Drug Shortages in the US: Causes and What the FDA Is Doing to Prevent New Shortages

Erin Fox, PharmD, Michelle Wheeler, PharmD


AccessMedicine from McGraw-Hill 

In This Article

The FDA's New Authorities Under FDASIA

The FDA received new authorities to help prevent drug shortages when the FDA Safety and Innovation Act (FDASIA) was signed into law on July 9, 2012.[7] Manufacturers are now required to notify the FDA of supply disruptions or discontinuations of products. Previously this was voluntary and required only for permanent discontinuations of sole source products. Early notification by manufacturers is an effective tool in preventing drug shortages. Between November 2011 and June 2012, approximately 300 shortages were averted[8] due to the early notification recommendations in President Obama’s executive order on drug shortages.

Even with this new authority, the FDA is limited in completely resolving the drug shortage problem. The FDA cannot force a manufacturer to continue to produce a medication, no matter how critical to patient care. Additionally, the FDA cannot require manufacturers to increase production of a medication. The new FDASIA requirements also do not address the significant quality problems occurring at many generic manufacturers.[9,10,11] These problems will require additional solutions and cooperation between government and drug manufacturers. In the meantime, health system pharmacists will need to continue to closely track shortages and develop strategies to mitigate effects on patient care. Such strategies can include making plans to conserve supplies by making changes to usual dispensing (drawing up doses, changing location of stock), educating clinicians on the use of an appropriate therapeutic agent, or working with prescribers on conserving remaining supplies for specific groups of patients.