by For years, the Food and Drug Administration has defended its efforts to intercept prescription drugs coming from overseas through the mail as necessary to prevent dangerous opioids, including fentanyl.
The pharmaceutical industry often cites such concerns in its fight to block several 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 the seizure of packages containing drugs coming through international mail provides little evidence that a significant number of opioids are entering that way. In the two years for which KHN received data from the agency, only a small fraction of the drugs tested contained opioids.
The vast majority were non-controlled prescription drugs that people ordered, probably because they can’t afford the prices at home.
The FDA is still stopping these drugs because they lack U.S. labeling and packaging, which the feds say ensures they were made under U.S. supervision and monitoring.
The FDA said it found 33 packages of opioids and no fentanyl mailed in 2022 out of nearly 53,000 drug shipments that its inspectors examined at international postal facilities. This is about 0.06% of the packets examined.
According to a detailed analysis of drugs intercepted in 2020, the lion’s share of what was intercepted – and most often destroyed – was pharmaceuticals. The No. 1 product was cheap erectile dysfunction pills like generic Viagra. But there were also prescription drugs to treat asthma, diabetes, cancer and HIV.
FDA spokesman Devin Koontz said the figures don’t reflect the full picture because U.S. Customs and Border Protection is the primary inspector at mail facilities.
But data obtained by the customs service shows that it also found few opioids: Of more than 30,000 drugs it intercepted in 2022 at international postal facilities, only 111 were fentanyl and 116 were other opioids.
On average, Americans pay more than double the price for the exact same drugs as people in other countries. In a poll, 7% of US adults say they don’t take their medicine because they can’t afford it. About 8% admit that they or someone else in their household has ordered drugs from abroad to save money, although it is technically illegal in most cases. At least four states — 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 combined with improved analytics technology and data analysis techniques will allow us to not only examine more packages, but also increase our targeting capabilities to ensure we are examining packages with a high likelihood of containing infringing products,” said Dan Solis, assistant commissioner. for submission work to the FDA.
But drug import advocates worry that increased inspections targeting opioids will result in more illegal substances being blocked in the mail.
“FDA continues to ask for more and more taxpayer money to stop fentanyl and opioids in international mail facilities, but appears to be using that money to deny and destroy a growing number of regular international prescription drug orders,” he said. president Gabe Levitt. of PharmacyChecker.com, which verifies foreign online pharmacies that sell drugs to customers in the US and around the world. “The argument that drug importation will fuel the opioid crisis makes no sense.”
“The crisis of importing fentanyl into the country should not be confused with safe personal importation of drugs,” Levitt said.
He wasn’t surprised at the low number of mail-order opioids: In 2022, an organization he leads, Prescription Justice, obtained 2020 FDA data through a Freedom of Information Act request. It showed FDA inspectors intercepted 214 packages of opioids and no fentanyl out of about 50,000 drug shipments. Instead, they found nearly 12,000 packages containing erectile dysfunction pills. They also blocked thousands of packages containing prescription drugs to treat many other conditions.
More than 90 percent of drugs found in international mail facilities are destroyed or denied entry into the United States, FDA officials said.
In 2019, an FDA document highlighted the agency’s efforts to stop fentanyl from entering the United States through the mail amid efforts to stop other illegal drugs.
Levitt was pleased that Congress in December added language to a federal spending bill that he said would refocus FDA mail inspections. It stated that “FDA’s efforts at International Mail Facilities should be focused on preventing controlled, counterfeit, or otherwise dangerous pharmaceutical products from entering the United States. In addition, the funds made available in this Act should give priority to cases where the introduction poses a significant threat to public health.”
Levitt said the language should shift the FDA from stopping shipments containing drugs for cancer, heart disease and erectile dysfunction to blocking controlled substances, including opioids.
But the FDA’s Koontz said the language won’t change the type of drugs FDA inspectors review because every drug is potentially dangerous. “Importing drugs from abroad simply to save costs is not a sufficient reason to expose yourself to additional risks,” he said. “The drug might be good, but we don’t know, so we assume it isn’t.”
He said even drugs made in the same manufacturing facilities as drugs intended for sale in the United States can be dangerous because they lack American labeling and packaging that ensures they were properly manufactured and moved through the U.S. supply chain.
FDA officials say drugs purchased from foreign pharmacies are 10 times more likely to be counterfeit than drugs sold in the United States.
To support this claim, the FDA cites congressional testimony from a former agency official in 2005 who — while working for a drug industry-funded think tank — said that between 8 percent and 10 percent of the global drug supply chain they are fake.
The FDA said it has no data to show which drugs it finds to be dangerously counterfeit and which drugs are not properly labeled or packaged. US Customs and Border Protection data show that, among the more than 30,000 drugs it inspected in 2022, it found 365 counterfeits.
Pharmaceutical Research and Manufacturers of America, the trade group for the industry, funds a nonprofit advocacy organization called the Partnership for Safe Medicines, which has mounted media campaigns to oppose efforts to import the drugs on the grounds that they will worsen the epidemic fentanyl.
Shabbir Safdar, executive director of the Partnership for Safe Medicines, a group funded by U.S. pharmaceutical manufacturers, said he was surprised that the amount of fentanyl and opioids that Customs and FDA inspectors found in the mail was so low. He said it has historically been a problem, but could not provide proof of that claim.
He said the feds aren’t inspecting enough packages to get the full picture. “With limited resources we may be tricked by smugglers,” he said. “We have to inspect the correct 50,000 packages every year.”
For decades, millions of Americans seeking to save money have purchased drugs from foreign pharmacies, with most sales occurring over the Internet. 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 the drugs could be safely imported and opened the door for states to petition the FDA to start import 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 Safer Medicines to block the federal drug importation program, saying it was unclear when, if ever, the federal government would approve any state programs.
Levitt and other import advocates say the process is often safe, largely because the drugs sold to people with valid prescriptions through international mail are FDA-approved drugs with a different label than what’s in U.S. pharmacies or foreign versions of the drug. that have been approved by the FDA and are manufactured in the same facilities as drugs sold in the U.S. or similar controlled facilities. Most drugs sold in US pharmacies are already produced overseas.
Because of the sheer volume of mail, even as the FDA has beefed up staffing at mail facilities in recent years, the agency can physically inspect less than 1 percent of packages purported to contain drugs, FDA officials said.
Solis said the agency is targeting its interdiction efforts on packages from countries it believes counterfeit or illegal drugs are most likely to come from.
Proponents of importation say efforts to block it would protect pharmaceutical industry profits and hurt US residents trying to afford their drugs.
“We’ve never seen a rash of deaths or harm from prescription drugs that people bring across the border from verified pharmacies, because these are the same drugs that people buy in American pharmacies,” said Alex Lawson, executive director of Social Security Works. advocates for lower drug prices. “The pharmaceutical industry uses the FDA to protect their price monopoly to keep their prices high.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth health journalism. Along with Political Analysis and Polling, KHN is one of the three main operating programs in the KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization that provides health information to the nation.
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