Recently, the Food and Drug Administration announced a multiyear effort to modernize its regulatory oversight role by, among other things, better supporting remote government inspections. This promising shift in policy comes on the heels of a government report detailing a dramatic decline in drug inspections during the pandemic, as well as subsequent warnings from industry experts of potential drug shortages and interruptions in the global pharmaceutical supply chain.
The need for modernizing regulatory oversight is not specific to the pharmaceutical industry, nor is it vital only during a pandemic. Remote and automated inspection technologies provide unique opportunities for government agencies across the board to improve their processes and provide better services. These technologies promise better health and safety for the public, fewer on-the-job hazards for inspectors, lower costs, and more resilience in the face of crisis.
Remote and automated inspection technologies encompass a wide range of tools and approaches. The simplest form, embraced by many agencies over the last year, involves a business sharing images or video chatting with inspectors to show them equipment, processes or documents. On the more complex end of the technological spectrum, robots scale dangerous equipment using sensors to take readings, then send this data off to another computer that processes the information and flags anomalies that may indicate defects.
Many remote and automated technologies can improve the effectiveness of inspections by identifying problems that inspectors might miss. Sometimes this is because humans are inconsistent, but often it is because the software is designed to detect problems that we cannot. Such inspection technologies can perform certain routine checks at a fraction of the cost. When the human touch is still necessary, complementing human inspectors with new technology can free up inspectors to focus on the most pressing problems.
Many industries have experimented with remote and automated inspections for years, but regulatory adoption has been slow, especially considering the large potential safety, health and monetary benefits. Over the last year, however, pandemic-related restrictions have accelerated the transition for many regulators, and the results are promising.
Increased remote inspections of offshore oil and gas sites over the last year led to improvements in efficiency and safety. Offshore magazine noted reduced travel and accommodation costs, shorter response times, potentially quicker inspections, greater scheduling flexibility, instant access to deep technical expertise and less operational downtime.
These improvements are from a sector where regulatory authorities were already adopting new technologies at a faster rate than most. Remote-controlled and autonomous vehicles were already collecting video, images, geo-positioning and sensor data for offshore sites, reducing the need for personnel to access high-risk locations.
Even more advancements in offshore site inspections are on the horizon. DNV, the world’s largest inspector of offshore structures, just launched a collaborative research project to automate data processing for wind turbine blade defects, effectively automating the entire inspection process. This will allow DNV to collect and analyze more information while further reducing costs and, to the extent that these efforts promote more automated data collection, putting fewer lives at risk.
Some railroads have begun attaching solar-powered inspection cars to freight trains. The cars are equipped with sensors that use artificial intelligence to scan and analyze tracks while en route. This increases the precision and frequency of inspections by identifying problems below ground and inside rails using radar and ultrasonic sensors and predicting poor conditions before they appear.
On a single test corridor, this technology helped CN railway reduce track defects by 90 percent. Plus, it cuts costs by performing inspections during revenue-generating trips, and increases both safety and efficiency by getting people off the tracks.
Remote and automated inspection technologies also create resilience in the face of crisis. In the first six months of the pandemic, the FDA conducted 85 percent fewer domestic inspections and 99.5 percent fewer foreign inspections compared to the same period of the previous year, and this was on top of an existing backlog. The potential drug shortage in the global supply chain could have added a second global health crisis on top of the worst pandemic in 100 years. With expanded remote and automated inspection capabilities, regulatory authorities could adjust to unconventional circumstances like stay-at-home orders.
As with any change, innovations in regulatory inspections create new risks and new costs. In those aforementioned circumstances where remote or automated inspections may not identify problems that a human could, they are best used with, and not instead of, human inspectors. In other circumstances, the risk of malfunction may be too high to rely on machines without years of testing (or ever).
Such risks and costs, however, should not breed obstinacy. Regulators should weigh the costs against the benefits. They should research new technologies and experiment when necessary to gauge the prospects. In most cases, the increased health and safety, the reduced costs and the greater systemic resilience will far outweigh the costs. Excessive caution, as has often been the norm, means missing out on everything these technologies have to offer.
As things return to normal, we should avoid the temptation to revert to old inspection practices or to technological complacency. Like the FDA, all regulatory bodies should use this opportunity to explore new and better ways of serving the public. Embracing remote and automated inspection technologies is an easy way to improve the well-being of the public, protect the government inspectors who work to keep the rest of us safe, and make sure we are better prepared for the next crisis.
Patrick McLaughlin is the director of policy analytics with the Mercatus Center at George Mason University. Tyler Richards is a doctoral candidate with the economics department at George Mason University and a former Mercatus Center research coordinator.
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