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Regulatory Focus™ > News Articles > 2019 > 2 > OPDP Issues First Untitled Letter of 2019

OPDP Issues First Untitled Letter of 2019

Posted 01 March 2019 | By Zachary Brennan 

OPDP Issues First Untitled Letter of 2019

The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) recently released its first untitled letter of 2019 for the promotion of an unapproved drug on Phoenix Molecular Imaging Center’s medical director Fabio Almeida’s blog.

The website’s article “suggests in a promotional context” that an investigational drug, known as 11C-Acetate, is safe and effective for the purpose for which it’s being investigated, the untitled letter says.

“Your webpage describes 11C-Acetate as a useful PET scan agent for detecting recurrent prostate cancer,” OPDP said. “This use is one for which a prescription would be needed because it requires the supervision of a physician and, thus, adequate directions for lay use cannot be written.”

According to FDA, part of what's wrong with the blog post is because it says: “11C-choline and 11C-acetate are lipid metabolism PET agents. Both of these agents are useful for detecting recurrent disease after a PSA [prostate-specific antigen] relapse.”

And while there is one sentence on the webpage related to how 11C-Acetate is available under expanded access, FDA says this statement does not convey that the product is investigational, “in light of the repeated suggestions the drug is interchangeable with, or even superior to the approved product 11C-choline.”

In response to the untitled letter, FDA is requesting an explanation on whether Almeida intends to comply with FDA's request to stop using such statements, listing all promotional materials for 11C-Acetate that contain such statements, or explain why "you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.”

Untitled Letter

Promotional Material

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