FDA Chief Criticizes Industry for Inaction on Opioids

Califf: ‘We are all sinners,’ but drug firms bear special responsibility

http://www.medpagetoday.com/Psychiatry/Addictions/58950

How many more parts of the Federal alphabet soup of agencies is going to get involved with how our health system deal with treating chronic pain and the mental health disease of addictive personality disorder ?

WASHINGTON — The new head of the FDA accepted some blame for the agency’s role in the growing opioid epidemic, while also chiding drug manufacturers for failing to take action.

“[W]e are all sinners,” said FDA Commissioner Robert Califf, MD, recalling the words of his Baptist grandfather.

“I think in this case, there’s a lot of sin to go around.”

Califf spoke to provisional members of a newly formed committee charged with advising his agency on how best to balance the needs of legitimate pain patients with the societal issue of opioid addiction. At the meeting, held at the National Academies of Sciences, Engineering, and Medicine on Wednesday, Califf said he’s spoken with R&D directors at most of the big drug companies and none have shown interest in investing in research on new non-addictive painkillers.

He told the committee that when it comes time to make recommendations, “I don’t think corporate responsibility should be off your list of things to emphasize. There’s a lot of money being made on opioids, and my view is if you make a lot of money on something, you do have some social responsibility for casualties of your success when they occur.”

The guidance the committee develops is intended to update the 2011 Institute of Medicine report “Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research.”

One committee member, Traci Green, PhD, MSc, an epidemiologist at Boston University Medical Center, noted that the update is especially needed, since the words “addiction,” dependence,” and “overdose” are nowhere to be found in the 2011 report.

In 2014, the CDC estimated there were 28,647 opioid-related deaths that year and that opioid overdoses had quadrupled since 2000.

In explaining the committee’s charge, Califf and his colleagues homed in on the issue of how to incorporate public health into a benefit-risk evaluation that has traditionally focused on the individual. He asked the committee what it would tell an advisory group about how to weigh the societal effects against the patient-prescriber effect.

For comparison, he looked to the problem of antimicrobial resistance: “We’re telling physicians to change their habits, not necessarily because it would have a devastating impact on the patient in front of them, but [because of] the impact it would have on the ecosystem.”

The FDA is also changing labeling so that veterinarians can no longer prescribe antibiotics for animal feed without first examining the animals and giving a diagnosis.

But, in trying to find strong examples of balancing individual risk with societal risk in the area of antibiotic resistance, Douglas Throckmorton, MD, deputy center director for regulatory programs at the FDA, said he and others researching this internally have yet to find broad research that says, “here’s how you do this.” That’s what the FDA needs the committee’s help to do, he said.

He noted that studies of development have explored this balance, but “it’s not a place where a lot has been written.”

Committee members also asked Califf about the agency’s limitations around revising its benefit-risk assessment.

Califf encouraged the committee to push the limits.

“Do free-range thinking, but check-in mid-course … there’s nothing wrong with saying there’s a need for a new set of laws if that’s what you believe, but that would just take a much longer period of time,” he said.

Another wrinkle in Wednesday’s meeting was the composition of the committee itself: Four provisional members were dropped prior to the meeting, including two specifically singled out last week by Sen. Ron Wyden (D-Ore.) for potential conflicts of interest — Mary Lynn McPherson, PharmD, and Gregory Terman, MD, PhD. A public relations representative for the National Academy of Sciences said she could not give the reason for their exclusion, citing NAS policy.

The spokesperson said that NAS is continuing the process of vetting committee members — current members are still provisional — and that a 20-day public comment period will be used for any members added in the future.

The committee will hold a public workshop on Sept. 22, 2016, and all members will be confirmed before that meeting, she said.