it ka are carries a warning statement. the manufacturer said, quote, the fact is that zohydro er is a novel pain medicine that fills an important medical need. joining me from fda headquarters is commissioner dr. margaret hamburg. welcome to the program. thanks for being here. >> thank you. >> this whole issue seems to have stirred up a lot of controversy. zohydro, state of massachusetts tried to ban it, 30 state attorney generals have asked you to reconsider this approval. your own advisory panel voted 11-2 against it. what are we missing here? why are those folks wrong on this issue? >> well, i think this should not really be about a single drug. it really reflects the growing concerns about opiate addiction abuse, misuse and overdose, and the need to balance strong strategies to combat that serious public health problem with ensuring access to