Pfizer Inc. - Comment

Pfizer appreciates the opportunity to review the interim final rule and offers the following comments: On ‘‘Discontinuance,’’ the FDC Act requires manufacturers who are the sole manufacturers of certain drug products to notify FDA at least 6 months before discontinuance of manufacture of the products. Pfizer suggests that for unplanned supply interruptions, notification should be provided when a company projects a patient will be unable to obtain product. This is determined by internal forecasting methodologies and is generally based on when a company projects that it will be unable to ship product to first paying customers for an extended period of time, thereby depleting system inventories. (This period is 8 weeks for Pfizer, but it might be different for other companies.) The anticipated length of shortage to be included. On ‘‘sole manufacturer’’ Pfizer suggests a definition should be provided which could include the market share. A company should be considered a sole manufacturer if it holds x% or more of market share (e.g. 95% of market share). In addition, Pfizer recommends exploring replacing the terminology “life-saving” with alternative wording such as “Medicines at Risk of being in Shortage” as all patients, whether they are managing a disease such as diabetes, heart disease or any other critical disease, view their medications as “life-saving.” Additionally, it is imperative that a root-cause analysis be conducted to determine why drug shortages are occurring and clearly identify a list of products most at risk of being in shortage. Once a list is identified by the FDA, it will then be far easier to manage a notification program for both the Agency and sponsors.