FDA Drug Safety and Risk Management Advisory Committee meeting
We request your much-needed comments to the rescheduled January 24-25, 2013, FDA committee meeting on unique aspects of chronic pain medications.
This is the first of two advocacy requests where your voice truly matters. This meeting is rescheduled from October 29-30, 2012, and was posted on the Federal Register December 19, 2012. (Due to the holidays, the NFMCPA just received notice of the opportunity for additional public input to this meeting.)
The second opportunity for you to weigh in on a national level is the FDA's public hearing (February 4-5, 2013) to obtain information, particularly scientific evidence, such as study data or peer-reviewed analyses, on issues pertaining to the use of opioid drugs in the treatment of chronic pain. Patient experiences are valued and considered. This hearing was scheduled because many patients effectively expressed personal experience with opioids during the FDA's public hearing in August of 2012. (Editorial note: The name of the meeting (Impact of Approved Drug Labeling on Chronic Opioid Therapy) does not indicate the broad range of information being sought from the public. Specifically, personal patient experiences are needed for consideration. Click here for the information on the February 4-5, 2013, hearing.)
#1 Drug Safety and Risk Management Advisory Committee meeting on January 24 and 25, 2013. The committee will discuss the public health benefits and risks, including the potential for abuse, of drugs containing hydrocodone either combined with other analgesics or as an antitussive. Jan Favero Chambers, President of the National Fibromyalgia & Chronic Pain Association, is a voting member of the 21-temporary member the Food and Drug Administration’s Drug Safety and Risk Management public advisory committee. The Department of Health and Human Services received a request from the Drug Enforcement Administration for a scientific and medical evaluation and scheduling recommendation for these products in response to continued reports of misuse, abuse, and addiction related to these products. The committee will also discuss the impact of rescheduling these hydrocodone products from Schedule III to Schedule II. The FDA seeks advice from its advisory committees when there is uncertainty in the regulatory decision.
All electronic and written submissions submitted to the docket (see the ADDRESSES section of the Federal Register document at the link below) on or before January 9, 2013, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 8:15 a.m. and 10:15 a.m. on January 25, 2013. Those individuals interested in making formal oral presentations, including those who have previously requested time to speak at the originally scheduled October 29–30, 2012, Drug Safety and Risk Management Advisory Committee meeting, should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before January 3, 2013. Any individuals who requested time to speak at the originally scheduled October 29–30, 2012, Drug Safety and Risk Management Advisory Committee meeting, will need to follow the above instructions to request time to speak at the January 24–25, 2013, Drug Safety and Risk Management Advisory Committee meeting, as any previous requests to speak at the originally scheduled meeting do not convey to this new January 24–25, 2013, Drug Safety and Risk Management Advisory Committee meeting. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by January 4, 2013.
Federal Register Docket for more information: http://www.gpo.gov/fdsys/pkg/FR-2012-12-19/pdf/2012-30517.pdf (Scroll mid-way to first page for this docket.)
Related article on FDA Hearing: Impact of Approved Drug Labeling on Chronic Opioid Therapy
Want to know more about the general purpose of DSARM Committee? Click here for more information.
