The Short And Controversial Life Of Zohydro Comes To An End
US FDA’s approval of the opioid over resounding opposition of an advisory committee has haunted the agency, and it has imperiled both of Robert Califf’s nominations to be commissioner. The latest company to own Zohydro stopped selling it and FDA withdrew approval of its NDA.
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Commissioner Robert Califf said the new plan should be released in August and include prongs to continue fighting the ongoing prescription opioid epidemic, as well as confront a new synthetic fentanyl and methamphetamine problem.
Republican opposition to Califf over the agency’s recent move to relax its Mifeprex restrictions is ominous since in order be confirmed as FDA commissioner he’ll need enough GOP votes to make up for Democratic opposition over his opioid track record and connections to the drug industry.
Confirmation hearing comment suggests FDA Commissioner nominee Robert Califf thinks an overwhelming advisory committee vote should give agency officials pause.