FDA to Revisit Opioid Labeling for Chronic Pain

Watch FDA to Revisit Opioid Labeling for Chronic Pain - Bloomberg on Dailymotion

Transcript

00:00Talk to us about opioids. Did the FDA fail?

00:02The FDA did fail. There were many parts of our health care system that failed.

00:08Look, I feel terrible about the opioid epidemic.

00:11I personally prescribed opioids with misinformation.

00:15It was taught to me by my chief resident in my surgical residency.

00:19And we sort of woke up to this problem around 2014, 2015,

00:25and thought, oh my God, what have we done?

00:28What information did we not have?

00:30I think it was regulatory capture at the agency.

00:32Now, we can't prove that, but when the reviewer immediately goes to work for Purdue Pharma

00:37after approving OxyContin for chronic pain,

00:40and the approval for chronic pain was based on a 14-day study.

00:44Have we seen the last chapter of that?

00:46No. We're going to look at the label for OxyContin and that class of medications

00:51and ask how can we ensure that it's accurate and consistent with the science.

00:56How does your approach to science and common sense avoid the next OxyContin?

01:01One of the first actions I took was to remove all industry members of FDA advisory committees

01:07wherever statutorily possible.

01:10And so we've got to preserve that scientific process,

01:12and we've got great scientists that are doing that right now.

01:16The second thing is that we need to have eyes on a drug and device the second it's approved

01:21and keep eyes on those drugs.

01:23We shouldn't be learning 19 years after OxyContin was approved

01:27that it may have killed nearly a million Americans in its downstream effects with other drugs.

01:34We should be able to approve a drug and with big data, go into big data with our eyes,

01:41with our epidemiologists, and watch a drug to see if there are safety signals that emerge.

01:47One of the broken things about the FDA that I learned just last week was that bureaucrats at the FDA

01:56had the ability, a small group had the ability to block a safety epidemiology study

02:01by our own safety epidemiology team.

02:06And so we are announcing we're getting rid of that ability to block a safety evaluation,

02:11and we want that safety team to work freely without any barriers.

02:17There's a bit of a conflict of interest if you're the team that approved a drug.

02:21You may not want to be embarrassed to learn that there's a safety signal down the road.