Experts Weigh In On FDA's Role Combating Opioid Epidemic

Experts Weigh In On FDA's Role Combating Opioid Epidemic

President Trump's newly appointed FDA Commissioner, Scott Gottlieb, told his first gathering of agency staff last week that "unquestionably, our greatest immediate challenge is the problem of opioid abuse." Gottlieb said the opioid epidemic is "a public health crisis of staggering human and economic proportion" and is a problem that the FDA "cannot solve alone." But the FDA has an important role to play by "giving health care providers the tools to reduce exposure to opioids to only clearly appropriate patients." The new Commissioner, who was previously senior advisor to former FDA commissioner Mark McClellan and was later Deputy Commissioner, acknowledged work already done but said "the epidemic has continued to grow." "I'll be working with FDA's senior career leadership and in the coming weeks hope to have more to say on how we take even more forceful steps to address this crisis," Gottlieb told his staff. "Addressing this tragedy is going to be one of my highest initial priorities."

What does the field think?

Industry magazine MedPage Today polled a cross-section of physicians and academics to get a feel for Gottlieb's remarks. Answers ranged from "Yes! Absolutely!" to a clear and simple "No." But all responses reveal thoughtfulness, if not agreement, on how the FDA should proceed. (Answers have been edited for brevity.)

Q1: Do you agree that combating opioid abuse should be the agency's top priority? If not, what would you pick?

"Yes, wholeheartedly! We are seeing a devastating increase in fentanyl and heroin use in our communities with increased rates of admissions and deaths." Petros Levounis, MD, Rutgers University "I agree that combating opioid abuse, specifically prescription opioid abuse and overprescribing, should be a top priority of the FDA." Dessa Bergen-Cico, PhD, Syracuse University "No. Combating opioid abuse should be a priority, but not the top priority for the FDA. The FDA's top priority should be combating the needless increase in the cost of prescription medications." Timothy A. Collins, MD, Duke University "I do not believe the FDA can do anything truly transformative to combat this problem. Where the FDA may help is in facilitation of the development of medications for...opioid and other drug use disorders [which have] received little priority from the pharmaceutical industry for a variety of reasons including...lack of financial incentives." Peter R. Martin, MD, Vanderbilt University "Yes. With no infectious epidemics raging and the death toll from opioids rising, it is a top priority. But I would put easing regulations for electronic cigarettes as a close second." Sally Satel, MD, American Enterprise Institute "FDA should really focus on the pipeline issues related to the opioids...and pain management related treatments more broadly. The immediate issues are the purview of the DEA, CDC, SAMHSA, CMS, not FDA." Jason M. Hockenberry, PhD, Emory University "No other FDA related issue [has] the scope of consequences as the opioid epidemic. But it's not just abuse. More important are complications of addiction, dependence, hyperalgesia and overdose death." Lewis Nelson, MD, Rutgers University

Q2: What can the FDA actually do about opioid abuse that it isn't already doing?

"Find a means to support more applied health system-level research among providers [to] help develop more effective interventions." Joseph A. Boscarino, PhD, MPH, Geisinger Clinic (A multisite physician-led health care system in Pennsylvania) "Better education for primary providers and better public education campaigns." Amol Patwardhan, MD, PhD, University of Arizona "Put special focus on development of non-addicting analgesics." Satel "Further facilitating and promoting treatment of opioid use disorder with safe and effective medications, such as buprenorphine, is greatly needed." Levounis "Mandate adequate training and education in addictions for healthcare professionals...what healthcare staff deal with on a daily basis." Bergen-Cico "Require end-to-end tracking of every opioid medication from manufacturer to distributor to pharmacy to patient pick-up [to] decrease diversion to the illicit market." Collins "Regulate advertising and direct marketing of prescription medications to consumers and revise pharma reps as the conduit of medication info to doctors." Bergen-Cico "Assessment of efficacy, safety, and cost...would find little basis for the ongoing approval and lax regulation of opioids for chronic pain. FDA loses sight of the risk/benefit relationship." Nelson

Q3: What effects, if any, have you seen from previous efforts by the FDA and CDC to combat opioid overuse and abuse?

"Significant improvement in patients' and physicians' attitudes toward chronic narcotic therapy." Patwardhan "A much greater awareness of the problems and increased discussion regarding doses and need of opioids. Unfortunately [this has not] decreased the rate of overdose and death." Collins "CDC identified scope of epidemic [but] FDA's focus on abuse deterrence [was] overly simplistic without true understanding of drug use disorders [and] simply enhanced transition to illicit drugs like heroin." Martin "More needs to be done to get those with opioid use disorders into treatment, and these issues involve financing and other issues outside of FDA and CDC purview." Hockenberry "Abuse deterrent formulations are simply nibbling at the edges of the epidemic. Public access to naloxone [is] akin to closing the barn door after the horse has escaped." Nelson "Abuse deterrent reformulation of OxyContin has been disappointing. Users shifted to heroin/fentanyl and others just use immediate-release generics." Satel Those of us working in the recovery industry welcome increased official and regulatory attention to solving the problems. But we agree that new and more effective ideas are definitely needed.

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