FDA takes action against 21 websites marketing unapproved opioids as part of agency’s effort to target illegal online sales

01, September 2018

Taking a tough line against websites marketing unapproved opioids online, the FDA has issued Warning Letters against four online networks that were managing as many as 21 websites that it found to be marketing illicit opioids, including the highly dangerous tramadol. The Warning Letter demands that this group of websites stop the online sale of these drugs immediately and reply to the agency within 10 working days. The four companies that have been served this notice are CoinRX, MedInc.biz, PharmacyAffiliates.org and PharmaMedics.

This warning to this set of websites brings to 13 the total number of Warning Letters the FDA has issued to over 70 websites only this summer. This series of strong actions by the agency is part of the US Department of Health and Human Services (HHS)’ initiative, its 5-Point Strategy to Combat the Opioid Crisis, to which the FDA has lent its support.

Part of serious initiative on controlling online opioid sales

Cracking down on internet traffic in illicit drugs is one of the focal points of this strategy. The Internet has become a relatively safer hiding place for illegal online pharmacies, drug dealers, and others in their league, as detection and subsequent consequences are harder to enforce.

The FDA is anguished that the online illicit sale of opioids has continued despite its requirement that FDA-approved tramadol carry boxed warning. The boxed warning is the FDA’s most serious warning and is reserved only for drugs that carry serious side effects that could include even death. Manufacturers of these medicines are required to prominently mention the adverse side effects of the drug on a conspicuous box on the product, which in the case of tramadol include:

• Addiction, abuse, or misuse
• Life-threatening respiratory problems
• Withdrawal symptoms in newborn babies
• Coma or death when taken with other central nervous system depressants such as alcohol

Follow up to earlier initiatives

This strict action against illegal online sale of websites marketing unapproved opioids is neither sudden or impulsive. It is part of the FDA’s ongoing active policy of combating this menace. It follows a similar crackdown in June, at the end of which month the FDA held an Online Opioid Summit, which was attended by internet stakeholders and thought-leaders, government entities, academic researchers, and advocacy groups.

At this summit, ways by which the availability of illegal opioids online could be reduced by collaborating and enforcing stronger action on this area formed a major part of the discussion. In addition to making an in-depth research into the ease with which illicit opioids are obtained online and what the industry can do about it, the summit also held an intense roundtable discussion for identifying gaps and proffering new solutions. Following the conclusion of this summit, the FDA has continued to be in constant touch with the participating organizations and says it will continue to do so in the future

The FDA wants to keep up its commitment to address the US-wide opioid addiction crisis with a multipronged approach. Some of these include:

• Focusing on bringing about a decrease in the exposure to opioids
• Taking steps to prevent new addiction
• Extending support to treating opioid use disorder addicts
• Nurturing the development of novel pain treatment therapies and opioids to which abuse, misuse and addiction are relatively lesser
• Enforcing legal action against those who play a part in the illegal importation and sale of opioids
• Evaluating the scenario in the legal as well as illicit opioid market and making efforts to regulate it as needed