The FDA Knew Doctors were Wrongly Prescribing Opioids

As one of the most important and powerful agencies in America, the Food and Drug Administration is responsible for a great deal. In addition to overseeing testing and approval for drugs and medical devices, the FDA also coordinate criminal investigations and compliance enforcement of illegal activities involving FDA-regulated products. This system is designed to protect the public from the unscrupulous use of high-risk drugs and devices, but it only works if it’s actually enforced. According to an expert panel from the Johns Hopkins Bloomberg School of Public Health, the FDA not only knew that several doctors were wrongly prescribing some of the most powerful opioids on the market, they did nothing to investigate or deter them.

Transmucosal immediate-release fentanyl (TIRF) products are among the most powerful opioids available, typically used to treat breakthrough cancer pain in patients who have developed a tolerance to standard opioids. They are especially potent – often as much as 100 times more powerful than morphine – and can be deadly if given to patients who have not built up a tolerance to opioids.

Using the FDA’s own documents, obtained via Freedom of Information Act (FOIA) requests, the team from Johns Hopkins uncovered some truly disturbing findings.

 “Our preliminary findings indicate that the TIRF REMS program has generated red flags for years. There have been multiple warnings that many providers have been engaged in inappropriate prescribing, placing patients at risk. Our review also raises important questions for the committee’s consideration regarding the sponsors and FDA’s response to these warning signals and the potential need for significant changes to the TIRF REMS program moving forward.”

Johns Hopkins officials found that TIRF products were prescribed to patients who had no tolerance for opioids, and for conditions like migraines and dental pain. According to their analysis of the more than 25,000 patients receiving TIRFs, a staggering 51 percent were not opioid tolerant.

With drugs as powerful and dangerous as TIRFs, the FDA has a level of control over how they are prescribed. The FDA requires doctors to undergo training in the proper use of the drug, and they also have the authority to remove doctors from the program, preventing them from prescribing TIRFS in the future. Of course, this is only meaningful if the FDA bothers to investigate and enforce its own policy.

 “What we found was that there wasn’t a single prescriber reviewed, let alone decertified,” said Dr. Joshua Sharfstein, a former FDA deputy commissioner and member of the Johns Hopkins study team.

The opioid epidemic in America is out of control. In 2016, over 42,000 people were killed due to opioids. And if the government agency tasked with protecting citizens from dangerous drugs continues to stand impotently by and allow doctors to recklessly overprescribe powerful opioids for benign conditions, those numbers will only continue to skyrocket.

Wexler Wallace is currently involved in litigation against pharmaceutical manufacturers in relation to their marketing of prescription opioids. Click here to read the Johns Hopkins testimony to the U.S. Food and Drug Administration in full.