HOW DO BIOTECHNOLOGY LAWS AFFECT REAL PEOPLE?

By Panda Kroll

The legal framework governing biotechnology comes to life when interest groups and real people push against agency interpretations and applications of federal and state legislation, regulations, and executive orders. Biotechnology law plays out in courts as well as in congressional chambers and agency offices, often with unpredictable and dynamic results. As just one example, laws governing stem cell research can serve as a catalyst for ethical and scientific controversy among detractors and backers.

Case in point: Sherley v. Sebelius, 644 F.3d 388 (D.C. Cir. 2011). After a judge granted an order shutting down research on human embryonic stem cells (hESCs), a scramble ensued in labs across the nation.

“I have had to tell everyone in my lab that when they feed their cells tomorrow morning, they better use media that has not been funded by the federal government,” said the director of a stem cell transplantation program at Children’s Hospital Boston, referring to food given to cells.

“This ruling means an immediate disruption  of dozens of labs doing this work since the Obama administration made its order [expanding hESC funding].” Note: the University of California is the largest beneficiary of the National Institutes of  Health (NIH) grants at issue.

Sherley was a lawsuit brought by conservative Christian interests on behalf of embryos, embryo adoption agencies, and scientists seeking to bar expanded NIH funding of biomedical research involving new hESC lines. By convention, the defendant in such lawsuits is the current head of the agency whose action is challenged, i.e., Kathleen Sebelius, Secretary of the Department of Health and Human Services. The lead plaintiff, Dr. James Sherley, uses adult stem cells in his research, but never hESCs. The plaintiffs sought to enjoin funding of competing NIH hESC research grants. Dr. Sherley cited as authority the Dickey-Wicker Amendment, a policy rider to appropriations legislation that precludes federal funding of research involving the destruction of embryos. Dickey-Wicker was the basis for  a Bush-era policy and related executive order limiting stem cell research to the 60 lines derived from embryos destroyed prior to 2001. Shortly after he was elected, President Obama rescinded the prior administration’s executive order, and required the NIH to draft new funding guidelines for projects involving hESCs “to the extent permitted by law.”

Prior to enacting its new “Guidelines for Human Stem Cell Research,” NIH issued a notice of proposed rulemaking containing draft guidelines, as required by the Administrative Procedure Act governing all agency regulation. 49,000 public comments were submitted for and against such research. The final guidelines authorized public funding of HESC research utilizing embryos that were “created using in vitro fertilization for reproductive purposes” but that were “no longer needed” and for which informed consent had been given for use in research. Under the guidelines, Dickey-Wicker precludes only funding for research which actively included derivation of hESCs from embryos, and does not unambiguously preclude research on privately-derived HESCs. Dr. Sherley challenged these guidelines in court, and a D.C. judge agreed, enjoining researchers to stop “any action whatsoever” taken under the guidelines, which were preliminarily ruled unlawful based on Dickey-Wicker. The disruption ensued.

Seventeen days later, an appellate court stayed the Sherley injunction, allowing the lab work to resume. The ruling turned on the definition of “research.” The appellate court found that the congressional intent behind Dickey-Wicker, while barring research “in which” embryos “are” presently destroyed, was not to bar research “for which” embryos “were” destroyed in a prior, privately-funded extraction phase of a project. The lower court, forced to dismiss Dr. Sherley’s case, grumbled that it had “become a grudging partner in a bout of linguistic jujitsu.” Further challenges to hESC research are expected, and Dr. Sherley’s most recent appeal was heard on April 23.

Panda Kroll, Esq., is a lecturer in CSUCI’s Martin V. Smith School of Business & Economics and a member of the CITATIONS Editorial Board.

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