Report: Drug Shortages Persist, Despite FDA Efforts

Published Online: Tuesday, March 11, 2014
Follow Pharmacy_Times:
The FDA has used its recently increased power to combat drug shortages nimbly, but so far the agency has not succeeded in reducing the overall number of shortages, according to a report released by the Government Accountability Office (GAO) on February 10, 2014.

The FDA was given additional authority to fight shortages in the 2012 Food and Drug Administration Safety and Innovation Act, which requires manufacturers to alert the FDA of potential shortages before they happen.

The GAO determined that the FDA prevented 154 potential shortages in 2012 compared with 35 in 2010. In addition, the number of new drug shortages declined in 2012 for the first time in years. However, the overall number of shortages continued to increase, reaching 456 in 2012, compared with 154 in 2007.

Regulatory discretion is one tool the FDA has used to prevent shortages. For instance, if batches of a drug in shortage are found to have particulate contamination, the manufacturer might be allowed to filter them rather than have its plant shut down.

In a congressional hearing on the report, an FDA official testified that approximately two-thirds of shortages are due to quality problems and the need to fix them. Small profit margins are also a problem, leading manufacturers to put off maintenance and emphasize production of products that make more money.

In the report, the GAO praised the FDA for its efforts, though it noted that the agency cannot force production of particular drugs. In addition, it urged the FDA to work to identify patterns in shortages to help it better predict when they are going to happen.

Related Articles
Maintaing drug inventory while providing appropriate patient care remains a daily challenge for pharmacists in light of national drug shortages.
This month, the Government Accountability Office will begin monitoring how well pharmacies are applying best practices for the development of prescription labels for the visually impaired.
Erin Fox, PharmD, director at the University of Utah Drug Information Service, discusses how pharmacists can rationalize the need to compound or import drugs that are in short supply.
Erin Fox, PharmD, director at the University of Utah Drug Information Service, discusses how strategies to mitigate drug shortages can lead to medication errors.
Latest Issues
  • photo
    Pharmacy Times
    photo
    Health-System Edition
    photo
    Directions in Pharmacy
    photo
    OTC Guide
    photo
    Generic Supplements
  • photo
    Pharmacy Careers
    photo
    Specialty Pharmacy Times
    photo
    Generic
$auto_registration$