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In an important step for modernizing drug formulation and biopharmaceutical development, FDA is launching a program to test the safety and suitability of novel inactive ingredients for use in new drugs and biologics. This final initiative, first proposed two years ago, supports a two-year pilot program to test up to four new excipients likely improve the effectiveness and safety of important new drugs.1 The aim is to encourage sponsors of clinical trials to formulate innovative therapies with those new excipients that FDA finds acceptable for use under this program.
FDA spelled out the pilot program in a Federal Register notice published Sept. 8, 2021.2 The agency explains that the initiative is open to novel excipients that have not been used previously in food or in FDA-approved products and how excipient manufacturers looking to participate should submit information by Dec. 7, 2021on the novel inactive ingredient and its potential for enhancing public health. The program aims to evaluate four selected novel excipients likely to advance drug development, such as by increasing solubility for an oral formulation taken chronically. Those ingredients authorized under this program then may be used in the formulation for an experimental drug slated for clinical trials, provided that the sponsor demonstrates that it is safe for use in that specific treatment. After FDA approves a new drug or biologic utilizing the new excipient, that ingredient then would be added to FDA’s Inactive Ingredient Database, making it available for use by other manufacturers, including those producing generic drugs.
Manufacturers of drugs and biologics, as well as excipient developers, have long sought a process for FDA to evaluate new inactive ingredients prior to use in a new drug or biologic to support the development of innovative formulations without fear of delay or complications in FDA review and approval of the new product. Biopharma companies support this effort to avoid difficulties in formulating innovative drugs with available, established excipients, for example, in looking to stabilize proteins in new formulations. Excipient makers similarly acknowledge that they would be more willing to invest in production and characterization of novel excipients if it’s possible to gain FDA review of the product’s benefits outside of clinical testing for a new molecular entity. The initiative, as well as ongoing efforts to set international standards for excipient use, have potential to enhance drug formulation and support modern manufacturing and quality control efforts.