No Oxy for You!

FDA showdown

Sen. Edward Markey (D–Mass.) has put a hold on the nomination of Robert Califf to be the new commissioner of the Food and Drug Administration (FDA). Markey hopes to force the agency to revisit its policies toward opioid painkillers, such as OxyContin. "The FDA must commit to shift the way it approaches and evaluates addiction," he said on the Senate floor in February, "before I can consider supporting Dr. Califf's nomination."

Markey believes the FDA has failed to take the risks of abuse seriously in its approval process for new opioid drugs and new uses for existing drugs. In particular, he focuses on a regulatory decision he calls "OxyContin for kids." He fails to note that the drug was approved for a very narrow use: kids 11 or older who are having trouble managing severe daily ongoing pain using first-line painkillers. In other words, the FDA wasn't approving power painkillers for use willy-nilly in the juvenile population; it was giving doctors who treat the sickest kids another tool to help them.

Markey's puritanical approach to pain management and his concern about the toll of drug abuse may be well-intentioned, but by pushing the mandate of the FDA closer to the role of law enforcement, he's more likely to further politicize and slow an already torturous process.