Regulatory creep creating ‘anti-competitive obstacles’ for US biotech

The GLP aggregated and excerpted this blog/article to reflect the diversity of news, opinion and analysis.

The advent of molecular genetic engineering techniques promised breakthroughs in a wide range of consumer products. The research and business sectors have failed to deliver on many of these promises, however, in large part because of creeping government regulation, which Congress is poised to make worse.

First, the FDA chose to subject genetically engineered animals to the same burdensome pre-market research and approval procedures as new veterinary drugs such as antibiotics and anti-flea medicines.

Under its authority to regulate veterinary drugs, FDA dithered for more than 20 years reviewing the AquAdvantage salmon. As a result of the feds’ treatment of this once-promising product, U.S. R&D on genetically engineered food animals is dead and gone.

Plants have fared little better. FDA has performed excruciatingly lengthy reviews instead of what should be routine, rapid evaluations of new varieties of genetically engineered plant varieties.

Delaying the availability of a faster-growing salmon is not the end of the world, but FDA is also delaying badly-needed genetically engineered insect-control products to prevent disease. A company called Oxitec has designed a product to reduce the population of mosquitoes carrying dengue fever and chikungunya.

Mosquito control is a major public health concern worldwide, with mosquito-borne diseases killing millions every year. Given that there are no vaccines or treatments for some of these illnesses, improved mechanisms for controlling mosquitos are desperately needed.

Twenty years of regulatory creep has led to the anti-competitive obstacles facing U.S. biotechnology. The first steps in the Obama administration’s “revisiting” regulation should be to oppose H.R. 1599 and to adhere to the principles in the Coordinated Framework.

Read full, original post: Biotech Regulation: Will Government Become The Solution Instead Of The Problem?

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