The Food and Drug Administration approved a powerful new opioid Friday for use in healthcare and rejected the criticisms made by some of its own advisers that this would inevitably lead to illicit use and more deaths from overdose.
The drug is five to ten times more effective than pharmaceutical fentanyl. The tiny pill – only three millimeters in diameter – is expected to exacerbate the nation's drug crisis, critics and an FDA expert say.
At the same time, FDA commissioner Scott Gottlieb made an unusual statement that he would seek more authority for the agency to consider whether there are too many similar drugs on the market. This could allow the Agency to reject future applications for new opioid approvals if the drugs do not meet unmet needs.
"We have to answer the question which, in my opinion, underlies the criticism that was raised before this admission," wrote Gottlieb. "To what extent should we evaluate each opioid on its own merits, and to what extent should we consider the epidemic of opioid abuse and misuse that surrounds our nation?"
The Worst Drug Crisis in US History Authoritarian officials and some public sector officials have argued in favor of this holistic approach to narcotic analgesics, rather than judging how the FDA decides on any opioid application on its own.
Gottlieb has agreed that the FDA will make greater efforts to offset this curbing of the epidemic ̵
Gottlieb said he would submit a plan to the Opioid Policy Steering Committee of the FDA and possibly Congress. The guidelines would allow the agency to assess the benefits of a public health narcotic, its risk of being misused or misused, and its unique benefits to groups of people suffering from pain, before deciding to approve an opioid.
[drug companies] would know in advance, where are the possibilities for the development of new drugs that meet the safety and efficacy standards of the FDA. "
The drug, which was approved on Friday, is a tiny, 30-microgram pill form of sufentanil, a potent 34-year-old opioid medication that is commonly used after surgery and in emergency departments. Any pill used for rapid absorption placed under the tongue would have the same effect as five milligrams of intravenous morphine, and each pill would be in a plastic applicator that looks like a syringe.
The drug is intended for use in medical facilities and possibly on the battlefield would not be available to consumers.
The manufacturer, a Californian company called AcelRx, will market the drug under the name of Dsuvia at a wholesale price of $ 50 to $ 60 per dose, a spokeswoman said the company has no information on expected sales
AcelRx aready has been approved for 15- and 30-microgram versions of the Medicament in Europe.
An FDA advisory panel recommended the approval of the new drug in a 10 October 12, but they vote. Raeford Brown, a professor of anesthesiology and pediatrics at the University of Kentucky and chairman of the committee, then took the rare step of publicly condemning this decision and called on the FDA to refuse the drug. Brown missed the meeting because he spoke at a conference at a medical conference.
Brown, Sen. Edward J. Markey (D-Mass.) And the Public Citizen advocacy group have predicted that Dsuvia will be diverted to unauthorized use and cause more deaths from overdose. Public Citizen claimed in a press release issued before the decision on Friday, "if Dsuvia is approved, it will be abused and begin killing people as soon as it comes on the market."
The drug is not sold in pharmacies. The FDA believes that drug controls in medical facilities are rigorous and pose the greatest risk of distraction to medical personnel themselves.
A 2016 survey conducted by the Federal Agency for Drug Abuse and Psychiatric Health Services shows that narcotics are rarely stolen from a doctor's office, clinic, hospital or pharmacy. Less than 1 percent of respondents said they had acquired opioids in this way.
But hundreds of millions of doses of prescription painkillers have been diverted from the pharmaceutical supply chain to illegal consumers in the past 15 years. According to the survey, illegal users often receive them from friends, relatives or rogue doctors and pharmacists.
One factor that weighed heavily on the Dsuvia decision is the military interest in the drug, Gottlieb said in his statement. The military wants to find out if the pill can be used as a painkiller on the battlefield and is less cumbersome than liquid painkillers. Public records show that the Pentagon spent millions of dollars funding AcelRx research.
"The FDA's mission is to ensure that our soldiers have access to treatments that meet the specific needs of the battlefield, even when they are intravenous. No administration is possible for the treatment of acute pain," wrote Gottlieb.
Pamela Palmer, anesthesiologist, said she founded the company to reduce the number of fatalities caused by opioid dosing errors in hospitals and ambulance centers, and said caregivers could make these mistakes when they see the amount of clear liquid painkillers such as morphine for intravenous administration.