FDAnews Drug Daily Bulletin


Oct. 24, 2006

The pharmaceutical industry's long -- and, so far, fruitless -- wait for revisions to 21 CFR Part 11 is about to get even longer.

The FDA probably will not meet its self-imposed end-of-year deadline for issuing the revisions, sources close to the agency say. The regulation was actually completed and presented to the FDA's legal team for review, according to Rita Geiger, InfoStrength president, fresh from discussions with FDA officials. However, the revised regulation did not meet the requirements of the legal department and is now back in the hands of the Part 11 team to review, evaluate and revise as needed, she said.

"We all hope that we will see the revised regulation in early 2007, but it is very questionable," she added.

Lisa Olson, an analyst at SEC Associates, agreed with other consultants that the delay has more to do with internal FDA logistical issues and should not be interpreted to mean the rule is going to be broader or more complex. "They are taking their time because they really want to make sure it is right and defensible," she said. At the same time, the agency is getting "beaten on by everyone" on unrelated issues such as drug safety and advertising, she noted.

The FDA, however, said it is soldiering on. "Part 11 is coming. We are working vigorously on reissuing the regulations for a scientific and risk-based approach," Joe Famulare, acting deputy director of CDER's Office of Compliance, told attendees at the 2006 Generic Pharmaceutical Association Fall Technical Conference Oct. 19.

The FDA first issued the Part 11 rule in 1997, but it was almost immediately criticized for its breadth and vagueness. Designed to stimulate regulated companies to embrace electronic record technology, the original iteration of the rule actually stunted its growth, critics charged. The FDA tacitly agreed when it issued what some experts labeled a "kinder, gentler" Part 11 in August 2003 that narrowed and clarified its scope. Industry generally applauded the 2003 revision.