FDA letter focuses on UCLA claims about an unapproved diagnostic

The FDA's Office of Prescription Drug Promotion homed in on Taumark.com, a website run by a University of California, Los Angeles research institute that claimed a type of PET scan can be used to diagnose tau protein levels.

Tau proteins are associated with Alzheimer's disease. The public, redacted version of the letter shows that the regulator's promotion watchdog had issues with the website for one key reason: It promoted the FDDNP-PET scan as safe and effective, but the FDA has not approved the product.

The website content described by the letter is no longer available, and Taumark.com is currently a bare-bones site that includes links to medical research and press releases.

The website described in the FDA letter included images of football players, seniors and a woman in military gear, and included information about concussions and traumatic brain injuries. It also indicated that these conditions could be associated with elevated tau protein levels.

The FDA wrote that the totality of the website's information made “numerous conclusory statements” about safety and effectiveness.

UCLA did not immediately respond to MM&M queries about when the copy described in the letter was taken down, or if the FDA's letter sparked the revision.


Next Article in Pharmaceutical