William A. Hyman.
There is a broadly held view that compliance with FDA regulations, and thereby U.S. federal law, is not only burdensome but also not even helpful. In other words, some people think that FDA compliance is pure burden, with no benefit. In fact, there has been ongoing litigation by at least one company arguing, in effect, exactly this point of view. Moreover, an even more negative view is becoming pervasive. Some think that FDA regulations have an adverse effect on U.S. healthcare in that valuable technologies are either delayed or never brought to market because of FDA's constraining effect. And for devices that are marketed, costs are substantially increased. In this regard, a manufacturer that sees its premarket approval application for a device denied may not be among the agency's biggest fans. The same could be true for a manufacturer in receipt of a warning letter, a consent decree, or a product seizure.
Similarly, it is not unusual at scientific meetings to hear research presentations that include off-the-cuff statements disparaging FDA. Some executives make comments to the effect that their company would be selling a particular device today were it not for FDA's pesky demands for proof of safety and efficacy. Or in academic seminars, it is not uncommon to hear the opinion that OEMs must have a quality control plan because FDA requires one. This burden-only view is reflected in both the name and perspective of many professional and commercial seminars. Such a view even appears in articles in MD&DI, and they often have titles like “Doing X,Y, and Z for FDA Compliance,” but they do not suggest that X, Y, and Z have any inherent value.
In addition, there are several software products available whose sole advertised purpose is FDA compliance. These perspectives collectively suggest that if there were no FDA regulations (or no FDA at all), we could (and would) stop doing many things that we only do now because FDA makes us. (Of course, this view is compromised by international regulations that impose many of the same requirements, albeit under different administrative structures.)
Of course, counterarguments to these we-only-do-it-because-they-make-us perspectives exist. One such argument is that it actually is a worthwhile goal to design and manufacture safe and effective devices that have valid and proven purposes, and labeling that supports the correct use of the device for those purposes. It may even be valuable to collect postmarket performance data to ensure that these devices are effective in the clinical environment and to make improvements if they are not.
Aside from an ethical perspective, it can be argued that making a high-quality product is good business, in that sales will be enhanced, malfunctions minimized, and adverse events mitigated. (Here, quality includes the full spectrum of design, manufacturing, marketing, and follow-up.) In addition, good product performance will bring more sales for the product itself and could possibly spill over to similarly branded product lines, whether related or unrelated. Therefore, quality sells, which produces profit. Strong sales might also reflect strong stock prices, further enriching both public stockholders and a company's executives. By contrast, demonstrated quality deficits (e.g., it becoming known that manufacturing defects were hidden from consumers) can have serious adverse effects on business operations. Moreover, high-quality products may be able to avoid and defend product liability claims. It is generally accepted that the quest for high-quality products requires a systematic approach. This is the essence of the quality system concept and FDA's quality system regulation (QSR) requirements. A fundamental question, then, is: “Do the QSR requirements result in quality systems that result in high-quality products?” One FDA official presented—half in jest—with this question responded—half in jest—“that's our position and we are sticking to it.”
The quality community also generally shares that view. Another telling anecdote came from an OEM's engineering vice president shortly after the QSR went into effect. To be fair, this vice president and his company are committed to high-quality engineering and high-quality products. As the QSR emerged, his concern was not that the QSR was groundbreaking in its requirements, but rather that specific structure and documentation requirements presented an unnecessary burden, given what the company was already doing.
For example, one requirement for design controls is that firms must have formal and documented design review meetings, rather than casual conversations around the coffeepot or at lunch. To explicitly meet the design review component of the requirements, the company restructured its design processes. Shortly thereafter, the executive said to me, “You know, Bill, we had our first design review meeting, and…it was good!”
All good practices require some level of documentation to reflect what the practice is, to capture the results of the process, and to provide a capacity to review those results. But a capacity to review is not very useful unless reviews actually occur. Paperwork (or the electronic equivalent) generally does increase with the further development of process and the recording and analysis of data. If there is a regulatory burden here, it occurs when the paperwork requirement stops providing value. Nobody wants to do paper or electronic work that has no value or that no one ever looks at. In that regard, without FDA there certainly would be no external medical device reporting. But wouldn't there still be value in reviewing reports of death, serious injuries, and malfunctions?
This question leads us to this editorial. When people start to gripe about FDA's burdensome quality requirements, ask them the following questions: If there were no FDA, would you not be careful about design inputs, design reviews, and design changes? Would you not do design verification? Would you not do clinical trials where they were necessary to prove that your device actually does what it is supposed to do in the real world? Would you not exercise GMPs, including process control and validation? Would you not investigate manufacturing deviations and field complaints? And, ultimately, and perhaps most importantly, if you did not do any of these things, would you want that product used on you?