- Denied change to maximum 100mg daily morphine equivalent (MEQ) dose
- Denied 90 day limit for noncancer pain
- Denied differentiation between cancer and noncancer pain
- Ingenious wording on the issue of “moderate to severe” v. “severe” pain. As one colleague aptly put it, “To say pain that is ‘severe enough to warrant around-the-clock opioids’ in fact is even more of a bow to the patient’s experience and the judgment of the prescriber than to say moderate to severe pain and tie it to a number.” This is aptly attached to extended release and long-acting opioids only.
- Immediate Release (IR) opioid labeling remains untouched pending further new evidence.
- Issued FDA ER/LA-Opioid Prescribing Changes (as posted on Pain-topics.org)
This is a victory for pain patients nationwide.
After more than a year of deliberation, the FDA has made their decision on a Citizen’s petition submitted by Physicians for Responsible Opioid Prescribing (PROP). It turns out that after careful consideration; perhaps the request was in fact “irresponsible”, at least in some ways. While the FDA and all of their staffers deserve kudos for all the deliberation, dedication, aggravation, and hard work, they finally came to a scholarly decision based on evidence or lack thereof that cost taxpayers probably tens of thousands of dollars in time, effort, brainpower, venue costs, and more.
In a response letter from the FDA to Dr. Andrew Kolodny (President, Physicians for Responsible Opioid Prescribing), the FDA clearly outlined the flaws of their petition. This was not a flippant decision. The FDA painstakingly reviewed hundreds of documents as outlined in their letter, including over 2500 written comments from the Hearing and petition documents combined.
According to the FDA response…
“FDA also received over 600 comments to the Part 15 Hearing docket. The majority were from patients voicing concerns that labeling changes could make legitimate patient access to opioid analgesics more difficult. The remainder reflected the same diversity of viewpoints and concerns presented during the hearing itself. FDA also received more than 1900 comments on the PROP Petition. Many public health agencies and organizations supported the requests in the Petition, citing concerns about increased opioid use and abuse. However, the majority of comments opposed PROP’s requests. Many professional societies (e.g., the American Academy of Pain Medicine, the American Medical Association, the American Society of Anesthesiologists, the American Pain Society) did not support the Petition and stated that the data cited by PROP did not support PROP’s requests (particularly those requests for limits on dose and duration of use of opioids). Professional societies also expressed concern that the labeling changes requested by PROP were not supported by scientific evidence, and that a ‘one-size-fits-all’ approach to a maximum dose or duration of treatment would be problematic and inconsistent with the need for individualized treatment and the variability among patient responses to opioids.”
As our followers know, shortly after the PROP petition was filed, a group known as Professionals for Rational Opioid Monitoring and Pharmacotherapy (PROMPT) surfaced that was manifested from dedicated pain peers nationwide. Interestingly, the FDA response aligns squarely with PROMPT’s Mission Statement. In fact, the FDA letter states, “Pursuant to section 505( o )(3) of the FD&C Act, FDA is therefore requiring all new drug application (NDA) sponsors of ER/LA opioids to conduct post approval studies and clinical trials (post-marketing requirements, or PMRs) to assess certain known serious risks of ER/LA opioid use: misuse, abuse, hyperalgesia, addiction, overdose, and death.”
PROMPT embraces this sort of careful study and post-marketing surveillance and the pharmaceutical industry will likely pay for it. Interestingly, nobody is criticizing big pharma for supporting such studies or developing innovative pharmaceutical dosage forms, abuse-deterrent technology in the form of prodrugs, nanotechnology, and more.
As an attendee at the April FDA Hearings and being caught directly in the crossfire, it is of particular interest to me that the pharmaceutical industry took a hard hit, at least verbally and on social media from PROP supporters. Day after day and week after week social media including some mainstream newspapers slammed honest patient-centered clinicians and the pharmaceutical industry for promoting use of opioids in patients for which they weren’t indicated for mere financial reward. But, just last week a major convention took place, PainWeek 2013, with over 2000 attendees that included prescribers and non-prescribers alike. Attendees included all sorts of scientists and professionals other than “responsible physicians”, including among them, pharmacists, physical therapists, nurse practitioners, physician assistants, pharmacologists, biologists, chemists, and many more. The pharmaceutical industry clearly has taken bold steps financially and scientifically to develop unusual dosage forms to deter abuse, side effects, and the like in order to make the world better for patients and to mitigate risks to patients and enhance public safety. True enough industry is in it to make money, but let’s not be naïve; you need to make money to support research, education, and advanced technology. Who do these PROPagandists think will pay for such advances?
I feel sorry for the many patients nationwide that anguished day after day and sent thousands of anxiety stricken e-mails to politicians, the FDA, and to me. But they all owe this country and the FDA a debt of gratitude for spending the time, energy, and money to review each and every document submitted and all the relevant literature to arrive at their resolution.
So in closing this chapter of the Great Opioid Divide between PROP and PROMPT, and in keeping with the good sense of humour to our north most brethren, perhaps our Canadian clinicians and families that aligned at the FDA Hearing and submitted docket comments now understand FDA to mean, “Final Decision, Aye?”
PROP Versus PROMPT: FDA Speaks. Practical Pain Management. 2013 October; 13 (9): 13-14.
The Last Word on FDA Opioid Labeling? PROP, PROMPT still disagree; REMS revisions next. Pharmacy Practice News. October 2013, Volume 40.