FDA Regulations Effect Drug Supply

According to data compiled by the University of Utah’s Drug Information Service, there were 265 drugs in short supply as of this year — down from a high of 456 in 2012, but still 74 percent above the total in 2010. These shortages include all forms of drugs, including antibiotics, but also sterile injectables, such as those used in chemotherapy treatment and anesthesia. Even by the more conservative tally of the Food and Drug Administration (FDA), there were 44 drug shortages last year.

In the University of Utah data, 25 percent of shortages last year were attributed to manufacturing problems, and another 47 percent were classified under the mysterious category of “unknown.” The FDA has emphatically argued that it has not increased its manufacturing-quality standards and does not expect pharmaceutical manufacturers to halt production of a drug after the agency identifies quality or contamination problems. But the agency has, over the last few years, increased its inspections of manufacturing facilities, especially facilities producing sterile injectables.

The FDA wants to work with companies to keep necessary pharmaceuticals in production, but it does not have the legal authority to require a pharmaceutical manufacturer to continue production of a drug that the agency has cited for quality or contamination regulatory violations, says NCPA senior fellow Thomas A. Hemphill.

As a result, supplies of in-demand pharmaceuticals decline — at least in the short run. In many cases, less effective substitute pharmaceuticals are employed to treat a patient’s malady.

Unfortunately, improvements in FDA regulatory effectiveness have, in some instances, resulted in the unintended consequence of exacerbating drug shortages.

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