Five members of Massachusetts’ Congressional delegation and 10 other Congressmen have signed a letter to the FDA, expressing concern over the agency's approval - in August - of the painkiller OxyContin being prescribed to children . The issue is a controversial one.
Congresswoman Niki Tsongas led the group who wrote the FDA. She says she’s concerned both with the addictive nature of OxyContin for kids, and with the the research that led to the agency’s ruling.
"The way in which this study was done raises altogether too many questions," Tsongas said. "And one we have to take very seriously given the opioid crisis we have in this country today."
The research was conducted by Perdue Pharma, the company that makes OxyContin. The FDA had asked Purdue to do the study, following a federal law called the Best Pharmaceuticals for Children Act, which provides incentives for pharma companies to study drugs in young patients.
“We’re simply asking that the FDA go back and revisit the process by which they made this decision and that they not depend upon a company that has an inherent conflict of interest in the ability of pediatricians to prescribe OxyContin for children as young as 11," she said.
Tsongas and her colleagues want the FDA to get input from an independent advisory committee.
“And should they issue the same outline based upon that, that would be far more acceptable," she said.
Dr. Sharon Levy supports the FDA decision. She’s the Director of the Adolescent Substance Abuse Program at Boston Children’s Hospital.
“Addiction in young people is a huge concern," said Levy. "But the way to address the issue is not by restricting access for children who need it to OxyContin."
Levy says doctors were already prescribing OxyContin to children who need round-the-clock management for severe pain, even though it hadn’t specifically been approved for kids. She says the FDA approval gives doctors more direction.
“Having the status change may actually improve the guidance that’s given to physicians and improve the way they use the drug, which is what we want in terms of cutting down on addiction."
Levy says when teenagers abuse prescription drugs, it’s usually because they get access to somebody else’s medication, not because they have prescriptions themselves. The FDA wouldn’t comment on the letter from the Congressman. They say they’ll respond directly to the lawmakers.
