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Executive Report:   


Published: 01/15/2003

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Changes to FDA Regulatory Agenda

The Food and Drug Administration's (FDA) Unified Agenda has slimmed down under President Bush. FDA has withdrawn 51 rules from its agenda over the past two years, none of which is economically significant, and has added 23. Of those added, five have already been withdrawn again.

While the Bush FDA has added five economically significant rules to its agenda, three were mandated by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, one deals with patent information, and the other makes it easier for pharmaceutical companies to classify products as over-the-counter drugs, which the agency has already completed.

Four of the economically significant rules still on the agenda are left over from the Clinton administration. The administration appears to be moving forward with one of these -- a rule requiring the labeling of the amount of trans fatty acids in food, which was proposed in 1999 and the subject of a prompt letter from John Graham, administrator of OMB’s Office of Information and Regulatory Affairs, urging FDA to complete the rulemaking. The rule was reopened for public comment in November of 2002, and FDA expects to issue a proposed rule in early 2003.

In another case, FDA is sitting on an economically significant rule to control salmonella enteritidis in shell eggs during production and retail. This rule -- proposed during the Clinton administration -- was withdrawn from OMB review by FDA in February of 2001, right after the Bush administration took office, and has been stalled at the agency ever since.