Supreme Court nominee issued three decisions on Hatch-Waxman regime as district court judge, including case in which she ruled against the FDA’s denial of orphan drug designation and another in which she deferred to the agency’s view on exclusivity. Her analysis of facts may play a role if the court takes up a case on administrative agency deference.

However, FDA must explain why denial of Sensipar's pediatric exclusivity was consistent with exclusivity award for J&J's Ortho Tri-Cyclen, US judge says. In swipe at plaintiff Amgen, court says pediatric study reports themselves guide exclusivity determinations, not the amount of effort a sponsor puts into those studies.

Supreme Court nominee's opposition to deference for administrative agencies could help biopharma industry in its battle over off-label communications if the issue ever goes before the court; he also supports securities litigation reform.