The effort to curb prescription drug abuse in America is getting a new top dog in federal drug safety oversight, and the recipient isn’t your average doctor and patient advocate. Before heading the country’s top drug safety agency, Robert Califf was the top medical drug exec at a pharmaceutical industry trade group and an aggressive FDA critic. Yet he was nominated by Barack Obama to lead the Food and Drug Administration, and now he’s one step closer to taking the helm there.
A drug-safety expert at Duke University, Califf is a fixture on the front lines of discussions about how to mitigate the rise of prescription drug abuse. In his work as the FDA’s chief medical officer, he regularly suggests alternatives to the agency’s current model, which he believes is too bureaucratic and lacks flexibility. In 2009, Califf explained his frustration with the antiquated system to the press:
“Here’s the situation,” Califf said. “The FDA is not always aware of the kinds of problems with the pharmaceutical manufacturers that physicians are complaining about. So it’s very, very difficult for the FDA to have the kinds of conversations with companies when they’re not sure the agency is on top of the situation.”
As FDA commissioner, Califf is likely to carry on the commissioner’s aggressive efforts to reform drug approval standards. In an episode of Public Radio International’s In the Public Interest, Califf explained in more detail what the FDA’s current drug approval framework—the process by which the agency decides which drugs to approve—is not equipped to deal with, particularly the rise of unsafe medical conditions:
“[In my] experience at Duke,” Califf said, “there is a strong reluctance on the part of most doctors to prescribe any sort of medication to treat a condition that has not been completely purged. And that’s a phenomenon that extends far beyond pain or the environment. It also extends to life-threatening and serious conditions, such as heart disease, where disease has been assessed and determined to be no longer life-threatening or serious. And so patients who are in that situation want to be reassured of the need for the medications they’re taking.”
As the FDA’s chief medical officer, Califf could have more influence than usual over the agency’s current struggle to contain prescription drug abuse. For some perspective on the scale of the challenge facing the FDA and the agency’s potential change at the helm, here’s a running diary of some of the most prominent efforts underway to curb the epidemic. Some highlights include evidence suggesting the FDA has failed to regulate opioids to their likely dangers, a widespread opioid shortage, steps to tighten requirements on Medicaid and Medicare benefit underwriting opioids, and the use of digital tools and metrics to measure progress. The new commissioner has yet to be formally confirmed, but he has been nominated by president Trump to lead the FDA.