Statement of Dr. Michael Carome, Director, Public Citizen’s Health Research Group
The Food and Drug Administration’s (FDA’s) action regarding the labeling of certain opioid pain medications represents a small step in the right direction, but it ultimately fails to adequately ensure the safety of chronic pain patients and favors the interests of the pharmaceutical industry over the interests of protecting public health.
For example, the FDA took no action to alter the label of short-acting opioid analgesics, and offered no clear rationale to justify why these drugs should be treated differently than long-acting and extended-release opioids.
In addition, the FDA denied the request by Physicians for Responsible Opioid Prescribing and by Public Citizen to recommend both a maximum duration of use and a maximum daily dosage for treatment of non-cancer pain in the labels of all opioid mediations. Without adding these instructions, the FDA has left the door wide open for drug companies to continue to promote the high-dose and long-term use of opioid analgesics for conditions where risks are likely to outweigh the benefits.
Federal law allows drug companies to market products only for uses that have been found by the FDA to be safe and effective for all indicated uses described in the label. By asking drug companies to conduct postmarketing studies of opioid analgesics to be completed several years from now, instead of appropriately amending the labeling now, the FDA is putting patients at risk.
The FDA must take additional substantive actions to ensure that labels on opioid analgesics are consistent with the existing scientific evidence which does not support long-term and high-dose use of opioids for chronic non-cancer pain.