Earlier this week, the FDA posted warning letters on its site to four drugmakers - Lilly, Bayer, Amylin Pharmaceuticals and Cephalon - for making inaccurate or incomplete statements while promoting their drugs. Amylin, for instance, was tagged because its reps made remarks that Byetta can be used as a stand-alone therapy, which was before the drug received that approval.
Bayer was chastised for suggesting its Mirena contraceptive women help would feel more romantic or intimate when, in fact, the side effects indicate the opposite may occur. A dosing card for Cephalon's Treanda, which treats chronic lymphocytic leukemia and non-Hodgkin's lymphoma, minimized risk and a Lilly promotional piece for its Cymbalta antidepressant minimized risk and overstated efficacy.
As The Pink Sheet points out, by issuing the letters in one fell swoop, the FDA may succeed in bringing more attention to violations, rather than letting them out in dribs and drabs.
In any event, here are the letters...
for Bayer, Lilly, Cephalon and Amylin. And here are the promotional materials from Cephalon, Bayer and Lilly that generated the heat.
6 Comments
I will only be impressed with the FDA's warning letters, when they effect a change, and this isn't apt to happen as long as Big Pharma's representatives sit on the FDA's approving committees.
And I understand that the White House isn't apt to change Big Pharma's behavior any time soon either. I'm a big Obama supporter in everything but this issue.
I agree that warning letters generally don't mean much. But if you look at the pattern beginning during the late Clinton administration through Bush 2, they almost disappeared.
Not all FDA administrations are equal. And the new top leadership needs to deal with a lot of deadwood careerists. We'll see what the future holds. I'm still hopeful for an FDA that has the funding, power, and will to do its job. Maybe I need a pro-depressant.
The FDA's bark is clearly worse than their bite. These letters will do nothing to stem the tide. Until there are real consequences for the actions of these companies, there will be no change. The FDA, OIG, AOG, DOJ, SEC and the rest of them lack the guts.
FDA thought that by sending warning letters to the CEO, they would be taken more seriously. All that does really is to give the CEO a heads up. The standard lingo in the letters is to require "corrective action", with no criminal penalties. Since the era of Dan Troy, all warning letters must be approved by FDA office of General Counsel before they go out. This is one reason for the dropoff, or perhaps why some letters go out as NOV'S rather than warning letters.
The FDA sent a stern warning letter to Morton Grove Pharmaceuticals a couple years ago due to their promotional materials and advertisements of lindane shampoo and lotion which the FDA said were very misleading and innaccurate and could lead to deaths.
Well Morton Grove/Wockhardt continues to defy the FDA with their website lindane.com of which the FDA is aware of.
lindane.com is a lobbing tool, and does not state the blackbox warning that the FDA issued many years ago either on their sponsored link or the main page consumers are sent to.
When will the FDA do its job and protect our children from such toxic products like lindane?
The Stockholm Convention has added lindane to its list for elimination, the EPA has also banned it for agricultural use due to its toxicity to humans,animals and the far reaching ill effects on the environment.
Need to advise the manufactures of Amoxicillin of the severe reaction I had to Amoxicillin. My type of reaction was not noted in any of the adverse reactions. I lost most of my hearing in my right ear. What I have left makes everyone sound very brassy. Went to an audiologist and had hearing aids made...all they did was increase the sound of the brassiness. I also had a severe rash. I had hoped my hearing would return to normal, but it has not. Any recommendations? This happened in March 2010.