Democrat Holds Obama FDA Nominee Over Opioid Reviews

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  • Sen. Edward Markey seeks FDA change in painkiller approvals
  • Obama nominated Robert Califf to lead FDA in September

A Democratic senator is holding up President Barack Obama’s nominee for head of the U.S. Food and Drug Administration, calling for changes in how the agency approves prescription painkillers that have been at the center of a deadly epidemic of drug abuse.

Senator Edward Markey of Massachusetts put a hold on Obama’s nomination of Robert Califf, a renowned cardiologist from Duke University, to serve as commissioner of the FDA, according to a statement from the senator’s office Monday. 

Overdoses on prescription painkillers such as OxyContin or Opana killed about 16,000 Americans in 2013, which was about twice the number of deaths from heroin overdose in the same year, according to government data. Markey is particularly upset that the FDA last year approved OxyContin for use in kids from 11 to 16 years old.

“Expert after expert has warned about the real world dangers of abuse of and dependence on these new supercharged opioid painkillers, but the FDA has willfully blinded itself to the warning signs,” Markey wrote. “The FDA needs to commit to shift the way it approaches and evaluates addiction before I can support Dr. Califf’s nomination.”

The Senate Health, Education, Labor and Pensions Committee voted earlier this month to approve sending Califf’s nomination to the full Senate for a vote. Senate Majority Leader Mitch McConnell, a Republican from Kentucky, hasn’t scheduled the full Senate vote yet, according to an e-mail from his office.

The Department of Health and Human Services, the parent agency for the FDA, said it would be in touch “directly” with Markey about his concerns.

“The Department has made addressing the opioid crisis a top priority, and work at FDA and across HHS will continue on this important effort,” according to an e-mailed statement from Kevin Griffis, a spokesman for the department.

Senator Lisa Murkowski, a Republican from Alaska, has also said she would hold Califf’s nomination, over the agency’s approval of genetically modified salmon without a requirement that the fish be labeled as genetically modified.

For the last year, Califf has been deputy FDA commissioner for medical products and tobacco. Before that, he was founding director of Duke’s Clinical Research Institute, the world’s largest academic research organization.