The U.S. Food and Drug Administration and the U.S. Drug Enforcement Administration have issued joint warning letters to four online networks, operating a total of 10 websites, illegally marketing unapproved and misbranded versions of opioid medicines, including tramadol, that are potentially dangerous. The warning letters issued to each of the networks state that they must immediately stop illegally selling these opioids to American consumers. This joint action demonstrates the federal government’s commitment to enhance interagency coordination to respond to the opioid crisis.
“As the FDA works to forcefully tackle the opioid crisis on all fronts, we cannot allow rogue online pharmacies to continue to fuel the crisis by illegally offering opioids for sale and circumventing the important safeguards that have been put in place for opioids to help protect the public health,” said Acting FDA Commissioner Ned Sharpless, M.D. “Today’s effort is also noteworthy because while the FDA partners regularly with the DEA, this is the first time we have issued joint warning letters with them. This action further strengthens the warning to the operators of these websites. We remain committed to using all available regulatory and enforcement tools to stop the illicit flow of opioids online.”
Patients who buy prescription medicines, including opioids, from illegal online pharmacies may be putting their health at risk because the products, while being marketed as authentic, may be counterfeit, contaminated, expired or otherwise unsafe. Additionally, several of these websites offer opioids online without a prescription, posing significant risks to patients. The FDA remains concerned that the easy availability of opioids online further fuels the crisis. As noted in the warning letters, these websites offer for sale opioids that are misbranded and unapproved new drugs, including unapproved tramadol, in violation of the Federal Food, Drug, and Cosmetic Act. In addition to health risks, illegal online pharmacies can pose other risks to consumers, including credit card fraud, identity theft and computer viruses.
The networks also violated the Controlled Substances Act (CSA) by failing to register their online pharmacies with the DEA despite knowingly or intentionally advertising the sale of controlled substances, including opioids. The CSA has, among other provisions, requirements that must be met for controlled substances (including opioids) to be legally distributed and dispensed via the internet. For example, an entity must be registered with the DEA to specifically dispense controlled substances; none are currently registered with the DEA to dispense or distribute controlled substances online.
“Issuing these warning letters is not only an effort to deter the availability of dangerous illegal opioids, but it is also a testament to the close cooperation between DEA and FDA,” said Acting DEA Administrator Uttam Dhillon. “We will continue to attack organizations that facilitate the sale of dangerous drugs, putting profit over public safety.”
The illegal sale of these opioids is particularly concerning because the FDA-approved tramadol carries a boxed warning, the agency’s most prominent warning, indicating that the drug carries a significant risk of serious or even life-threatening side effects. The boxed warning for tramadol addresses risks including addiction, abuse, misuse, life-threatening respiratory depression (breathing problems) and neonatal opioid withdrawal syndrome (withdrawal symptoms in newborn babies). In addition, when taken with other central nervous system depressants, including alcohol, tramadol’s use may result in coma or death.
The networks receiving warning letters include:
The FDA and DEA have requested responses from each of the companies within 15 working days. The companies are directed to inform each agency of the specific actions taken to address the violations noted in the warning letters. Companies that fail to correct the violations, as outlined in the warning letters, may be subject to legal enforcement action.
Opioid addiction is an immense public health crisis. Addressing it is one of the FDA’s highest priorities and supports the U.S. Department of Health and Human Services’ 5-Point Strategy To Combat the Opioid Crisis. Illegal online pharmacies, drug dealers and others continue to use the internet to further their illicit distribution of opioids, where the risk of detection and repercussions is significantly reduced.
The FDA has been active in combating the illegal online sales of opioids. In May and August 2018 and in March of this year, the FDA issued a similar series of warning letters. Earlier in 2019, the FDA hosted internet stakeholders and thought-leaders, government entities, academic researchers and advocacy groups at its second Online Opioid Summit to discuss ways to collaboratively take stronger action in combatting the opioid crisis by reducing the illicit availability of opioids online. The second summit focused on collaboration with internet registries and registrars. The DEA also participated in the FDA’s Online Opioid Summits to explore more proactive approaches in collaboration with internet stakeholders to crack down on the illegal sales of opioids online. Topics that were addressed during the first summit included: research into the ease with which opioids can be purchased online and industry approaches to addressing opioids marketed online, followed by a roundtable discussion to identify gaps and new solutions.
The FDA remains committed to addressing the national crisis of opioid addiction on all fronts, with a significant focus on decreasing exposure to opioids and preventing new addiction; supporting the treatment of those with opioid use disorder; fostering the development of novel pain treatment therapies and opioids more resistant to abuse and misuse; and taking action against those who contribute to the illegal importation and sale of opioids. The agency will also continue to evaluate how opioids currently on the market are used, in both medical and illicit settings, and take regulatory action where needed.
The U.S. Department of Justice’s Narcotic and Dangerous Drug Section attorneys assigned to the DEA’s Special Operations Division and Policy Unit assisted in drafting the warning letters sent to these websites.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
September 30, 2019