Washington (March 22, 2016)— Senator Edward J. Markey (D-Mass.) released the following statement after the U.S Food and Drug Administration (FDA) today announced new warnings for immediate-release opioid pain medications and additional labeling changes to be made on all opioid products intended to reflect the risks of these pain medications including risks of misuse, abuse, addiction, overdose and death.
“Today’s announced changes to the labels of opioid products will finally reflect what we have known about these drugs for decades - they are dangerous and addictive and can lead to dependency, overdose and death. Whether it's immediate or extended release, or abuse-deterrent, the labels given by the FDA have done little to prevent opioid addiction. Unfortunately, it has taken FDA far too long to address the grave risks of these drugs that have claimed the lives of thousands this year alone.
"There is much more that needs to be done to ensure that the FDA is fulfilling its mission to protect Americans from the dangers of opioid painkillers. To start, FDA should ensure that every opioid that comes to the agency for approval has the benefit of being reviewed by an external advisory committee. By refusing to convene advisory committees to inform all of its opioid approval decisions, the FDA continues to ignore outside experts who could help stem the tide of tragic deaths and overdoses plaguing the country.
"We also need requirements to ensure all prescribers of opioid painkillers are educated in safe prescribing practices and the identification of possible substance use disorders. I will continue to work with my Congressional colleagues to pass legislation that ensures all prescribers of opioid pain medication get the education needed to help prevent addiction before it takes any more lives of our friends, families and loved ones.”