Megan Brooks

In response to the ongoing opioid abuse epidemic, top officials at the US Food and Drug Administration (FDA) today announced plans to reassess the agency's approach to opioid medications.

"We are determined to help defeat this epidemic through a science-based and continuously evolving approach," Robert Califf, MD, the FDA's Deputy Commissioner for Medical Products and Tobacco, said in a news release. "This plan contains real measures this agency can take to make a difference in the lives of so many people who are struggling under the weight of this terrible crisis."

The plan is further outlined in an article published online today in the New England Journal of Medicine.

"Nationally, the annual number of deaths from opioid overdoses now exceeds the number of deaths caused by motor vehicle accidents," write Dr Califf and coauthors Janet Woodcock, MD, and Stephen Ostroff, MD, also from the FDA. "Regardless of whether we view these issues from the perspective of patients, physicians, or regulators, the status quo is clearly not acceptable. As the public health agency responsible for over-sight of pharmaceutical safety and effectiveness, we recognize that this crisis demands solutions. We are committed to action, and we urge others to join us."

The multicomponent plan will focus on policies aimed at reversing the epidemic, while still providing pain patients access to effective medication. Specifically, the FDA plans to:

* Re-examine the risk-benefit paradigm for opioids and ensure that the agency considers their wider public-health effects;

* Convene an expert advisory committee before approving any new drug application for an opioid that does not have abuse-deterrent properties;

* Assemble and consult with the Pediatric Advisory Committee regarding a framework for pediatric opioid labeling before any new labeling is approved;

* Develop changes to immediate-release opioid labeling, including additional warnings and safety information that incorporate elements similar to those of the extended-release/long-acting (ER/LA) opioid analgesics labeling that is currently required;

* Update Risk Evaluation and Mitigation Strategy requirements for opioids after considering advisory committee recommendations and review of existing requirements;

* Expand access to, and encourage the development of, abuse-deterrent formulations of opioid products;

* Improve access to naloxone and medication-assisted treatment options for patients with opioid-use disorders; and

* Support better pain-management options, including alternative treatments.

The FDA says they will seek guidance from outside experts in the fields of pain management and drug abuse. The agency has already asked the National Academy of Medicine to assist in developing a framework for opioid review, approval, and monitoring that balances an individual's need for pain control with considerations of the broader public-health consequences of opioid misuse and abuse.

The FDA says it will convene independent advisory committees made up of physicians and other experts when considering approval of any new opioid drug that does not contain abuse-deterrent properties. The agency will also convene a meeting of its standing Pediatric Advisory Committee to provide advice on a framework for pediatric opioid labeling and use of opioid pain medications in children.

The FDA also plans to tighten requirements for drug companies to generate postmarket data on the long-term impact of using ER/LA opioids, an action, they say, that will generate the "most comprehensive data ever collected in the field of pain medicine and treatments for opioid use disorder. The data will further the understanding of the known serious risks of opioid misuse, abuse, overdose and death."

Drug overdose deaths, driven largely by overdose from prescription opioids and illicit drugs like heroin and illegally-made fentanyl, are now the leading cause of injury death in the United States.

"Things are getting worse, not better, with the epidemic of opioid misuse, abuse and dependence," Dr Califf said in the FDA statement. "It's time we all took a step back to look at what is working and what we need to change to impact this crisis."

"Agencies from across the Department of Health and Human Services and throughout the federal government are united in aggressively addressing this public health crisis," US Health and Human Services (HHS) Secretary Sylvia M. Burwell, said in the news release. "The FDA is a vital component to combating this epidemic, and the innovation and modernization they have committed to undertaking is an important part of the overall efforts at HHS."

Last spring, HHS announced a major initiative to address the opioid abuse epidemic in the US. The initiative focuses on informing opioid prescribing practices, increasing the use of naloxone, and using medication-assisted treatment to move people out of opioid addiction.

The FDA says it will provide updates on progress with the goal of sharing timely, transparent information on a regular basis.
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NEJM. Published online February 4, 2016. Abstract

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More people died from drug overdoses in the United States in 2014 than during any previous year on record, with increases in opioid overdose deaths the driving factor, according to new statistics released today by the US Centers for Disease Control and Prevention (CDC).
In 2014, opioid overdose deaths, including deaths from the use of opioid painkillers and heroin, hit record levels, with an "alarming" 14% increase, the CDC said.
The death rate from the most commonly prescribed opioid pain relievers (natural and semisynthetic opioids) rose 9%, the death rate from heroin jumped 26%, and the death rate from synthetic opioids, a category that includes illicitly manufactured fentanyl and synthetic opioid pain relievers other than methadone, spiked 80%.



"Nearly every aspect of the opioid overdose death epidemic worsened in 2014," the CDC said.
Their analysis of National Vital Statistics data was reportedDecember 18 in the Morbidity and Mortality Weekly Report.
During 2014, a total of 47,055 drug overdose deaths occurred in the United States, representing a 1-year increase of 6.5%, from 13.8 per 100,000 persons in 2013 to 14.7 per 100,000 persons in 2014. Rates of opioid overdose deaths jumped significantly, from 7.9 per 100,000 in 2013 to 9.0 per 100,000 in 2014, a 14% increase.
In 2014, opioids were involved in 28,647 deaths, or 61% of all drug overdose deaths; the rate of opioid overdoses has tripled since 2000, the CDC said.

"Increases in prescription opioid pain reliever and heroin deaths are the biggest driver of the drug overdose epidemic. Deaths from heroin increased in 2014, continuing a sharp rise that has seen heroin overdoses triple since 2010. Deaths involving illicitly made fentanyl, a potent opioid often added to or sold as heroin, also are on the upswing," the CDC notes in a news release.

Drug overdose deaths have increased in both men and women, in non-Hispanic whites and blacks, and in adults of nearly all ages, the CDC said. Rates of drug overdose deaths were highest in West Virginia, New Mexico, New Hampshire, Kentucky, and Ohio.

Intertwined Drivers
The CDC says two distinct but intertwined trends are driving the overdose epidemic in the United States: a 15-year increase in deaths from prescription opioid pain reliever overdoses as a result of misuse and abuse, and a recent surge in illicit drug overdoses driven mainly by heroin overdoses. Both of these trends worsened in 2014.

The agency reports that more than 6 of 10 drug overdose deaths in 2014 involved opioids, including opioid pain relievers and heroin. The largest increase in opioid overdose deaths involved synthetic opioids (not including methadone), which were involved in 5500 deaths in 2014, nearly twice as many as in 2013.

Heroin-related death rates jumped 26% from 2013 to 2014, totaling 10,574 deaths in 2014. "Past misuse of prescription opioids is the strongest risk factor for heroin initiation and use — especially among people who became dependent upon or abused prescription opioids in the past year. The increased availability of heroin, its relatively low price (compared to prescription opioids), and high purity appear to be major drivers of the upward trend in heroin use, overdoses, and deaths," the CDC notes.

Call to Action
"The increasing number of deaths from opioid overdose is alarming," CDC Director Tom Frieden, MD, MPH, said in a statement. "The opioid epidemic is devastating American families and communities. To curb these trends and save lives, we must help prevent addiction and provide support and treatment to those who suffer from opioid use disorders. This report also shows how important it is that law enforcement intensify efforts to reduce the availability of heroin, illegal fentanyl, and other illegal opioids."

The CDC said the new data point to four ways that overdose deaths may be prevented:

• Limit initiation into opioid misuse and addiction through education of healthcare providers;
• Expand access to evidence-based treatment of substance use disorder, including medication-assisted treatment, for people with opioid use disorder;
• Protect people who have opioid use disorder by expanding access to and use of naloxone;
• Get state and local public health agencies, medical examiners and coroners, and law enforcement agencies to work together to improve detection of and response to illicit opioid overdose outbreaks.

Earlier this year, US Health and Human Services Secretary Sylvia Burwell announced a targeted initiativeaimed at reducing prescription opioid- and heroin-related overdose, death, and dependence. The evidence-based approach focuses on three areas: informing opioid prescribing practices, increasing the use of naloxone, and using medication- assisted treatment to cure people of opioid addiction.
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MMWR Morb Mortal Wkly Rep. Published online December 18, 2015. Full text


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