And the first FDA drug marketing warning letter of the year goes to ... a drug that’s not yet approved. The agency's Office of Prescription Drug Promotion (OPDP) issued an untitled letter (PDF) to Phoenix Molecular Imaging Center for its investigational Sodium Acetate C-11 (11-C Acetate).
According to the filing, Phoenix is jumping the gun by suggesting the investigational drug is safe and effective for a purpose for which it’s still undergoing investigation.
11-C Acetate is meant to be used as a PET scan agent for detecting recurrent prostate cancer. However, information on a webpage reviewed by OPDP contains claims that it says already promote the aspiring drug as safe and effective.
Although letters from OPDP have dwindled over the past five years, this letter follows two current patterns from the enforcement group, Mark Senak, a public relations professional and author of the Eye on FDA blog, said in a recent post.
“A feature of enforcement letters over the past few years is that they are predominantly directed at entities that are not household names—smaller pharmaceutical companies or in this case an imaging center (though last year did include letters to Pfizer and Eisai)," he wrote.
And Phoenix isn't alone in receiving a warning over an unapproved drug. "The second, and more significant characteristic is the violation that is being more often cited—for the promotion of an investigative compound,” Senak said.
In his review of the 330 letters issued since 2004, only 5.5% have been for unapproved drugs. However, half of the letters ever issued over unapproved drugs have come since 2016.
“Risk information—either presenting it in a way that minimizes risk or under circumstances that omit risk information entirely—still is the most common violation, but clearly promotion of an investigational compound has the focus of the agency just now,” he said.
With one enforcement letter now in the books for 2019, OPDP's issuing is about on track with where it was last year, when the office similarly issued just one letter by the end of February. For the full year 2018, OPDP sent a total of seven letters. In 2017, it sent just five.
Senak, a longtime FDA and OPDP observer, said the drop in the number of letters as likely being due to the agency’s allocation of resources. However, as he also pointed out, low enforcement doesn’t mean no enforcement.