In December of 2009, I argued that President Obama’s Executive Order 13505, that lifted President Bush’s 2001 Order banning the use of federal funds for embryonic stem cell (ESC) research, should be a Top Biotech Story of 2009. The Bush Order had banned all federal funding for ESC research except for research on a small number of lines that existed prior to his order. Obama’s substitute order permitted agencies like NIH to fund research on cell lines produced after the Bush ban, so long as the funding was not used to produce the lines by the destruction of embryos. NIH went on to develop guidelines for approving fundable new cell lines.
In the December 2009 post, I noted that Congress had annually enacted the so-called Dickey-Wicker amendment that banned federally-funded research that harms or destroys human embryos. The Administration tried to argue that Order 13505 did not permit funding of obtention of ESCs from embryos, but the Judge found this a distinction without a difference.
Questions remain. While Judge Lamberth (D.C.D.C.) stated that the decision was intended to restore the status quo, the status quo, e.g., the Bush Order, is long gone. Research projects using newly approved lines have been started. Even if they can be continued with private funding, it is far from clear that these “illegal” cell lines can be used at all. But what if the lines were produced abroad and sent to a U.S. lab? Would even the limited research permitted under the Bush order be fundable now? What is supposed to happen to ongoing projects that cannot find non-federal funds to keep the laboratory lights on? With patent protection for ESCs uncertain at best, the future of this research in the U.S. is cloudy at best.