The Report on Drug Shortages for Calendar Year 2017 (here), which is required by Section 506C-1 of the Federal Food, Drug and Cosmetic Act, issued last Thursday, and describes some real progress in the drug shortage arena.
The report notes that “][d]uring 2017, FDA helped prevent 145 potential new shortages, and there were 39 new shortages for 2017.” The 39 new shortages were compared “to a peak of 251 new shortages during the full calendar year of 2011.” While this progress is impressive, shortages today still result in some very real public health issues. The report notes that early notification to FDA of problems with a product, a temporary disruption in availability, or a firm’s decision to permanently discontinue a product has helped the situation, but also notes that natural disasters like the devastating hurricane in Puerto Rico or explosions at a plant cannot be anticipated.
In addition, certain types of shortages, like significant disruption in the availability of IV saline or parenteral nutrition products can create real medical problems in the treatment of patients. Shortages of certain drugs may also cause health care providers to seek alternate treatments which may not be optimal for the patient, especially for oncology products.
Various charts in the report outline the number of shortages from 2010-2017, as well as the number of shortages prevented over the same period. There is also a graph that describes the number of ongoing shortages by year from 2013-2017. The report also outlines the statutory provisions, the FDA’s Strategic Plan for shortages, the President’s Executive Order on drug shortages, and the Final Rule requiring manufacturers to notify the FDA of permanent discontinuations or interruptions of certain drug or biologic products. The latter actually generated a lot of activity as FDA reports. “[F]or calendar year 2017, FDA was notified of 520 potential drug and biological product shortage situations by 86 different manufacturers.” Obviously, the Agency and/or the firms successfully resolved many of these potential shortages before they rose to a level of a shortage of concern. In addition, the report indicates that FDA expedited the review of 132 applications or supplements and expedited 30 establishment inspections to address shortage or potential shortage issues.
Another tool the Agency has is its ability to utilize regulatory flexibility and discretion when faced with a potential shortage. The report indicates that “[d]uring CY 2017, FDA exercised regulatory flexibility and discretion in 57 instances, affecting 33 products.” The report provides examples of some of these efforts.
This report provides useful information on additional Agency activities in the field of drug shortages and should be read by all manufacturers. The information on communication with the FDA could be invaluable if such a situation is possible with any of your company’s products.