Categories: FDA, Pharmaceuticals

On December 23, 2015, the Food and Drug Administration's (FDA) released draft guidance on the Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base. This was a positive step towards helping pharmaceutical companies invest and implement emerging technologies that improve overall drug quality.

Pharmaceutical companies have spent millions of dollars issuing recalls for products because of a variety of quality issues caused by outdated manufacturing technologies. These issues have caused significant delays in providing patients access to drugs and have the potential of harming patients. Manufacturers have argued that new and emerging technologies will help avoid these kinds of issues but use of such technologies may delay the approval of new drugs. This guidance provides a pathway for pharmaceutical companies wanting to modernize manufacturing technology to help prevent adverse drug quality.

By the very nature of new, innovative technology, the FDA lacks experience reviewing such technologies, which in turn discourages pharmaceutical companies from pursuing such ventures. Given the time it may take for FDA to get comfortable with the technologies, such innovations may add significant time to drug application reviews. To address this, FDA has initiated a new Emerging Technology Team (ETT), through the Center for Drug Evaluation and Research (CDER), to which pharmaceutical companies would be able to submit pre-submission questions and proposals and obtain early engagement to work through the manufacturing design, development and required submission content.

To be accepted into this optional program, the sponsor must submit its proposed plans regarding an Investigational New Drug (IND) or an original or supplemental Abbreviated New Drug Application (ANDA), Biologics License Applications (BLA) or New Drug Application (NDA) in a written request for a Type C meeting to three months prior to the planned submission. The planned submission will need to include any aspects of the submission that FDA would have limited experience with and where the technology could modernize the pharmaceutical manufacturing body of knowledge. The guidance provides as an example an update to a manufacturing line where a contemporary aseptic facility uses highly automated use of isolators to decrease the risk of contamination from the processing line. FDA expects to notify companies as to their status in the program within 60 days of the request.

This guidance reminds industry that the FDA is willing to be flexible and work with applicants to continuously improve and develop new and existing manufacturing processes. This type of collaboration between the FDA and industry may lead to reduced drug shortages and patient risk with respect to drug quality. However, this assumes that the ETT does indeed have adequate resources and expertise to help industry assess novel technologies moving forward.

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