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Following a somewhat static decade, FDA has shaken up one half of the drug world by introducing the Novel Excipient Review Pilot Program. Proposals are accepted through Dec. 7, 2021. Universally welcomed, the pilot also carries a burden of very high expectations for being enlarged. Below are three veteran industry voices that harmonize in the hopes for more streamlined approvals.
As drugs become more complex and difficult to manufacture, the role of excipients becomes more pivotal. Dr. Stephen Hoag of the University of Maryland pointed out, in an interview with Pharmaceutical Technology, “It’s a real need of the industry ... the example right in front of us is the Pfizer and Moderna vaccine where the lipid nanoparticle for the delivery of the vaccines are very specialized excipients. They’ve created a platform that can be used for a lot of different possible disease states ... it’s a real need with these poorly soluble drugs, it would be nice to have a lot broader tool chest than what we currently have. And that’s why IPEC is really working on trying to streamline the pathway for approving excipients, obviously you need to worry about toxicity and protecting patient safety, but having said that, you need a pathway to get excipients approved, and IPEC is working to get that pathway as smooth as it can be.”
Chris Moreton of FinnBrit Consulting also considers the pilot positive, and said in an interview with Pharmaceutical Technology, “...applications must be in in early December. The sponsors of the excipients selected by the FDA will then need to submit their data package (CMC and safety/tox). If they do not have a complete package at the time of selection, they will need to provide a realistic timeline as to when they expect to have the rest of the data available. There are potential benefits for both excipient manufacturers and users. My personal hope is that the pilot will be successful and extended to cover the whole range of novel excipients.”
Combining these threads together Dave Schoneker of Black Diamond Regulatory Consulting stated in an interview with Pharmaceutical Technology, “[the pilot]...is a great step forward to improve innovation in excipient and drug development. However, it will be very important to open up the scope of the program after the pilot program, if it is successful, to all the various types of novel excipients such as co-processed excipients, higher levels of use and new routes of administration of existing excipients, and the use of existing food and cosmetic ingredients for first use in drugs. This will be critical to the overall success of the program since there will always be a limited number of NCE type novel excipients which require full toxicology programs costing millions of dollars. These other types of novel excipients will be what ultimately will provide the biggest overall benefits to patient-centric drug development, dosage form innovation, and improvements in advanced manufacturing methods.”
We will watch the pilot program progress, along with our colleagues, with both excitement and great expectations.