September 10, 2015

Senators Call for Investigation into FDA Decision on Oxycontin

Senators Joe Manchin (D-W.V.), Tim Kaine (D-Va.) and Mark Warner (D-Va.) sent a letter to the Health, Education, Labor and Pensions (HELP) Committee Chairman Lamar Alexander (R-Tenn.) and Ranking Member Patty Murray (D-Wash.) calling for an investigation into the Food and Drug Administration’s (FDA) decision to approve OxyContin for use by children as young as 11-years-old and an examination of the rise in the opioid misuse, abuse and consequent overdose deaths.

“The decision by the FDA to prescribe OxyContin to children as young as 11-years-old is a horrifying example of the disconnect between the agency’s approval process and the realities the deadly epidemic of prescription drug abuse are having on our communities,” Manchin said in a news release. “The Senate must act swiftly to examine this decision, which was made without the advice of an independent advisory committee, and take a look at the opioid abuse epidemic more broadly.”

“In August, I traveled across the Commonwealth and heard from local leaders, law enforcement, and medical professionals about the impact opioid abuse is having on our communities,” said Kaine in a news release. “The over prescription and misuse of opioids has contributed to the drug abuse crisis, and I’m deeply concerned that FDA’s decision to approve OxyContin for children as young as 11-years-old will further complicate this epidemic.”

“The exponential rise in opioid abuse is devastating Virginia and the rest of the country. I am troubled by the FDA’s decision to expand the approved population who use these addictive drugs to include children as young as 11 years old. I’m especially concerned that this decision was made without the advice of an independent advisory committee, which is required by FDA regulations in cases like these,” Warner said in a news release. “A comprehensive investigation will provide accountability and transparency about how this decision was reached.”

The letter was also signed by Senators Jeanne Shaheen (D-N.H.), Bill Nelson (D-Fla.), Ed Markey (D-Mass.), Kelly Ayotte (R-N.H.), Angus King (I-Maine) and Claire McCaskill (D-Mo.).


CADCA’s online course: “Applying the Strategic Prevention Framework to Prescription Drug Abuse”


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