The Courts

The U.S. Supreme Court agreed last week take up a case that will determine the constitutionality of the patent office’s inter partes review process -- an administrative procedure for challenging patents that some drug industry stakeholders have said undermines the drug pipeline and unfairly uses a lower standard for reviewing patents than that used by a district court.

Amgen's pediatric exclusivity lawsuit against FDA was stayed after the agency agreed to reconsider its May 22 decision not to grant pediatric exclusivity to Amgen's Sensipar, a drug to treat secondary hyperparathyroidism.

The U.S. Supreme Court on Monday (June 12) issued a biosimilar-friendly ruling in the high-profile Amgen v Sandoz case involving key policies surrounding the biosimilar pathway, but one justice opined that FDA potentially could still depart from the court's interpretation as it gains more experience with the law.

The White House Office of Management and Budget finished its review of a proposed rule to revise the contentious provision banning pre-dispute arbitration agreements for long-term care facilities Friday (June 2), coming after OMB officials met with a number of beneficiary advocacy groups last month.

Women's advocates warn the Trump administration to be prepared for a court battle should it move forward with a draft interim final rule under review by the White House that would make it easier for employers to opt out of the Affordable Care Act's requirement to provide cost-free coverage of FDA-approved contraceptives.

An HHS official said the administration continues to weigh options on future payment of the Affordable Care Act's cost-sharing reductions -- even as it has agreed to continue to hold a related court case in abeyance rather than end the payments -- and suggested the issue could be resolved by passing the GOP's health care bill and reforming “Obamacare's failed funding structure.”

A coalition of groups including the Center for Food Safety sued FDA Monday (May 22) in an attempt to block the voluntary generally recognized as safe (GRAS) notification system created by the agency's August 2016 final rule, which the plaintiffs say violates both the Administrative Procedure Act and the Food, Drug and Cosmetic Act, and is unconstitutional because it forecloses judicial review of GRAS determinations.

Tucked into the FDA user fee package that cleared the Senate health committee Thursday (May 11) are technical changes to orphan drug law that one legal expert says would bolster the agency's legal stance in both current and past litigation, and effectively unravel a case that FDA lost.

The White House Office of Management and Budget is reviewing a CMS proposed rule to revise a highly contentious provision on arbitration contracts that was included in updated requirements for long-term care facilities -- mainly nursing homes -- to participate in Medicare.