US FDA cites investigator for promoting brow furrow jab before its approval
This article was originally published in Scrip
The US FDA has stepped up its scrutiny of clinical trial investigators, not just drug makers, for pre-approval promotion that is violative. In a case that has drawn much attention, the agency criticised a researcher for having "promoted" an investigational product in US media outlets before FDA approval, in violation of agency regulations. The move has had the effect of "sending shudders" through key opinion leaders who often want to be quoted for publicity purposes, The New York Times said.
The FDA's division of drug marketing, advertising and communications (DDMAC) sent an untitled regulatory letter to Dr Leslie Baumann, a dermatologist and clinical researcher operating out of the Baumann Cosmetic and Research Institute in Miami Beach, Florida, chiding her for making "promotional statements" in the magazines Allure and Elle, and on NBC's Today Show, for Ipsen Biopharm's injectable brow furrows treatment Dysport (abobotulinumtoxin A) in 2007 and 2009, before the drug was approved. Specifically, she is alleged to have promoted the product as superior to the approved product, Allergan's Botox (onabotulinumtoxin A).
The January 11th letter from the DDMAC, which was only recently posted on the FDA's website, was not aimed at Ipsen Biopharm (the BLA holder) or Medicis, which has licensed the product for the cosmetic indication, but at Dr Baumann. Dysport received FDA approval in April for the treatment of both cervical dystonia and moderate to severe glabellar lines; Medicis, as licensee for the aesthetic indication, launched the product in the US in June (scripnews.com, June 19th, 2009).
In its letter, the FDA said its regulations on pre-approval promotion apply to investigators as well as sponsors.
The agency noted that it learned from Ispen and Medicis that Dr Baumann had acted on her own and not on behalf of either drug maker.
Dr Baumann had participated in Phase III trials on the safety and effectiveness of Dysport in the treatment of glabellar lines and for the conduct of a Phase III open-label extension study to assess long-term safety of repeated administrations of Dysport in the treatment of glabellar lines.
The agency cited various statements from 2007 that were considered violative, including one from the Allure article which had Dr Baumann stating: "Reloxin [the previous US name], the new Botox, will likely come out later this year. Early data shows it may last longer and kick in faster than Botox. It will be nice to have competition on the market – the Botox people (Allergan) raised their price another 8% this year!"
The dermatologist was also quoted as telling Elle magazine: "I can't wait to use Reloxin, known in Europe as Dysport. This Botox alternative will be available in the US next year. Effects last longer than Botox and, hopefully, it will cost less."
In its letter, the FDA stated: "These statements [are violative] because they represented that Dysport was safe and effective before the product was approved and otherwise promoted the drug before it was approved (ie, as superior to the approved product Botox). We note that this suggestion of superiority, in addition to promoting the product before approval, is also misleading in that it is not supported by substantial evidence or substantial clinical experience. In fact, we are not aware of any adequate and well-controlled head-to-head trials that compare Dysport to Botox to determine whether Dysport lasts longer or starts working faster than Botox."
The agency asked Dr Baumann to explain how she intended to prevent similar violations in the future.
While it pointed out there are mechanisms by which investigators and sponsors may engage in the full exchange of scientific information concerning drugs that are under investigation, the FDA said that Dr Baumann's promotional activities "do not constitute such exchange".
A further explanation came from Thomas Abrams, director of the DDMAC, who told The New York Times that "investigators were free to have scientific conversations about investigational drugs with their peers and with journalists, but ... should not promote any unapproved prescription drug." At least one dermatologist who often speaks to media outlets said that, in light of the FDA's letter, he might limit his future comments to scientific facts and published studies.