Letter calls for explanation why FDA approved use of OxyContin for children without the benefit of independent Advisory Committee review


Washington (September 18, 2015) – In the wake of the troubling decision by the Food and Drug Administration (FDA) to approve the use of the opioid prescription painkiller OxyContin for children as young as eleven years old, Senator Edward J. Markey (D–Mass.) and a bipartisan group of Senators have sent a letter today expressing their concern and asking the agency why it approved the pediatric prescription use of OxyContin without the benefit of an independent Advisory Committee review. Additionally, it is not clear whether the FDA sought any information about the potential for addiction and abuse by children. Children, whose brains are not yet fully developed, are especially vulnerable to drug dependency and abuse.


“The country is in the midst of an opioid abuse crisis, with more than 2 million Americans aged 12 or older abusing or dependent on opioids,” write the Senators in the letter to the FDA. “Opioid overdoses, once almost always due to heroin use, are now increasingly due to abuse of prescription painkillers like OxyContin. We recognize that, in serious cases, children may need appropriately approved and prescribed narcotics.  But an increase in the availability of opioids like OxyContin to children — and the potential for abuse — poses a serious U.S. public-health issue.”


A copy of the letter to the FDA can be found HERE.


Senators Kelly Ayotte (R-N.H.), Joe Manchin (D-W.V.), Dianne Feinstein (D-Calif.), Tim Kaine (D-Va.), Angus King (I-Maine), Jeanne Shaheen (D-N.H.), and Dick Durbin (D-Ill.) also signed the letter.