Opioid Abuse Crisis Must Be Solved: Califf

In what is likely his last public statement as FDA commissioner, before leaving as part of the change in administrations, Robert Califf chose to focus on the nation’s opioid abuse crisis and to offer his perspective on what needs to be done in the future. Writing in an FDA Voice blog post, Califf says it would be difficult to identify any community in America that has not been touched by friends, family members, or colleagues suffering from addiction and, far too often, losing their lives to it.

“We have taken a number of actions at FDA over the past several years to help reduce the number of people who become addicted, or who ultimately overdose from prescription opioids,” he writes. “We’ve improved product labeling, pushed for prescriber education, and encouraged the development of abuse-deterrent formulations. In addition, we have approved new intranasal and auto-injector forms of naloxone, products to reverse opioid overdoses, which can be administered by laypersons and are, therefore, better able to save lives.”

He says that as he prepares to turn over the “awesome responsibility of FDA commissioner” to the next administration, he feels compelled to call for public and private efforts in this area to continue and be strengthened. “In particular,” Califf writes, “I want to call on the pharmaceutical companies that manufacture and sell these drugs to dig deeper into their expertise and resources to prioritize finding solutions to this public health problem. I have consistently been impressed that the motivation to cure disease and improve quality of life for patients is shared across the spectrum of federal agencies, public health workers, healthcare providers, and scientists within the pharmaceutical industry. However, the financial incentives in the industry can lead to a focus on short-term profits instead of patient well-being. This is the time for both branded and generic drug companies to go beyond marketing and distribution plans and instead commit their expertise and resources to confronting the devastating negative consequences of a class of drugs that brings much needed pain relief when used appropriately.”

Califf concludes with seven priorities he hopes will be the focus of all working on the issue: 

•          encouraging appropriate prescribing by healthcare practitioners;
•          considering the family as well as the patient;
•          finding better ways to treat pain with new medications and with more holistic pain management;
•          improving how companies, professional societies, and academics communicate about their activities in this area;
•          finding new ways to curb diversion and misuse of opioids;
•          increasing pragmatic research to better understand how to implement appropriate pain therapy in general and use of opioids in particular; and
•         treating addiction as a disease, not as criminal behavior.

 “I leave FDA’s efforts to the many leaders at the agency who have been working tirelessly on this issue, and will continue doing so, and look forward to supporting public and private efforts to bring this epidemic to an end,” Califf says.