FDA Public Hearing in Bethesda, Maryland

Foundation President Judy Rummler and Vice President Lexi Reed Holtum presented at the FDA Public Hearing held on February 7-8 in Bethesda, Maryland.  The hearing was scheduled by the FDA to allow them to gather information on the Impact of Approved Drug Labeling on Chronic Opioid Therapy.  The FDA panel was headed by Douglas Throckmorton, MD, Deputy Center Director, Center for Drug Evaluation and Research, FDA.  There were fifty-five presenters, many of whom supported the labeling changes recommended in the PROP petition.  The Foundation’s Board of Directors and all members of the Foundation’s Medical Advisory Committee support these labeling changes designed to curb the over-prescribing of opioids while protecting access to these medications for pain patients who need them.