Public Comments May 4, 2016: Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee Meeting

Jan Favero Chambers 5-minute Public Comments May 4, 2016 in Silver Spring, MD, White Oaks Campus May 3-4, 2016: Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Re:  REMS


My name is Jan Chambers. I am the president and founder of the National Fibromyalgia & Chronic Pain Association. I have no relevant relationships to declare. Thank you for your service and the opportunity to make public comment.


Pain is a disease with neuroplasticity that increases over time if not treated. Undertreated and unmanaged pain has clinical, psychological and social consequences, including limitations in life activities, lost work productivity, reduced quality of life and stigmatization.  Families become care providers and relationships get burned out.


Chronic pain affects 100 million American adults.  Our organization conducted a 2015 survey of chronic pain patients with 6420 responders and was published in Pain Medicine of the American Academy of Pain Medicine in December 2015.  This survey was the only snapshot captured of the “unintended consequences” to people with chronic pain 100 days after the rescheduling of hydrocodone from Schedule III to II. We are now conducting the second part of that survey one year after rescheduling.


I’ll give you some statistics from that report since the rescheduling:

  • 1462 (27.2%) reported having thoughts of suicide
  • Of those who could no longer get hydrocodone, 
    • 1067 (18.1%) borrowed pain medications
    • 1007 (17.1%) turned to marijuana
    • 773 (13.1%) used alcohol
    • 135 (2%) used illicit drugs
  • Most (64.2%) respondents had to visit their healthcare providers more often
  • 1735 (30.3%) reported some type of issue interacting with their pharmacy
  • Most (88.3%) felt that the rescheduling was neither a fair nor appropriate solution to the abuse of hydrocodone
  • For those still working, 801 (46.2%) reported that they had missed work because of the stricter regulations

The FDA REMS Blueprint should include screening for mental disorders and suicidality.


Recent policies and legislation are focusing only on prescription opioids in the big picture of drug addiction and overdose. Street heroin and illegal fentanyl patches need to be accounted for in the war on drugs.


Abuse deterrent formulation on all opioids, including methadone paid for by Medicaid, are necessary.  The FDA must help in this important strategic approach to get serious about preventing opioid-naïve young people from trying them.


Please make recommendations that stop villainizing and torturing people with chronic pain.  Just like other medical conditions, they need medical care and access to pain medicine in integrative treatments.


Thank you for your time and attention.

EV SSL