The new FDA chief, who has said for weeks that his first priority will be the opioid problem, said that the agency can be most useful in stemming new addictions. He stressed the same point in a blog post on the FDA website and an “all-hands email” that was sent to the FDA's 18,000 employees.
As a first step in ratcheting up the agency's role, he created the Opioid Policy Steering Committee made up of senior FDA officials. He charged them with exploring three specific areas: Whether the FDA should require opioid education for health-care professionals; how the agency could ensure that the number of doses prescribed patients are “more closely tailored” to the medical needs, and whether the agency is properly weighing the risk of opioid abuse as part of the drug-approval process.
Any federal mandate on doctors' education — which some states are already requiring — would be strongly opposed by groups such as the American Medical Association and the American Academy of Family Physicians. Clif Knight, senior vice president of education for the family physicians, said that such a mandate would result in “one-size-fits all education" that "doesn’t hit the mark.”
Thomas Frieden, the former director of the Centers for Disease Control and Prevention, said there's “no easy answer” to the nation's addiction problem — and that studies have shown that physician education doesn't change practice patterns.
But Michael Carome, director of Public Citizen's Health Research Group, strongly supported requiring physicians to undergo mandatory training. “That would be a good step,” he said, adding that the ultimate value would depend on the content and whether it was developed by people without a financial conflict of interest. Former FDA officials said many in the agency back doctor training, but believe it should be run through the Drug Enforcement Administration.
Gottlieb, in discussing the proper duration for prescriptions, said that while a few situations require a 30-day supply of opioids, many conditions can be managed with a two- or three-day course of medication.
To limit the length of the prescriptions, he said, the FDA might be able to work with provider groups to develop guidelines for the proper duration for various medical conditions; then those guidelines could be added to the drug labels. He said that studies show that patients whose first experience with opioids is for 30 days have a 35 percent likelihood of continuing their opioid use after a year.
Public Citizen's Carome said that having such information on the drug's label “would send a strong message to health care professions about the need to limit the use of these drugs.”
The FDA might soon get some high-level advice on opioids. A National Academies of Sciences, Engineering and Medicine committee is expected to report this summer on the science regarding opioid abuse, including prevention, management and intervention. The report is expected to make recommendations to the agency on how to balance the needs of pain patients and the imperative to prevent abuse.
Sen. Edward J. Markey (D-Mass.) who opposed Gottlieb's confirmation as commissioner, was unenthusiastic about Gottlieb's Tuesday directive. “We don’t need another committee to study the opioid crisis, we need a real commitment from Dr. Gottlieb and the FDA to end the vicious cycle of opioid addiction,” he said.
He called on Gottlieb to overhaul the FDA’s approval process for addictive drugs. “Until there is real change at the FDA, the opioid addiction and overdose crisis will only worsen,” Markey said.
Sen. Lamar Alexander (R-Tenn), chairman of the health committee, praised Gottlieb's announcement, saying that the opioid epidemic kills more Tennesseans every year than gunshots or car wrecks.
The FDA has been criticized for years 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.
During his campaign, President Trump spoke frequently about the epidemic, and in March he created a national opioid commission headed by New Jersey Gov. Chris Christie (R). But he and Republicans in Congress have also taken steps that will hinder anti-opioid efforts, critics say, such as including proposing huge budget cuts in Medicaid, which pays for many drug-treatment programs.