FDA Chides Discovery Labs For Dissing Animal Products
Share us on: By Jeff Overley
Law360, New York (March 10, 2015, 8:06 PM ET) -- Specialty biotech firm Discovery Laboratories Inc. misled consumers by suggesting its synthetic lung drug is superior to competing products derived from animals, according to a disciplinary letter released Tuesday by the U.S. Food and Drug Administration.
The so-called untitled letter took issue with numerous claims on the website for Surfaxin, or lucinactant, which is used to prevent respiratory distress syndrome in premature babies. One problem was the use of images of a pig, then a cow and then a robot beside the phrase, “Join the Therapeutic Evolution.”
“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,” the FDA wrote.
The letter specifically said that it would be unfair to assert that Surfaxin, a lung surfactant, is better than such products as Chiesi Farmaceutici SpA’s Curosurf, which is derived from pig lungs, or AbbVie Inc.’s Survanta, which is derived from bovine lungs. Although the Surfaxin website cited two studies to support superiority, those studies didn’t actually provide any backing, according to the FDA.
For example, in one study of Surfaxin, some participants were given Survanta as an “active comparator” product. But the study “was not powered to make any meaningful efficacy comparison between Surfaxin and Survanta,” the FDA said.
The second study included a Curosurf treatment group, but that group was only examined for safety, not effectiveness, and so direct comparisons aren’t appropriate, according to the letter.
Going further, the FDA noted that Surfaxin’s labeling describes adverse reactions that are in fact more common with use of the synthetic product than other surfactants.
“Therefore, the phrase ‘therapeutic evolution’ is misleading because the adverse reactions section of the [labeling] indicates that Surfaxin is not safer than animal-derived surfactants,” regulators wrote.
On another front, the website also claimed that doctors and parents have concerns about animal-derived medications, and then linked to a survey where such concerns were expressed. But that survey didn’t specifically discuss Surfaxin, and as a result, “the results from the survey cannot support any suggestion or claim that Surfaxin is superior to animal-derived surfactants,” the untitled letter said.
In a brief statement, a Discovery spokesman said that company officials “take our relationship with [regulators] very seriously” and are “working diligently to respond to their concerns.”
As is customary, the FDA’s letter directed Discovery to immediately stop making the unsupported claims. On Tuesday, Surfaxin’s website had been largely stripped of information, containing little more than a link to prescribing information.
Tuesday’s untitled letter was the third this year from the FDA’s Office of Prescription Drug Promotion, which in recent months also criticized promotions from Luitpold Pharmaceuticals Inc. and a researcher at the UCLA Health System School of Medicine.
Share us on: By Jeff Overley
Law360, New York (March 10, 2015, 8:06 PM ET) -- Specialty biotech firm Discovery Laboratories Inc. misled consumers by suggesting its synthetic lung drug is superior to competing products derived from animals, according to a disciplinary letter released Tuesday by the U.S. Food and Drug Administration.
The so-called untitled letter took issue with numerous claims on the website for Surfaxin, or lucinactant, which is used to prevent respiratory distress syndrome in premature babies. One problem was the use of images of a pig, then a cow and then a robot beside the phrase, “Join the Therapeutic Evolution.”
“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,” the FDA wrote.
The letter specifically said that it would be unfair to assert that Surfaxin, a lung surfactant, is better than such products as Chiesi Farmaceutici SpA’s Curosurf, which is derived from pig lungs, or AbbVie Inc.’s Survanta, which is derived from bovine lungs. Although the Surfaxin website cited two studies to support superiority, those studies didn’t actually provide any backing, according to the FDA.
For example, in one study of Surfaxin, some participants were given Survanta as an “active comparator” product. But the study “was not powered to make any meaningful efficacy comparison between Surfaxin and Survanta,” the FDA said.
The second study included a Curosurf treatment group, but that group was only examined for safety, not effectiveness, and so direct comparisons aren’t appropriate, according to the letter.
Going further, the FDA noted that Surfaxin’s labeling describes adverse reactions that are in fact more common with use of the synthetic product than other surfactants.
“Therefore, the phrase ‘therapeutic evolution’ is misleading because the adverse reactions section of the [labeling] indicates that Surfaxin is not safer than animal-derived surfactants,” regulators wrote.
On another front, the website also claimed that doctors and parents have concerns about animal-derived medications, and then linked to a survey where such concerns were expressed. But that survey didn’t specifically discuss Surfaxin, and as a result, “the results from the survey cannot support any suggestion or claim that Surfaxin is superior to animal-derived surfactants,” the untitled letter said.
In a brief statement, a Discovery spokesman said that company officials “take our relationship with [regulators] very seriously” and are “working diligently to respond to their concerns.”
As is customary, the FDA’s letter directed Discovery to immediately stop making the unsupported claims. On Tuesday, Surfaxin’s website had been largely stripped of information, containing little more than a link to prescribing information.
Tuesday’s untitled letter was the third this year from the FDA’s Office of Prescription Drug Promotion, which in recent months also criticized promotions from Luitpold Pharmaceuticals Inc. and a researcher at the UCLA Health System School of Medicine.