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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 5:10 PM
Updated: Apr 5, 2018 5:10 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."

Indiana Coronavirus Cases

Data is updated nightly.

Cases: 1524527

Reported Deaths: 20751
CountyCasesDeaths
Marion2077652558
Lake1010411517
Allen946081024
Hamilton73638551
St. Joseph65362761
Elkhart50026632
Vanderburgh48959530
Tippecanoe44411338
Johnson38772527
Hendricks36850462
Porter34709476
Madison29301547
Clark26328328
Vigo25941346
LaPorte23600313
Monroe23478249
Howard22382381
Delaware21877370
Hancock18857220
Bartholomew18433216
Kosciusko18124203
Warrick17207215
Wayne16474303
Floyd16129257
Grant15566299
Morgan14615232
Boone13622138
Noble11983142
Shelby11877152
Dearborn11825113
Henry11771201
Marshall11444171
Dubois11418152
Jackson10772104
Cass10380143
Lawrence10308221
DeKalb10292132
Huntington10277140
Gibson9749126
Montgomery9377144
Knox9162125
Harrison9157117
Whitley886771
Steuben8739105
Jasper8325116
Putnam8306100
Clinton827596
Miami8249135
Jefferson8030127
Wabash7914139
Ripley7278116
Adams6713103
Daviess6661130
Scott663586
White624484
Greene6159112
Clay615275
Decatur6062120
Wells6001120
Jennings600081
Fayette5886122
Posey561648
LaGrange535797
Randolph5171129
Washington511470
Owen5068100
Fountain482580
Spencer457456
Sullivan449866
Starke443986
Fulton440393
Orange435083
Jay419964
Rush418839
Perry397555
Carroll384549
Franklin382850
Vermillion363562
Pike327845
Parke327338
Tipton320675
Blackford275955
Pulaski275375
Newton235461
Brown233556
Benton221521
Crawford220132
Switzerland201414
Martin191822
Warren179522
Union172619
Ohio125216
Unassigned0759

Ohio Coronavirus Cases

Data is updated nightly.

Cases: 2496243

Reported Deaths: 31987
CountyCasesDeaths
Franklin2696772100
Cuyahoga2600613087
Hamilton1742641756
Montgomery1162791651
Summit1084961418
Lucas929121193
Butler82981963
Stark766321431
Lorain63976809
Warren52895489
Mahoning50955930
Lake47462611
Clermont46371452
Delaware40674220
Trumbull39527790
Licking38492416
Medina38487427
Fairfield35469349
Greene33906435
Portage32283366
Clark31960453
Richland29400444
Wood29143301
Allen25702403
Miami23931408
Muskingum23316255
Columbiana22903409
Wayne21965365
Tuscarawas19512428
Erie18531224
Ashtabula18489362
Marion18456235
Scioto17888214
Ross17287260
Pickaway16251181
Hancock16004232
Geauga15456229
Lawrence14746186
Belmont14033248
Union1403384
Huron13838184
Jefferson13519261
Sandusky13180200
Athens12624107
Knox12037201
Seneca11934204
Darke11316202
Ashland11157184
Washington11009172
Auglaize10785147
Crawford10333178
Shelby10308160
Brown9972145
Fulton9661154
Highland9632151
Guernsey9612122
Defiance9486137
Logan9403147
Clinton9299132
Mercer9015112
Madison8971111
Preble8428170
Williams8263138
Putnam8024136
Champaign7974113
Ottawa7909123
Jackson7763121
Perry7415102
Coshocton7345136
Morrow723984
Fayette703292
Pike658489
Hardin6532133
Gallia634391
Adams6159127
Van Wert6025121
Henry598196
Hocking5835105
Wyandot498894
Carroll4961101
Holmes4857167
Paulding421665
Meigs397774
Monroe313868
Harrison296362
Noble295652
Morgan289448
Vinton254646
Unassigned08
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