Too often in recent years, medicines for life-threatening conditions have been in short supply. It is unnecessary and avoidable for patients, their families, and health care professionals to experience and worry about medicine availability on top of the anxiety caused by their medical conditions.
A reliable supply of high-quality medications is something all drug makers strive for and regulatory authorities build stringent requirements to help ensure. Even so, the supply of medicines has been affected by manufacturing-related problems including delays, product quality issues, recalls, and raw material shortages. Recently, the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) explored the issues driving drug shortages and also identified “the inability of the market to observe and reward quality” as a key problem. Though drug shortages may be caused by unanticipated events and natural disasters, the great majority of issues can be attributed to inadequate quality management, including a lack of sustained investment. At a time when we have access to improved and more efficient technology, we owe it to patients, and to the health-care system, to invest in the best manufacturing practices to help eliminate the potential for unexpected supply shortfalls of critical drugs.
In my seven years at Amgen and over my entire 30 year career in the pharmaceutical industry, it has been my passion and duty to advance quality assurance and improvement initiatives with the goal of helping to ensure a reliable supply of high-quality medicines. I have watched and learned from manufacturing challenges that have arisen in our industry and I’m proud to say that despite facing a few challenges of our own, for nearly 30 years, Amgen has been able to avoid shortages of our biologic therapies, as defined by the FDA.
Recently, the FDA Drug Shortages Task Force asked for input from stakeholders on how we can ensure that patients receive the medicines they need. Here are some of my thoughts on what industry can do.
1. Learn from other industries with effective quality management systems
Consequences of poor quality can be significant. To enable survival in challenging financial times, reduce defects in their products, and to gain a competitive advantage, leading companies in the semi-conductor, consumer electronics, and automotive industries have effectively implemented simple, robust and sustainable quality systems. The rationale for quality systems in these cases are applicable to our industry, too, but beyond them, quality is crucially needed to ensure regulatory compliance and provide the patients we serve with high quality medicines. This is best achieved by creating a culture of quality that promotes its benefits, works cross-functionally, drives operational excellence, and implements new techniques and technologies. We need to continue get it right the first time, building quality processes from the start.
2. Invest in risk mitigation strategies
At Amgen, we have invested considerably in quality processes and pioneering technologies to help ensure the continuous supply of our quality biologic therapies. Between 2005 and 2016, we project this investment will reach approximately $1.5 billion. Our strategy is clear and we have identified four key elements to help meet this commitment: prevention, which includes ensuring regulatory compliance, robust quality management processes, operational excellence, supply chain security, infrastructure investments, and business continuity planning; technology, to enhance product quality and purity and the robustness of the manufacturing process; inventory management, to ensure we have the right quantities of the product housed in diverse locations; and diversification of manufacturing capacity and implementation of second-sourcing within Amgen’s network.
3. Contribute and collaborate with authorities
Working with regulatory bodies is central to approaching the drug shortages challenge successfully. The formation of the FDA’s Drug Shortages Task Force, to meet the requirements of the Safety and Innovation Act (FDASIA), is a great example of how pooling new ideas can encourage high quality, and facilitate the expansion of manufacturing capacity. Amgen has contributed to the Task Force by sharing its own best practices, including the way we measure and monitor production time and the importance of applying the same high standards of quality management systems to contract manufacturing partners.
We also believe that information about all companies’ manufacturing quality should be made available and shared with purchasers, prescribers and consumers, to make informed choices that will help ensure a continuous and reliable supply of quality medicines to patients. The FDA can also help by assisting with faster and more streamlined product and technology approvals, facilitating greater transparency of compliance status of manufacturing sites with the public, reducing certain regulatory oversights and extending the interval between routine GMP inspections.
4. Collaborate with industry to share key insights
The benefit of inter-industry collaboration can be observed from the successes of groups such as the not-for-profit Rx-360 consortium (of which I am an officer), which actively shares information on thedevelopment of processes related to the integrity of the healthcare supply chain and the quality of materials within it.
The value of collaboration is perhaps most evident when issues arise – such as when Amgen identified lamellae (thin particles of delaminated glass) in non-distributed batches of one of our products. Through a robust investigation into these lamellae we were able to narrow down the causes, develop better techniques for characterizing (glass) quality, and enhance our evaluation of glass manufacturers. We shared these learnings with regulators and other companies to improve the quality of glass used to store products across the industry.
It is imperative for drug makers to solve the drug shortage problem – patients are counting on us. To make a tangible difference, all companies must make the necessary investments in quality manufacturing and work together to better serve patients right from the start.