FDA's Gottlieb: Opioid Epidemic Always 5 Steps Ahead of Us

FDA's Gottlieb: Opioid Epidemic Always 5 Steps Ahead of Us

Speaking to a National Press Club Luncheon in Washington, D.C., recently, FDA Commissioner Dr. Scott Gottlieb said, "We've watched over a 10 or 15 year period this epidemic grow in proportion. And even as we've tried to take measures to intervene in various ways, the epidemic was always 5 steps ahead of us and always growing well out of proportion to what anyone anticipated."

The opioid epidemic is "a unique threat to the country," Dr. Gottlieb said, "and requires very dramatic action on the part of public health authorities to get in front of it."

He said that to try to get ahead of it now, we need to be willing to take much more dramatic action and be much more potentially intrusive in what we might have to do - beyond what might have been our "comfort zone" 5 or 10 years ago.

"Having failed to intervene hard enough at the time when we might have been able to quell the epidemic - and I was at the FDA for part of that period of time - and having failed to recognize how this epidemic was going to grow in proportion and take vigorous enough action, I think we need to be far more vigorous so we don't continue to make that mistake."

Fewer prescriptions, shorter durations of doses

The FDA is focused on the devastating opioid addiction crisis in America, and among several actions the FDA is planning are two key responsibilities: the rate of new addiction, and fostering treatments that also help people remain sober.

"As you know, this is a top priority of the administration and, as such, the FDA has an important role to play in every aspect of this crisis. But two of our key obligations are FDA's influence on the rate of new addiction, and our impact on the availability and use of treatments that can help people live lives of sobriety.

"Science based evidence shows that the key to reducing new addiction is to reduce exposure to opioid drugs in the clinical setting," Dr. Gottlieb said. "This means making sure that fewer prescriptions are written, and shorter durations of doses are dispensed."

Dr. Gottlieb said many people who become addicted to opioids will become "medically addicted." Their first exposure is often through a lawful prescription for an immediate release formulation of an opioid drug.

"We recently released a Federal Register notice that will begin a process at the FDA to evaluate, and perhaps implement, steps to reduce exposure to opioids through our influence on prescribers," he said. "Some of the steps we're evaluating are how we require doctors to be educated, our role in regulating how products are packaged, and how doses are dispensed based on indication, among other influences we believe we can have on bending the rate of new addiction."

Reconsidering risks and benefits

The agency is also "reconsidering how we address risk and benefit to make sure we're taking appropriate measure of the risk associated with misuse and abuse of opioid drugs, both as part of our pre- and post-market review," he said.

An example of this approach came earlier this year when the FDA asked Endo Pharmaceuticals to withdraw Opana ER from the market, based on a new analysis of the risks associated with the drug's illicit use. Opana ER, an extended release, tamper- or abuse-resistant formulation of the opioid oxymorphone hydrochloride, drove one the deadliest outbreaks of HIV/AIDS and Hepatitis C in a decade, along with overdose deaths, among addicts in Indiana.

Studies showed that the formulation, when abused and injected, released an excipient that caused autoimmune phenomena that contributed to the alarming spread of disease associated with its abuse. The drug was also more prone to injection than other abuse-resistant formulas in use today.

"I recently have seen media reports stating that Endo is participating in a re-launch of the old version of Opana ER," Dr. Gottlieb said. "This is the version of that drug that Endo had previously withdrawn from the market when it launched its reformulated version of Opana - because that older version didn't purport to have abuse deterrent features."

The Commissioner said he wouldn't speak about regulatory intentions regarding specific drugs, but that the agency will "address oxymorphone products more generally." He said a study already commissioned is looking at the possibility that oxymorphone "is more likely to be abused than other Schedule II opioids, including through illicit routes of administration such as snorting and injection."

"I'm announcing that study for the first time. If the scientific results of this study demonstrate that this ingredient has qualities that make it more likely to be abused, FDA would consider taking regulatory actions that could limit patient exposure to oxymorphone."

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