Biotech Bottleneck: Can Support From Bush, FDA Speed Things Up?

In February, President Bush announced "major new ground rules" to streamline the regulation of the biotechnology industry. And on the same day, the president's Council on Competitiveness published--under the auspices of the Office of Science and Technology Policy (OSTP)--a policy for all biotech-regulating agencies that set out a "risk-based, scientifically sound approach to the oversight of planned introductions of biotechnology products into the environment." OSTP's risk-based approach means that biotechnology products, whether used as therapeutics or released into the environment for agricultural or environmental-cleanup purposes, will be regulated like nonbiotech products, solely on the basis of their potential environmental hazard. On the heels of the Bush administration policy pronouncements on streamlining biotechnology regulation, Food and Drug Administration commissioner David Kessler announced personnel additions that would increase his agency's responsiveness. Kessler said at a March 5 meeting of the Massachusetts Biotechnology Council that he has appointed two new directors and will add 50 new employees specifically to deal with biotechnology-related permits. Kathryn Zoon, a biochemist and an FDA official, was chosen to head the Center for Biologics Evaluation and Research, the division that reviews new biotech products. As a postdoc in the late 1970s, Zoon worked with Nobel laureate Christian Anfinsen on the purification of the first human interferons. Then, at FDA she rose to head the Division on Cytokine Biology. "Dr. Zoon was the driving force in the licensing of the first interferon product and in the licensing of other products derived from biotechnology," Kessler said. "Dr. Zoon possesses another valuable asset. She comes from inside the agency. Not only is she an eminent scientist, she is an experienced FDA regulator with critical knowledge about the agency and the workings of the center." FDA will also begin hiring 50 new research and review staff dedicated solely to biotech products. "These 50 new positions are only a beginning. But they will make us more responsive and will expedite reviews--once the reviewers are on board and fully trained," he said. Kessler said he has also has brought in a new senior adviser for science, Elkan Blout, a biochemist with the Harvard School of Public Health. In appointing Blout, Kessler said, "The agency is for the first time forging--in a systematic way--links with the academic community to assure ourselves that we are communicating with those working at the cutting edge of science." --S.V. In keeping with the streamlining theme, FDA commissioner David Kessler early this month announced the appointment of a new permanent director for the agency's Center for Biologics Evaluation and Research, which reviews biotech therapeutics, and the addition of 50 new biotech reviewers (see story on page 8). "For the young, start-up, single-product company, the time taken up by the FDA review process can mean the difference between success and failure," Kessler said. "To these firms, I say: `We will go the extra mile to meet your needs. Our level of response will match your level of scientific innovation.' " But in the case of agricultural products, FDA is not the problem, says Marc Goldberg, president of the Worcester-based Massachusetts Biotechnology Research Institute and past president of the Massachusetts Biotechnology Council. "Clearly the FDA has done a reasonable job of moving products out the door," he says. "With them the issue is, Can we do it better?" The Environmental Protection Agency (EPA), Goldberg contends, is where the real streamlining needs to happen. Reflecting an apparent distrust of recombinant organisms, the agency has created "an absolute quagmire" for the agricultural biotech sector by excessive and inefficient scrutiny, Goldberg says. "EPA seems to say, `If you make it by a new scientific technique, we have to look at it,' " he says. "At least what the Council on Competitiveness has said [via the OSTP policy] is, `One, the issue is the product, not the way it's made; and two, the onus is on the government' " to show it's not safe. The regulatory problems for agricultural biotechnology have had a long history, and neither the policy paper from the OSTP nor the president's statement will put an immediate end to the difficulties, according to Susanne Huttner, a neurobiologist based at University of California, Los Angeles, who directs the office overseeing biotechnology programs for the entire University of California system. "All this is is a policy statement from the White House. This [OSTP] policy statement won't break the EPA bottleneck, but it's a step forward," Huttner says. With the OSTP statement, the Office of Management and Budget (OMB) now has guidance as it undertakes a required review of new EPA rules under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), she says. (OMB is charged with examining the rules to determine whether any are overly burdensome to industry.) EPA uses its authority under this act to regulate and delay field experiments on plants or microbes that have pesticide qualities. But even as new FIFRA rules are aligned with this risk-based approach, there is another area of EPA authority under the Toxic Substances Control Act. Those new rules are still two years away from completion, Huttner says. In laying out the risk-based approach, OSTP validated the National Research Council's 1989 report "Field Testing Genetically Modified Organisms." NRC reached the conclusion that organisms that have been genetically modified are not, per se, of inherently greater risk than are unmodified organisms. That is, "no conceptual distinction exists between genetic modification of plants and microorganisms by classical methods or by molecular techniques that modify DNA and transfer genes." In its recent statement, OSTP went a step further and said, "The new technologies of molecular modification may increase the potential for safe, planned introductions because they employ techniques that are more precise and efficient than traditional cross-breeding, and therefore yield a better-characterized and more predictable organism." Richard Godown, president of the Industrial Biotechnology Association, says he thinks the OSTP policy statement "sweeps away the uncertainty" over how federal agencies should view biotech products. As a result of the statement, he expects that OMB's review of EPA's biopesticide regulations should be completed promptly. Next on the horizon, the biotechnology subcommittee of the Council on Competitiveness is to finish work on the "road maps" that will clearly describe the pathways for obtaining federal approvals to commercialize biotechnology products including foods, animals, microorganisms, and plants.

Biotech Bottleneck: Can Support From Bush, FDA Speed Things Up?

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