The FDA considers how safe and effective a new drug is before approving it. But for addictive opioid painkillers, which have triggered a massive public health crisis, should the agency also weigh the potential for the medication to be abused?
That’s one of the questions that new FDA Commissioner Scott Gottlieb is posing as he takes the reins of the nation’s drug regulator. The FDA has a role to play in addressing the opioid crisis, and its regulatory tools could help ensure that prescription medications are used only under the right circumstances, he wrote in a blog post on Tuesday. Reducing the scope of the nationwide epidemic, he said, is “my highest initial priority.”
Nearly 2 million Americans abused or were dependent on prescription opioids in 2014, the most recent government figures available, Gottlieb noted. Emergency rooms treat more than 1,000 people each day for misusing prescription opioids. Deaths linked to such drugs topped 33,000 in 2015—most of them involving prescription medication.
In his confirmation hearings last month, Gottlieb called the nation’s opioid abuse crisis a public health emergency, one that requires “the full gamut of public resources.” Gottlieb made no formal policy plans regarding the opioid crisis in his blog post Tuesday, but he did announce the formation of an “Opioid Policy Steering Committee” comprised of senior FDA officials now tasked with developing strategies to curb abuse.
In a message sent by email to the committee, and repeated in his blog, Gottlieb posed three questions. First, whether the FDA should mandate education to physicians to make them aware of the risks of abuse. Second, how the FDA’s role in crafting risk management plans could apply to opioids. For example, many pain-killing medications are needed for only two or three days. But in many cases, prescriptions are filled for 30 days. Perhaps the FDA should work with physician organizations to develop prescribing standards for opioids to make sure each patient’s individual needs are met, Gottlieb wrote. And third, whether the agency’s drug approval process should also consider the risks of potential abuse and misuse of new therapies.
Gottlieb’s thoughts on risk management follow one of the goals of the opioid action plan started last year by his predecessor, Robert Califf. That plan led to stricter warnings on the labels of opioid medications, draft guidance to support the drug industry’s development of non-addictive, generic versions of approved opioids, and a mandate that drug companies conduct post-approval studies to get a better understanding of the long-term risks of extended-release/long-acting opioids.
Gottlieb said that the steering committee will seek public feedback on additional steps that the FDA should consider. It’s not yet clear how the FDA’s efforts will work with other federal efforts to fight opioid addiction. In March, President Trump issued an executive order that created a commission to fight drug addiction and opioid abuse. But the president’s initial budget plans proposed deep cuts to the Office of National Drug Control Policy, which has programs that some drug treatment supporters say help fight opioid addiction. On Tuesday, Richard Baum, acting director of the agency, told CNN that the scope of those cuts has been reduced, leaving $27.8 billion for drug control efforts.