Endocrine Insider
July 1, 2010

(See full issue)

On June 25, a federal appeals court reinstated a suit challenging the revised NIH guidelines on human embryonic stem cell (hESC) research.  In response to President Obama’s 2009 Executive Order lifting a ban on federal funding for most hESC research, the revised Guidelines allow for funding of research on hESC derived after the 2001 limits were set in place. 

In filing the original case last year in district court, the plaintiffs argued that the revised guidelines violated the Administrative Procedure Act (APA) by being inconsistent with the Dickey-Wicker Amendment. The Amendment has been attached to the L-HHS appropriations bill every year since 1996 and prohibits federal funding of research in which a human embryo is destroyed.  The plaintiffs also requested a preliminary injunction to prevent NIH from implementing the new Guidelines pending the final outcome of the case.  The district court last year ruled that the plaintiffs did not have standing and dismissed the suit along with the request for a preliminary injunction. 

In reinstating the case, the appeals court has ruled that two of the plaintiffs have standing in that, as NIH-funded investigators specializing in adult stem cell research, the two researchers will face stiffer competition for federal stem cell funding, thereby placing them at risk of “imminent” injury as a direct result of that competition.

The appeals court further concluded that the plaintiffs have standing under the APA and reversed the district court decision, including the district court’s dismissal of the motion for a preliminary injunction.  Though the plaintiffs had further asked the appeals court to consider the motion for an injunction, the ruling indicates that such consideration does not fall under the usual practices of the appeals court.  Thus, the case is now remanded to the district court for further proceedings and for consideration of the motion for an injunction.

The appeals court’s ruling can be accessed in full here.