Biotech Regulation: Will Government Become the Solution Instead of the Problem?

— Written By

John J. Cohrssen and Henry I. Miller

The advent of molecular genetic engineering techniques in the 1970’s promised potential breakthroughs in a wide range of consumer products–more efficient means for producing pharmaceuticals, improved food plants, safer “biorational” pesticides, cleaner energy from biomass and improved traits for animals. The research and business sectors have failed to deliver on many of these promises, however, in large part because of creeping, stultifying, discriminatory government regulation, which Congress is poised to make much worse with legislation that would create an additional layer of regulation for certain products.

Spurred by the policies of the Ronald Reagan and George H.W. Bush administrations, research and development accelerated in many of these areas . . . and then the Clinton administration reined in progress with excessive regulation, R&D costs grew and commercial interest in many sectors evaporated.

The FDA is just one example. Early on, the FDA’s stated policy toward products made with molecular genetic engineering techniques–the prototype of which was recombinant DNA technology, sometimes called “genetic modification, or “GM”—was that they would be treated no differently than products with similar characteristics made with conventional technologies. However, consistent with the quip of former FDA Commissioner Frank Young that, “dogs bark, cows moo and regulators regulate,” in 1993 the Clinton FDA began to expand its traditional areas of oversight to capture for regulatory review all “genetically modified” animals, including insects. This was surprising, and also destructive, in a couple of ways.

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