Request that the FDA impose a moratorium on approval of all NDAs for new opioids or new opioid formulations-WITHDRAWN 4/5/19
Public Citizen’s Health Research Group Approval of New Drug Applications for New Opioids or New Opioid Formulations non-existent opioid regulatory framework opioid crisis in the U.S. National Academies of Sciences, Engineering, and Medicine (the National Academies), OPEN CDER
2019-08-02 2019-08-01 2019-08-05
FDA-2019-P-1364-0007 FDA-2019-P-1364-0006 FDA-2019-P-1364-0008
04:00:00 04:00:00 04:00:00
https://api.regulations.gov/v4/comments/FDA-2019-P-1364-0007 https://api.regulations.gov/v4/comments/FDA-2019-P-1364-0006 https://api.regulations.gov/v4/comments/FDA-2019-P-1364-0008
Anonymous Anonymous Anonymous
Anonymous Anonymous Anonymous
The FDAs continued approval of new potent opioids, which are known to threaten the public health, without first significantly improving the review process by creating and finalizing an opioid regulatory framework recommended by the National Academies, represents a clear and present continuing danger to the health and safety of people in this country. The Nations opioid epidemic / crisis is far from over. The time has long past that we try to deal with it using a band-aid approach. The pharmacutical companies are not evil, but they have apparently chosen to not address this epidemic which is well documented and keep manufacturing far more of the varous opioid drugs than this country needs. Responsible government and private sector management should dictate a focus on developing sound opertional strategies to solve the current epidemic before we should be approving additional new opioid drugs. If this were a contagious disease there would be a mandated containment effort. Why do we think this isnt the same type of problem? I support the fight against addiction, overdose and the import of illicit drugs into the United States. While FED UP fights for these causes however, you leave in your wake millions of chronically ill patients who suffer with severe pain as they are being denied appropriate opioid pain management. These are people who were on a long term managed and monitored regimen of opioid pain medication while adhering to every clause in their physician/patient contract. Both the New England Journal of Medicine and the Substance Abuse and Mental Health Services Administration (SAMHSA) released studies showing that less than 1% of those prescribed opioids for the purpose of managing chronic pain became addicted. Likewise, the study below explains that prescription opioid use to manage acute pain almost never results in addiction. Researchers note that despite a documented doubling of opioid analgesic use from 2000 to 2010, they cannot find evidence that prescribing opioids for chronic pain is the principal driver of rising addiction rates in adults. OUD develops in only a small percentage of adults who are prescribed opioids for acute pain. In a large study of 640,000 opioid-naive patients in which chronic opioid use was examined one year after surgery for 11 surgical conditions, the prevalence was found to range from 0.12% for cesarean section deliveries to 1.4% for total knee replacement surgeries. In another study in which chronic opioid use was examined in approximately 18 million people with acute pain who had not undergone surgery and had never taken opioids, only 0.14% of those who were prescribed opioids were found to still use the medications a year later.I hold no ill will toward those fighting addiction. They were a community stigmatized by those who hold office, the news media and the public at large. This has and continues to change but the fight must continue. In their place however are now those who suffer with intractable, chronic illness and resulting pain. This is now a community stigmatized by the same people who are coming to realize that it is far more effective and far more humane to offer treatment to those fighting addiction. But now those who live with debilitating pain become the lepers, refused treatment by the very same people who once turned a blind eye to those addicted. I would ask that those involved in creating the message FED UP uses to reach out to the masses PLEASE adjust your language to highlight that pain patients must not be made the new target. Please take this request into consideration. 