11 - 12 September 2017 | Boston, MA

Wednesday, March 11, 2015

A Pig, a Cow, a Robot, an FDA Warning Letter

In a March 5, 2015, Warning Letter to Discovery Laboratories, Inc. (here), regarding its Surfaxin promotional website, FDA cited "evolution" as a false claim of superiority. Well, not exactly.

FDA noted the phrase "Join the Therapeutic Evolution...", which was used in conjunction with graphics of a pig, a cow, and a human-like robot (see screen capture below).

Click on image for an enlarged view.

Here's what the FDA had to say about the pig, the cow, and the robot:

"These claims and presentations are misleading because they imply that Surfaxin, a synthetic surfactant depicted by the image of the human-like robot, is superior because it has 'evolved' from more primitive, animal-derived surfactants, such as Curosurf (poractant alfa), an extract of natural porcine lung surfactant, and Survanta (beractant), an extract of natural bovine lung surfactant. We are not aware of substantial evidence that supports the implication that Surfaxin is superior to Curosurf or Survanta."

FDA should also have pointed out that it is impossible to extract lung surfactant from robots because they don't have lungs! Duh!

No comments:

Post a Comment

Related Posts Plugin for WordPress, Blogger...