SHORTAGES OF PHARMACEUTICAL drugs, a long-standing problem in the United States, appear to be getting worse. Reports by the US Food and Drug Administration (FDA), the American Hospital Association (AHA), and the American Society of Health-System Pharmacists point to patients having to take less effective drugs or delay treatments because of shortages. The situation is prompting action in Congress, where legislation has been introduced that would give the FDA the ability to require early notification from pharmaceutical manufacturers when situations arise that may lead to a shortage of a particular drug. Currently, drug manufacturers are not required to notify the FDA about most potential shortages, although the FDA encourages notification. Companies that are the sole source of a medically necessary drug are legally required to inform the FDA 6 months before they stop making the product; however, there is no penalty if they choose not to do so. The Pharmaceutical Research and Manufacturers of America, the drug industry’s trade association, cites the following factors associated with drug shortages: natural disasters; shifts in clinical practices, wholesaler practices, and pharmacy inventory practices; shortages of the raw material used to manufacture a drug; adherence to FDA-mandated distribution protocols; and individual company decisions to discontinue specific medicines. According to the FDA, the number of drug shortages has nearly tripled over the last 6 years from 61 drug products in 2005 to 178 in 2010— and those shortages do not include vaccines, immunoglobulin products, and other biologics.
Read full abstract