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Quality and Safety “Just Don’t Get No Respect”

In every successful company, the glittery careers and the recognizable names belong to people who develop new products that meet consumer and patient needs. Innovation in new products (and careful husbanding of intellectual property and market share) is what brings in the revenue and determines corporate success.

By comparison, there is little recognition and often sparse resources for the people devoted to making sure those products (new and old) are safe and of high-quality. The best product ever developed is worthless, and possibly harmful, if standards are not maintained and manufacture and supply carefully monitored. The stakes are so much higher for FDA-regulated products.

FDA Matters has previously analyzed how “safe” has many meanings. My focus in this column is the safety of processing, manufacturing and distribution of FDA-regulated products. Is the milk we drink safe from adulteration (either intentional or unintentional)? Are medical devices manufactured with sufficient precision?

Does every batch of a biological product deliver consistently safe results? Are sterile conditions maintained when drugs are manufactured? The list of questions is endless because there are a limitless number of ways in which products can be unsafe.   

When FDA Matters has covered quality and safety issues in the past, we have almost always mentioned our suspicion that CEO’s and others in the corporate suites are not concerned enough.  It is reflected in the recalls, the extended plant closings, the drug shortages caused by suppliers unable to produce quality products, and the number of inspection reports (483’s) that contain substantive and non-trivial problems.

We assume that CEO’s want to produce safe and high-quality products. After all, it is bad for business to do otherwise. Yet, we suspect too many corporate executives are overly focused on new product development, marketing and sales and worry too little about the quality and safety of what they already produce.

Close accountability and adequate resources are the necessary ingredients of quality and safety. Too often, the opposite appears to be the case in corporations: inattention, underfunding, delegation to distant subordinates and overreliance on vendor guarantees.

FDA won’t back down from its vigilance. Commissioner Hamburg’s reorganization of the agency was, in part, to consolidate authority over quality and safety and put it in the hands of an immediate subordinate. Dr. Hamburg did what I hope every corporation would do—insist on closer accountability to the CEO with regard to production of safe, high-quality products. This becomes more urgent as the scope of this responsibility becomes global, more complex and harder to manage.

The foundation of the Food, Drug and Cosmetic Act was enacted so long ago and generally has been so successful, it is easy to forget that FDA was created and built for the specific purpose of protecting consumers and the public health from dangerous products. It is the FDA that cleaned up the market in tonics and patent medicines, ensured there were serious consequences for companies that adulterated food and drug products, and created a basic public trust in the foods, medicines, devices and cosmetics that we use daily.

Quality and safety of FDA-regulated products is also on the mind of Congress. A little more than a year ago, it passed the Food Safety Modernization Act, a thorough overhaul of our nation’s approach to assuring Americans have a safe food supply in a global environment.

This year, as part of the reauthorization of user fee legislation, Congress is probably going to adopt additional provisions addressing the safety of drug imports, the need to eliminate drug shortages, and the necessity of supply chain integrity. Also in that legislation will be the Generic Drug User Fee Act, which funds a significant expansion of FDA’s efforts to inspect generic drug facilities.

Industry, Congress and FDA need to continue their focus on innovation and new products. This is the path that will bring better lives to Americans and allow our nation to better compete in the global economy.

While doing so, they must also pay sufficient attention and provide adequate resources to the fundamental, but less glamorous, job of assuring the processing, manufacturing and distribution of safe, high-quality FDA-regulated products. We must insist on this standard in the American marketplace.

Steven

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