The Wall Street Journal reported on a citizens petition to the FDA signed by more than 30 leading pain-addiction experts and prominent health officials from the New York City Department of Health, Mayo Clinic and Cleveland Clinic asking for clarification and guidance to physicians on how to use extended-release painkillers. The petition also seeks to limit claims pharmaceutical companies can make about the high-dosage medications. The FDA recently issued an REMS for opioids, which are ever increasingly in the news for abuse problems.
If the FDA takes action, then drug manufacturers would be prohibited from marketing more powerful painkillers as remedies for common aches and pain. Consequently, drug manufacturers are not happy with the citizen petition, because the resulting change in physicians’ prescribing habits would greatly affect the $5 billion made per year from the sale of extended-release painkillers.
The citizens petition asks that noncancer usage of the powerful opioids be limited to roughly 100 milligrams a day for a maximum of 90 days of round-the-clock use. The petition also asks that the FDA only allow the drugs to be marketed for those with severe pain. Currently no dosage or time limits exist. When patients say their pain is in a range of four to six on a 10-point scale, their pain is considered to be “moderate,” according to doctors. In turn, prescriptions of powerful painkillers are given to people with sore backs, broken toes or toothaches. Physicians would still be able to prescribe the drugs for “off-label” use, but drug makers would no longer be able to promote them for anything other than cancer pain or severe, non-cancer pain.
The FDA has 180 days to approve, deny, or provide a tentative response to the petition.