FDA Chief: Long-Awaited Opioid Review Still in the Works

A long-awaited review of prescription opioid medications, including their risks and contribution to the U.S. overdose epidemic, is still underway at the Food and Drug Administration, the agency’s commissioner said Tuesday.

Dr. Robert Califf wrote in a blog entry that the FDA is still studying “what revisions are needed to support appropriate use” of opioid painkillers like OxyContin and Vicodin. The update comes as part of a broader outline of the FDA’s ideas for combating drug misuse and addiction.

Califf promised to conduct a full review of FDA’s approach to opioids, including their prescribing instructions, to clinch Senate confirmation early this year. He told the Associated Press last month that the public would soon hear “a lot more about this.”

But Tuesday’s update is unlikely to appease his critics, including five Senate Democrats who voted against his nomination, largely over concerns that the FDA hasn’t taken bolder action to reduce opioid prescribing and misuse.

It’s not the first attempt at a reset on opioids for the FDA — or even for Califf. During his brief stint as FDA commissioner at the end of the Obama administration, Califf had also vowed to conduct a “sweeping review” of opioids.

Last year, U.S. overdose deaths soared to a record of 107,000, driven overwhelmingly by fentanyl and other illegal opioids. Opioid prescriptions have fallen about 40% in the last decade but deaths tied to the medications remain at 13,000 to 14,000 per year.

Califf’s post lays out a framework for combating drug addiction and overdoses overall, focusing on reducing inappropriate prescribing, developing new addiction and overdose therapies and shutting down suppliers of illicit drugs.

But many of the agency’s specific ideas have failed to gain traction.

For example, a recent FDA proposal that would require pharmacies to dispense “mail-back” envelopes with every opioid prescription has faced resistance from pharmacists, drugmakers and other groups. Elsewhere the FDA has tried for nearly a decade to require doctors and other health professionals to undergo training in safe opioid prescribing. That effort has been stalled over questions of whether it requires action by Congress. Medical societies generally oppose any blanket requirement.

Califf said another priority will be approving an over-the-counter version of naloxone, the medication that can reverse opioid overdose. Most states have passed measures allowing pharmacists to dispense the drug without a prescription, but experts say an over-the-counter version would further expand access.

(Source)

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