Nine senators are urging their colleagues on the Health, Education, Labor, and Pensions Committee to investigate the US Food and Drug Administration (FDA)’s August approval of oxycodone (OxyContin, Purdue Pharma LP) for children ages 11 to 16.
In the letter, dated September 9, the senators said that the approval would not increase access to children with cancer or chronic pain, “as pediatricians already prescribe medications that are not specifically approved for use in children when it is needed.”
They also stated that the approval decision had been made without the input of an advisory committee, which should have been warranted, given the significant public health interest and controversy surrounding opioids.
“The lack of an advisory board and the potential consequences of the FDA’s decision make this an issue ripe for congressional oversight and in need of a thorough examination by the US Senate,” the senators, led by Joe Manchin (D-WVa) write.
The letter is similar to one sent in August by Manchin to Stephen Ostroff, MD, the acting FDA commissioner.
Manchin said then that he would be calling for a senate investigation, adding that he was “disgusted” by the agency’s August 13 approval for pediatric patients aged 11 to 16 years with pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Manchin pointed out “evidence that shows that drug use at an early age makes a child more likely to abuse drugs later in life” and added that children needed to be protected “from these harmful drugs.”
The West Virginia senator also noted that his state was struggling with the fallout of opioid abuse. “We must be doing everything in our power to stop the flow of these devastating drugs into our communities; it seems that the FDA is grossly out of touch with the epidemic facing our communities and is working to do the exact opposite,” he said in the August letter to Dr Ostroff.
Senators Kelly Ayotte (R-NH), Tim Kaine (D-VA), Angus King (Independent-ME), Edward Markey (D-MA), Claire McCaskill (D-MO), Bill Nelson (D-FL), Jeanne Shaheen (D-NH), and Mark Warner (D-VA) joined Manchin in calling for the committee inquiry.