April 15, 2003 | THE TIMING OF THIS REPORT couldn't be better. For nearly six years, complying with 21 CFR Part 11 — the federal rules governing the use of electronic records and signatures for FDA submissions, as well as in manufacturing and production — has been problematic, to put it mildly, for any drug or biotech organization. Confusion has reigned inside the FDA and in the marketplace as to what's included in Part 11 and how the regulations will be enforced. Meanwhile, the cost of buying new compliant software and/or retrofitting systems is projected to run into millions of dollars per company by 2006.
The result: the exact opposite of what the FDA wanted. Rather than encouraging companies to adopt new technology, for example, to submit New Drug Applications electronically, Part 11 has hobbled the introduction and full use of such technology. This is what economists call "the law of unintended consequences," and fortunately the FDA has recognized it. Our lead story, by Barbara DePompa Reimers, includes an interview with Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. Woodcock candidly explains the need for, and the steps toward, regulatory reform.
Two attorneys from Hale & Dorr's FDA Group, Mark Heller and Stephanie Philbin, provide expert deconstruction of this reform effort and offer advice on avoiding citations amid the agency's shifting enforcement priorities. Deborah Ausman profiles the Baylor College of Medicine's successful Part 11 compliance with software it developed for managing paperless clinical trials. And for an industry perspective, Paul Bleicher, founder of Phase Forward, dissects the challenges of collecting clinical data electronically with no original paper records — the regulatory equivalent of working without a net.
The regulatory climate is changing, apparently for the better, and we hope this report will help you better assess your compliance strategy.
Tony Strattner
Special Projects Editor
ILLUSTRATION BY ALEX NABAUM