WASHINGTON, DC - Bipartisan leaders of the House Energy and Commerce Committee today sent a letter to Food and Drug Administration Acting Commissioner Dr. Stephen Ostroff regarding the labeling of certain opioids, particularly the discrepancy between Extended Release and Long-Acting (ER/LA) opioid analgesics and Immediate Release (IR) opioid analgesics. The Oversight and Investigations Subcommittee has held a number of hearings on the threat of prescription drug and heroin abuse in recent months.
Chairman Fred Upton (R-MI), Ranking Member Frank Pallone, Jr. (D-NJ), Oversight and Investigations Subcommittee Chairman Tim Murphy (R-PA), and Subcommittee Ranking Member Diana DeGette (D-CO), today write, “In 2013, FDA adopted labeling changes affecting Extended Release and Long-Acting (ER/LA) opioid analgesics, requiring manufacturers to adopt the most restrictive language that can be found in drug labeling, a ‘black box’ warning about their potential for abuse, the risk of fatal overdose, and a warning that maternal use of these products during pregnancy can result in neonatal opioid withdrawal syndrome. At the time, similar requirements were not imposed on manufacturers of Immediate Release (IR) opioid analgesics."
The letter continues, “In addition, FDA’s posted ‘Guide to Safe Use of Pain Medicine’ states: ‘According to NIH, studies have shown that properly managed medical use of opioid analgesic compounds (taken exactly as prescribed) is safe, can manage pain effectively, and rarely causes addiction’ and ‘pain medications are safe and effective when used as directed.’"
The bipartisan leaders continue, “Experts have raised concerns with staff about the basis and effectiveness of these and other FDA labeling and risk-management strategies, and a recent review on opioid use for chronic pain by the Agency for Healthcare Research and Quality (AHRQ) found no evidence that risk mitigation strategies were effective. Additionally, Democratic members of the Committee, led by Ranking Member Frank Pallone, recently wrote FDA to request that the agency ensure that all IR opioid formulations bear the same black box warning as ER/LA formulations."
The bipartisan leaders are requesting documents and information explaining the difference in labeling practices.
Read the complete letter online HERE.
