RECOMBINANT DNA RESEARCH: ELIMINATION OF NIH GUIDELINES SUPPORTED BY FDA

Executive Summary

RECOMBINANT DNA RESEARCH: ELIMINATION OF NIH GUIDELINES SUPPORTED BY FDA "in favor of other existing risk-based mechanisms of governmental oversight and regulation," Henry Miller, MD, director of FDA's Office of Biotechnology, argues in a statement submitted to the National Institutes of Health Recombinant DNA Advisory Committee (RAC). If the guidelines were eliminated, regulation of genetically engineered organisms "would then continue to be accomplished by the broad existing net that currently ensures the safety of uses of new organisms ranging from new cultivars of wheat and soybeans to new vaccine strains of influenza virus and vaccinia-based AIDS vaccines," Miller said. The statement notes that the existing regulation includes a handbook written by NIH and the Centers for Disease Control, "Biosafety in Microbiological and Biomedical Laboratories." Miller's letter was initially submitted to RAC at the first of seven regional meetings held to gather comments from industry, academia and the public about the future role of RAC and its guidelines. At the final regional meeting, held Oct. 15 at NIH, Miller told RAC members that "on the basis of scientific analysis, there is no rationale any longer for maintaining the guidelines purely based on a single technique." He added that "perhaps it's time to permit the guidelines to sunset." Miller's submitted statement concludes that "the guidelines have evolved such that they now oversee almost nothing, but their existence confounds the complete implementation of a scientifically sound U.S. government policy that focuses on the risks inherent in the characteristics of products, rather than on the use of certain techniques." The Pharmaceutical Manufacturers Association does not support eliminating the guidelines. PMA Assistant VP for Biotechnology and Biologics Thomas Copmann, PhD, told RAC members that "the industry urges the RAC to maintain the...NIH guidelines for research. The RAC provides the rational scientific basis for risk assessment of novel recombinant therapeutics and production technologies that the industry needs to continue to discover and develop new therapies using rDNA technology." Similarly, Joseph Van Houten, PhD, director of laboratory safety for the Robert Wood Johnson Pharmaceutical Research Institute, stated that the guidelines "are internationally renowned as the code of prudent practice for the safe handling of organisms containing recombinant DNA." He added that "operating in compliance with the guidelines provides for protection of employees and reassurance to the communities in which we operate that we are 'doing things right'." Former NIH Director Donald Fredrickson urged RAC to focus its future efforts on supervising human gene therapy protocols and laboratory safety, and to avoid becoming involved in overseeing releases of genetically engineered organisms into the environment.