FDA’s OPDP Sends Third Untitled Letter of 2019
The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) recently released its third untitled letter of 2019 because of a direct-to-consumer video on Aclaris Therapeutics’ Eskata (hydrogen peroxide) that failed to adequately present the drug’s serious risks.The video, which originally aired on ABC’s The View last September, does not include “prominent, balancing risk information about Eskata,” OPDP said, noting that it is indicated for the treatment of seborrheic keratoses (SK) that are raised.
The untitled letter also noted the video’s omission of warnings and precautions about serious eye disorders that can result from unintended exposure and about severe local skin reactions.
“By omitting the warnings and precautions associated with Eskata, the video fails to provide material information about the consequences that may result from the use of the drug and creates a misleading impression about the drug’s safety,” OPDP said.
OPDP also pointed to several adverse reactions not discussed by the paid physician spokesperson in the video, saying it’s misleading to tell patients they can experience stinging upon application, but not other common local adverse reactions, many of which occur within minutes of treatment with Eskata.
The spokesperson also says in the video: “And, typically in one or two treatments the lesions go away, they resolve, and that’s the end of it.”
But OPDP said this statement was misleading because local adverse reactions have been observed up to 15 weeks after treatment. And although superimposed text is used in the video to convey common side effects, OPDP noted that the company also simultaneously presented a “large amount of unrelated information” in a span of about 10 seconds.
The untitled letter is not the first time OPDP sought to help Aclaris edit promotional materials.
In March 2018, OPDP recommended that Aclaris revise draft materials similar to the video so that the company would not omit or misrepresent risk information, or overstate the efficacy of Eskata.
Aclaris told Focus in a statement: “Aclaris is complying with all FDA requests and will formally respond to the agency by the June 28 deadline.”
The other two untitled letters issued by OPDP in 2019 relate to the promotion of an unapproved drug on Phoenix Molecular Imaging Center’s medical director Fabio Almeida’s blog and unsubstantiated claims made on Vivus’ website about its weight-loss drug Qsymia (phentermine and topiramate).
With just three enforcement letters sent so far in 2019, FDA is continuing a recent trend of declining enforcement action over prescription drug promotion. In 2017 OPDP issued a record low of three warning letters and one untitled letter and in 2018 the office issued two warning letters and five untitled letters.
Untitled Letter
Promotional Material