The agency sent the biotech a warning letter for using what it called a 'false and misleading' consumer brochure to promote its Sensipar kidney med to patients. The problem? The brochure "omits and minimizes the risks associated with the use of Sensipar and broadens the indication for Sensipar," according to
the letter.
For instance, Amgen failed to note that Sensipar, which is used to treat patients undergoing dialysis for chronic kidney disease, is associated with the risk of adynamic bone disease and poses a risk to patients with hepatic impairment, the FDA letter states. And these are serious risks (here is the brochure).
For its part, Amgen says it will address FDA concerns. "We immediately ceased distribution of the brochure. Amgen is committed to responsible marketing that reflects the benefits and risks of our medicines," the company said in a statement given Reuters. [Our thought: Don't you think the marketing folks should have noticed the omissions in the first place? Or is the biotech like a teenager who feels the need to test parental limits?]
5 Comments
I understand that the FDA issues nearly 50 thousand warning letters to drug companies for such activities every year, which clearly is not a deterrent, and likely an attempt to pacify the public with the perception of fictional regulationn by the FDA.
Dictionary definition DTC: testing limits of credible marketing - because you can never have enough Viagra / Cialis ads....
Doing a quick search for the last two years of warning letters, it appears that it would be closer to 50 rather than 50,000. Here is a summary of DDMAC warning letters for the past say 10 years: YEAR # OF DDMAC WARNING LETTERS
2008 13 (first 3 quarters only) 2007 20 2006 22 2005 29 2004 23 2003 25 2002 28 2001 64 2000 75 1999 108 1998 156 1997 139
Based on that there haven't been 50,000 (let alone 1000) in the past 10 years. I always prefer to work with facts....
Amen, amen, Pharmalot. Pharma KNOWS the rules and thumbs their collectives noses at them, repeatedly. If they DON'T know the rules, they should lose their license to operate.
Also, if the FDA can't/won't be vigilant and excercise their authority to the full extent of the law, defund their budget of taxpayer dollars. Let's face it...with few exceptions, the FDA's budget seems to be spent protecting the industry, NOT consumers.
As with kids, if there are no consequences for disobedience, you may as well save your breath.
Compliance A. I was a wee bit suspicious at the 50K letters too. So I did a search of FDA DDMAC warning letters in the last three years at http://www.accessdata.fda.gov/scripts/wlcfm/export_report_excel.cfm
But I found different results: 2008 first 3 quarters (33 letters), 2007 (2), 2006 (0).
Here were the 2007 letters: Morton Grove Pharmaceuticals, Inc. Dec 13, 2007 Center for Drug Evaluation and Research DDMAC/Promotional Claims False & Misleading/Misbranded
Wyeth Pharmaceuticals Inc. Dec 10, 2007 Center for Drug Evaluation and Research DDMAC/Promotional Claims False & Misleading/Misbranded
Seems strange that these numbers are all over the place. What's driving them? Some extra time on DDMAC's hands?
Also, are you counting warnings from divisions other than DDMAC?