Congressman Lynch Leads Letter to HHS Secretary Sebelius over concerns with the FDA’s recent approval of high-dose narcotic Zohydro ER

Nov 25, 2013

WASHINGTON, DC—Congressman Stephen F. Lynch, a founding co-chair of the Congressional Caucus on Prescription Drug Abuse, led a bipartisan group of Members of Congress in expressing concern regarding the U.S. Food and Drug Administration’s recent decision to approve the high-dose narcotic painkiller Zohydro ER. Importantly, the letter to Health and Human Services Secretary Kathleen Sebelius highlighted the group’s apprehension over the high likelihood for abuse and the inherent risks for the public that are created by allowing access to this drug.

Lynch said, “This approval is extremely troubling and runs counter to recent, positive FDA announcements relative to the regulation of opioids.  We support the FDA efforts to reclassify hydrocodone combination products such as Lortab and Vicodin to a more restrictive Schedule II drug and the updated labeling requirements for all extended release/long acting (ER/LA) opioid analgesics, but view this approval of Zohydro ER as a giant step backward.”

Lynch emphasized the effect that prescription drug abuse has had on our country, adding, “Substance abuse is exacting a toll on America.  The Centers for Disease Control and Prevention reported that there were 38,329 drug overdose deaths nationwide in 2010 and that prescription drugs were involved in nearly 60 percent of those deaths.  The report also details that, consistent with previous years, opioid drugs, which include OxyContin and Vicodin, contributed to 3 out of 4 medication overdose deaths. In addition the National Institutes of Drug Abuse estimates the total overall cost of substance abuse in the United States, including lost productivity and health and crime-related costs, exceeds $600 billion annually. On many levels we simply cannot afford to move yet another highly addictive opioid into the mainstream and potentially onto Main Street.”

Full text of the letter can be found here.

Co-signers of the letter: Harold Rogers (R-KY), Nick R. Rahall (D-WV), William R. Keating (D-MA), Vern Buchanan (R-FL), John F. Tierney (D-MA), Michael E. Capuano (D-MA), and James P. McGovern (D-MA).