FDA Guidance Buoys Pharma Manufacturers

Overview

In recent years, hundreds of drug shortages have been reported to the US Food and Drug Administration (FDA).  In response, FDA is working with pharmaceutical manufacturers to help them identify and implement new, scientifically sound technologies, and the FDA guidance buoys pharma manufacturers.  The goal is not just to produce quality medicines that are consistently safe and effective, but also to implement processes that can help prevent drug shortages.  

When problems arise in drug manufacturing facilities, drug shortages often follow.  According to FDA, disruptive manufacturing and product quality issues cause 65 percent of all drug shortages.  These can pose a risk to patients with serious conditions such as cancer, life-threatening infections, and severe malnutrition. The shortages can delay or prevent care to patients and force medical practitioners to prescribe less effective therapies.

FDA believes that the pharmaceutical industry can learn from the chemical, automotive, aeronautics, electronics, and other industries that have already improved manufacturing and business performance by exploring and implementing new and advanced manufacturing technologies.  FDA believes that the pharmaceutical industry can adopt similar technologies to help improve manufacturing efficiencies, production, and product quality to prevent shortages.

Adopting New and Emerging Technologies

FDA recently formed a team and issued a draft guidance document aimed at helping drug companies pursue new technologies that can help improve manufacturing efficiency and/or product characteristics.  Examples include working with drug manufacturers to enable them to use 3D printing techniques to produce pills that disintegrate faster in a patient’s mouth, greatly aiding those who have trouble swallowing.  FDA recently approved a 3D-printed pill for epilepsy patients.

Personalized drugs are another area that pharma manufacturers will have to address in the coming years. Companies will need to implement technologies that allow them to efficiently manufacture individualized drug products that are both high quality and affordable.

Other technologies that ARC Advisory Group believes hold promise for modernizing pharmaceutical manufacturing facilities include the use of robots, drones, virtual reality, augmented reality, virtualization, analytics, auto-configuration, manufacturing intelligence, cloud computing and simulation technologies.  The Industrial Internet of Things (IIoT), new mobility apps, and social media also offer potential benefits for manufacturers that want to improve efficiencies in research and development, manufacturing, and supply chain. 

Emerging Technology Team

FDA recently established the Emerging Technology Team (ETT), which includes representation from the Agency’s Office of Pharmaceutical Quality and the Office of Regulatory Affairs.  This specialized team is working directly with industry to help identify and resolve scientific issues for new technologies. This unique (for FDA) approach enables these types of discussions to occur early in the technology application process before a drug company submits an application to FDA.  By engaging early, the ETT can help proactively identify and address potential roadblocks and eliminate possible delays in the adoption of promising new technologies and manufacturing processes.

By their nature, innovative technology approaches have a limited knowledge and experiential base. Pharmaceutical companies may have concerns that using such technologies could result in delays while FDA reviewers familiarize themselves with the new technologies and determine how they fit within existing regulatory approaches. Through the ETT, FDA intends to encourage adoption of innovative manufacturing approaches by leveraging existing resources within the Agency to facilitate the regulatory review of submissions.

FDA Guidance Buoys Pharma Manufacturers on Emerging Technology Applications

To clarify the mission and scope of the ETT, the FDA issued a draft guidance in December 2015 titled, “Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base.”   The document provides recommendations to pharmaceutical companies on effective ways to work with the ETT. The document explains that the FDA will work with manufacturers on an individual basis, provide specific recommendations and feedback regarding submissions, and provide guidance on new manufacturing technologies.

According to the guidance, Modernizing manufacturing technology may lead to a more robust manufacturing process with fewer interruptions in production, fewer product failures (before or after distribution), and greater assurance that the drug products manufactured in any given period of time will provide the expected clinical performance. The guidance goes on to explain, Encouraging the development of emerging manufacturing technology may lead to improved manufacturing, and therefore improved product quality and availability throughout a product’s lifecycle.

Addressing Drug Shortages through Manufacturing Quality

The initiative has several goals, including encouraging the early adoption of new technological advances by the pharmaceutical industry and ensuring that regulatory review, compliance, and inspection policies are based on state-of-the-art pharmaceutical science.

The current initiative builds on FDA’s earlier efforts to modernize the pharmaceutical industry.  These include the 2002 cGMP initiative (see sidebar) and 2004 guidance on Process Analytical Technologies (PAT) as a framework for innovative pharmaceutical development, manufacturing, and quality assurance.  The PAT guidance describes the concept that quality cannot be tested into products; but should be built in or present by design.

Recommendations

The goal of the FDA’s ETT team and associated guidance is to encourage pharmaceutical and biotech companies to upgrade manufacturing technologies to improve product safety, purity and quality, and prevent drug shortages. 

ARC recommends the following actions for pharmaceutical manufacturers and other participants in FDA-regulated industries:

• Research new technologies that other industries are implementing that offer potential to help modernize pharmaceutical manufacturing and address new complex and/or personalized therapies
• Focus on adopting emerging technologies with clear business benefits
• Engage with the FDA’s ETT team for guidance and approvals

• Contact ARC Advisory Group to learn more about modern and emerging technologies and best practices

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Keywords: Pharmaceutical Manufacturing, Quality, Emerging Technologies, FDA, FDA Guidance, ETT, Pharma Modernization, ARC Advisory Group.