Regulatory Focus™ > News Articles > Untitled Letter to Acorda Therapeutics Highlights Recent FDA Review Trends

Untitled Letter to Acorda Therapeutics Highlights Recent FDA Review Trends

Posted 09 July 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) sent two untitled warning letters to pharmaceutical companies in as many days in June, warning two companies regarding alleged infractions contained within marketing videos.

The first of the letters cited Valeant Pharmaceuticals-which owns the New Drug Application for Xenazine, actively marketed by Lundbeck-for purportedly omitting risk information from a video posted on its website. While the majority of the product's risk information was posted below the video, FDA said the "overall effect of the risk presentation undermine[d] the communication" of the risk information by putting it in a different medium. The company said in a statement it had "discontinued use of all patient assessment videos in response" to FDA's notice of violation.

FDA's second untitled letter was sent 21 June 2012 to Ardsley, New York-based Acorda Therapeutics regarding the marketing of its multiple sclerosis (MS) drug Ampyra (dalfampridine). FDA said in its letter that it believes a video used by Acorda to market the drug overstates the efficacy of [Ampyra] and minimized important risk information associated with Ampyra," making the drug misbranded as a result of the marketing.

Patient Testimonials-An Emerging Trend of Violations?

Acorda's video features a MS patient, Bonnie, who associates her greater ability to walk with her treatment with Ampyra. "I've been on it [Ampyra] for three months. . . . I'm not using my cane as much," Bonnie says. "I can go across Home Depot. . . . It's great."

While the claims may be true for the patient, FDA still highlighted the claim as violating its marketing regulations. "While these statements may be an accurate reflection of Bonnie Leedy's own experience as an Ampyra-treated individual, the above statements imply that as a result of treatment with Ampyra, patients will be able to walk longer distances with decreased use of assistive devices such as canes," explained FDA. "[FDA] is not aware of substantial evidence or substantial clinical experience to support whether a change of at least 10%, 20%, or 30% in walking speed results in the ability to walk longer distances with decreased use of assistive devices.  If you have data to support these claims, please submit them to FDA for review."

FDA's response to Acorda in regards to this claim is nearly identical to one made in late May to Cambridge, Massachusetts-based Vertex Pharmaceuticals, who received a warning regarding its Hepatitis C drug Incivik (telaprevir). FDA's letter chided Vertex for allegedly overstating the efficacy of its drug after it used a patient testimonial as a case study for the success of Incivik.

"[O]ne patient's treatment response does not constitute substantial evidence," wrote FDA in its untitled letter to Vertex.

Small-scale Survey Studies Draw FDA Fire

FDA made several other claims in its untitled letter to Acorda that were similar to ones made in an untitled letter to Pfizer on 19 June 2012. In the letter to Pfizer, FDA took aim at the company's use of a consumer survey of patients in which they were asked if they would use the same medicine again if faced with the same indication. FDA tagged this information as "not sufficient to support the outcomes claimed because these survey questions cannot adequately assess all of the various factors which may influence patients' or caretaker's decision to take any particular treatment again."

Acorda, too, was similarly chided by FDA for drawing attention to a study conducted by the Multiple Sclerosis Association of America (MSAA) which found 87% of respondents limited their activities as a result of their MS.

Acorda's video pairs this information with footage of its patient, Bonnie, snowboarding and horseback riding. FDA explained this "misleadingly suggests that treatment with Ampyra can have a positive impact on the disability caused by MS such that patient can carry out daily activities that they may not have chosen to do before because of difficulty in walking."

"The results from the poll discussed above do not constitute substantial evidence or substantial clinical experience to support the above claims for Ampyra," FDA wrote. "Although Ampyra has been shown to improve walking speed in patients, substantial evidence, as demonstrated through adequate and well-controlled trials using well-developed instruments that can validly and reliably measure these outcomes, are necessary to support these claims of treatment benefit."

Promotional Materials and Acorda's Response

Finally, FDA took aim at Acorda's promotional materials, which the agency called "misleading."

"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," noted FDA. The disconnect between FDA's untitled to Acorda is again similar to one issued in June 2012 to Valeant, which was cited for having risk information contained in a format not readily accessible to the viewer of the content.

In a statement, a spokesman for Acorda said the company had worked to address FDA's untitled letter. "We have taken FDA's letter seriously and are addressing their concerns," wrote Jeff Macdonald, Senior Director for Corporate Communications at Acorda. "We have taken action to ensure that the Balancing Act video is no longer available."


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe