Sen. Joe Manchin wants the U.S. Senate to hold hearings on the Food and Drug Administration's recent decision to approve, in limited cases, prescriptions for the widely-abused painkiller OxyContin in children as young as 11 years old.
Manchin, D-W.Va., and eight other senators (six Democrats, one Republican, one independent) wrote a letter Wednesday to the leadership of the Senate's Health, Education, Labor and Pensions Committee urging hearings on the FDA's decision, as well as on the "exponential rise in the misuse and abuse of opioid painkillers."
There are 2.1 million Americans abusing or dependent on opioid painkillers, the senators write, and 44 people die each day from overdoses on prescription painkillers.
"As we work to stop this crisis, the FDA's decision to approve the use of OxyContin in pediatric patients is a step in the wrong direction," the senators write, "as it may lead to an increase in inappropriate prescribing and use among a population that are already at a higher risk for developing dependency and addiction."
In mid-August, the FDA approved the use of OxyContin, a powerful prescription painkiller, for use in children ages 11 to 16 suffering from cancer, major trauma or major surgery and needing at least several weeks of pain management. The FDA had requested studies from Purdue Pharma, OxyContin's manufacturer, into OxyContin's safety and effectiveness in children.
"To manage pain in pediatric patients, physicians often have to rely on their own experience to interpret and translate adult data into dosing information for pediatric patients," Dr. Sharon Hertz, a director with the FDA's Center for Drug Evaluation and Research, said in an interview listed on the agency's website. "Similar to adults, OxyContin is approved for use in these patients to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate."
OxyContin is an extended-release version of the painkiller oxycodone, meaning a pill is needed, on average, only every 12 hours, as opposed to every four to six hours.
The FDA approved OxyContin only for children who already are responding to and tolerating lower-dose versions of oxycodone.
"This way, their health care providers know that these pediatric patients can be treated safely with OxyContin," Hertz said.
Dr. Rahul Gupta, commissioner of the West Virginia Bureau for Public Health, noted that more than half of abused opioid painkillers come from friends or relatives and the FDA needed to consider that its decision could increase the supply of the painkillers.
"At a time when the nation and, specifically, West Virginia are undergoing an epidemic of opioid prescription drug abuse and resulting suffering," Gupta said, "this may not be the most appropriate time for this type of decision."
Gupta wondered what prompted the FDA to request studies on OxyContin's potential use in children.
"We need to be careful, because actions have consequences," he said. "We can no longer afford to function in our own silos."
Manchin and the other senators called the FDA's decision a "troubling example of the disconnect between the FDA approval process and the realities of this deadly epidemic."
They note that, in 2007, Purdue Pharma pleaded guilty, and paid $635 million in fines, for deceiving doctors about the addictiveness of OxyContin.
In 2010, the company reformulated OxyContin in an attempt to discourage abuse.
More people die from prescription painkiller overdoses than from heroin and cocaine combined, according to the National Institutes of Health.
The problem is especially acute in West Virginia, which has, by far, the highest rate of drug overdose deaths in the country, according to a recent report from the Robert Wood Johnson Foundation.
In their letter, the senators object to the FDA's decision to forgo an independent advisory committee, required for matters that are highly controversial or of significant public interest.
They argue that the FDA's decision is unnecessary, as physicians already can prescribe medications not specifically approved for children when needed.
The FDA's action, the senators said, gives Purdue Pharma the right to begin advertising OxyContin to pediatricians for use in children.
"We have seen the devastating impact of this targeted advertising as the number of opioid prescriptions quadrupled between 1999 and 2012," they write. "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 United States Senate."
In addition to Manchin, the letter was signed by Sens. Kelly Ayotte, R-N.H.; Tim Kaine, D-Va., Angus King, I-Maine; Ed Markey, D-Mass., Claire McCaskill, D-Mo.; Bill Nelson, D-Fla.; Jeanne Shaheen, D-N.H., and Mark Warner, D-Va.
Sen. Shelley Moore Capito, R-W.Va., said she already is working with the Senate HELP Committee on the issue and wanted to gather more information from the FDA before signing on to the letter.
Reach David Gutman at david.gutman@wvgazette.com, 304-348-5119 or follow @davidlgutman on Twitter.