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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.


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

  1. Mark McCarty says:

    Hi Steven,

    I guess the problem I have with this posting is the nebulousness of your allegation that corporate officials are “overly focused on new product development, marketing and sales and worry too little about the quality and safety of what they already produce.”

    It may well be true, but reliance on insinuations offers little in the way of a compelling reason to take that assertion at face value. I’d like to see the history of food and medical product safety compared to today in order to be able to critique your posting. Here are some problems I see offhand.

    Where food safety is concerned, where are the data? I can see instances in which a supermarket failed to handle the fish properly, but I can also see an instance in which the purchaser failed to and got sick. Statistically speaking these events are subject to clustering just as they are to dispersion. If half a dozen people living within a 15-mile radius of the store get sick on the fish that week, it might be an incidental grouping of people who left the fish out too long before cooking it. That’s not the grocery store’s fault.

    Where implantable devices are concerned, let’s take the example of a drug-eluting stent. It’s often tough to tell after the fact whether a stent was manufactured badly or the cardiologist botched the insertion. If you want to talk about thinner electrophysiology leads, I’ll note that FDA did not anticipate that bench testing would not disclose the problems with the Riata and the Sprint Fidelis any more than St. Jude Medical or Medtronic did.

    I just find it difficult to comprehend how executives marketing in the U.S. – which is probably the most heavily regulated market in the world for many of these products – can be alleged to suffer from a pandemic of inattention to quality when you offer no evidence of deteriorating quality standards. You make no distinctions at all between bad actors and everyone else, and hence it can only be assumed you allege this of all the companies in those fields. The absence of a baseline (historical data) further weakens your argument.

    I think you need to either craft a more nuanced argument – including historical safety data – or face allegations that you’re engaging in a very commonplace broad smear of corporate America. Really, isn’t that kind of a shopworn item to be hauling out yet again with nothing more than vague insinuations to support it?

  2. gordida says:

    The CEOs are focused on the bottom line and thus cutting cost which include those cost associated with manufacturing. They will outsource, contract, and part time workers so that a few bucks can be saved. However, as [company name deleted] and [company name deleted] demonstrate, that kind of bottom line thinking ran their manufacturing operations into the ground leading to warning letters, recalls and loss of reputation.

    Why does it continue to happen? Because there is no penalty for a bad decision i.e. the CEO still gets his bonus, pay, restricted stock options.

    I would propose to the FDA that instead of fining the company who takes the pay from the shareholder, they nail the CEO for the fine and let him/her pay the cost of their bad decisions. I would bet that things would change big time. Hold the CEO/President accountable.

  3. This column produced a lot of feedback. Please keep communicating your thoughts…I love the feedback. The most gratifying were a couple of letters that described personal experiences with trying to intervene and correct quality and safety problems. One in particular described a CEO who had lived through a prior quality control disaster and years later, at a subsequent company, kept telling his employees: if there is a problem, tell me!

    Not all companies have the problems I described…but it is in the nature of both biology and human control systems that everyone is vulnerable. In that spirit, I should have referenced an earlier blog column that was very much relevant, entitled “Quality Control Woes: What’s a CEO To Do?” Its at: http://www.fdamatters.com/?p=962.

    I choose not to approve two notes when they were sent to me for publication because I felt an explanation was needed beforehand.

    The first commentor focused on the difficulty of telling whether a company was at fault because of the actions of patient, physicians and retailers. While those situations certainly occur, my blog column was explicitly about “processing, manufacturing and distribution of FDA-regulated products,” that is to what happens when the product is still under the control of a company, its vendors and its contractors.

    The same author felt that the column was weak because I didn’t document that quality and safety problems are increasing. I actually never asserted that they were….and feel my points are valid whether safety and quality are better or worse than at some time in the past.

    The other commentor asserted that CEO’s only cared about profit…and named specific companies that were paying the price for inattention to quality. FDA Matters’ policy is not to name specific companies, brands and people unless it is unavoidable. I have chosen to delete the company names and publish this second comment.

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