FDA To Baxter: Start Telling The Truth
3 CommentsBy Ed Silverman // August 31st, 2010 // 10:56 am
File this under three strikes and you’re out: Baxter Healthcare was dinged by the FDA for circulating a brochure for its Aralast NP emphysema treatment that contains misleading efficacy claims. As many of you know, this sort of overstatement is not all that unusual, but in Baxter’s case, well, the FDA has about had it.
In its Aug. 3, warning letter, the agency points out that Baxter is a corporate recidivist. “We are very concerned by your continued violative promotion of your products,” the agency writes. “Baxter was cited for similar violations (overstatement of efficacy and unsubstantiated claims of superiority) in an April 14, 2009, Warning Letter and a July 7, 2008, Untitled Letter from OCBQ (the Office of Compliance and Biologics Quality).”
And so, the agency wants Baxter to not only explain how it will correct the Aralast situation, but also come up with a plan - in writing - about how it can behave and disseminate brochures that don’t violate any laws. “Since we have cited you for similar violations in the recent past, we request a response in writing indicating what policies and procedures your firm intends to adopt to ensure your prescription drug promotional activities comply with the (Federal Food, Drug, and Cosmetic) Act and its implementing regulations, and an explanation of why/how you expect these policies and procedures to succeed.”
We recommend the Baxter team start by reading up on how to follow instructions.
Rich Meyer
Ouch. There is a very fine line between being aggressive in promotional material and having bad processes to maintain checks and balances. Not sure exactly what happened here but obviously someone at Baxter is not following good management practices for DDMAC guidelines.
pharmavet
Pharma reps are much worse than device and supply reps.
Medspeaker
I was a speaker at one of Baxter’s promotional programs and they were so far from following the PhRMA guidlines that it was simply outrageous. The rep and manager bought extra bottles of wine to give to participants, let spouses come to the meeting, interupted and spoke off label in between my presentation. I should have been a whistle blower and turned them in. I made the decision to never speak for them again. they deserve whst they get.