FDA Targets Websites Selling Illicit Opioids

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration is trying to put more teeth into efforts to stop the sale of unapproved or misbranded opioid medications online.

The FDA has launched a pilot program with the National Telecommunications and Information Administration (NTIA) that could result in online pharmacies being blocked or having their domain names suspended for selling illicit opioids. The NTIA is a branch of the U.S. Commerce Department that is responsible for telecommunications and information policy issues.

Under the pilot program, the FDA will notify three internet registries – Neustar, Verisign and Public Interest Registry – when the agency sends a warning letter to a website operator for selling opioids illicitly and the operator does not respond adequately within the required time frame. The internet registries could then voluntarily block or suspend the website domains, which would effectively take them offline.

“Stopping abuse of illegal opioids, including those sold online, has been one of President Trump’s top health priorities. The men and women of FDA have worked tirelessly over the years with the private sector and federal partners, like NTIA, to fight illegal online opioid sales,” Health and Human Services Secretary Alex Azar said in a statement.

For now, according to an FDA spokesperson, the pilot program will not target websites selling kratom, an herbal supplement that the agency considers an opioid.

“Websites selling kratom are not being included in this pilot at this time,” the spokesperson said in an email to PNN. “FDA continues to express concerns about kratom, which affects the same opioid brain receptors as morphine and appears to have properties that expose users to the risks of addiction, abuse, and dependence.”

In recent years, the FDA has sent hundreds of warning letters to rogue online pharmacies that sell counterfeit drugs or illegal medication. When they are caught, the websites often reappear under new domain names or move offshore.

‘Our Best Selling Product’

Sometimes the letters are simply ignored. For example, in September 2019, the FDA sent a warning letter to Euphoria Healthcare, which operates an online pharmacy called “Generic Wellness.” The letter warned Euphoria about selling the opioid tapentadol under the name “Aspadol” – a generic version of Nucynta. The FDA considers Aspadol to be an unapproved and misbranded drug, and gave Euphoria 15 days to respond to the letter or face possible civil or criminal charges.

Nine months later, Generic Wellness not only continues marketing Aspadol, it calls the drug “our best selling product” and claims the company is a “well known online pharmacy for selling FDA approved high quality generic medicines.”

The FDA had better luck with a March 2019 warning letter to the online pharmacy “The Don Rx” for selling misbranded versions of the opioid tramadol. That website has apparently been blocked or is no longer operating.  

The FDA’s new pilot program is apparently the result of meetings the agency had with internet stakeholders and registries to discuss ways to collaboratively stop sales of illicit opioids online. As a result of those meetings, Google began to de-index websites named in FDA warning letters, and social media platforms like Facebook and Instagram redirected users looking to buy opioids to a government run help line.

How to Connect When You Have No Connection

By Barby Ingle, Columnist

A friend of mine who is going through a rough time physically and financially has shared a thought about the people who get left behind.

We often assume that everyone is online. The truth is about 16% of American adults do not use the internet and most of them are elderly, disabled and in households with incomes of less than $30,000, according to a study by Pew Research.

What can those who have limited or no access to the online world do to stay e-connected? I did a little research and found some ways that may be helpful.

As an Extreme Time Cheater, I like to save time, effort, and energy. Although I have internet access at home, living with chronic pain still limits my life and resources. For instance, if my internet service were to go down, I don’t have a vehicle to get to a library and I’d be out of luck. My living situation is very rural and isolated.  

One of the things I would miss immediately is the ability to Google a location, fact or a phone number. When phone books come to the house from our phone company, I typically put them in the recycle bin, but I will keep my next phone book for the time when I may actually need it.

When it comes to groceries, I typically order them online to save time. Some delivery services have a fee, so I use Safeway because they offer free delivery on orders over $100. When there is a charge it is typically $5 to $10, which is very reasonable. They also let customers call in their orders if they don’t have internet access, and they don’t allow their delivery drivers to accept tips. I have my driver bring the groceries right into my kitchen. 

Next time you are at a doctor’s office or hospital, check to see if they have any support groups for people with your condition or chronic pain in general. Even if you can’t keep up with the group online, you can see them at local meetings. Having someone to connect with on an emotional level that is going through similar life challenges is really important when you are isolated most of the time. 

You can keep a hand written calendar to keep track of doctor appointments and life events on paper. Back before the internet I would take blank paper and a straight edge and make my own calendars to stay organized.  

When it comes to phone numbers, who memorizes them these days? But if you lose your cell phone service, what can you do? I keep a written notebook of all of the phone numbers and addresses in my cell phone so that if I ever lose it, I have a backup in writing and can still make a call to family or friends when needed.

Finally, advocacy. We often ask, “Where are all of the pain patients?” Why aren’t more people involved in advocacy efforts? I would venture to say that a large number are physically and financially limited, and many do not have that e-connection we all covet. How do we reach them and how can they help spread the word about chronic pain and its effects on society?

People with internet access should speak up for those who can’t be heard, recognizing the commonalities that we all share. Offline advocates can look at more traditional strategies, such as setting up a meeting at your legislator’s office or speaking to a local support group. Offline advocating is just as important as sharing a tweet or blog, or posting a comment online. 

Remember that not everyone is plugged into the chronic pain community online. Those who are not still need support, education, and assistance. They also need to have their voices heard. Let’s pay more attention and start listening to those who are currently e-voiceless.  

Barby Ingle suffers from Reflex Sympathetic Dystrophy (RSD) and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation. She is also a motivational speaker and best-selling author on pain topics.

More information about Barby can be found at her website.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.