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Michael Kopcha

FDA Compliance

Modernizing Pharmaceutical Manufacturing to Improve Drug Quality

FDA offers guidance for working with its Emerging Technology Team

Published: Friday, February 19, 2016 - 15:50

The U.S. Food and Drug Administration (FDA) is working with drugmakers in a new way to help the industry adopt scientifically sound, novel technologies to produce quality medicines that are consistently safe and effective—with an eye toward avoiding drug shortages.

When manufacturing problems arise in drug manufacturing facilities, drug shortages may follow. In fact, 65 percent of all drug shortages are caused by manufacturing and quality issues. This underscores the need for a safe and reliable drug supply chain.

In recent years, hundreds of drug shortages have been reported to the FDA. The agency has done much to minimize their impact and prevent future shortages. For example, it expedited the review of new applications for generic drugs when potential shortage issues arise with approved drugs.

Unfortunately, a significant number of these shortages have affected patients with serious conditions, including cancer, life-threatening infections, and severe malnutrition. These shortages can delay or prevent care to patients and can leave practitioners with no other option but to prescribe less effective therapies.

Other industries (such as electronics, chemicals, and automotive) have embraced the use of advanced manufacturing technologies and demonstrated improved quality, increased efficiency, and a reduced number of product failures. These lessons learned could be replicated. Working to modernize pharmaceutical manufacturing technology is key to FDA’s new approach to help the industry reduce and prevent drug quality and shortage problems.

By adopting similar technological advances as other industries, the pharmaceutical industry can create a more robust drug manufacturing process with fewer interruptions. This will minimize product failures and provide greater assurance that the product will consistently deliver the expected clinical performance.

The FDA strives to support the modernization of pharmaceutical manufacturing by providing guidance to drug companies that are pursuing new technologies. One example is the recent approval of the first-ever 3D printed pill, which was for Spritam (levetiracetam), a medication to treat epilepsy. In this case, the FDA worked closely with the manufacturer to make 3D printing technology a reality.

By adopting this technology, the drugmaker is able to produce pills that can disintegrate more rapidly in a patient’s mouth, greatly aiding those who have trouble swallowing. This approval is a strong example of the FDA’s efforts to put emerging technology to work for the health of Americans.

The FDA is taking further measures to improve drug quality. To help advancements in pharmaceutical manufacturing, the FDA established the Emerging Technology Team (ETT). This specialized group—which includes representation from the agency’s Office of Pharmaceutical Quality and the Office of Regulatory Affairs—works directly with industry to help identify and resolve scientific issues for new technologies. What makes this approach novel is that this dialogue can occur during early technology development prior to the submission of a drug application to the FDA. Such early engagement enables the FDA to proactively identify and address potential roadblocks and helps eliminate potential delay in the adoption of promising new technologies.

To clarify the mission and scope of the ETT, the FDA recently issued a draft guidance titled, “Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base.” It provides recommendations to pharmaceutical companies on effective ways to work with the ETT. The document explains the ETT and provides specific recommendations to drug manufacturers for obtaining important early feedback from the FDA regarding their efforts to develop novel manufacturing technologies.

FDA has received much positive feedback. Expanding this program will not only help to prevent drug shortages, it also will help reinvigorate the United State’s pharmaceutical manufacturing sector while fulfilling a critical part of the FDA’s mission: ensuring that safe and effective drugs are consistently available to the American public.

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About The Author

Michael Kopcha

Michael Kopcha serves as Director of the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research. Kopcha’s areas of expertise include formulation and process development, process validation, technology transfer, off-shoring/outsourcing, and change management. Prior to FDA, Kopcha was vice president and a global research and development franchise head at Novartis Consumer Health Inc. Kopcha has also served as vice president for pharmaceutical development at KV Pharmaceutical Inc. Kopcha earned his doctorate and master’s degrees in pharmaceutical science, and a bachelor’s degree in pharmacy, from Rutgers University in New Brunswick, New Jersey.