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Opioids: A First For The FDA

Written by Michael A. Walsh


On June 8, 2017, for the first time ever, the Food and Drug administration took “steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse.” The product is an opioid known as Opana ER that had been approved in 2006 for long term around-the-clock management of moderate-to-severe pain.

In 2012, the company reformulated the opioid tablet product in an attempt to make it resistant to abuse by snorting or injecting. Even though the product met the regulatory standards for approval, the FDA determined that the data did not support any meaningful reduction in abuse and declined the company’s request to label the reformulated product as possessing abuse-deterrent properties.

The FDA’s decision came after an FDA advisory committee of independent experts found that the risks of the reformulated product outweighed the benefits. The FDA advisory committee reviewed post marketing data that demonstrated consumers were misusing the tablet, by inhalation and injection. This product misusage was associated with an outbreak of HIV, hepatitis C, and a serious blood disorder (thrombotic microangiopathy).

The FDA Commissioner, Scott Gottlieb, M.D., put it this way:

“[W]e are facing an opioid epidemic – a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse. We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse.”

The opioid crisis is unique in a number of ways not the least of which is consumer’s intentionally misusing the product in a manner known to create an increased risk of bodily injury or death. The United States is also unique in its consumption of opioids. The U.S. comprises about 5% of the world’s population yet consumes 80% of the opioids produced.

According to reports, the number of prescriptions filled in some states exceeds the number of residents.  Couple these statistics with the growing medical literature questioning the safety and efficacy of long term opioid therapy and what emerges is a clearer picture of the unintended consequences of treating chronic pain with opioids.

In the mid-1990s, it was not uncommon for practitioners to prescribe opioids long term to control pain. As the treatment pendulum begins its slow and reluctant swing towards alternative non-opioid treatment modalities and pre-1990s opioid prescribing patterns, state and federal regulatory authorities, legislatures and private stakeholders, including manufacturers, distributors, dispensers, hospitals, healthcare providers, employers, payors, schools and municipalities should reexamine their own policies and practices to determine whether they adequately balance the risk and benefit of opioid use for their constituents.

If nothing else, this extreme action by the FDA is an indication of the severity of the opioid issue facing the nation.  There are many products in our society that consumers intentionally and knowingly misuse, that result in serious harm or risk of harm or death, e.g. drinking alcohol and operating automobiles. But opioid addiction is an altogether different circumstance. And the evidence suggests that ordinary principles of deterrence alone will not be enough to address the factors that contribute to this public health crisis.


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