Postmarketing Requirements for the Class-Wide Extended-Release/Long-Acting Opioid Analgesics; Public Meeting; Request for Comments
cder cder201424
2017-03-24 2017-03-20
FDA-2014-N-0374-0009 FDA-2014-N-0374-0005
04:00:00 04:00:00
https://api.regulations.gov/v4/comments/FDA-2014-N-0374-0009 https://api.regulations.gov/v4/comments/FDA-2014-N-0374-0005
Anonymous Anonymous
Anonymous Anonymous
I want to thank the FDA for inviting me to this important stakeholders meeting.  My 2 cents in no particular order:1. I commend the FDA and the industry partners for tackling this issue.  We all recognize the critical issues we are discussed.  Id like to acknowledge the tremendous amount of work already done and left to do.2. If I ask myself the fundamental question, do I believe these studies will move the field forward?  The answer is an emphatic YES!.  3. Do I believe these studies will provide the definitive answers to all the questions in this area?  The answer is a resounding NO!  However, this gives us researchers and funders reason to continue to address the questions raised.  4. My concerns were articulated beautifully by other stakeholders/meeting participants.  The philosophical bent of these studies was an almost exclusive focus on the harms of these medications.  And very limited attention to the potential benefits.  While this leaning towards harms really addresses important questions, there is the wonderful opportunity to address more questions.  In the current framing, the answers will likely help the FDA from a regulatory standpoint and industry to meet the postmarketing requirements.  But have limited influence on clinical decision making and possibly unintended consequences by focusing exclusively on harms.  I worry that the current environment were become even more opioiphobic among prescribers and lead to restricted access to opioids for pain sufferers that benefit from them.  5. question:  I may have missed it, but I did not hear the rationale for the ambitious timelines to conduct the studies.6. An opportunity to triagulate data sources and incorporate qualitative data might be considered especially for the doctor/pharmacy shopping study.  A better understanding of drug seeking could benefit from talking with patients (qualitative data collection).  What is the patients view of this concept?   Subject: Marketing and discussion of home-brew (i.e., non-approved) urine testing on FDA property without any discussion of severe limitations.I watched the public meeting via the webcast feature.  Dr. Passik  an employee of a urine lab  touted the use of expensive mass spectrometry-based urine testing without revealing its severe limitations. Others, perhaps ignorant of these limitations, made statements that cannot be supported with evidence. In order to protect FDAs reputation as an evidence-based institution, I provide the information that follows. While I could provide an exhaustive and lengthy summary of the medical literature, the federal court case noted below is succinct and accurate.In a case called Millennium Laboratories, Inc. v. Ameritox, Ltd., 924 F. Supp. 2d 594 (D. Md. 2013), between two of the largest laboratories in the United States performing urine drug testing, Millennium Laboratories, Inc. and Ameritox, Ltd., the Court noted that:By processing patients urine samples through sophisticated laboratory equipment, Millennium and Ameritox can provide doctors with considerable information.  Their tests can determine the presence (and, by necessary implication, absence) of the prescribed pain mediation and a wide variety of other drugs, whether prescription, non-prescription, legal, or illegal. The test can also quantify the amount of pain medication or its metabolite present in the urine.Even using this advanced technology, however, UDT [urine drug testing] has its limitations.  First, it provides only a snapshot of current drug use; drugs and their metabolites remain in a persons urine only for so long.  Additionally, because individuals metabolize drugs at different rates, UDT cannot determine the dosage taken by the patient or when he took the dosage.  During the litigation, Millennium and Ameritox agreed that UDT can determine whether certain drugs are present or absent, but it cannot determine prescription compliance.Id. at 597-598.