The Food and Drug Administration recently unveiled a new draft guidance for tackling opioid addiction, and scheduled a public hearing for Sept. 17 to discuss the crisis.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.
One doctor, however, thinks the risk-benefit analysis should be made by doctors and not federal agencies.
“Individual physicians need to do risk-benefit analysis for each patient,” Jane Orient, executive director of the Association of American Physicians and Surgeons and president of Doctors for Disaster Preparedness told the FDA Reporter. “Bureaucrats can't do it properly. Dependence is unavoidable and needs to be distinguished from addiction.”
Orient said the increase in overdoses is almost entirely due to illegal fentanyl.
“The government seems to be ignoring the main problem: transnational drug cartels and the sanctuary cities and other government collusion that enable them. Instead, it is tormenting pain patients and burdening or destroying doctors who still are willing to prescribe for them,” Orient said.
According to a FDA press release, the new draft guidance describes what information the FDA recommends companies provide in their opioid analgesic new drug applications.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.”
