U.S. Senator to Call for Investigation into FDA’s OxyContin Decision for Children

U.S. Sen. Joe Manchin (D-W.Va.) says he will call for a Senate investigation into the FDA’s decision to allow OxyContin to be prescribed to children as young as 11.

In a letter to FDA Acting Commissioner Stephen Ostroff, Manchin calls the decision allowing Purdue Pharma to market the drug to children who can tolerate opioids reckless, pointing out that 2.1 million Americans abuse opioids and 44 people die each day from prescription opioid overdose.

But the FDA had asked for and reviewed a study of the drug and determined that children who required extended pain management can safely switch to OxyContin from another opioid.

Manchin’s office did not explain why his criticism focused on OxyContin and not the other opioid drugs that can be prescribed to pediatric patients. Another extended-release opioid, Janssen Pharmaceuticals’ skin patch Duragesic (fentanyl), has FDA approval for pediatric use, while some immediate-release opioids have pediatric information included in their labels.

Manchin claims the agency should have sought the advice of an independent advisory committee before approving Purdue’s labeling change. He points out that FDA regulations require convening a committee when a matter is of significant public interest, highly controversial or in need of a specific type of expertise — and this decision met all of those criteria.

This is not the first time Manchin has challenged the FDA’s approval of a painkiller. In March 2014, he joined Sen. Chuck Schumer (D-N.Y.) in calling for HHS to revoke the FDA approval of Zogenix’s Zohydro ER (hydrocodone bitrate), claiming it hit the market without any abuse-deterrent measures.

In last week’s letter, Manchin again raps the FDA for approving Zohydro, what he calls a pure hydrocodone drug, despite an advisory committee voting against approval because of the danger of overdose and death.

Read Manchin’s letter at www.fdanews.com/08-19-15-OxyContin.pdf. — John Bechtel