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FDA Rule Would Strike “Alphabet Soup” Label Units For Maternal Risks

This article was originally published in The Pink Sheet Daily

Executive Summary

Proposed rule creates prominent role for registries and a new labeling format that would group risk information into three sections.

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Final regulation eliminates use of letter-based categories to designate level of risk during pregnancy and lactation; in a change from the 2008 proposed rule, information relevant to drug effects on reproductive potential will now be housed in dedicated section.

Pending regs promote pre-emption

FDA has inserted pre-emption language into seven proposed rules that have yet to be finalized. FDA first mandated that its labeling pre-empts state requirements in the 2006 physician labeling rule. Similar language is included in a proposed rule on pregnancy and lactation labeling (1"The Pink Sheet" DAILY, May 28, 2008). It is also in proposed rules on skin bleaching drug products, labeling of OTC drugs, OTC analgesics, labeling on calcium claims, labels for sunscreens and a proposed rule on fatty acids. Three of these rules were proposed in 2006 and three in 2007. They must go into effect 60 days before President Bush leaves office

Pending regs promote pre-emption

FDA has inserted pre-emption language into seven proposed rules that have yet to be finalized. FDA first mandated that its labeling pre-empts state requirements in the 2006 physician labeling rule. Similar language is included in a proposed rule on pregnancy and lactation labeling (1"The Pink Sheet" DAILY, May 28, 2008). It is also in proposed rules on skin bleaching drug products, labeling of OTC drugs, OTC analgesics, labeling on calcium claims, labels for sunscreens and a proposed rule on fatty acids. Three of these rules were proposed in 2006 and three in 2007. They must go into effect 60 days before President Bush leaves office

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