Federal Stem Cell Funding Approved by Appellate Court

28 August 2012 Personalized Medicine Bulletin Blog

Good news for patients and stem cell researchers alike. On August 24th, the United States Courts of Appeals for the District of Columbia Circuit affirmed the District of Columbia court decision granting the government’s motion for summary judgment allowing the continued funding of research involving human embryonic stem cells (“hESCs”). Sherley v. Sibelius, No. 11-5241, slip op. (D.C. Cir. August 24, 2012). This is the most recent decision in the dispute between U.S. researchers in the field of adult stem cells, the Secretary of Health and Human Services, and the Director of the National Institutes of Health (NIH).

History of the Dispute

On March 9, 2009, President Barack Obama’s signed an Executive Order that overturned the previous administration’s policy banning the use of federal funds for research using embryonic stem cells created after August 9, 2001. (Removing Barriers to Responsible Scientific Research Involving Human Stem Cells, Executive Order 13505, 74 Fed. Reg. 46, 10667 (March 11, 2009)). This action renewed the hope of scientists and supporters of research using embryonic stem cells that the increased availability of funding would make it easier to conduct such research in the United States.

Soon thereafter, a group of plaintiffs filed suit challenging the NIH’s authority to issue the 2009 NIH Guidelines that implemented President Obama’s 2009 Executive Order. Plaintiffs argued that legislation known as the Dickey Amendment or the Dickey-Wicker Amendment bans the use of federal funding to support research involving human embryos. Congress originally passed this legislation in 1996, and former President Clinton signed it into law. The Dickey Amendment prohibits the Department of Health and Human Services (HHS), which includes the NIH, from funding research where human embryos are destroyed. Congress has included the Dickey Amendment in every subsequent HHS appropriations bill without substantial alteration. In subsequent years, the rider was enacted in Title V (General Provisions) of the Labor, HHS, and Education Appropriations Act. 

The August 2012 Circuit Decision
 
Judge Sentelle wrote the panel’s opinion. Judge Henderson and Brown wrote separate concurring opinions. At its core, the 3-judge panel decision held that the 2009 Guidelines do not violate the Dickey Amendment because in deferring to the defendant’s interpretation of the Dickey Amendment, the research funded by the NIH did not include the banned destruction of human embryos. The judge also indicated that the NIH had authority to interpret the Dickey Amendment under a doctrine known as “Chevron” deference. Chevron U.S.A., Inc., v. Natural Resources Defense Counsel, Inc., 467 U.S. 837, 843 (1984). Under Chevron, a court must first ask whether Congress has directly spoken to the precise question at issue and if it has, a court must give effect to the unambiguously expressed Congressional intent. If however, such as the court determined here, the statute is silent or ambiguous with respect to the specific issue, then the court must defer to the agency’s (in this instance the NIH) interpretation provided it is based on a permissible construction of the statute. Under the NIH’s interpretation, Judge Sentelle noted, the Dickey Amendment permits federal funding of research projects that utilize already-derived hESCs – which are not themselves embryos – because no human embryo or embryos are destroyed in the funded projects.
 
Judge Henderson concurred but disagreed with Judge Sentelle that a Chevron review is applicable because Congress did not unambiguously delegate to the NIH the authority to interpret the Dickey Amendment. In addition, she wrote that the Dickey Amendment is not under the NIH’s area of expertise. Judge Henderson opined that the current panel, however, was bound to an earlier decision and therefore concurred with Judge Sentelle. Judge Brown agreed with Judge Henderson, but on the ground that the lower court’s holding did not rise to the level of clear error under which the district court’s decision could be vacated.
 
Looking Ahead
 
This decision moves judicial resolution one step closer to finality. Plaintiffs could seek rehearing en banc from the full Court of Appeals, based on the concurring opinions. A petition for certiorari could also be filed with the Supreme Court. In the meantime, federal funding of hESC research will continue to the end of providing potential cures for many unmet medical needs.
 
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