Despite Pharma claims, the illegal drug supply in the US is not full of opioids. This is Generic Viagra.

For years, the FDA has defended its efforts to intercept prescription drugs coming from overseas through the mail as it is necessary to keep dangerous opioids, including fentanyl, out of the way.

The pharmaceutical industry often cites such concerns in its fight to thwart Washington’s many proposals to allow Americans to buy medicines in Canada and other countries where prices are almost always much lower.

But the agency’s own data in recent years on seizures of drug parcels arriving via international mail provide scant evidence that significant quantities of opioids are being shipped this way. In the two years that KHN received data from the agency, only a small proportion of the drugs tested contained opioids.

The vast majority were over-the-counter prescription drugs that people ordered, presumably because they couldn’t afford the prices at home.

The Food and Drug Administration (FDA) is still suspending these drugs because they lack US labeling and packaging, which federal officials say ensures they were manufactured under US control and traceability.

The FDA said that in 2022, out of nearly 53,000 drug shipments screened by its inspectors at international postal services, 33 mail-order packages of fentanyl-free opioids were found. This is approximately 0.06% of packages tested.

According to a detailed breakdown of drugs intercepted in 2020, the lion’s share of what was intercepted – and most often destroyed – was pharmaceuticals. Item #1 was cheap erectile dysfunction pills like generic Viagra. But there were also prescription drugs for asthma, diabetes, cancer and HIV.

FDA spokesman Devin Koontz said the numbers don’t tell the whole story because US Customs and Border Protection is the primary screening of mail facilities.

But data from the customs agency shows that it also detected few opioids: of more than 30,000 drugs intercepted in 2022 at international postal facilities, only 111 were fentanyl and 116 other opioids.

On average, Americans pay twice as much for the same drugs as people in other countries. In a survey, 7% of American adults said they didn’t take medication because they couldn’t afford it. About 8% admit that they or someone in their family ordered medicines from abroad to save money, although this is technically illegal in most cases. At least four states – Florida, Colorado, New Hampshire and New Mexico – have offered programs to allow residents to import medicines from Canada.

Although the FDA has found only a relatively small number of opioids, including fentanyl, in international mail, Congress awarded the agency a total of $10 million in 2022 and 2023 to expand efforts to curb the supply of opioids and other unapproved drugs.

“The additional staffing, combined with improved analytics and data analysis techniques, will not only allow us to screen more packages, but will also improve our targeting capabilities to ensure we screen packages with a high likelihood of containing incompatible products,” said Dan Solis, Assistant Commissioner. for import operations to the FDA.

But drug importers fear that increased screening for opioids will lead to more unscheduled substances being blocked in the mail.

“The FDA continues to ask taxpayers for more and more money to stop fentanyl and opioids from international postal services, but it appears to be using that money to deny and destroy more and more regular international prescription drug orders.” said Gabe Levitt, president of PharmacyChecker.com, which accredits foreign online pharmacies that sell drugs to customers in the US and around the world. “The argument that drug imports will fuel an opioid crisis doesn’t make any sense.”

“The country’s fentanyl import crisis should not be confused with safe personal drug imports,” Levitt said.

He wasn’t surprised by the small number of opioids coming through the mail: in 2022, an organization he leads called Prescription Justice obtained 2020 FDA data at the request of the Freedom of Information Act. This showed that FDA inspectors intercepted 214 packages of opioids and no fentanyl from approximately 50,000 drug shipments. On the contrary, they found almost 12,000 packages of erectile dysfunction pills. They also blocked thousands of packages of prescription drugs for a variety of other conditions.

More than 90% of drugs found in international mailers are destroyed or banned from entering the United States, according to FDA officials.

In 2019, an FDA document touted the agency’s efforts to prevent fentanyl from entering the United States by mail amid efforts to prevent other illegal drugs.

Levitt was pleased that Congress added language to the federal spending bill in December that he says would refocus FDA mail inspections. It states that “The FDA’s efforts with respect to international postal services should be focused on preventing controlled, counterfeit, or otherwise dangerous pharmaceuticals from entering the United States. In addition, funds allocated under this law should give priority to cases where importation poses a serious threat to public health.”

Levitt said the wording should shift the FDA from halting supplies containing drugs for cancer, heart disease and erectile dysfunction to blocking controlled substances, including opioids.

But the FDA’s Kunz said the wording won’t change the type of drugs FDA inspectors check because every drug is potentially dangerous. “Importing medicines from overseas just to save money is not a good enough reason to expose yourself to additional risks,” he said. “The drug may be fine, but we don’t know, so we assume it’s not.”

He said that even drugs that are made in the same manufacturing facilities as those intended for sale in the United States can be dangerous because they do not have US labels and packaging that guarantee they were produced properly and processed within the US supply chain.

FDA officials say drugs bought from overseas pharmacies are 10 times more likely to be counterfeit than drugs sold in the United States.

To support this claim, the FDA cites a Congressional testimony from a former agency employee in 2005 who, while working at a drug industry-funded think tank, said that 8% to 10% of the global drug supply chain is counterfeit.

The FDA has said it does not have data showing which drugs it finds are unsafe counterfeits and which drugs are not properly labeled or packaged. US Customs and Border Protection data shows that among more than 30,000 drugs tested in 2022, 365 counterfeits were found.

Pharmaceutical Research and Manufacturers of America, a trade group for the industry, is funding a non-profit advocacy organization called the Safer Medicines Partnership, which has campaigned in the media to counter drug importation efforts, arguing that it will exacerbate the fentanyl epidemic.

Shabbir Safdar, executive director of the Safe Medicines Partnership, a group funded by US pharmaceutical manufacturers, said he was surprised that the amount of fentanyl and opioids found in the mail by customs and FDA inspectors was so low. He said that historically this has been a problem, but was unable to provide evidence for this claim.

He said federal agencies are not checking enough packages to get the full picture. “With limited resources, we can be fooled by smugglers,” he said. “We need to check the correct 50,000 packages every year.”

For decades, millions of Americans looking to save money have bought their medicines from overseas pharmacies, with most of the sales done over the Internet. Although the Food and Drug Administration (FDA) says people are not allowed to bring prescription drugs into the United States except in rare circumstances, dozens of cities, counties, and school districts help their employees buy drugs from overseas.

In 2020, the Trump administration said drugs could be safely imported and provided states with the option to apply to the FDA to start import programs. But the Biden administration has yet to approve any.

In February, a federal judge dismissed a lawsuit filed by PhRMA and the Safer Medicines Partnership to block the federal drug import program, saying it was unclear when the federal government would approve any state programs.

Levitt and other import advocates say the process is often safe, largely because drugs sold to people with valid prescriptions via international mail are FDA-approved drugs with different labeling than those found in U.S. pharmacies or foreign versions of approved drugs. FDA drugs manufactured in the USA. the same facilities as drugs sold in the US or similarly regulated facilities. Most of the drugs sold in US pharmacies are already made overseas.

Due to the sheer volume of mail, the FDA said even though the FDA has increased its post office staff in recent years, the agency can physically check less than 1% of packages suspected of containing drugs.

Solis said the agency is focusing its efforts on cutting off shipments from countries it believes counterfeit or illicit drugs are most likely to come from.

Import supporters say attempts to block it protect drug industry profits and hurt U.S. residents trying to afford their drugs.

“We have never seen a surge in deaths or harm from prescription drugs that people bring across the border from verified pharmacies because they are the same drugs that people buy from American pharmacies,” said Alex Lawson, chief executive of Social Security. Works, which advocates lower drug prices. “The pharmaceutical industry uses the FDA to protect its price monopoly and keep prices high.”