FDA chief: Opioids are 'biggest crisis facing the FDA'

Running the Food and Drug Administration is one of the toughest jobs in government. Running it for a boss with a reco...

Posted: Apr 5, 2018 4:10 PM
Updated: Apr 5, 2018 4:10 PM

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 last May, seems to be holding his own.

The opioid epidemic is the biggest crisis facing the FDA, Gottlieb says

Mandated physician training, proper drug labeling could help, he says

Tobacco is another key health crisis, and youth e-cig use must be curtailed

During the first 8 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 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 the over-the-counter anti-diarrheal Imodium AD. 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's 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 currently underway 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," said Gottlieb. "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 that 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 reeducate a generation of physicians."

To accomplish that, Gottlieb wants US physicians to undergo mandatory training on prescribing opioid analgesics. He suggests training occur at the point when doctors obtain their DEA license, a registration required by the US Drug Enforcement Administration to be licensed 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," said Gottlieb.

Though supportive of physician education, the American Medical Association has previously opposed federally mandated training.

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."

Gottlieb is also focusing on improving the labeling of drugs, with suggested prescribing standards for specific conditions and procedures. Those would be enforced, he says, with new packaging that contain only a few days of pills instead of a 30-day supply.

Despite the desire to control the flow of opioids, Gottlieb also points to the needs of those with chronic pain or undergoing major procedures such as open-heart surgery.

"We can't lose sight of people who have appropriate medical reasons to be using these drugs," he told Gupta. "And in some situations, opioids are the only thing that's going to work."

A crackdown on Big Tobacco

"Dramatically lowering smoking rates could be the single greatest intervention that we undertake over any reasonable period of time," Gottlieb told Gupta.

To do so, the FDA is proposing to lower the amount of nicotine, which is addictive, in cigarettes. On average, a cigarette has anywhere from 10 to 15 milligrams of nicotine in it.

"The issue is not the nicotine, it's the combustion," said Gottlieb, referring to the cancer-causing properties of the tar and other chemicals that are released into the body when smoking a cigarette. "Nicotine's not a completely benign substance but it doesn't cause cancer.

"The nicotine is what hooks people on the combustion," Gottlieb continued. "If we can get people who want access to nicotine on to medicinal products, for example, or products that don't have all the risks associated with combustion, we can save a lot of lives."

The FDA hopes that if nicotine levels in cigarettes are reduced to 0.4 milligrams, about 5 million adult smokers will quit within a year. They also project the regulatory action will keep another 33 million Americans from becoming regular smokers by 2100.

But Gottlieb says the FDA is not stopping there. The agency also plans to crack down on companies who are marketing e-cigarettes to America's youth.

"No kid should be using any tobacco product," said Gottlieb firmly. "We're going to be taking some enforcement actions very soon to target companies that we think are marketing products in ways that are deliberately appealing to kids."

Recent research shows that e-cigarettes are a gateway to regular smoking for adolescents, while other studies show that the 'e-juice' that produces vapor may contain harmful, even cancer-causing chemicals. Despite these concerns, e-cigarette use, or vaping, is on the rise among teens.

"If these trends continue, the viability of the e-cigarettes and vaping products as an alternative for adult smokers could be lost," said Gottlieb. "It just won't be acceptable.

"If the companies don't take certain actions on their own, it's going to force us to be more vigorous in the actions we would take as a regulator," he continued. "Blunt instruments which may have a much deeper effect on their business models."

Mississippi Coronavirus Cases

Data is updated nightly.

Confirmed Cases: 92432

Reported Deaths: 2792
CountyConfirmedDeaths
Hinds6931154
DeSoto535455
Harrison370771
Jackson335867
Madison319086
Rankin316174
Lee256166
Jones237678
Forrest231769
Washington216371
Lafayette205039
Lauderdale1990124
Bolivar177565
Oktibbeha174149
Lamar157733
Neshoba1529103
Panola142426
Sunflower139643
Lowndes138957
Warren137250
Leflore135380
Pontotoc121216
Pike120448
Monroe118265
Scott115925
Copiah115733
Coahoma111227
Holmes108558
Marshall107115
Grenada105035
Lincoln104953
Yazoo103529
Simpson100742
Union97724
Tate95037
Leake93735
Adams90936
Wayne87121
Pearl River85150
Marion83633
Prentiss80317
Covington79622
Alcorn76311
Newton75022
Itawamba74621
Tallahatchie74518
George74013
Winston72019
Tishomingo65336
Chickasaw64124
Attala64025
Tippah63716
Walthall59025
Clay56516
Hancock55720
Noxubee54015
Jasper53815
Clarke53138
Smith51814
Calhoun50612
Tunica47613
Montgomery45320
Claiborne45116
Lawrence42312
Yalobusha41514
Perry39417
Humphreys37215
Quitman3725
Stone34811
Greene33817
Webster32813
Jefferson Davis32311
Amite31110
Carroll31012
Wilkinson30117
Kemper28615
Sharkey26212
Jefferson2379
Benton2181
Franklin1873
Choctaw1775
Issaquena1033
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Alabama Coronavirus Cases

Confirmed Cases: 128818

Reported Deaths: 2284
CountyConfirmedDeaths
Jefferson18772333
Mobile12975289
Montgomery8598173
Madison742275
Tuscaloosa7081114
Lee560359
Shelby557250
Baldwin503348
Marshall378442
Etowah330645
Calhoun324939
Morgan314226
Houston264422
Elmore249747
DeKalb232619
St. Clair219835
Walker219180
Talladega203426
Limestone194219
Cullman180817
Franklin173428
Dallas173226
Russell16922
Autauga166424
Lauderdale161633
Colbert158126
Escambia155424
Blount152714
Jackson148511
Chilton146327
Covington130327
Dale130043
Coffee12488
Pike11359
Tallapoosa112983
Chambers111742
Clarke104617
Marion92128
Butler90638
Barbour8247
Marengo69619
Winston68712
Lowndes64527
Pickens62814
Bibb61910
Hale61028
Randolph59112
Bullock58514
Lawrence57820
Monroe5738
Geneva5564
Cherokee54816
Washington54513
Perry5366
Clay5317
Wilcox53011
Crenshaw51931
Conecuh51711
Macon46720
Henry4594
Sumter41719
Fayette4159
Choctaw34412
Lamar3372
Cleburne3166
Greene30015
Coosa1603
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