New FDA chief calls for ‘forceful’ opioid action
New leader aims to reduce duration of prescriptions.
Scott Gottlieb calls battling the addiction crisis highest priority, weighs mandatory doctor training.
Scott Gottlieb, the new head of the Food and Drug Administration, called on his staff Tuesday to explore “additional, more forceful steps” to curb the opioid crisis — and especially to find ways to reduce the number of new cases of addiction.
Calling the epidemic his “highest initial priority,” Gottlieb suggested that the agency consider mandatory education for doctors about the dangers of opioids and work to ensure that patients aren’t prescribed the medications for unnecessarily long periods that increase the risk of addiction.
“Patients must be prescribed opioids only for durations of treatment that closely match their clinical circumstances and that don’t expose them unnecessarily to prolonged use,” he wrote in a blog post on the FDA website. He made the same points in an “all-hands email” sent to the FDA’s 18,000 employees and obtained by The Washington Post.
As a first step in ratcheting up the agency’s role, he announced the creation of an Opioid Policy Steering Committee made up of senior FDA officials to develop new strategies for confronting the epidemic. He charged the panel with exploring three areas:
■ Whether the FDA should require education for health-care professionals to ensure they are informed about public health recommendations involving opioids, how to identify the risk of abuse in individual patients and how to get addicted patients into treatment. Last year, an FDA advisory panel urged the agency to implement mandatory training, but the agency has not done so. Several physician groups adamantly oppose such a requirement.
■ Whether and how the agency should take additional steps to ensure that the number of doses prescribed patients are “more closely tailored” to the patients’ medical needs. Only a few medical conditions require a 30-day supply of opioids, he said; many conditions can be managed with a two- or three-day course of medication. He said the FDA might have to work closely with provider groups to develop standards for appropriate prescribing in various clinical situations. He noted that studies show that for someone whose first experience with opioids is for 30 days, the likelihood is 35 percent that he or she will continue to use opioids after one year.
■ Whether the FDA is using the “proper policy framework” to assess the risk of misuse as part of the approval process. Should the agency, in other words, weigh more heavily a drug’s potential for abuse when it clears the drug for sale?
The new opioid committee will be run by Rachel Sherman, deputy FDA commissioner for medical products and tobacco, Gottlieb said in the email to employees.
The commissioner noted that in 2015, opioids were implicated in the deaths of more than 33,000 people, and that most of the fatalities involved prescription opioids.
The FDA has been criticized by some in the public health community and on Capitol Hill for not moving more forcefully to counter the opioid crisis.
Some have complained, for example, that the FDA approved OxyContin for use by children without first convening an expert panel for advice. And during Gottlieb’s confirmation process, some Democratic senators said he wasn’t the right person to fight the epidemic because of his previous ties to the pharmaceutical industry.
Some of the same complaints were leveled against Robert Califf, Gottlieb’s predecessor.
In February 2016, Califf, then the agency’s deputy commissioner, launched an anti-opioid plan that included enhanced safety warnings for immediate-release opioid pain medications and efforts to increase the use of naloxone, an anti-overdose medication and encourage the development of abuse-deterrent formulations of opioids.
During his campaign for office, President Donald Trump spoke frequently about the epidemic, and in March he created a national opioid commission headed by New Jersey Republican Gov. Chris Christie. But he and Republicans in Congress have also taken steps that critics have blasted as hindering anti-opioid efforts, including proposing huge budget cuts in the office of the drug czar and in Medicaid, which pays for many drug-treatment programs.