The regulator warned UCLA, a partner in TauMark and the sponsor of the investigational new drug FDDNP, that it is violating the FD&C Act by promoting the brain diagnostic drug without market authorization and by failing to include adequate directions for use.
UCLA, which is the sponsor of FDDNP, received a warning letter from the FDA after the regulator found that the website for its investigational new drug implies that the product is safe or effective for the purpose for which it is being investigated. According to the letter, FDDNP is consequently misbranded.
The OPDP took issue with the website’s description of FDDNP for use in brain PET scans to diagnose traumatic brain injuries, Alzheimer’s disease and other neurological conditions, stating that the uses require a prescription and supervision of a medical practitioner. Therefore, adequate direction for lay use can’t be written, rendering the drug misbranded. The letter further notes that UCLA’s investigational drug fails to satisfy the requirements for an exemption from adequate directions for use by promoting the product and representing that it’s safe and effective for the purpose it is being investigated for.
The letter also targets a number of claims and presentations on the website, including that TauMark is intended for “prevention and intervention,” is an “easy and safe method,” and stating that they imply “in a promotional context” that FDDNP is safe and effective for such uses even though the FDA hasn’t granted approval for any use.