After a group of activists called on the head of the Food and Drug Administration (FDA) to quit over the approval of the painkiller Zohydro, three FDA officials say the drug’s approval was warranted.
The officials say it is misguided to advocate for restricting the use of one opioid, instead of addressing the underlying issue of widespread abuse and inappropriate prescribing, The Wall Street Journal reports.
Last month, a coalition called FedUp! called on FDA Commissioner Margaret A. Hamburg to quit. The coalition, comprised of doctors, addiction specialists and family members who have lost loved ones to prescription drug overdoses, critized 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.