FDA Guidance Unlocks Pharma Opportunities

The U.S. Food and Drug Administration is working with pharmaceutical manufacturers to tackle manufacturing and product quality issues that can lead to drug shortages.

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

When problems arise in drug manufacturing facilities, drug shortages often follow. Disruptive manufacturing and product quality issues cause 65 percent of all drug shortages, according to the FDA. 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.

The 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. The pharmaceutical industry could adopt similar technologies to help improve manufacturing efficiencies, production and product quality to prevent shortages.

New and emerging technologies

The FDA recently formed a team and issued a draft guidance document aimed at helping drug companies pursue new technologies that can help improve manufacturing efficiency and/or product characteristics.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 helping drug manufacturers 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 robots, drones, virtual reality, augmented reality, virtualization, analytics, auto-configuration, manufacturing intelligence, cloud computing and simulation. The Industrial Internet of Things (IIoT), new mobility apps and social media also offer potential benefits for manufacturers that want to improve efficiencies in R&D, manufacturing and supply chain.

Emerging technology team

The recently established Emerging Technology Team (ETT), which includes representation from the FDA’s Office of Pharmaceutical Quality and the Office of Regulatory Affairs, 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 the 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 might 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, the FDA intends to encourage adoption of innovative manufacturing approaches by leveraging existing resources within the agency to facilitate the regulatory review of submissions.

Guidance 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. It 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 time period will provide the expected clinical performance. The guidance goes on to explain that encouraging the development of emerging manufacturing technology could lead to improved manufacturing, and therefore improved product quality and availability throughout a product’s lifecycle.

Addressing 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 the FDA’s earlier efforts to modernize the pharmaceutical industry, including the 2002 cGMP initiative and 2004 guidance on process analytical technologies (PAT) as a framework for innovative pharmaceutical development, manufacturing and quality assurance.

>>Janice Abel, jabel@arcweb.com, is principal consultant at ARC Advisory Group.

 

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