December 08, 2017

Manchin calling on FDA to properly fight opioid epidemic | Register-Herald

U.S. Sen. Joe Manchin, D-W.Va., is calling on the Food and Drug Administration to adopt three policy changes to properly fight the opioid epidemic. In a letter to FDA Commissioner Dr. Scott Gottlieb, Manchin asked for the following changes through the Opioid Policy Steering Committee:

l Mandatory and continuing education for every health care provider who prescribes opioids.

Manchin said in the letter, “Too many of our medical professionals have received too little training on the dangers of opioids, signs of addiction, and alternatives to opioids for pain management. We must ensure that they have the information that they need to make medically appropriate decisions for their patients’ care.”

l Advisory Committee guidance and review of every opioid product on the market to determine for each if the risks outweigh the benefits.

“These risks include not just addiction and overdose deaths, but also outbreaks of HIV and Hepatitis C that occur when a drug is too easy to abuse,” Manchin said. “Every opioid that an Advisory Committee determines is more dangerous than beneficial should be immediately removed from the market.”

l For every new opioid medication approved, the FDA should remove one or more older opioid medications from the market with a particular focus on opioids that are not crush-resistant and are more easily abused.

Manchin said, “There are several dozen opioid extended-release and long-acting opioid medications that have been approved by the FDA and at least two dozen short-acting opioid medications. This market is saturated and we can currently treat everything from short-term, acute pain to excruciating cancer pain. We simply do not need to increase the number of opioid medications on the market.”

With more than 33,000 opioid overdose deaths in 2015 and estimates showing a greater number in 2016, Manchin told Gottlieb he supports the effort to establish the Opioid Policy Steering Committee to strengthen FDA’s response to the crisis.

“I have been very critical of the role that the FDA has played in this epidemic, but I have been heartened to see the changes that the agency has been making to take responsibility for the public health impact of these deadly drugs,” he said. “I appreciate the opportunity to submit three commonsense policy changes for the Opioid Policy Steering Committee to consider. I believe that these simple steps could have a dramatic impact in reducing the number of unnecessary and dangerous opioid medications on the market.”

By:  Wendy Holdren