs is going to inflame the opioid crisis doesn't make any sense.'
'The nation's fentanyl import crisis should not be conflated with safe personal drug importation,' Levitt said.
He wasn't surprised by the low amount of opioids sent via the mail. In 2022, Prescription Justice, the organization he runs, received 2020 FDA data from Prescription Justice through a Freedom of Information Act request. The FDA inspectors had intercepted 214 packages containing opioids, but no fentanyl from a total of approximately 50,000 drug shipments. They found almost 12,000 packages with erectile dysfunction pills. They also blocked thousands more packages that contained prescription medications to treat a variety of conditions.
Over 90% of the drugs found at international mail facilities are destroyed or denied entry into the United States, FDA officials said.
The agency highlighted its efforts to prevent fentanyl from entering the United States via mail, as well as other illegal drugs.
Levitt was happy that Congress added language to a federal funding bill in December that he claimed would refocus FDA mail inspections. The FDA's International Mail Facilities efforts must be focused on preventing dangerous, controlled, counterfeit or other dangerous pharmaceuticals from entering America, according to the document. The Act also provides funds that should be prioritized in cases where importation is a serious threat to public health.
Levitt said the language should shift the FDA from stopping shipments containing drugs for cancer, heart conditions, and erectile dysfunction to blocking controlled substances, including opioids.
Koontz, the FDA's spokesperson, said that the FDA will continue to inspect all drugs because they are potentially dangerous. He stated that importing drugs from overseas simply to save money is not enough to put yourself at risk. "The drug might be okay, but we don’t know so we assume that it isn’t."
He said even drugs that are made in the same manufacturing facilities as drugs intended for sale in the United States can be dangerous because they lack U.S. labeling and packaging that ensure they were made properly and handled within the U.S. supply chain.
FDA officials say drugs bought from foreign pharmacies are 10 times as likely to be counterfeit as drugs sold in the United States.
To back up that claim, the FDA cites
from a former agency official in 2005 who — while working for a drug industry-funded think tank — said between 8% and 10% of the global medicine supply chain is counterfeit.
The FDA said it doesn't have data showing which drugs it finds are unsafe counterfeits and which drugs lack proper labeling or packaging. The U.S. Customs and Border Protection data shows that, among the more than 30,000 drugs it inspected in 2022, it found 365 counterfeits.
To oppose drug importation efforts arguing that it would worsen fentanyl addiction
, executive director of the Partnership for Safe Medicines, a group funded by U.S. pharmaceutical manufacturers, said he was surprised the amount of fentanyl and opioids found by customs and FDA inspectors in the mail was so low. He said that historically it has been a problem, but he could not provide proof of that claim.
He said federal agencies are not inspecting enough packages to get the full picture. 'With limited resources we may be getting fooled by the smugglers,' he said. 'We need to be inspecting the right 50,000 packages each year.'
For decades, millions of Americans seeking to save money have bought drugs from foreign pharmacies, with most sales done online. Although the FDA says people are not allowed to bring prescription drugs into the United States except in rare cases, dozens of cities, county governments, and school districts help their employees buy drugs from abroad.
The Trump administration said in 2020 that drugs could be safely imported and opened the door for states to apply to the FDA to start importation programs. But the Biden administration has yet to approve any.
A federal judge in February threw out a lawsuit filed by PhRMA and the Partnership for Safe Medicines to block the federal drug importation program, saying it's unclear when, if ever, the federal government would approve any state programs.
Levitt and other importation advocates say the process is often safe largely because the drugs being sold to people with valid prescriptions via international mail are FDA-approved drugs with labeling different from that found at U.S. pharmacies, or foreign versions of FDA-approved drugs made at the same facilities as drugs sold in the U.S. or similarly regulated facilities. Most drugs sold at U.S. pharmacies are already produced abroad.
Because of the sheer volume of mail, even as the FDA has stepped up staffing at the mail facilities in recent years, the agency can physically inspect fewer than 1% of packages presumed to contain drugs, FDA officials said.
Solis said the agency targets its interdiction efforts to packages from countries from which it believes counterfeit or illegal drugs are more likely to come.
Supporters of importation claim that efforts to stop it will protect the profits of the pharmaceutical industry and harm U.S. citizens trying to pay for their medicines.
The, which advocates lower drug prices. "The FDA is being used by the pharmaceutical industry to maintain their price monopoly and keep their prices high.