Pharmaceutical manufacturer Acorda Therapeutics has been sent a Warning Letter by the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) regarding marketing materials used by the company to promote its multiple sclerosis drug Amyra that did not contain the necessary risk information.
The Warning Letter, of which OPDP sends relatively few, references a small consumer print advertisement published in the Des Moines Sunday Register in February 2013. A copy of the ad provided by FDA shows a couple and their son, and is entitled "Has Multiple Sclerosis affected you or someone you care for?" The ad goes on to note that Ampyra (dalfampridine) is "indicated as a treatment to improve walking in patients with multiple sclerosis," and invites people to attend an informational presentation at a local museum.
The problem, OPDP notes, is that nowhere in the ad does Acorda list any of the drug's safety risks-a blatant violation of FDA's "fair balance" rule and advertising regulations that require any benefit statements to be counteracted with equal treatment for the risks of a product.
Regulators said the company had also violated rules by failing to submit the advertisement to it per 21 CFR 314.81(b)(3)(i). Review ordinarily permits the agency to flag any suspect advertisements, which it was unable to do in a timely manner, it said.
Regulators said the "serious and repeated" nature of the violations would require not only the cessation of the current marketing piece, but also the submission of a "comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed in this letter to the audience that received the violative promotional material."
That corrective advertising would, "to the extent possible," need to air in the same media outlets as the original, FDA said.
As the letter notes, this is not the first time Acorda has been in trouble with OPDP in recent years. In 2012 the company was the recipient of an Untitled Letter (slightly less serious than a Warning Letter) after the company created a video in which Ampyra was presented favorably-a bit too favorably, according to OPDP.
"The video minimizes the risks of Ampyra by failing to convey significant risk information associated with the use of Ampyra during the main part of the video," wrote FDA. "The majority of risk information associated with the use of Ampyra is relegated to a running telescript format, with rapidly scrolling text in small type font, which makes it difficult for viewers to adequately process and comprehend the important risk information."
"Furthermore, some of the risk information is scrolling at the bottom of the screen simultaneously with the audiovisual portion of the presentation (mainly consisting of benefit information) displayed at the top of the screen, which further distracts from this risk presentation," FDA added.
Warning Letter to Acorda