Experts say efforts to develop viable alternatives to opioid drugs to treat chronic pain have been an “abject failure” that has aided the stark rise in drug use and overdose deaths over the past decade.
But Dr. Robert Califf, the newly confirmed commissioner of the U.S. Food and Drug Administration, said the agency would fully back efforts to develop harder-to-abuse painkillers, part of a sweeping government drive to stop the overdose epidemic.
The FDA has assembled a group of its leading outside experts to recommend additional steps toward curbing abuse and misuse of pain drugs such as OxyContin, Percocet and codeine.
A major research challenge is assessing pain, which can be subjective and not based on empirical scientific data, said Dr. Daniel Clauw, professor of Pain Management at the University of Michigan School of Medicine. He said that's hindered development of new therapies, requiring providers to use standard treatments that have limited effect and put a patient at risk of addiction.
“If we look critically at our commonly used analgesics that we're using in 2016, they're all derivatives of drug or compounds that have been around for decades for hundreds of years,” Clauw said at a hearing held Tuesday by the FDA's Science Board.
Califf pledged the agency would do "everything possible under our authority to prevent abuse, save lives and treat dependence."
On Tuesday, FDA Science Board members reviewed a report from the Centers of Excellence in Regulatory Science and Innovation (CERSI), which evaluated the FDA's role in promoting regulatory science and recommended the agency create a road map to identify areas where it could provide support for the advancement of research.
The FDA had already proposed including the use of advisory committees to review new drug applications for opioid drugs that do not have abuse-deterrent properties, adding warning labels and safety information for immediate-related pain medications, and creating requirements for drug companies to conduct more rigorous post-marketing surveillance of opioids.
Those changes come after what critics say has been years of inaction on the part of the agency in addressing the overuse of opioid medications. In 2012, the FDA implemented limits on prescribing the number of pain relievers, which led to a decline in use.
But patient advocates say the FDA has approved a number of pain medications in recent years despite the risk of those drugs becoming addictive. One example is the drug Zohydro, which in October 2013 became the first approved prescription opioid to contain pure hydrocodone without combining it with a weaker substance such as acetaminophen.
Still, new ways to treat pain is at the forefront of government efforts.
Finding an alternative to effectively treat pain was a point President Barack Obama recently made when he met with governors in Washington, D.C. The state leaders were calling for federal action to reduce the nation's level of opioid drug use, which has caused a 137% increase in overdose-related deaths since 2000.
“If we go to the doctors right now and say don't overprescribe without providing some mechanism for people in these communities to deal with the pain or the issue that they have, then we're not going to solve the problem,” Obama said. “The pain is real, the mental illness is real, in some, the addiction is already there."
The Associated Press contributed to this report.
