On July 5th, Eli Lilly, Johnson & Johnson, Novartis, Novo Nordisk, Pfizer, and Sanofi-Aventis filed a Citizen Petition with the FDA asking the agency to clarify its policies on how truthful, non-misleading scientific information not included in approved product labeling can be communicated.
According to the petition, communicating accurate scientific information about new research would enhance health care quality and potentially lead to better patient outcomes, but that companies lack precise guidance on how to communicate such information.
“Scientific exchange,” broadly defined, is the sharing of research and clinical information about investigational medical products or new information on approved products without representing the product as safe and effective for that use. FDA said in a 1963 regulation that it does not intend to restrict “scientific exchange.” The concept of “scientific exchange” however, is not precisely described in FDA’s regulations and therefore leaves ambiguity about the limits of what is permitted.
We now have, thanks to those wonderfolks at DDMAC, some clarity when it comes to one kind of scientific exhange – open label trials.
DDMAC has cited Nycomed for a flashcard that based many of its claims on articles that “describe the preliminary and follow-up efficacy results of an uncontrolled, open-label study in patients with actinic keratoses."
"Results from a single open-label trial with no control group do not constitute substantial evidence or substantial clinical experience to support these, or any other, efficacy claims," DDMAC said, referring to graphs purporting to show how effective Solaraze is at "clearance of target lesions" of actinic keratoses.
This study also was not acceptable as a basis for a claim about the effectiveness of Solaraze in treating subclinical lesions, the letter adds. The company also cited an open-label study - it is unclear whether it was the same one - to claim that "the majority of patients were compliant with treatment," which also was unacceptable, according to DDMAC.
DDMAC has sent several sponsors (Arbor Pharmaceuticals, Hill Dermaceuticals, AMAG Pharmaceuticals) letters recently making it clear that open-label trials are not considered to be acceptable evidence of clinical efficacy.
You ask for clarity. You get clarity.
For a change.
