WASHINGTON — 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.”
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 10 to 15 milligrams of nicotine in it.
“The issue is not the nicotine; it’s the combustion,” Gottlieb said, 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,” Gottlieb said 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,” Gottlieb said. “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.”
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