Clearest impacts of Chevron ruling will be on disputes over exclusivity, other non-science issues

It will take years to determine the effects on FDA and regulated industry of the Supreme Court’s decision to overturn a legal doctrine that led courts to defer to federal agencies’ interpretations of ambiguous laws. An onslaught of litigation probing the meaning of Thursday’s decision is inevitable, as are steps by FDA to bolster its legal defenses.

A majority of the Supreme Court’s justices have expressed disdain for Chevron deference for some time, so neither the decision, nor the 6-3 split between conservative justices in the majority and liberal justices in the minority, were surprising. Attorneys specializing in FDA law have been speculating for years about the effects of such a decision. ...