- The FDA is expanding its efforts to address opioid abuse in 2019, with plans to utilize data analytics, implement new policies, and enhance research and innovation to combat the ongoing public health crisis.
In a recent press release, FDA Commissioner Scott Gottlieb, MD, discussed the FDA’s past actions to reduce opioid misuse, as well as the agency’s strategies for the upcoming year.
Gottlieb recognized the significant steps taken in 2018 to combat the epidemic, including the agency’s efforts to achieve more appropriate prescribing as well as increased opioid education among both patients and providers.
While Gottlieb acknowledged the progress made in recent years, he noted that there is still a lot of work to be done.
“The opioid crisis is one of the largest and most complex public health tragedies that our nation has ever faced. At the FDA, we’ve worked to learn from past mistakes, and we intend to make sure that we’re acting forcefully enough to address new threats that could extend this crisis,” Gottlieb said.
“In this epidemic, waiting for the accumulation of definitive evidence of harm left us a step behind a crisis that was evolving quickly, and sometimes furtively, in vulnerable communities that were too often being tragically ignored.”
In 2019, the FDA is planning to build on its efforts by creating a large-scale data warehouse. Funded by a $20 million grant, the warehouse will enable the agency to improve its data analytics capabilities and better evaluate social and clinical trends that may be contributing to the opioid crisis.
“This warehouse can facilitate data analytics, including machine learning algorithms, to help better assess vulnerability points in the population through predictive analytics, identify early trends that may be contributing to the epidemic, and target early regulatory changes to address the changing opioid epidemic,” Gottlieb said.
In addition to leveraging data analytics, the agency is using new policies to help reduce exposure to opioid analgesics, which will lead to lower rates of new addiction.
One such policy stems from the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) Act, which gives the FDA the authority to limit or curtail access to certain drugs after assessing the risks associated with illicit use of these drugs.
“We’re taking new steps to reduce exposure to opioid analgesics by helping to ensure that these drugs are appropriately prescribed, with dose, quantity and treatment durations that match the indication,” Gottlieb wrote.
“Passage of the SUPPORT Act has provided the FDA with important new authorities to assist in our effort to reduce the risk of addiction and misuse associated with opioid analgesics.”
The new law will enable the FDA to require that certain packaging be made available for opioids and other drugs that may present a serious risk of misuse or overdose. The agency is planning to implement the initial steps that would require such packaging in early 2019.
The agency is also planning to facilitate the discovery of alternative, non-addictive methods of treating pain.
“In 2019, we’ll be issuing updated guidance outlining the appropriate clinical endpoints and clinical trial approaches for the development of non-opioid drugs for use in the treatment of acute and chronic pain,” Gottlieb said.
“We’ll also advance new steps to promote the development of abuse-deterrent formulations of opioids by exploring new methods for analyzing and evaluating abuse-deterrent features; further evaluating the nomenclature used to describe these abuse-deterrent features; and facilitating development of science for generic versions of these products.”
Gottlieb noted that the FDA will also continue their efforts to target those who unlawfully market or distribute unapproved opioids, including illicit drugs brought into the country and those sold online.
The agency will hold its second Online Opioid Summit in April to discuss how to reduce the availability of opioids online, Gottlieb said. The first event, held in June 2018, resulted in major technology companies initiating effective strategies to combat online opioid sales.
“Since the initial Summit was announced, internet stakeholders have taken concrete steps to prevent the illegal sale of opioids through their platforms and services,” Gottlieb stated.
“For example, Google now deindexes websites based on our warning letters that cite the unlawful sale of opioids to U.S. consumers. Social media platforms such as Facebook and Instagram redirect users who are looking to buy opioids online to the Substance Abuse and Mental Health Service Administration National Helpline.”
It will take consistent innovation to overcome the opioid epidemic, Gottlieb said, but the agency is prepared to do the necessary work to reduce opioid misuse.
“Looking back across modern times, this is perhaps the biggest public health tragedy ever created through the deliberate actions of people,” he concluded.
“The opioid crisis took hold over the course of decades of action and inaction. Now, its scope is so large, and so devastating, its toll is self-evident. It will, unfortunately, take years of aggressive action to reverse its course for good. We won’t lose our focus on this fight.”