As part of FDA’s work to prevent and mitigate drug shortages, the Agency 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.
Guerbet was recognized for its efforts related to the shortage of Ethiodol (ethiodized oil) injection, currently approved as Lipiodol, including acquiring the new drug application, submitting several post-approval supplements to restart manufacturing with acceptable compliance records, and gaining further approval to market the product for a well-known and medically necessary indication in the United States.
the link to the FDA announcement is at http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm415807.htm
Assisting Guerbet throughout the process were WCIO Executive Officers Michael Soulen, Riccardo Lencioni, and Jeff Geschwind, along with former SIR Presidents John Kaufman and Anne Roberts, David Eschelman, and Thierry de Baere.
Guerbet Group CEO Yves Lepine noted that “the favorable outcome of the drug shortage situation that US patients faced in 2010, has been made possible with the efforts of a multidisciplinary team gathering you [physician experts], FDA drug shortage team - Guerbet HQ – Guerbet US– and industrial operations (internal and external). This outcome has even overcome our initial ambition as we have now not only reached a sustainable supply of Lipiodol from FDA certified sites, (Lipiodol will soon be removed from the FDA Drug Shortage List) but also we validated a new indication that addressed the use of the contrast agent in patients with certain types of cancer. I can say our efforts have not been motivated with the goal to receive this FDA distinction - as it did not even exist at that time - but with the conviction that we have done what we had to do, our mission. I know this word is a bit simplistic and naive but sometimes simple words drive more energies. Through this experience, optimization of minimally invasive, image-guided procedures has become a new priority for Guerbet and we will continue to develop Lipiodol and new medical products / solutions to better cure patients suffering from cancers in the future.”
Guerbet LLC Director, North America Medical and Regulatory Affairs, Corina Harper reflected “Remember how it all started: the patient outreach to you and us, you the doctors offering your unconditional support and knowledge, the societies (ie. SIR, ASRM) lobbying FDA, congress representatives contacting FDA and Guerbet, an amazing amount of time, manpower and investment from the French headquarters team, a past president and a new President with the vision to see it complete and making Lipiodol available to US patients. “
Accolades from the IO community rapidly followed:
John Kaufman: “This is fantastic!!!!! Congratulations to Guerbet!!!!! This is a great example of the good that can come from collaboration. However, without your initial willingness to listen, followed by the full support of Guerbet to the highest level, this would never have happened. Everyone at Guerbet should be justifiably proud about this award.”
Riccardo Lencioni: “Thank you for showing to all of us that combining a company's business plans with an ethical, patient-centered approach is indeed possible and successful.”
Jeff Geschwind: ”What I find especially impressive is that the FDA recognized the importance of Lipiodol in our field.”