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Jan 22, 2001
 |  BioCentury  |  Politics, Policy & Law

Reporter's Notebook: Parting shots

WASHINGTON - The last week of the Clinton administration started with a flurry of new biotech regulations; it ended with the Bush team giving FDA Commissioner Jane Henney the bum's rush out of office.

Responding to the clamor

The FDA proposed rules on two politically charged topics: gene therapy and genetically modified foods.

Responding to the firestorm created by the death of Jessie Gelsinger in a gene therapy trial, FDA decided to break from decades of tradition and for the first time mandate public disclosure of data in INDs (see "Regulation," A5). The IND proposal only will be finalized if the Bush administration chooses to do so, and any final rule is likely to be challenged in court.

In the latest example of regulation by referendum, the FDA said it received 50,000 comments on GM food labeling, which the agency said demonstrated the need for guidance on voluntary labeling of biotech foods. It didn't mention that the vast majority of the comments were form letters or pre-printed postcards created by the organic food industry, nor did it indicate what the bulk mail threshold would be for imposing mandatory labeling. In the latter case, the standard may have been set by the 250,000 comments the USDA cited in deciding to exclude biotech foods from its organic designation.

On the other hand, FDA's decision last week to require pre-market notification for biotech foods, and not to impose stringent pre-market approval requirements, was cheered by the biotech and mainstream food companies and booed by anti-biotech activists...

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