Biotechnology An Industry Comes of Age (1986) / Chapter Skim
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Governmental Regulation of Biotechnology
Governmental Regulation of Biotechnology
Pages 64-83
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From page 64... ...
Out of that letter arose a chain of events that led to two of the most important events in the early history of genetic engineering: a voluntary moratorium on certain types of recombinant DNA experiments deemed particularly hazardous, and the International Conference on Recombinant DNA Molecules, which was held at the Asilomar Conference Center in Pacific Grove, California, February 24-27, 1975. Although primarily a scientific meeting, Asilomar was marked by a debate that had a prominent public policy component.
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From page 65... ...
Issued in June 1976, the Guidelines for Research Involving Recombinant DNA Molecules assigned different types of experiments to different categories of risk. Certain experiments were prohibited outright.
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From page 66... ...
At the same time, research has progressed so quickly that previously prohibited experiments for which concern about safety or ethics still exists, such as the release of genetically engineered organisms into the environment or human gene therapy, are ready to begin. This rapid evolution of biotechnology has left the government with several distinct goals.
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From page 67... ...
They assert that if the government imposes burdensome regulations on biotechnology, new products will take longer to reach the marketplace. Biotechnology firms in countries with less encumbering regulations could then catch up with and surpass their American counterparts, securing patents and market presences that would thereafter be denied
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From page 68... ...
According to William B Ruckelshaus, former head of the Environmental Protection Agency, "If there is one thing that we learned from the recent upheavals at the EPA, it is that when the agency charged by society with protecting the public health and the environment comes apart, to the point that society no longer really trusts that institution, then those dependent on those decisions for the marketing of their products are in more trouble than anyone else." The biotechnology industry is in a position somewhat similar to that of the scientists who gathered at Asilomar.
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From page 69... ...
Even many foreign countries conducting recombinant DNA research have adopted slightly modified versions of the guidelines. The RAC's distinguished members, its sophisticated deliberations, and the widespread influence of its guidelines have made it a respected central clearinghouse for discussion of the scientific and social issues surrounding biotechnology.
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From page 70... ...
(For a discussion of the scientific issues surrounding environmental release, see Chapter 5.) The NIH guidelines require that any experiment involving the environmental release of genetically engineered organisms first be approved by both the RAC and the director of NIH.
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From page 71... ...
District Court Judge John Sirica issued a preliminary injunction prohibiting the field test of the bacteria and prohibiting NIH from approving any further environmental releases of genetically engineered organisms. NIH appealed the order, and on February 24, 1985, the U.S.
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From page 72... ...
will regulate applications of genetic engineering primarily under the Food, Drug and Cosmetic Act and the Public Health Service Act. These statutes give FDA authority over human and animal drugs, human biologics, food and color additives, and medical devices (including in vitro diagnostic tests that employ monoclonal antibodies)
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From page 73... ...
If changes are made to an IND or NDA before or after its approval, amendments must be submitted and approved by the FDA, some of which may require additional clinical testing. The approval process is somewhat different for human biologics, which the law defines as any "virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product or analogous product .
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From page 74... ...
Says Meyer, "Our regulation over the past several years of recombinant-produced human insulin, growth hormone, interferon, lymphokines, vaccines, and numerous products produced by hybridomas has been characterized, at least in my opinion, by what I see as our posture for the future -- problem solving through joint efforts with industry and the use of scientific consensus to guide the direction of investigational efforts." In addition to regulating human drugs and biologics for domestic use, the FDA oversees the export of these substances to foreign countries. In particular, the FDA interprets the Food, Drug and Cosmetic Act as forbidding the export for commercial purposes of new drugs or biologics that have not been approved in the United States.
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From page 75... ...
However, for us to implement this philosophy would require a change in the law." The Environmental Protection Agency The Environmental Protection Agency (EPA) will regulate applications of genetic engineering primarily under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
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From page 76... ...
Genetically engineered microorganisms used in the environment for other purposes, such as treating oil spills or toxic waste dumps, would not fall under FIFRA. To ensure adequate overview of these applications, the EPA plans to apply the Toxic Substances Control Act.
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From page 77... ...
But because of the possibility that genetically engineered microorganisms might transgress the bounds of a field test and multiply, the EPA is considering defining any quantity of such organisms used in field tests as not small. Certain kinds of research involving genetically engineered microorganisms would therefore always require a PMN.
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From page 78... ...
It has stated that it plans to treat products produced through biotechnology in the same way that it treats products produced through conventional means. It does not expect to encounter any problems unique to applications of biotechnology, although it does plan to continually reevaluate its position as the state of the art evolves.
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From page 79... ...
Other federal agencies with various degrees of sway over genetic engineering and biotechnology include the National Science Foundation, the Patent Office, the Department of Energy, the Department of the Interior, the National Bureau of Standards, and the Department of State. An important piece of federal legislation that has already left its mark on the development of biotechnology is the National Environmental Protection Act (NEPA)
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From page 80... ...
It could also conduct analyses of broad scientific or social issues with an eye toward developing generic guidelines applicable across the entire field. The committee would be subject to periodic review to determine if it should continue to exist.
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From page 81... ...
"Most of the serious generic issues have been or are in the process of being addressed by the RAC," says Johnson. "After deliberate release of microorganisms and the concept of gene therapy, I am not sure what the next major issue is going to be." The Role of Congress and the Public in Biotechnology The Cabinet Council Working Group on Biotechnology concluded that no new legislation was needed to give federal agencies adequate regulatory authority over the anticipated products of biotechnology.
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From page 82... ...
Nicholas, former staff director of the Subcommittee on Investigations and Oversight under the House Committee on Science and Technology. Legislation may be forthcoming in such areas as the export of unapproved drugs and biologics, human gene therapy, patent laws, and environmental risk assessment.
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From page 83... ...
Taken together, such efforts could begin to close the gap that has traditionally existed in the United States between scientific developments and public understanding. Concludes Ruckelshaus, "We need to do a much better job, not just in this area but across the board, as we try to grapple with the complexity involved in public participation in decisions of enormous scientific uncertainty." Additional Readings Thomas O
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