The US Food and Drug Administration (FDA) last month sent the University of California Los Angeles (UCLA) an untitled letter over promotional claims about an imaging test that uses an unapproved imaging agent to diagnose prostate cancer.

Specifically, FDA says that statements made on a website and in a brochure for a prostate-specific membrane antigen (PSMA) positron emission tomography (PET) imaging test for prostate cancer being developed by UCLA promoted an unapproved drug as safe and effective.

"The claims in the webpage and brochure are concerning from a public health perspective because they make conclusory representations in a promotional context regarding the safety and efficacy of an investigational new drug that has not been approved by the FDA and whose safety and efficacy have not been established," FDA writes.

According to FDA, the Gallium-68-based imaging agent used for the test is still being studied as an investigational new drug.

Some of the statements FDA took issue with include:

• "New imaging test accurately detects prostate-cancer cells throughout the body"
• "At UCLA, with the availability of PSMA-PET imaging patients now have a new option of detecting prostate cancer cells anywhere in the body more accurately than traditional methods"
• "There are no common side effects or significant risks"

As a result of these statements, FDA says the imaging test is misbranded and UCLA should immediately cease violating the Food, Drug and Cosmetic Act by discontinuing the use of any violative statements and materials.

Untitled Letter