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Engineered-food-and-the-fda
By Biotechcrossing
To get bioengineered medicines, grains, vegetables, and animals on the market for human consumption, U.S. biotech companies must pass their products through the Food and Drug Administration (FDA).
Recently, the FDA has been in the news because its Prescription Drug User Fee Act of 1992, which forces drug companies to pay in to expedite drug approval, came up for renewal. That same year, the FDA rejected mandatory labeling of genetically modified organism (GMO) products. How might the FDA affect the future of bioengineered food?
The User Fee Act has, in Harvard professor Jerry Avorn's opinion, "pretty much transformed the FDA. The sense now is we report to the industry; they pay our salaries; we had better be quick on these approvals."
Some biotech products will zoom through the FDA because they are advances in medical treatment, and, of course, we all want the sick to get the best new therapies. The problem is that the FDA is underfunded, so most resources are dedicated to medical advances. Thus, according to David Kessler of the FDA, "other parts of the agency—post-market surveillance, food safety, the field resources—those areas of the agency suffer."
In addition, the FDA is essentially rubber-stamping the tests performed by each company that has developed a product, and since they're bogged down in analysis of drug tests, they hardly ever follow up on the market to see if bioengineered products are having a negative impact on consumers. One publicized mishap in 2000 resulted in traces of StarLink Bt10 corn, meant only for industrial purposes, cross-pollinating with conventional corn and winding up in taco shells. We know the FDA isn't catching problems like this one--and that, as yet, consuming products deemed marginally unsafe won't cause an epidemic—but eventually the biotech industry may get consumer backlash for causing a serious problem that could have been avoided if the budget were expanded.
I should probably note that the U.S. Department of Agriculture (USDA) oversaw the restrictions on this brand of corn, and the Department
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