Sept. 8, 2016 — The FDA’s Office of Prescription Drug Promotion (OPDP) takes issue with a conference panel for an unapproved cancer treatment in an Untitled Letter to Celator Pharmaceuticals Inc. issued Aug. 25. In the letter (CPX-351 Letter), OPDP states that a panel displayed at the June 2016 American Society for Clinical Oncology (ASCO) annual meeting for Celator’s investigational product CPX-351 Liposome Injection “suggests, in a promotional context,” that the investigational new drug “is safe and effective for the purposes for which it is being investigated or otherwise promotes the drug.”
According to OPDP, Celator’s investigational new drug, designed to treat acute myeloid leukemia (AML), is misbranded because, under 21 CFR 312.7, drug sponsors are not permitted to make promotional claims or assert safety and efficacy.
“This letter is a clear warning that FDA intends to vigorously defend its marketing limits while a drug approval is pending,” said Coalition for Healthcare Communication Executive Director John Kamp. “The letter is not a surprise to those who have followed this area closely, and should be considered a clear warning to all companies with new drugs pending approval at FDA.”
OPDP cites Celator for using the investigational drug’s proprietary name (VYXEOS™) without identifying it as an investigational product, and with the company promoting claims that “make conclusions that the drug has been proven to be ‘optimal’ for the treatment of cancer and improves survival relative to ‘7+3’ chemotherapy in newly diagnosed patients with high-risk AML, when FDA has not approved CPX-351 for any use.”
Further, the letter states that the ASCO panel and the area around the display “did not include any information to indicate that CPX-351 is an investigational drug product that has not been approved for commercial distribution.”
The letter to Celator is only the third enforcement letter issued by OPDP during this calendar year.