FDA Commissioner Scott Gottlieb issued an unusual statement saying he would seek more authority for the agency to consider whether there are too many similar drugs on the market, which might allow the agency to turn down future applications for new opioid approvals.
“We need to address the question that I believe underlies the criticism raised in advance of this approval,” Gottlieb wrote. “To what extent should we evaluate each opioid solely on its own merits, and to what extent should we also consider . . . the epidemic of opioid misuse and abuse that’s gripping our nation?”
As the worst drug crisis in U.S. history has accelerated, agency critics and some public officials have clamored for a holistic approach to narcotic painkillers, instead of the FDA’s practice of evaluating each opioid application on its own.
Gottlieb has pledged the FDA would do more to balance efforts to curb the epidemic — which killed a record 49,000 users in 2017, according to preliminary data — with the needs of people who need strong pain relief. But Friday’s statement is the first detailed indication of how the FDA might use its drug-review process to tackle the problem.
Gottlieb said he would bring a plan to the FDA’s Opioid Policy Steering Committee and perhaps Congress. The guidelines would allow the agency to consider a narcotic’s benefit to public health, its risk of being diverted for inappropriate use or abuse and its unique benefits to groups of people in pain before deciding to approve an opioid.
“In this way, [drug companies] would know up front where the opportunities are for developing new drugs that meet the FDA’s standards for safety and effectiveness,” he wrote.
A spokesman for the Pharmaceutical Research and Manufacturers of America said the organization shares the “FDA’s commitment to reducing the risk of addiction and combating the opioid crisis while also ensuring new treatments reach patients in need.”
The drug approved Friday is a 30-microgram pill form of sufentanil, a powerful, 34-year-old opioid commonly used after surgery and in emergency rooms. Each pill, placed under the tongue for quick absorption, would have the same impact as five milligrams of intravenous morphine. Each would come in a plastic applicator that looks like a syringe.
The drug is intended for use within health-care settings and perhaps on the battlefield. It would not be available in retail pharmacies.
The manufacturer, a California company called AcelRx, will market the drug beginning in early 2019 under the name Dsuvia, at a wholesale price of $50 to $60 per dose. A spokeswoman said the company is not providing information on expected sales.
AcelRx already has approval for 15- and 30-microgram versions of the drug in Europe.
An FDA advisory committee recommended approval of the new drug in a 10-to-3 vote on Oct. 12. But Raeford Brown, a professor of anesthesiology and pediatrics at the University of Kentucky who chairs the committee, then took the rare step of publicly condemning that decision and urging the FDA to reject the drug. Brown missed the meeting because he was speaking at a medical conference that day.
Brown, four U.S. Senators and the advocacy group Public Citizen have predicted Dsuvia will be diverted to illicit use and cause more opioid overdose deaths.
“It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly,” Sidney Wolfe, founder of Public Citizen’s Health Research Group, said in a statement. “It will be taken by medical personnel and others for whom it has not been prescribed. And many of those will overdose and die.”
Brown added he has personally tried to resuscitate health-care providers who abuse sufentanil, “some successfully.”
“Clearly the issue of the safety of the public is not important to the commissioner, despite his attempts to obfuscate and misdirect,” Brown said in his joint statement with Public Citizen.
The FDA says controls on drugs inside medical facilities are tight and the greatest risk of diversion is among medical personnel themselves.
A 2016 survey conducted by the federal Substance Abuse and Mental Health Services Administration(SAMHSA) shows narcotics are rarely stolen from doctors’ offices, clinics, hospitals or pharmacies. Fewer than 1 percent of people said they acquired opioids that way.
The rate of overdose deaths among health-care workers is relatively high, however, according to an August study by the Centers for Disease Control and Prevention, with 876 succumbing to prescription opioids between 2007 and 2012.
Hundreds of millions of doses of prescription painkillers have been diverted from the pharmaceutical supply chain to illegal users over the past 15 years. In many cases, illicit users obtain them from friends, relatives or rogue doctors and pharmacists, according to the SAMHSA survey.
One factor that weighed heavily in the Dsuvia decision is military interest in the drug, Gottlieb said in his statement. The military wants to explore whether the pill can be used as a battlefield painkiller that is less cumbersome than liquid analgesics. The Pentagon has spent millions of dollars helping to fund AcelRx’s research, public documents show.
“The FDA has made it a high priority to make sure our soldiers have access to treatments that meet the unique needs of the battlefield, including when intravenous administration is not possible for the treatment of acute pain,” Gottlieb wrote.
Pamela Palmer, an anesthesiologist, said she founded AcelRx to reduce the number of deaths caused by opioid dosing errors in hospitals and ambulatory care centers. She said caregivers can make these mistakes as they calculate the amount of clear liquid painkillers such as morphine to administer intravenously.
“The FDA approval of Dsuvia is the culmination of nearly 15 years of research to improve the standard of care for managing acute pain in medically supervised settings,” Palmer said in a statement.
Including brand name and generic drugs, there are nearly 400 opioids on the market.