Actions speak louder than words. That, at least, is how Seattle Genetics urged investors to think about a tongue lashing the company received during an advisory committee review of the cancer agent Adcetris Seattle Genetics may be right on two levels: the practical outcome of the meeting was positive, and the FDA rhetoric may not have been as directly aimed at the sponsor as a warning to all oncology drug developers.

Positive tandem ICER reviews for bluebird bio’s and Vertex/CRISPR’s gene therapies show the impact that concerns about addressing racial inequities could create a favorable context for products as they enter pricing and coverage discussions.

Robert Califf’s nomination to return as FDA commissioner will raise protests about a ‘revolving door’ pathway between industry and agency. But, in this case, it may be more apt to talk about how Califf’s time outside FDA led to evolving views on the role of big data in drug regulation.