CDER Outlines Actions on Drug Shortages

Late yesterday, Dr. Douglas Throckmorton, Deputy Center Director for Regulatory Programs in FDA’s Center for Drug Evaluation and Research, issued a statement on the FDA’s ongoing efforts in the area of drug shortages. Based on our post yesterday (here), which outlined the FDA’s new report on drug shortages for 2017, we felt it was necessary to...

Late yesterday, Dr. Douglas Throckmorton, Deputy Center Director for Regulatory Programs in FDA’s Center for Drug Evaluation and Research, issued a statement on the FDA’s ongoing efforts in the area of drug shortages.  Based on our post yesterday (here), which outlined the FDA’s new report on drug shortages for 2017, we felt it was necessary to provide a link to Dr. Throckmorton’s statement (here) as it provides some concrete descriptions of some of the shortages the pharmaceutical industry is currently dealing with and FDA response to the specific events.

The statement details some of the FDA actions in the following major shortages the industry, FDA, and patients are facing.

  • IV fluids shortage
  • Injectable Opioid Analgesic shortage
  • EpiPen supply

While these are just a few of the numerous shortages being dealt with, they are having major impact on patient treatments, which FDA is attempting to mitigate through the use of its statutory and regulatory authority.  As mentioned in the blog cited above, while the number of new shortages has decreased, the significance of each is medically important to caregivers and patients.  FDA continues to work diligently to address these shortages.

Source: www.lachmanconsultants.com