Wednesday, September 24, 2014

Activist Group: FDA Head Should Quit Because of Worsening Opioid Overdose Epidemic
September 24th, 2014/

A group of activists says the Food and Drug Administration (FDA) has worsened the opioid overdose epidemic. They are calling on the head of the agency, Commissioner Margaret A. Hamburg, to quit, The Washington Post reports.

The coalition, called FedUp!, is comprised of doctors, addiction specialists and family members who have lost loved ones to prescription drug overdoses, according to the newspaper. The group is planning a rally on Sunday in Washington, D.C. to draw attention to what it called “a slow and tragically ineffective federal response” to the “worst drug addiction epidemic in our nation’s history.”

“We have come to believe that without new leadership at FDA the opioid crisis will continue unabated,” the group wrote this week to Health and Human Services Secretary Sylvia Burwell. “We are especially frustrated by the [FDA’s] continued approval of new, dangerous, high-dose opioid analgesics that are fueling high rates of addiction and overdose deaths.”

The group criticized Hamburg’s defense of the FDA’s decision to approve Zohydro ER, a pure hydrocodone drug. Zohydro was approved for patients with pain that requires daily, around-the-clock, long-term treatment that cannot be treated with other drugs. In December 2012, a panel of experts assembled by the FDA voted against recommending approval of Zohydro ER. The panel cited concerns over the potential for addiction.

The FDA said in a statement that Hamburg has been a “tireless public health advocate” for more than two decades and “is committed to continuing to champion the rights of patients.” The agency added that preventing opioid abuse and ensuring pain sufferers have access to appropriate treatments are “both top public health priorities for the FDA.”

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