Having worked in the pharmaceutical/biotech industry for more than 22 years, I’ve come across a recurring viewpoint that the highly regulated nature of our industry precludes good science and sometimes even common sense. Phrases such as “compliance, not science” are often spoken, and discussions of the “cumbersome” federal regulations regarding pharmaceutical production are common.

While some may feel that American business is overregulated in general, I like to teach employees that pharmaceutical and medical device regulations are only as difficult as you make them. Having a background in science, quality and manufacturing, in addition to a business degree, has led me to firmly believe that solid technical scientific development and efficient compliant quality systems are not anathema to good business, but are actually synergistic.

Safe and effective medicines begin with solid biochemical process design.  Medical device regulations call the regulations around the development process “design controls,” while the Federal Drug Administration guidelines simply refer to them as “quality by design.” Either way, good technical development and efficient yet compliant quality systems are the embodiment of the teachings of quality guru Joseph Juran. His “cost of poor quality” model calculated the impact to businesses of backend costs (recalls, regulatory actions and lawsuits) relative to proactive costs such as good process design and designing appropriate and accurate test methods. While short-sighted companies think they are gaining a competitive advantage by cutting the design process for a quick buck, the costs will catch up quickly and could be enormous. In an industry such as pharmaceuticals, where drugs with strong biochemical effects are injected or ingested, costs due to design variation or production mistakes can be disastrous and potentially company ending.

For example, one consulting firm reported that, “according to a study released by the American Society for Quality (August 2003), each product recall costs an organization, on average, more than $8 million.” With inflation and the increasing litigious nature of Americans, this is certainly a much higher amount today. This conservative estimate includes “reimbursement expenses to consumers, recall execution costs, and compensatory damages from litigation. It does not include lost sales due to reduced marketplace credibility and lost market share.” These additional costs are difficult to accurately calculate, but can be the biggest impact of all. For example, “Applied Public Relations: Cases in Stockholder Management” tells of the strain on both the financial results and brand name recognition of a major pharmaceutical company after numerous quality problems and recalls in recent years.

In short, quality system regulations are extensive but not overly detailed. They mandate that you need systems to design and manufacture your medicine safely. The FDA inspects companies to ensure that the regulations are met; however, how complicated and inefficient those processes are is up to the company. Well-run companies make optimal use of quality tools, such as the use of Six Sigma to statistically track and measure process variation (and reduce it).

Other commonly used tools include lean or lean manufacturing, to analyze production and logistical processes to remove unnecessary steps or waste. Japanese companies have almost made a religion of this approach to removing non-value added steps; they are so focused on removal of process waste that they even have a name for it (Muda). New software tools for analyzing optimal process production parameters (i.e., design space) and performing design of experiments—an information gathering exercise that results in huge amounts of process data from limited numbers of well-designed studies—are becoming standard in pharmaceutical development.

This alignment of good business, good science and good compliance really became clear for me a few years ago when I passed the American Society for Quality’s Certified Quality Manager (CQM) test. I had completed business school the year before, and was pleasantly surprised that at least 60 percent of the information in the CQM study guides had been presented to me in business school. In short, it is in the vested interest of pharmaceutical companies in a free market to place well-spent dollars on the front end to protect the safety of their patients and customers. This is a perfect example of how regulations, market-driven business interests and good science can not only coexist, but actually complement each other. The result is an industry where American products are the most plentiful, most desired and safest in the world.

		Dr. Kevin Rote is currently vice president of quality affairs for Emergent BioSolutions, the only licensed manufacturer of anthrax vaccine. Rote has worked for both Abbott Laboratories and Amgen in R&D, product development, manufacturing and in all aspects of quality organizations.