FDA calls for new opioids standard

In FDA's continuing response to critics of the agency's approval of Zohydro ER hydrocodone bitartrate, CDER Director Janet Woodcock and colleagues have called on states, medical boards and clinicians to impose prescribing rules on all opioids as a "new standard of care for appropriate pain management," rather than single out one drug for restrictions.

Writing in a Viewpoint article in the Oct. 3 Journal of the American Medical Association, Woodcock and Christopher Jones and Peter Lurie of FDA's Office of the Commissioner repeated the agency's rationale for approving Zohydro from Zogenix Inc. (NASDAQ:ZGNX), writing the drug was needed for patients who require around-the-clock, long-term opioid treatment and are not adequately served by alternatives. The drug was approved without abuse deterrence technology and raised calls from members of Congress for FDA to reverse itself. ...