Last month, New York Mayor Michael Bloomberg put limits on how public hospitals there filled prescriptions for opioid pain drugs, saying the city was fighting an epidemic of overdoses. With that action, the mayor of the country's most populous city inserted himself into the middle of the national debate over what constitutes the proper use of such painkillers, a debate that played out last week in a two-day hearing before the FDA.
According to the Centers for Disease Control and Prevention, more than 16,000 people died of opioid overdoses in 2010, a number The Wall Street Journal says is more than those who fatally overdosed on all other illegal drugs combined. The FDA is trying to walk a very fine line between the dangers of addiction and the need for flexibility in how doctors treat patients with chronic pain.
The agency was taking evidence as it considers a petition from a group of three dozen doctors from the Physicians for Responsible Opioid Prescribing (PROP), The Wall Street Journal points out. They have asked the agency to have the labels on the painkillers changed to put daily limits on their use and to have doctors limit prescriptions to a 90-day supply. The proposed limits would not apply to cancer patients. The FDA also heard from parents whose children overdosed on opioids and from members and others. Dr. Edward Michna, of the American Pain Society, who practices at Brigham & Women's Hospital in Boston, said he is concerned that restrictions will make it hard to treat patients who suffer from chronic pain, MedPage Today reports.
The prescription pain drug market is valued at about $9 billion. But the use and abuse of pain meds means it is a category that elicits strong opinions about how the drugs should be prescribed. The FDA is actually facing more than whether labels should be updated. It also is considering whether to require all opioids to come with tamper-resistant features, particularly now that generics of some of the most used pain drugs are about to launch in the U.S. Purdue Pharma reworked its OxyContin formula to make the powerful opioid pills more difficult to abuse, as did Endo Pharmaceuticals ($ENDP) with its Opana ER. Congress also has considered whether to give the FDA authority to yank regulatory approval for generic drugs that aren't designed with such safety features.
The FDA has only hinted at where it is leaning. Last month, in draft guidance on developing such features, the FDA said that while opioid analgesics are important to modern pain management, their abuse has created "a serious and growing public health problem." It called development of abuse-deterrent formulations "a high public health priority."
At last week's hearing, MedPage Today reports that Andrew Kolodny, of Maimonides Medical Center in Brooklyn and co-founder of PROP, said the group is not trying to limit doctors' use of the medications for addressing patients with chronic pain. It just believes that the risks need to be more clearly spelled out and that going beyond certain doses should be an off-label treatment, given the lack of evidence that long-term use of opioids is beneficial against chronic pain, he said.