Responding to criticism, FDA takes action on opioid oversight
The agency's proposed new rules will require drugmakers to conduct studies examining the effectiveness of their medications for chronic conditions.
The FDA has come under bipartisan fire in recent years for its oversight of opioids. Treatment advocates and lawmakers have blamed the agency for turning a blind eye to the widespread abuse of prescription medication, both by approving powerful new opioids for medical use and for failing to put in place effective rules to prevent inappropriate prescriptions.
The agency has proposed new rules that will require drugmakers to conduct studies examining the effectiveness of their medications when used for chronic conditions.
The rules aim to address the fact that doctors are often prescribing highly addictive drugs to treat chronic pain. Many experts have argued that powerful opioids should only be used occasionally to treat acute pain.
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Notably, the FDA approved the use of OxyContin for chronic pain with no evidence that it can effectively reduce pain in the long-term.
“There are certain important questions that we could answer by properly studying the chronic administration, looking at the efficacy over time,” explained FDA Commissioner Scott Gottlieb in recent testimony to a Congressional committee.
Experts have highlighted a number of medical practices that have facilitated widespread opioid addiction. Not only have those dealing with chronic conditions become addicted to painkillers due to what were likely inappropriate prescriptions, but prescriptions often include far more pills than necessary to deal with the pain that is being targeted, such as recovering from wisdom tooth removal.
Painkiller addiction has played a major role in fueling an explosion in heroin use, as opioid addicts who have exhausted their prescriptions turn to a cheaper fix on the street. Since 2017 nearly 50,000 Americans have died of opioid overdoses.
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