Back in August, the FDA approved Purdue's powerful painkiller, OxyContin, for children ages 11 to 16. But nearly two months later, the public backlash hasn't died down.
Lawmakers and public officials working to ward off opioid abuse in their communities have continued to lob criticism at the agency's decision, The New York Times reports. Last week, presidential candidate Hillary Clinton jumped into the fray, calling the OxyContin go-ahead "absolutely incomprehensible."
For the FDA's part, it recognizes that "this is a very nuanced issue," Stephen Ostroff, its acting commissioner, told the paper. "It needs to be understood in the context of why this was done." As Sharon Hertz, director of the body's Division of Anesthesia, Analgesia, and Addiction Products, wrote in an August post, without solid data, doctors too often use OxyContin off-label in children suffering from cancer and other pain-heavy conditions by relying "on their own experience to interpret and translate adult data into dosing information for pediatric patients."
Still, some critics are worried that patterns of use for the drug--whose label specifies that it's not meant as a first-line treatment, nor as a solution for short-term pain--will change.
"This approval allows Purdue Pharma to market and promote this product for use in children, and … with this ruling, the horse is out of the barn," Dr. G. Caleb Alexander, an internist and a director of the Center for Drug Safety and Effectiveness at Johns Hopkins Bloomberg School of Public Health in Baltimore, told the Times.
Purdue, though, has pledged not to promote the new pediatric safety and dosing info to pediatricians or other doctors, with spokesman Robert Josephson telling the NYT in a statement that "we share Secretary Clinton's concerns about opioid overuse and abuse." The company--which in 2007 pleaded guilty in federal court to criminal charges that it misled physicians, patients and regulators about OxyContin's abuse potential--has recently stepped up its own efforts to combat opioid addiction, rolling out informational website TeamAgainstOpioidAbuse.com.
Meanwhile, it's far from the first time recently that the FDA has taken heat for green-lighting a high-strength pain drug. Last year, controversy raged for months over the approval of Zohydro--an all-hydrocodone product that lacked abuse-deterrent properties--with opponents calling on then-FDA commissioner Margaret Hamburg to resign over the decision.
- see the NYT story (sub. req.)
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