W.Va. senator slams FDA for giving OxyContin to 11-year-olds

Sen. Joe Manchin (D-W.V.) is condemning the Food and Drug Administration’s (FDA) recent decision to approve the use of OxyContin to treat children as young as 11 years old.

In a letter to the FDA’s acting Commissioner Stephen Ostroff, Manchin said he’s “disgusted,” and the agency should be “ashamed of itself for this reckless act.”

“I have pleaded with your agency since I became a senator almost five years ago to cease the flood of painkillers that is killing so many people in my state and around the country,” he wrote. “Instead, you continue to ignore the agency’s purpose and show allegiances with everyone but the people you are charged to protect.”

{mosads}Manchin said there are 2.1 million Americans abusing or dependent on opioids and 44 people die every day as a result of prescription opioid overdose.

In adults, FDA said OxyContin is approved to manage pain that is severe enough to require daily, around-the-clock, long-term opioid treatment.

FDA said the drug is not intended to be the first opioid drug used in pediatric patients, but data shows that changing from another opioid drug to OxyContin is safe if done properly.

Manchin disagrees.

“An 11 year old’s brain has another 14 years before it is fully developed. We have years of evidence that shows that drug use at an early age makes a child more likely to abuse drugs later in life,” he said in his letter to the FDA. “You have ignored all of this. Instead, under your new guidance, we are literally poisoning our children’s brains and setting them up for future drug abuse.”

Manchin is calling for a Senate investigation into the agency’s recent decision. He said FDA is required to convene an advisory committee when a matter is of significant public interest, highly controversial, or in need of specific type of expertise, but it skipped this critical step.

“There is no sound argument to be made that this decision does not meet every single one of those criteria,” he said in the letter. “Given the extraordinary public health crisis that we are facing and the well-documented damage that dangerously addictive drugs like OxyContin can do to a developing brain, it is difficult to believe that an independent panel of experts would have recommended the approval of this drug in children.”