Patients in different areas of the U.S. are reporting difficulties accessing a relatively new nuclear medicine imaging technique known as the Gallium 68 (Ga-68) scan. These reports prompted a member of the NETRF team to take action.
Josh Mailman, treasurer, NETRF Board of Directors, and president of NorCal CarciNET is a NET patient advocate with a specialized interest in nuclear medicine. In late July, Josh was invited to give a lunch presentation to directors at the Food and Drug Administration (FDA) in Washington, D.C., including results from a patient survey he conducted online.
“The directors are concerned about Ga-68 availability,” said Josh, “FDA maintains information on drug shortages, but the agency has challenges in tracking radiopharmaceuticals availability.”
A small generator is used to produce the Ga-68, which has a short half-life, of about an hour, limiting the time it can be used. Generators that produce Ga-68 need to be replaced approximately every 300 days. Areas of the country that would like to have Ga-68 availability are competing with communities that need their generators replaced resulting in some areas losing a generator and the availability to produce Ga-68.
The Society of Nuclear Medicine and Molecular imaging (SNMMI) recently sent a letter to FDA outlining the Ga-68 shortage. Some of the actions underway to help address the shortage, include:
- The manufacturer that produces the approved generator continues to ramp up production.
- One manufacturer that has an approved Ga-68 generator is seeking approval to be used for imaging with the FDA-approved imaging agent.
- A manufacturer and distributor of Ga-68 generators announced plans for a North American production site in Texas. This new site will have to undergo rigorous regulatory certification prior to any use in patient care.
As a member of Patient Advocacy Advisory Board for SNMMI and a member of the Ga-68 working group, Josh will continue to monitor the issue on behalf of patients.
We appreciate all those that participated in Josh’s survey, which allowed him to bring the voice of the patient before the FDA.