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FDA Statement

FDA statement on FDA’s modern approach to advanced pharmaceutical manufacturing

For Immediate Release:
Statement From:
Scott Gottlieb, M.D.

One of today’s most important tools for modernizing the pharmaceutical industry is a process known as continuous manufacturing (CM). This approach transforms the traditional, step-wise manufacturing processes into a single system that’s based on modern process monitoring and controls. It enables a steady output of finished drug products as raw materials are continuously added to the closed system.

Today, we’re taking new steps to help advance the adoption of these manufacturing innovations.

The closed and continuous nature of these CM systems means that the process is easier to control than the decades-old, traditional “batch” manufacturing. Under that traditional approach, the finished drug product is made using a long series of discrete steps that involve many stops and starts. Each step in this traditional staggered manufacturing process introduces a degree of complexity and uncertainty.

CM helps to ensure consistently-made products, allows manufacturers to more easily scale their manufacturing operations to meet demand, and can help reduce drug shortages by minimizing operational stops and starts. CM systems also require smaller footprints to operate. The high tech and small footprint attributes of these systems promote localized manufacturing, helping to shorten the drug supply chain. Furthermore, these continuous processes are much more efficient. This may help manufacturers reduce costs of production in the long run. This efficiency could eventually be captured for consumers in the form of lower drug prices.

This area is still new and developing. Harnessing the full potential of these innovations will require us to invest time and resources in developing scientific standards and policy and supporting implementation. This is why we’ve charged the FDA’s Emerging Technology Team to help early adopters of CM (and other advanced manufacturing technologies) surface and resolve implementation challenges and navigate the application review process for products made with these modern methods. We’re also taking additional steps to help facilitate broader adoption of CM by providing guidance and information to interested companies, whether brand name or generic drug manufacturers.

We’re beginning to see encouraging progress. Less than four years ago, there was only one approved product manufactured using CM processes. Today, there are four companies manufacturing five approved products using CM, treating diseases like cystic fibrosis, HIV-1 infections, breast cancer and leukemia. About 20 additional companies -- both brand and generic -- have engaged the FDA in their efforts to develop and implement CM processes.

We’ve talked about the benefits CM can offer compared to traditional batch manufacturing in terms of reliability and efficiency of production. To advance these goals, we’ve provided grants to fund research and we are conducting internal laboratory investigations to study CM and other technologies. However, we understand that some companies still have questions and concerns they need to address before making the changeover. For one, the cost of new equipment is a key concern. The FDA can help address these issues by providing clear guidance on what process and control strategy designs (including equipment) are needed to meet regulatory considerations and how a CM platform technology can be used to manufacture multiple products, so that product developers can have more certainty about the capital investments they need to make. This can provide sponsors with more assurance about the costs of adopting these new methods and the payoffs they can anticipate from making these investments.

Since processes and facilities for CM differ from traditional operations, some companies have questions about how using this new technology will impact the way the FDA and other regulators assess new drug applications when the products are being produced using these methods, and how regulators will approach facility inspections. It’s incumbent on the FDA to ensure that companies clearly understand our regulatory approach so they’re confident in making this investment.

We’ve seen early adopters find innovative solutions to overcoming challenges in developing their CM facilities. For example, companies have designed and built modular and miniature CM equipment in their facilities. This design not only allowed the company to run their CM operations in a smaller physical footprint, but also allowed the company to transfer identical units to different sites, and therefore help to start their CM operations more quickly in different locations. To continue to advance greater predictability and quality around the adoption of these systems, today the FDA is issuing draft guidance to industry to help further support the development and implementation of CM for brand, generic, and over-the-counter drugs.

This draft guidance will clarify the FDA’s current thinking regarding innovative CM approaches and can help resolve potential issues some companies have as they consider implementation, such as concerns that use of new CM technology might impact the time FDA takes to assess applications for new products and switching from a batch to CM process for existing products.

The draft guidance also supports a global effort with other regulatory authorities to encourage implementation of CM. The FDA also proposed development of a guidance on CM to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The ICH assembly accepted the FDA’s proposal and set a goal of finalizing the guidance by 2021. This harmonized guidance will help advance the brand and generic drug industries ability to obtain approvals for products manufactured using CM processes in multiple regions.

We’ve also taken other steps to advance the adoption of these technologies, including a request for funding to help advance continuous manufacturing as part of the President’s 2019 budget.

We’re encouraged to see a growing number of companies embracing CM. It’s a key step towards promoting drug quality and improving the efficiency of pharmaceutical manufacturing. We’ve worked hard to help industry develop the tools to start advancing these goals. The FDA is committed to helping more companies advance these CM platforms owing to the public health benefits of these more modern approaches. We support the early adopters that are embracing this innovative technology and we look forward to working with other interested companies.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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