CNN - FDA chief: "Opioids are biggest crisis we face" - LICADD [4/12/18]
Channel: LICADD, Inc.
Date: 2018-04-12

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Originally posted on & copyright 2018: CNN https://www.cnn.com  Available here for informational purposes.

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(CNN) - Running the Food and Drug Administration is one of the toughest jobs in government. Running it for a boss with a record of firing political appointees adds another level of complexity.

Yet Dr. Scott Gottlieb, who took over the job in May, seems to be holding his own.

During the first eight months of his leadership, the FDA approved a record number of generic drugs (1,027), hastened the approval of a record number of novel drugs and biologics (56) and eliminated the backlog of "orphan" drug applications (200), drugs for rare diseases that won't make a profit.

Gottlieb's also taken on Big Tobacco with plans to reduce levels of nicotine in cigarettes and asked Endo Pharmaceuticals to remove Opana ER from the market, after it became apparent that the opioid was being widely abused by addicts and was associated with a serious outbreak of HIV and hepatitis C.

Recently, the FDA cracked down on kratom, a Southeast Asian herb with opioid-like effects often used for recreation and to fight withdrawal symptoms, and issued an alert on loperamide, the active ingredient in over-the-counter antidiarrheal medications such as Imodium AD. Sometimes called the "poor man's methadone," loperamide is being abused by those looking to keep their high, often taking upwards of 200 or 300 pills at a time.

"What we've learned is, you've got to jump on these things quickly," Gottlieb told CNN Chief Medical Correspondent Dr. Sanjay Gupta, "because they can evolve in ways that become very hard to put back in the box. And I think that's the lesson of the opioid crisis."
'Biggest crisis facing the FDA'

Gupta interviewed Gottlieb during his visit Wednesday to the National Rx Drug Abuse & Heroin Summit in Atlanta. One of the first topics: the national opioid crisis that President Trump has vowed to end.

"This is the biggest crisis facing the FDA," Gottlieb said. "But this crisis has gotten so big that it's beyond the purview of any one entity to really impact it in a very meaningful way. I think the way we're going to do so is by working together, not just at a federal level but also at a state and local level."

For his part, Gottlieb says the FDA will tackle one of the root causes of the problem: overprescribing.

"When you have tens of millions, even hundreds of millions of prescriptions being written, that's a lot of potential for abuse," Gottlieb told Gupta. "So, I think a key is to try to bring down overall exposure to these drugs."

He points to data the agency has recently collected showing that for most outpatient procedures, only one day of opioids is necessary to control pain. Yet doctors continue to prescribe "30 days of opioids for a tooth extraction."

"Even if they're not using it, those pills are going in the medicine cabinet, and they're becoming a river of drugs in our neighborhoods," Gottlieb added.

Overprescribing is common, Gottlieb said, because of the training many physicians underwent during medical school in the '90s and early 2000s, which advocated aggressive pain management.

"We now recognize that wasn't appropriate," he said, "So I think that there needs to be some effort to try and re-educate a generation of physicians."

To accomplish that, Gottlieb wants US physicians to undergo mandatory training on prescribing opioid analgesics. He suggests that training occur at the point when doctors obtain their DEA license, a registration required by the US Drug Enforcement Administration to prescribe controlled substances. It is renewed every three years. The new training could also go further, he said, and include treatment for addiction.

"So, at the very time you're educating them about the appropriate prescribing of opioids, you're also educating them about how to spot signs of abuse and treat it If they do have a patient who becomes addicted," Gottlieb said.

Though supportive of physician education, the American Medical Association has previously opposed federally mandated training that is "one size fits all."

In a December letter to the FDA, the association said, "We instead encourage the FDA to work to increase information about, use of, and dissemination of all of the effective strategies for treating pain and reducing the risk of opioid use disorders"....

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https://www.cnn.com/2018/04/05/health/fda-gottlieb-opioid-crisis-tobacco-crackdown/