Questions I Want to Ask the FDA – or Someone in Charge? – National Pain Report

Chronic Pain Advocate Jeff Edney listened/watched (when the feed was working) to the FDA meetings last week, it spawned many questions in his mind that chronic pain advocates should have in mind when they discuss or meet with Congressional, federal or state policy or state legislative officials.

Jeff Edney

Look at his list (which was lightly edited by Alliance for Treatment of Intractable Pain leader, Richard “Red” Lawhern, Ph.D.)

As you read them—and I’ve whittled the list to ten—we encourage you to react to them in our commentary section, of course, but also to ask your own federal and state officials. (For some tips on how you can advocate from your home courtesy of Shaina Smith of the US Pain Foundation—read this)

1. Consider the lack of correlation between prescription opioids and overdose fatalities, implications of such lack of correlation, and how to stop overdoses that are due to illegal not prescription opioids. Why is the federal government solving the wrong problem? Where are the data?
2. Why is the FDA considering additional regulations of high dose opioids that could lead to the same problems as the broadly misapplied 2016 CDC guidelines? Considering that many overdose deaths have been attributed to heroin, illicit fentanyl analogues, or other illegal opiates, why devastate the health care of chronic pain patients?
3. How can the FDA address the separate problems of addiction and overdose deaths on one hand, and chronic pain and inadequate pain management on the other hand, such that both problems can be solved without mutual interference?
4. How many people have been driven to social security disability simply because they lost access to adequate pain management, and how can the FDA alter this outcome?
5. What is the federal government going to do about the likely outcome of losing manufacturers of opioid analgesics who are being driven out of business by state governments? Doesn’t loss of suppliers threaten to further exacerbate the shortage of opioids?
6. How will the FDA influence health insurance companies to pay for opioid prescriptions deemed medically necessary by a physician in treatment of pain, both chronic and acute? How can the FDA drive reforms to prevent private health insurance and HHS/CMS from imposing artificial MME limits based on the 2016 CDC guidelines that were never intended for this purpose?
7. What can the FDA do to protect physicians who prescribe medications within existing FDA standards, such that physicians can resume medically necessary pain management care?
8. What can the FDA do to discourage state medical license boards from threatening or revoking the license of physicians who have fought for their patients against misapplication of CDC opioid guidelines?
9. Can the FDA work with the federal government to stop the Drug Enforcement Agency from coercing physicians to force compliance with the CDC guidelines that the CDC states should never have used as such?
10. How can the FDA work to restore trust in the physician-patient relationship which has been damaged by government imposing limits per the CDC “guidelines”?