John Dale Dunn
John Dale Dunn
The Food and Drug Administration unveiled yet another draft guidance on opioid addiction, but one doctor remains unimpressed.
The agency scheduled a public hearing for September 17 to discuss the crisis. The meeting “will include a discussion of whether an applicant for a new opioid analgesic should be required to demonstrate that its product has an advantage over existing drugs in order to be approved,” according to a FDA press release.
“If you start off with a bad idea you will surely end up with a bad idea,” John Dale Dunn, an emergency physician in Brownwood, Texas, told the FDA Reporter. “The problem is they don't recognize the problem — the bad statistics on opiod deaths don't address the problem of people dabbling in fentenyl and designer drugs. These are not people who have gone from pain meds to abuse — they are abusers.”
Dunn said the new guidance does nothing when combating the problem of addiction.
“It does nothing to fight the opiate abuse that produces the deaths — the important thing when policy is established is to determine the problem — the problem is fentanyl and potent designer drugs that sneak up and kill abusers, not this artificially created ‘crisis’ that the CDC and other agencies are pushing — whatever excess deaths are occurring is not about opiate users who go hog wild.”
So what does Dunn think the FDA should do?
“How about start with a better diagnosis of the problem and a better analysis of the nature of the abuse,” Dunn said.
The new draft guidance describes what information the FDA recommends companies provide in their opioid analgesic new drug applications.
“In terms of patient safety, the agency recommends that companies consider providing information on whether their drug has any characteristics that would mitigate the risks of overdose, abuse or the development of addiction,” the press release said. “Companies should also indicate whether their drugs have novel or greater risks compared to other opioids on the market and also note the public health implications of their products in terms of risks to non-patients, including members of the patient’s household, visiting relatives, friends and others.”
The FDA said it uses the benefit-risk assessment as a foundation for review of human drugs and biologics.
“These assessments capture the evidence, uncertainties and reasoning used by the agency to arrive at its regulatory decisions,” the press release said. “The FDA evaluates a drug product’s risks against its benefits in the context of the use indicated in the labeling. When it comes to regulating opioids, we do so with an understanding that any action taken by the agency should be considered in light of the opioid crisis.”
