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Cape Cod Times: Markey: FDA must change drug approval policies

Citing policy blunders that might have increased the opiate crisis, Sen. Edward Markey, D-Mass., continues to try to block President Barack Obama’s Food and Drug Administration Commissioner nominee, Dr. Robert Califf.

On Jan. 25, Markey placed the nomination on hold until the FDA commits to immediate changes in policies on the approval of opioid-based medicines.

Specifically, Markey is calling for the FDA to convene an advisory committee for any future opioid approvals. He wants the FDA to consider “addiction abuse and dependence” as part of its determination of which opioids are safe. He is also asking the agency to rescind the approval of OxyContin for children and convene an advisory panel to provide direction as it reconsiders that decision.

“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 said in a statement. “The FDA needs to commit to shift the way it approaches and evaluates addiction before I can support Dr. Califf’s nomination. Until it does, we will continue to see this tsunami of opioid overdoses engulf family after family.”

The FDA made several decisions to approve powerful opioid medications without the advice, or against the advice, of the agency’s own advisory panels. In 2012, a panel voted 11-2 against approving the drug Zohydro, but the FDA overruled its own experts and approved it anyway.

In 2014, the FDA approved Targiniq ER and Hysingla ER, extended-release opioid analgesics, without convening an advisory committee.

In August 2015, the FDA approved a new pediatric indication for OxyContin without convening an advisory committee.

On Feb. 4, several days after Markey put Califf’s nomination on hold, the FDA proposed changes, including agreeing to convene advisory panels before approving opioid medicines without abuse-deterrent properties. The actions are not enough, Markey said, and he’ll continue to use parliamentary rules to put a hold on the nomination.