Tuesday, May 3, 2022

FDA promo watchdog dings Azurity for misleading leukemia drug email targeting physicians

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.

Sponsored by Clinical Ink

Deploy Configurable, Fit-for-Purpose ePRO Solutions, Fast.

Clinical Ink’s enhanced Lunexis™ ePRO+ module streamlines processes through a flexible, unified platform that allows patients and sites a high degree of optionality.

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.

RELATED: FDA ad watchdog slaps 2 pharmas with warning letters for promo emails, Google link

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.

RELATED: FDA ad police’s warning letters have stalled during COVID-19, and that’s likely the new norm: expert

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.

Source link

Latest Articles

Widely used chemical linked to 1,00,000 US deaths per year: Study

NEW YORK: Daily exposure to phthalates, a group of chemicals used in everything from plastic containers to makeup, may lead to approximately 100,000 deaths...

Foods to Reduce Inflammation and Strengthen the Immune System

Did you know that you can greatly reduce inflammation and boost your immune system by simply incorporating more anti-inflammatory foods and beverages into your...

Personal Selling

INTRODUCTION Early sellers and traders were not held in high esteem. The Roman word for salesman meant ‘Cheater’ and...

Building Muscle on a Vegan Diet

There are a lot of  misconceptions surrounding veganism. The notion that those who practice it are lacking in protein and therefore muscles is the...

Electrodes in brain new hope for severe cases of epilepsy

Neurosurgeons at All India Institute of Medical Sciences have devised a new technique for operating on children suffering from a severe form of epilepsy...