Six and a half years later and in his second tenure as the FDA chief, Califf is still working the problem.
On Tuesday in a blog post, Califf said the agency was still studying what measures are needed to “support appropriate use” of painkillers such as Purdue Pharma’s OxyContin.
“While the FDA’s previous strategies have largely focused on opioid use and overdoses, the evolving nature of the overdose crisis calls for both a new approach and honest reflection about what the FDA can do differently moving forward,” Califf wrote.
To that end, Califf has introduced an Overdose Prevention Framework, a strategy targeting unnecessary prescriptions, prolonged prescribing and counterfeit drugs, while promoting the development of treatments for substance use disorders and education programs for doctors.
In 2021, the United States saw a record 107,000 drug overdose deaths, Califf pointed out, four years after the opioid crisis was classified as a public health emergency, which remains in effect. The Substance Abuse and Mental Health Services Administration estimates (PDF) that 18.4 million people are addicted in the U.S., with Black, American Indian and rural people most affected.
In his blog post, Califf also said that the agency would work to expand access to overdose reversal products such as naloxone and is encouraging the industry to develop over the counter and generic versions of the product.
In securing his nomination earlier this year, Califf cited opioid abuse as a priority. For decades, Congress has criticized the FDA for approvals and labeling of painkillers.
“The goal is not looking back to cast blame,” Califf told Bloomberg on Tuesday. “It’s looking back to understand the basis for the decisions and ask the question: Knowing what we know now, should we think about things differently?"