Guerbet, a pioneer in the field of contrast agents for medical imaging, has received a Drug Shortage Assistance Award from the U.S. Food and Drug Administration for its assistance in preventing or alleviating a drug shortage.
Guerbet is being recognized for its efforts related to the shortage of Ethiodol (ethiodized oil) injection, including acquiring the new drug application, submitting several post-approval supplements to restart manufacturing with acceptable compliance records, and to market the product for a well-known and medically necessary indication in the United States. These actions by Guerbet resolved a critical drug shortage affecting patients with cancer.
Ethiodol (ethiodized oil) injection, now under the tradename of Lipiodol®, is an oil-based radiopaque contrast agent used to image tumors in patients with certain types of cancer.
Through the Drug Shortage Assistance Award program, FDA recognizes companies for making a substantial contribution to preventing or alleviating a critical drug shortage. This award also recognizes companies for their commitment to public health, as well as a commitment to quality manufacturing.
"We are pleased that the FDA recognizes our commitment to ensuring U.S. patients have access to the medications they need," commented Yves L'Epine, CEO of Guerbet.
Drug shortages pose a substantial public health threat, delaying, and in some cases even denying, critically needed care for patients. Working with drug manufacturers, the FDA helped prevent over 280 drug shortages in 2012 and 170 in 2013.
There were 44 new drug shortages in 2013, down from 117 new drug shortages in 2012. Two key prevention strategies have helped drive this significant decrease in new shortages: 1) early notification and 2) a focus on quality manufacturing.
FDA is committed to working with companies, like Guerbet, to prevent and mitigate drug shortages.