Dear CDER Staff:
On September 6, 2012, CDER Center Director Janet Woodcock informed you that she would be proposing important organizational changes within the Center to sharpen the Center’s focus and strengthen resources around pharmaceutical quality.
As part of these organizational changes, we will also be proposing that the Drug Shortages Staff (DSS) be moved from the Office of New Drugs and be elevated to the Office of the Center Director under the leadership of Deputy Director for Regulatory Programs, Dr. Doug Throckmorton.
On July 9, 2012, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012. In this new law, Congress provided FDA with new authorities to combat shortages of drug products in the United States and imposed new requirements on manufacturers regarding early notification to FDA of issues that could lead to a potential shortage or disruption in supply of a product.
Drug shortages can occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. They have reached crisis proportions for many healthcare systems and are creating personal crises for many patients. Fortunately, the Agency has been able to prevent a significant number of drug shortages. In 2011, FDA helped prevent 195 drug shortages; as of August 2012, FDA prevented close to 100 shortages.
FDA places tremendous value on the Center’s efforts to curb drug shortages. In addition, with the new authorities brought by FDASIA, we look forward to an ever-increasing focus on this crucial program.
The proposed elevated placement for DSS -- with its greater visibility and prominence within the Center -- reflects how important the work of the DSS is to ensuring that patients in need have critical and life-saving drugs available to them. Undoubtedly, this work is paramount to the Center’s mission to guarantee that safe, effective, and high-quality drugs are available to the American public.
Deputy Director for Regulatory Programs, Office of the Center Director
Director, Office of New Drugs