The FDA has become keenly aware within the past several years of the impact that their audits have on the availability of drugs becoming available to the consuming public. Douglas C. Throckmorton, MD, Deputy Director for Regulatory Affairs, CDER, FDA recently presented at the ISPE meeting on June 4, 2014 where he discussed this and illustrated the “FDA Response to Drug Shortages”.
Within his presentation, he discusses 1) shortages as a significant public health threat; 2) FDA’s role in drug shortages; 3) recent FDA activities; and 4) future FDA directions. He noted that the three primary sources of drug shortages include Quality manufacturing issues of 1) Quality: facility remediation efforts (35%); 2) Quality: product manufacturing issues (31%), and 3) discontinuation of product (14%). Examples of Quality manufacturing issues included sterility, particulates, crystallization, precipitation, etc.
For sterile injectables, he noted that the state of industry was an issue because a small number of manufacturers make up most of the market, a lack of redundant manufacturing, complex manufacturing processes, and very inexpensive products (in some situations).
It was noted that an Executive Order from President Obama directed the FDA to use its authorities to encourage early notification of potential shortages. It became particularly obvious within any Warning Letters that were issued within the past several years. As a result, close to 200 drug shortages were prevented in 2011 and more than 280 in 2012. Injectables were a large percentage of those averted in the time frame of 2010-2013. The two primary notification sources for sterile injectable drugs were manufacturers (40%) and FDA inspections (43%).
To review the Strategic Plan and learn of the Future of Drug Shortages, please review the following web site that contains all of the slides presented as well as illustrated graphics. Please visit: http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM400503.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery
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