July 11, 2018 – A booth display and a webpage for the investigational new drug (IND) Crenolanib besylate “suggest, in a promotional context” that the IND is safe and effective for the purposes for which it is being investigated and, therefore, misbrand it, according to an Untitled Letter issued June 28 to Arog Pharmaceuticals Inc. by the FDA’s Office of Prescription Drug Promotion (OPDP) (https://bit.ly/2zvjIP9).
“The claims and presentations made on the booth display and webpage are concerning from a public health perspective because they make conclusory representations in a promotional context regarding the safety and efficacy of an investigational new drug that has not been approved by the FDA and whose safety and efficacy have not yet been established,” OPDP states in the letter, which is the third enforcement letter issued by the agency in 2018.
“It’s clear that OPDP is paying attention and bringing actions when companies violate long-standing marketing policies,” asserted Coalition for Healthcare Communication Executive Director John Kamp. “Expect more such letters unless companies tighten up their regulatory reviews.”
OPDP specifies in its letter that a drug is misbranded without adequate directions for use. It states that the company’s booth display for Crenolanib at the American Society for Hematology’s 59th Annual Meeting, as well as a webpage describing the use of Crenolanib in treating acute myeloid leukemia (AML) in general and FMS-like tyrosine kinase-3 positive AML in particular. Although a potential exemption from the adequate directions for use requirement exists, OPDP states that Arog’s investigational drug fails to qualify for that exemption.
Booth display claims cited in the letter suggest that Crenolanib has been established as being safe and effective in treating AML in general when combined with “chemotherapy at full doses.” This suggestion “is especially concerning given the lack of adequate safety and efficacy of Crenolanib, as well as the toxicity of current chemotherapy regimens and issues regarding the tolerability of such regimens,” OPDP states. OPDP also takes issue with suggested established efficacy claims and notes that the booth display did not include any information to indicate Crenolanib is an IND.
OPDP finds similar problems with the Arog Pharmaceuticals webpage for Crenolanib, stating that promotional claims made on the page suggest that the IND “has been shown to be different from or superior to other approved therapies for treating AML, and is safe or effective for such uses.”
In summary, the letter states, “the above cited claims and presentations on the booth display and webpage represent the drug as having an established role in the AML treatment paradigm, when Crenolanib has not been proven to be safe and effective within the meaning of the FD&C Act and has not been approved as a drug under that authority for any use.”