No doubt some are tired of hearing me go on about the FDA budget, but industry thinks the agency is under-funded, too. Most who are part of this discussion believe FDA would be more functional with appropriate appropriations, but they ignore the dynamic necessary to fully fund FDA. Hence, the dysfunction persists. To wit: Dealing with FDA’s public affairs staff is typically not a bad experience unless they have to consult with others at the agency on fairly detailed matters. For instance, I’d written last year about a Federal Register notice addressing pre-emption of state law with regard to the...

The Supreme Court decision in Mayo v. Prometheus and the Court’s remand of Myriad have provoked a lot of angst on the part of those in the life sciences. Still, the degree to which these cases might prove cataclysmic is tough to forecast, and those who think Chicken Little is overdoing it have some basis for skepticism. So in the spirit of Prometheus and Epimetheus, the sibling Greek deities whose names translate respectively as forethought and afterthought, let’s examine the prospects for patents in this strange new world. First, let’s ask Epimetheus about the Supreme Court decision in KSR v....

The February advisory committee hearing for cranial electrotherapy stimulator (CES) devices was chock full of controversy during the course of the hearing, but one of the companies with an offering in this space is arguing that FDA violated its own rules in the conduct of the hearing and has filed a citizen's petition regarding FDA's proposed classification of CES devices as class III devices.