Regulatory Compliance with One Eye on Cost

For various reasons, including a scarcity of resources, FDA cannot closely monitor the drug-production process from start to finish. Consequently, the agency allows manufacturers to regulate themselves in many respects. Even though the industry might prefer this strategy, it can result in problems, as Sandy Weinberg notes in his new book Cost-Contained Regulatory Compliance. "Many companies find themselves imposing regulatory requirements in excess of FDA guidelines and intent; find themselves expanding submissions evidence in excess of requirements; find themselves adding inefficient pot-processing quality controls; find themselves in a product delay situation, scrambling to retrofit regulatory controls after an FDA audit of their poorly planned internal controls; and generally find themselves significantly overspending on regulatory controls."

In his book, Weinberg presents eight strategic considerations to "lead to clear cost-reduction recommendations that can maintain product safety (and FDA acceptance of that quality)." Some strategies are simple, such as knowing operational (as opposed to formal) requirements, and outsourcing at the appropriate level. Others are based on much deeper insights, such as managing FDA visits and understanding the advantages of common submission strategies. The book contains 284 pages of practical advice, real examples, templates, checklists, and other aids that allow the regulatory-affairs professional to create and implement a cost-effective regulatory system.

Cost-Contained Regulatory Compliance by Sandy Weinberg, Wiley, Hoboken, NJ, 2011, 296 pp., ISBN: 978-0470552353

The first of the book's three sections focuses on cost-containment strategies. Each chapter in this section briefly describes the concepts and approaches to a cost-containment strategy, including cost control, definitions, internal or third-party audits, and quality by design. Entire books have been written about each of these topics, but Weinberg presents them in just enough detail to give readers a basic understanding so that he may later demonstrate how the concepts should be applied.

The second section of the book is devoted to operational topics. Each chapter begins with explanatory statements about a topic, such as outsourcing and its effects on regulatory compliance, electronic submissions, international coordination of submissions, and managing FDA inspections. These explanations are followed by extensive appendices that include guidances and checklists that, in many cases, can be directly added to the reader's regulatory toolbox. This section of the book is at greatest risk of becoming outdated, but at the moment it represents a collection of important documents for the regulatory-affairs professional.

The third section of the book shows readers how to apply the principles to real-world cases. The section examines risk assessment, case studies, cost containment, and differences in global regulations. Here, Weinberg illustrates how all of the previously discussed concepts reinforce each other, and explains how these ideas work in practice. In only 20 pages, one chapter lays out many of the important considerations and calculations readers need to complete a risk analysis in their facilities. The chapter titled "Cases" includes 11 examples using the same template that describe a problem, suggest the appropriate solution, and calculate the cost savings achieved through various strategies. These two chapters alone make this book worthwhile.

In the book's final chapter, Weinberg makes predictions about the future. He identifies four major trends that will affect future regulatory practice, including increased agency transparency, new triage of agency resources, increased international harmonization, and updates of regulatory guidelines. His predictions are based on sound data, and it will be interesting to reread this book in 10 years to see how accurate the predictions turned out to be.

Cost-Contained Regulatory Compliance is a wonderful primer for new regulatory-affairs employees, for regulatory-affairs professionals in small startups and biotech companies, and for long-time professionals who want to keep up to speed in this rapidly changing regulatory environment. Weinberg has created a book based on good concepts, sound advice, specific examples for applying the concepts, and enough additional tidbits to meet the needs of many audiences.

Todd Cecil, PhD, is vice-president of compendial science at the US Pharmacopeia, 12601 Twinbrook Pkwy., Rockville, MD 20852-1790, tel. 301.816.8234, tlc@usp.org. He also is a member of Pharmaceutical Technology's Editorial Advisory Board.