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Regulatory Focus™ > News Articles > 2 > Gottlieb: FDA Looking Beyond Opioids in Overdose Epidemic

Gottlieb: FDA Looking Beyond Opioids in Overdose Epidemic

Posted 15 February 2018 | By Michael Mezher 

Gottlieb: FDA Looking Beyond Opioids in Overdose Epidemic

As the US Food and Drug Administration (FDA) grapples with the ongoing opioid overdose epidemic, FDA Commissioner Scott Gottlieb said the agency is taking steps to proactively identify emerging issues related to prescription drug abuse.

At a public workshop on strategies for the safe use and appropriate prescribing of opioids, hosted by the Duke Margolis Center for Health Policy in Washington, DC, Gottlieb said he is focused on reducing the number of patients who become addicted to prescription drugs by looking to new sources of abuse and stronger risk management tools.

According to the latest data from the US Centers for Disease Control and Prevention (CDC), deaths from drug overdoses rose more than 20% from 2015 to 2016. Of the roughly 64,000 overdose deaths in the US in 2016, more than 42,000 were attributable to opioids, with 40% of those cases involving prescription opioids.

However, as the overdose epidemic has shifted from overprescribing of short-acting prescription opioids to cheaper and more dangerous alternatives, such as illicit fentanyl, Gottlieb said FDA is looking to the internet and social media to identify new problems before they spiral out of control.

"We sharply increased the number of agents we have working the dark web looking for sources of fentanyl," he said.

Gottlieb also said that FDA is actively looking into the potential misuse and abuse of gabapentinoids, a class of drugs that includes Pfizer's Neurontin (gabapentin) and Lyrica (pregabalin), which have been approved to treat a number of conditions such as postherpetic neuralgia, fibromyalgia and neuropathic pain.

While Gottlieb said that gabapentinoid abuse does not appear to be widespread, the agency's preliminary data shows that abuse of these drugs, either alone or in combination with opioids and other central nervous system (CNS) depressants, may be on the rise.

Within the last year, a number of publications have cited gabapentinoid use as a potential emerging area of prescription drug abuse, including the New England Journal of Medicine, Physician Medicine & Rehabilitation and Drugs.

"We've looked at social media sites where opioid users share comments that describe methods and motivations for misusing or abusing gabapentinoids," Gottlieb said, adding that the agency has tasked its surveillance and epidemiology group with looking for early patterns of abuse related to gabapentinoids.


Gottlieb also said that a national e-prescribing system for controlled substances, such as the one proposed in the Every Prescription Conveyed Securely Act, introduced by Rep. Katherine Clark (D-MA) in July, could help reduce prescription drug abuse and strengthen efforts to reduce the risk of certain prescription drugs.

"It would allow us to think differently about our [risk evaluation and mitigation strategy] REMS program," Gottlieb said, adding that FDA could use a system to institute requirements for drop down menus for prescription duration and prompts for certain drugs.

Gottlieb added that a national e-prescribing system would address issues with interoperability seen with the myriad of state prescribing systems and prescription drug monitoring programs.

Right now, Gottlieb said, "You can't look across state lines. If you're a border physician you can't see what a patient might be doing in another state."



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