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.
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.
Don’t look now, but Medtronic has quite possibly just become the poster child of the opposition against the Medical Device Tax. During a call with analysts in February, the med-tech giant said that it expected to pay up to $175 million in costs because of the tax.