Regulatory Update : The IPEC Novel Excipient Safety Evaluation Procedure

a substantially lower number of drug formulations containing new molecular entities (NMEs) in the past decade (1). In 2008, the agency approved formulations containing 21 NMEs and four biologics, slightly higher than the 2007 total of 17 NMEs and two biologics. The growth between 2007 and 2008, however, was not enough to counter the marked downward spiral of drug approvals during the past 10 years (1). Behind the trend may be tightening safety standards, the complexity of clinical trials that have escalated drug-development costs, and even perhaps a shift in emphasis as pharmaceutical companies move away from truly innovative solutions toward more complex therapeutic profiles. An additional barrier to the development of new drug formulations is that, in some cases, active pharmaceutical ingredients (APIs) that show promising activity in animals or in vitro biologic systems fail to show sufficient efficacy in human clinical trials. In some cases, this discrepancy may be due to a lack of bioavailability and desired effect at the target site in the human body—properties potentially linked to the specifics of the formulation. The choice of excipients also can be a critical factor for developing clinically efficacious drug formulations. The current regulatory environment both inside and outside the United States, however, strongly discourages development of new excipients, limiting the choices to those already approved. The International Pharmaceutical Excipients Council of the Americas (IPEC–Americas) has proposed specific regulatory changes to encourage new excipient development which, if adopted, could Regulatory Update: The IPEC Novel Excipient Safety Evaluation Procedure