With just one month left in the year, the FDA promo police dispatched its sixth letter. The Office of Prescription Drug Promotions dinged Azurity Pharmaceuticals in an untitled letter for an email to doctors about its oral leukemia drug Xatmep.
The reprimand details false or misleading risk omissions and benefit presentations in the Azurity-submitted email. Pharma companies file promotional materials with the FDA for review through OPDP but don't require approval to begin distributing them.
Xatmep was originally approved in 2017, but the leukemia med was then marketed by Silvergate Pharmaceuticals. Last year, CutisPharma acquired Silvergate and renamed the combined company Azurity Pharmaceuticals.
The OPDP's current complaints were apparently raised with Silvergate for its initial promotions back in 2017. In a heavily redacted section from the new letter, OPDP references its advisory comments to Silvergate in June of that year. “Azurity appears to be promoting Xatmep without presenting serious risks of the drug in a truthful and non-misleading manner, despite concerns previously expressed by OPDP," the letter states.
The count of six OPDP letters for 2020 so far falls short of 2019’s 10 reprimands but is still on par with 2018’s seven letters.
While the COVID-19 pandemic is likely to blame in part for the slow pace of OPDP enforcement letters this year—none was filed between March and August—one FDA observer said the more deliberate pace of filings is likely to continue.
Fewer resources for the FDA means less staff and budget for OPDP as promotions, even really egregious ones, remain low-risk, Eye on FDA blogger and public relations professional Mark Senak said. A patient's conversations with a physician or personal label-reading can set the record straight, he said.
OPDP will likely continue to focus its efforts, as the new letter shows, on smaller pharma companies that are still learning the regulatory ropes.