by This article originally appeared on KHN.
For years, the FDA has defended its efforts to intercept prescription drugs from overseas through the mail as needed to keep out dangerous opioids, including fentanyl.
The pharmaceutical industry often cites such concerns in its battle to block 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 regarding the confiscation of packages containing drugs that arrive through international mail provides little evidence that a significant number of opioids come in this way. In the two years that KHN received data from the agency, only a small fraction of the drugs inspected contained opioids.
The majority were non-controlled prescription drugs ordered by people, probably because they cannot afford the prices at home.
The FDA still stops those drugs because they don’t have US labeling and packaging, which federal authorities say ensures they were made under US supervision and tracking.
The FDA said it found 33 packages of opioids and no fentanyl sent through the mail in 2022 out of nearly 53,000 drug shipments examined by its inspectors at international mail facilities. That’s about 0.06% of the exam packages.
According to a detailed breakdown of drugs intercepted in 2020, the lion’s share of the amount intercepted – and most often destroyed – was pharmaceuticals. Item No. 1 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 screener at the postal facilities.
But data obtained from the customs agency shows that not many opioids were found either: Of the more than 30,000 drugs 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 the exact same drugs as people in other countries. In the poll, 7% of US adults say they don’t take their medication because they can’t afford it. Around 8% admit that they or someone else in their family has ordered medicines from abroad to save money, even though 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.
Although the FDA found only a relatively small amount of opioids, including fentanyl, in international mail, Congress gave the agency a total of $10 million in 2022 and 2023 to expand efforts to disallow shipments of opioids and other unapproved drugs.
“Additional staffing along with improved analytical 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 that have a high probability of containing infringing products,” said Dan Solis, assistant commissioner. for import operations by the FDA.
But drug importation advocates worry that increased investigations focused on opioids will result in more illegal substances being intercepted 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 fill an increasing number of regular international prescription drug orders rejected and destroyed,” said Gabe Levitt, president. of PharmacyChecker.com, which believes foreign online pharmacies sell medications to customers in the United States and around the world. “The argument that importing drugs to inflame the opioid crisis makes no sense.”
“The nation’s fentanyl importation crisis should not be conflated with safe personal drug importation,” Levitt said.
He wasn’t surprised by the low number of mailed opioids: In 2022, an organization called Prescription Justice obtained the 2020 FDA data through a Freedom of Information Act request. It revealed that FDA inspectors intercepted 214 packages with opioids and no fentanyl out of about 50,000 drug shipments. In contrast, they found almost 12,000 packages containing erectile dysfunction pills. They also blocked thousands of packages containing prescription drugs to treat many other conditions.
More than 90% of drugs received at international mail facilities are destroyed or denied entry into the United States, FDA officials said.
In 2019, an FDA document related to the agency’s efforts to stop fentanyl coming into 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 the FDA’s postal inspections. He said “FDA’s efforts at International Mail Facilities must focus on preventing controlled, counterfeit or other dangerous pharmaceuticals from entering the United States. In addition, funds provided in this Act should give priority to cases where importation poses a significant 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.
But the FDA’s Koontz said the language won’t change the type of drugs FDA inspectors examine, because all drugs can be dangerous. “Importing drugs from abroad for the sake of cost savings is not a good enough reason to expose yourself to the additional risks,” he said. “The drug may be OK, 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 could be dangerous because they lack US labeling and packaging that ensures they are properly manufactured and handled within the US supply chain.
FDA officials say that drugs purchased from foreign pharmacies are 10 times more likely to be counterfeit than drugs sold in the United States.
To back up that claim, the FDA cites congressional testimony from a former agency official in 2005 — working for a drug industry-funded think tank — that said between 8% and 10% of the global medicine supply chain is counterfeit. .
The FDA said it does not have data that shows which drugs it finds to be counterfeit and unsafe 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 run media campaigns to oppose drug importation efforts with the argument that it would make the fentanyl epidemic worse.
Shabbir Safdar, executive director of the Partnership for Safer Medicines, a group funded by US pharmaceutical manufacturers, said he was surprised that the amount of fentanyl and opioids found by customs and FDA inspectors at the post was so low. He said it has historically been a problem, but could not provide proof of that claim.
He said federal agencies are not inspecting enough packages to get the full picture. “With limited resources, the smugglers may be outsmarting us,” he said. “We need to be inspecting the correct 50,000 packages every year.”
For decades, millions of Americans looking to save money have purchased drugs from foreign pharmacies, with most of the sales made online. Although the FDA says people are only allowed to bring prescription drugs into the United States in rare cases, many 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 none have yet to be approved by the Biden administration.
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 because the drugs sold to people with valid prescriptions through international mail are labeled differently than those found in US pharmacies, or foreign versions of FDA-approved drugs. the same facilities as drugs sold in the US or similarly regulated facilities. Most of the drugs sold in US pharmacies are already produced overseas.
Due to the volume of mail, even as the FDA has increased staffing in mail facilities in recent years, the agency is able to physically inspect less than 1% of packages suspected of containing drugs. , FDA officials said.
Solis said the agency focuses its divestment efforts on packages from countries it believes are more likely to contain counterfeit or illegal drugs.
Import advocates say efforts to block it protect the pharmaceutical industry’s profits and hurt US residents trying to afford their medications.
“We haven’t seen a rash of deaths or injuries 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. Lawson, executive director of Social Security Works. advocates for lower drug prices. “The pharmaceutical industry is using the FDA to protect their price monopoly to keep their prices high.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Along with Policy Analysis and Polling, KHN is one of the three major operating programs of the KFF (Kaiser Family Foundation). KFF is a not-for-profit endowment organization that provides information on health issues to the nation.
