Apr 12th, 2010
Before launching IPQ, Bill served for over two decades as the primary author of “The Gold Sheet.” During his career tracking the drug and biotech quality regulatory process, Bill’s identification of key issues and problem areas and emerging solutions has been influential in the targeting of resources by industry and FDA and has impacted the dialogue on the shaping of new CMC and GMP policies.
Pointing to some of the highlights of the evolving regulatory process over the last quarter century, Bill comments that he “took over the helm of ‘The Gold Sheet’ at a pivotal time in pharmaceutical regulation — right after the Waxman/Hatch legislation was passed back in 1984, which was really the genesis of the current generics industry in this country. The act forced FDA to come to grips with and try to standardize its CMC submission policies for both generic and new drug applications. At that time, the emergence of the biotech industry was also forcing FDA to wrestle with putting in place some meaningful guideposts on CMC in that technologically complex arena.”
The CMC application and review challenges for generic drugs played out in the inspection and enforcement arena as well. Bill’s coverage of the “generics scandal” and its implications, including the emergence of the current preapproval inspection program, was widely followed and referenced by Congress in its review of the generics industry developments. His analysis of the U.S. v. Barr court case is still cited as a key reference in interpreting the significance of this pivotal development in FDA compliance policy.
As another important enforcement chapter, Bill cites FDA’s efforts in the 1990’s to pump up its foreign inspection program and better enforce GMP standards worldwide to keep pace with the increasing internationalization of the supply and manufacturing chain. His analysis in 1998 of drug counterfeiting was cited in letters from the House Commerce Committee to the FDA Commissioner as prompting a Congressional inquiry into the issue. Subsequent hearings were held and new regulations pursued on drug imports as a result of this inquiry.
More recently, Bill’s reports have provided influential insight into the principles and practical implications of the effort by FDA and the International Conference on Harmonization (ICH) to evolve and harmonize the quality regulatory paradigm.
The 21st century initiative spearheaded by FDA represents an effort to “rethink the whole way drug and biotech quality is regulated – so that the process encourages rather than discourages technological improvements and is flexible enough to address the new technologies and products,” Bill comments. At issue, “is how to leverage the evolving concepts around quality by design to build a more efficient and effective regulatory approach domestically and internationally.” International Pharmaceutical Quality, he stresses, “will provide in-depth analysis of the problems involved and highlight the emerging solutions.”