Senator slams FDA ‘culture’ on opioids

The Food and Drug Administration’s attempts to do more on combating the opioid epidemic hasn’t mollified its biggest critic, just as the nominee to head the agency remains in Senate limbo.

Sen. Joe Manchin, D-W.Va., introduced a bill Thursday that adds language to the FDA’s mission statement that it is needs to strongly consider the danger of addiction and overdose deaths when considering approval of opioids.

Manchin, who hails from a state ravaged by opioid abuse, has been a frequent critic of the FDA and its decision to approve controversial opioids such as a kiddie-size version of painkiller Oxycontin.

“The FDA’s number one priority must be the public’s health and well-being, nothing else,” he said in a statement introducing the Changing the Culture of the FDA Act. “Yet, time and time again, the FDA has stood in the way of efforts to address the opioid abuse epidemic and improve public health.”

Recently Manchin said he would filibuster the nomination of Robert Califf to become the new FDA commissioner. Sen. Ed Markey, D-Mass., also said he would issue a procedural hold on Califf’s nomination also because of concerns about opioid approvals.

With the Senate opposition getting serious, earlier this month the FDA issued a new plan to revamp the agency’s policies on opioid approvals. Provisions included encourage development of abuse-deterrent opioids that include features making a drug impossible to chew or snort.

But when the plan was issued, Manchin said he was impressed but it wasn’t enough.

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