As part of FDA’s work to prevent and mitigate drug shortages, the Agency has created the FDA Drug Shortage Assistance Award to provide public recognition to drug companies and manufacturers who have demonstrated a commitment to preventing or alleviating drug shortages of medically necessary drugs. This award recognizes efforts of drug companies and manufacturers who have worked in cooperation with FDA and have implemented strategies to help provide a steady supply of medically necessary drugs for patients at a time when critical drug shortages pose a challenge for health care providers and patients nationwide, while maintaining a commitment to quality manufacturing.
FDA's Drug Shortage Assistant Awards recently awarded to:
Guerbet Group - Award Letter (pdf)
Clinigen Group Plc - Award Letter (pdf)
Both companies worked diligently with FDA to help ensure adequate supplies of important medicines for patients in need.
Guerbet Group helped FDA to alleviate the shortage Ethiodized oil injection, an important imaging agent for a variety of patients with certain patients with certain forms of liver cancer. The company's work included acquiring the New Drug Application (NDA) for Ethidol, a form of ethiodized oil; submitting the relevant applications to restart its manufacture under the trade name Lipiodol; and gaining additional approval for a medically necessary indication that was of critical concern during the shortage.
Clinigen helped ensure supplies of a medication needed for patients with AIDS who also have a serious eye condition called CMV (cytomegalovirus) retinitis. The company's work included acquiring NDA for Foscavir (foscarnet sodium) injection, and submitting relevant applications to return the product to market.
USFDA plans to continue to recognize manufacturers with this award based on their ability to meet the crtiteria for Drug Shortage Assistance Award.
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