Friday Feedback: Should Opioids Be FDA’s Top Priority?

Experts review agency’s actions thus far & offer additional strategies

https://www.medpagetoday.com/painmanagement/painmanagement/65433

During the new FDA Commissioner Scott Gottlieb’s first all-hands address to agency staff, he declared the opioid abuse epidemic as the agency’s “greatest immediate challenge.”

As opioid abuse and overdose deaths continue to rise, it’s clear that the crisis should be a public health priority. However, the jury is still out on what efforts the FDA can and should take to increase awareness and better manage the issue.

Do you agree that combatting opioid abuse should be the agency’s top priority? If not, what would you pick?

Petros Levounis, MD, Rutgers University: Yes, wholeheartedly! We are seeing a devastating increase in fentanyl and heroin use in our communities with increased rates of admissions and deaths.

Dessa Bergen-Cico, PhD, Syracuse University: I agree that combatting opioid abuse, specifically prescription opioid abuse and overprescribing, should be a top priority of the FDA.

Peter R. Martin, MD, Vanderbilt 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 psychiatric disorders, including opioid and other drug use disorders. Although there have been some advances in medication assisted treatment of opioid and other drug use disorders, these advances have received little priority for the pharmaceutical industry for a variety of reasons, including stigma associated with drug use disorders (“addiction”) and lack of financial incentives to pharmaceutical companies.

Timothy A. Collins, MD, Duke 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.

Sally Satel, MD, American Enterprise Institute: 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.

Jason M. Hockenberry, PhD, Emory University: To the extent it fits in the FDA purview, yes. This means FDA should really focus on the pipeline issues in pharmaceutical and device development related to the treatment of opioids, and pain management related treatments more broadly. The bigger immediate issues in the opioid epidemic are the purview of the DEA, CDC Center for Injury Prevention, SAMHSA, CMS, and the broader healthcare system, not FDA.

Lewis Nelson, MD, Rutgers University: No other FDA related issue is associated with the scope of consequences as is occurring with the opioid epidemic, but it is not just abuse. More important are complications of long-term use due to addiction, dependence, and hyperalgesia (worsening pain due to opioids), as well as overdose death. Therefore, this very realistically should be priority number one.

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

Joseph A. Boscarino, PhD, MPH, Geisinger Clinic: I’d say find a means to support more applied health system-level research among providers. This knowledge will help in development of more effective interventions at the healthcare delivery site.

Satel: Put special focus on development of non-addicting analgesics.

Levounis: The FDA has done a lot for the epidemic already, but further facilitating and promoting treatment of opioid use disorder with safe and effective medications, such as buprenorphine, is greatly needed.

Amol Patwardhan, MD, PhD, University of Arizona: Better education for primary providers and better public education campaigns.

Bergen-Cico: Require and mandate adequate training and education in addictions for healthcare professionals. It is not required and it is a major factor of what healthcare staff deal with in on a daily basis. Regulate advertising and direct marketing of prescription medications to consumers and revise practices of pharmaceutical reps being the main conduit of information for medications to doctors and nurse practitioners.

Collins: The FDA could require end-to-end tracking of every opioid medication. The ability to track from the manufacturer plant to the distribution center, then to pharmacy and patient pick-up, would significantly decrease the diversion of opioids to the illicit market. They can limit marketing of opioid products, require additional studies of longer duration for newly developed opioids, and potentially remove products from the market (if there is evidence of a safety issue).

Nelson: Overhauling the assessment of value — meaning the interplay of efficacy, safety, and cost, for all FDA regulated products would likely find that there is little basis for the ongoing approval and lax regulation of opioids for chronic pain. The FDA does not, however, currently take cost into account, and they occasionally lose sight of the risk/benefit relationship for a drug due to external forces, particularly legislative realities, pharmaceutical industry efforts, and vocal advocacy groups (which often have misaligned incentives).

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

Patwardhan: Very positive outcomes. Significant improvement in patients’ and physicians’ attitudes toward chronic narcotic therapy.

Collins: The previous efforts of the CDC (and to a lesser extent the FDA) have resulted in a much greater awareness of the problems with opioids, and increased discussion between patients and their provider regarding doses and need for opioid medications. Unfortunately, this does not appear to have altered the abuse or diversion of opioids, and does not yet appear to have decreased the rate of overdose and death from prescription opioids.

Martin: The CDC has done an incredible service by bringing the opioid use “epidemic” to the attention of most Americans through seminal publications that have identified the scope and cost of this problem. Unfortunately, the policy response to this crisis immediately led to a focus by the FDA on altering pharmaceutical formulations of opioids to make them less liable to abuse. In retrospect, this response seems overly simplistic and without true understanding of drug use disorders because limiting availability of abusable opioids has simply enhanced transition of the using population to illicit drugs like heroin that are now readily available throughout the country and expanding the epidemic.

Levounis: We have an increase in regulatory oversight of opioid prescribing with good results. Prescription monitoring programs and opioid labeling changes have already given us significant results. Making naloxone easily available to users has also helped decrease the lethality of the illness.

Hockenberry: CDC has helped coordinate efforts to implement public health policies, such as prescription drug monitoring programs and pain clinic laws, that are reducing opioid prescribing, and translating into lower rates of overdose deaths. 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.

Boscarino: Addiction use disorders are complex and multifactorial. The FDA and the CDC have worked within their regulatory limitations to address these issues. I think they have had an some impact, but as we see the list of casualties grow in our local towns and cities, most wish to see more done to prevent this epidemic.

Nelson: There has certainly been a greater recognition of the extent and complexity of the use of opioids to treat pain. Some of the good and necessary efforts, such as abuse deterrent formulations, are simply nibbling at the edges of the epidemic, while others, such as public access to naloxone, are akin to closing the barn door after the horse has escaped. What we need to see is primary prevention of the short- and long-term consequences of opioid use, which will require further shifting patients’, physicians’, and regulators’ understanding and expectations about the value of opioid use for pain.

Satel: The abuse deterrent re-formulation of OxyContin has been disappointing. Some users have shifted to heroin/fentanyl and others just use immediate-release generics. The substitution dynamic makes the problem very difficult.