Part 11 Revision Not Likely Until 2007

The FDA’s long-awaited revision to 21 CFR Part 11 is probably not going to meet the agency’s self-imposed end-of-year deadline, sources close to the FDA tell PIR.

The regulation was actually completed and presented to the FDA’s legal team for review, said Rita Geiger, InfoStrength president, fresh from discussions on it with FDA officials. However, the revised regulation did not meet the legal department’s requirements 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.

Other consultants who work with the FDA have told PIR they would be very surprised to see the revised Part 11 rule issued very early in 2007. “They’ve surprised us before, but everything they are telling us points to mid-2007 or even later,” one consultant said.

“It doesn’t surprise me, but I am disappointed,” said Lisa Olson, analyst at SEC Associates. Like other consultants, she agrees that the delay probably 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. Also, 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 the Center for Drug Evaluation and Research’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 was almost immediately criticized for the rule’s breadth and vagueness. Designed to stimulate regulated companies to embrace erecord 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.

But industry is still looking for clarification on, among other issues, how the FDA assesses risk and what it expects of regulated companies. These companies appear to be divided into two camps. One group is seizing the initiative and developing its own risk assessment programs that can be easily explained to FDA inspectors. Another group is waiting to get clearer direction from the FDA before it develops its programs.

“I’m concerned about the lack of direction and guidance from the FDA,” said Ty Mew, president of Ofni Systems. “If they are not the group that defines these requirements, there may be multiple splinter groups that arise and define their own standards, and companies will need to spend more time and effort to determine what they feel they need to do to meet regulatory requirements.” — Michael Causey