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Oct 1, 2011 (Vol. 31, No. 17)

Assessing the Impact of Biotech Regulation

Significant Rulings Made Early On Laid the Foundation for Current Growth

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    Frank E. Young, M.D., Ph.D.

    Several seminal regulatory decisions made 20–30 years ago enabled biotechnology to flourish in the U.S. and in certain parts of Europe and Asia. Having served as U.S. FDA Commissioner during much of the 1980s, I thought it would be useful to review these developments in light of their effects on the evolution of biotechnology.

    The major scientific advances resulting in the advent of recombinant DNA technology (rDNA) in the U.S. were based on extensive fundamental research supported in large measure by the NIH. Scientists called for a research moratorium after DNA from one organism was introduced and replicated in another species in 1973—plasmids containing frog RNA were spliced into E. coli—and when studies demonstrated that a mammalian tumor virus could be replicated in E. coli. The moratorium was followed by a meeting at Asilomar in 1975.

    This new technology evoked concern in the scientific, academic, political, religious, and legal communities. The NIH-chartered recombinant DNA Advisory Committee (RAC) extensively debated the path forward and finally issued guidelines for rDNA research.

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    One of the most important FDA statements that greatly stimulated the growth of biotechnology during its formative years was that no NEW regulations would be required for the regulation of recombinant products.

    However, harnessing this technology to produce medicinal and agricultural products vexed regulatory agencies. I’m sure it is difficult for those who did not live through this contentious period to appreciate the depth of the controversy regarding appropriate boundaries, if any, for industrial-scale production of safe and effective products using rDNA.

    A number of key events that shaped much of today’s regulatory landscape occurred in the 1980s and 1990s.

  • New Legislation

    First, did rDNA technology need new legislation or would the usual regulatory framework apply to rDNA-generated biologics and diagnostics? This was a question that would determine the future of biotechnology.

    USDA and EPA favored a more stringent regulatory approach, while FDA opined that existing regulations were sufficient to evaluate rDNA products. This was a battleground because a number of congressional and state legislative bills were introduced in the 1970s to regulate rDNA research.

    While at the University of Rochester I was heavily involved in rDNA research. My laboratory discovered the third site-specific endonuclease, Bam H1. I was also a participant in the Asilomar meeting, the author of appendix A of the Asilomar guidelines, and served as a charter member of the Recombinant Advisory Committee before joining the government as FDA Commissioner.

    This expertise strengthened the resolve of FDA that neither new legislation nor regulations were required. Furthermore, I was charged by Secretary of Health and Human Services Margaret Heckler to revitalize the drug and biologics evaluation process with particular emphasis on biotechnology (as well as on medical devices, including diagnostics developed through rDNA).

    These actions were implemented through an FDA-developed action plan that had input from consumer groups, academe, and industry. The action plan helped galvanize the FDA’s decision-making in formulating the regulatory framework for rDNA and monoclonal antibodies.

    Another important development was the decision to divide the Center for Drugs and Biologics into two organizations: Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). Biotech products were assigned to CBER because this new field needed to have a cadre of well-trained scientists to evaluate the safety and effectiveness of rDNA and monoclonal antibody products.

    Furthermore, it was posited that these reviewers needed time for their own research in molecular genetics and immunology to hone their qualifications for evaluating new scientific advances.

    Regretfully, the emphasis on science and biotechnology diminished in the 1990s, but lip service remains. The “research reviewer” is now an endangered species. Physicians and scientists with expertise in biotechnology instead were recruited to the Office of the Commissioner to support domestic and international policy considerations.

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