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Is the FDA Misleading Congress About the Safety of Imported Medicines?

FDA misleads Congress about drug importation

Properly licensed foreign pharmacies help Americans access medicines that they can’t afford here. Counterfeit drug makers and sellers, fentanyl and opioid dealers, and dangerous pharmacy websites are worthy targets of serious regulatory or criminal enforcement actions. There’s no gray there.

An article I wrote that was recently published in The Nation hopefully brings to greater public attention the FDA’s conflation of clearly safe channels for personal prescription imports with counterfeit drugs, the opioid crisis, and rogue online pharmacies. That conflation, one associated with the media relations work of the pharmaceutical industry – is used to justify FDA enforcement actions that exacerbate the crisis of high drug prices by threatening programs that facilitate prescription fulfillment from foreign, licensed pharmacies.

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Want to go to jail for illegal drug importation? Here’s how…

People buying medications to fill prescriptions in Canada or other countries because prices are too high domestically don’t get prosecuted for it. But people who import drugs illegally and resell them—especially controlled drugs, like prescription opioids, benzodiazepines, and amphetamines— get busted and go to jail for a pretty long time. Even seemingly small-time drug dealers.

As reported in Madawaska, Maine’s local news WABI5, Tristan Nelson was sentenced to a year and a half behind bars for illegally importing 950 pills of Ritalin (an amphetamine) and 450 pills of Xanax (a benzodiazepine) from the Philippines with intent to sell.

Of note is that neither of the medications was a prescription opioid, which is the highest enforcement priority of the U.S. FDA. Addiction to non-opioid controlled drugs, however, is also a public health problem, and clearly law enforcement takes illegal imports of them seriously.

The short story reported in WABI5 simply noted: “Nelson admitted to investigators he ordered the pills and planned to sell them.” It did not say how he ordered them, such as from a rogue online pharmacy, but perhaps I’ll find his court documents later this month to find out more.

Rogue online pharmacies selling controlled drugs for import, and domestic drug dealing, menace the Internet. But according to government data, they are not a major factor in the nation’s crisis with drug addiction and overdose.

FDA enforcement actions leading to prosecution, fines and/or jail for illegal drug importation focus on illegal wholesale importation of all prescription drugs, whether controlled or non-controlled prescription drugs. While it prioritizes counterfeit drugs, the illegal imports can be lawfully-manufactured, safe and effective. Recently, its focus is on stopping imports of fentanyl, mostly its ingredients. Part of that battle is stopping Internet activity that leads to the illegal fentanyl trade. Such ingredients, ordered online and then imported, are used to make fake opioid prescription drugs, which have exacerbated our nation’s crisis with drug addiction and overdose.

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FDA Warns 21 Online Pharmacies to Stop Selling Unapproved Opioids

FDA Crackdown on Illegal Online PharmacyThe FDA is warning 21 online pharmacies to stop selling certain prescription opioid drugs to people in the U.S.

According to the FDA, the 21 websites at issue are operated by four separate networks:

CoinRx,

PharmacyAffiliates.org,

PharmaMedics,

and MedInc.biz.

Each network received a similar warning letter from the FDA, which singles out their alleged illegal sales of unapproved and misbranded tramadol, also noting that a prescription was not required.

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