The US regulator of pharmaceutical advertising, the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP), has issued a new warning to the University of California for allegedly promoting an investigational new drug for conditions for which it had not obtained approval.
A Rare Letter
OPDP's letter is exceedingly rare in that nearly all of the office's letters in recent years have been sent to established pharmaceutical companies—not academic centers like the University of California, Los Angeles' (UCLA) Semel Institute for Neuroscience and Human Behavior, the target of OPDP's latest letter.
As FDA's heavily redacted letter explains, the Semel Institute is, in conjunction with a West Virginia company called Taumark, in the midst of developing a new drug to assist in brain diagnostics. The drug, known as FDDNP, has not yet been approved by FDA for marketing.
In its so-called "Untitled Letter" to UCLA, FDA warns the academic institute that Taumark's website implies that FDDNP is safe and effective for use in violation of Section 502(f)(1) of the Federal Food, Drug and Cosmetic Act (FD&C Act). In plain terms: Since the drug isn't yet approved for use, marketing it as being safe and effective makes it a misbranded product under the law.
As OPDP writes in its letter, "Your website describes FDDNP for use in brain PET scans to diagnose traumatic brain injuries, Alzheimer’s disease, and other neurological conditions. These uses are ones for which a prescription would be needed because they require the supervision of a physician and adequate directions for lay use cannot be written."
Taumark's website claims the drug has a "high safety profile," "no reported adverse effects" and is "currently available." In reality, FDA writes in its letter, none of those claims have yet been proven to regulators.
Not Your Fault, but Still Your Problem
The letter serves as a reminder that even though UCLA wasn't the one marketing its product improperly, as the product's sponsor it is UCLA's responsibility to ensure its partners are not improperly marketing the product either.
As federal regulation 21 CFR 312.7 states:
“A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug."
So while Taumark may have had the improper claims on its website, FDA's letter is only addressed to UCLA.
FDA Letter to UCLA
FDA Screengrab of Taumark's Website