FDA Not Powerful Enough: Needs to Regulate Economy and Environment Too


Science is publishing today what at first appears to be a fairly innocuous Policy Forum article on assessing the health and safety impacts of genetically modified salmon. AquaAdvantage salmon have been submitted under new animal drug application process for pre-market approval by the Food and Drug Administration. The agency is currently mulling over the largely specious health and environmental concerns posed by these salmon genetically enhanced to grow much faster while eating less feed. The FDA is basically asking whether or not eating the enhanced salmon poses any greater health and safety concerns than eating unenhanced salmon. 

The Policy Forum authors think this focus on health and safety is too narrow. Instead they want the FDA is consider a much wider range of issues, e.g, the effects of salmon farms on the environment and the impact of cheaper salmon on public health. As the authors put it in a press release about their article:

"Instead of focusing on the safety of a food taken one portion at a time or whether it was produced through genetic modifications or through classic breeding, a more useful approach would be to evaluate whether society is better off overall with the new product on the market than without it, (emphasis added)" says Jonathan B. Wiener, William R. and Thomas L. Perkins Professor of Law at Duke Law School. …

"The approval of genetically modified salmon will set an important precedent for other transgenic animals intended for human consumption," Smith says. "It's essential that FDA establishes an approval process that assesses the full portfolio of impacts to ensure that such decisions serve society's best interests.(emphasis added)"

In general, the way "society" has so far determined what new products or services are in its "best interests" has been for entrepreneurs to bring them to market and see if anyone has any interest in buying them. If they can make a profit that means enough people in "society" think their benefits outweigh their costs. If they can't make a profit, then not. The FDA's approval process for new drugs is already way too cautious. Empowering the agency to make pre-market technology assessments based on politically-contested economic, public health and environmental rationales would be a grave blow to future innovation.

This proposal has more than just a whiff of the precautionary principle, the evilest meme of the 21st century, about it.

For more background see my colleague Katherine Mangu-Ward's, "Let Them Eat Frankenfish."