["but if you’re like me, it will make you wonder whether it makes sense to prevent problems with warnings when a warning like this didn’t suffice:...Under no circumstances should PHENERGAN Injection be given by intra-arterial injection due to the likelihood of severe arteriospasm and the possibility of resultant gangrene (see WARNINGS—Injection Site Reactions). The preferred parenteral route of administration is by deep intramuscular injection."]

is high sophistry. There are plenty of warnings against intra-arterial injection, yet **no** explicit contra-indication against “IV push”. Wyeth dropped the ball here and (I think) rightfully they have to pay.

By the way, you can see phenergan/grangrenous adverse event reports here: http://www.fdable.com/aers/advanced_query/4d724e1fe33d

You don’t want companies to decide what the warnings should be? Well, Sir, that is the way it has been from the beginning because the manufacturer drafts and submits the label language. FDA approves the label, not the drug.

Can you show your audience any evidence that you (or Pharma) have ever been critical of FDA and called for FDA to write the label and not the company? Any letters, editorials, or blog entries? I submit to you the answer is “No” because the drug company cherishes the ability to draft the label in the most favorable way possible. While there is a give and take process, a negotiation, the drug company will always want the greatest control over label language.

As far as FDA goes, did you miss the entire section of the opinion that reveals FDA is grossly underfunded and understaffed and that the GAO and FDA itself have reported the FDA cannot adequately monitor drugs or protect consumer safety? Did FDA get it right with Fen-Phen, Vioxx, Baycol, Prempro, Provera, Premarin, Baycol, and on and on?

Did you also miss that part of the opinion that stated before 2007, FDA did not have legal authority to require drug companies to modify the label once it was approved? How in the world could FDA get it right when it was powerless to do so, even if new information on risks emerged or if review of prior adverse information revealed the warning was insufficient? Do seriously believe drug companies desire the FDA have authority to call up the company after seeing some adverse event report and say, “fix this insufficient warning, or else?”

Then, there is the whole issue of drug companies over promoting benefits, even promoting non-FDA approved benefits, ghost writing, and downplaying the risks. Do you seriously believe drug companies desire the FDA have authority to do anything more than what it can do today, which is to send a scolding letter? C’mon!

Finally, a lot of reasonable people said Wyeth got it wrong. In particular, the jury picked by plaintiff and defense counsel that heard ALL of the evidence. It’s strange that we believe juries are capable and reasonable in deciding whether a person is guilty of murder and in recommening a death sentence or in deciding a complex securities fraud case, but not so when comparing the plain language of a drug label to the facts of what the drug company knew about the risks and deciding whether the label did or did not adequately inform the reader.

To me, the real question is who gets to decide. I don’t want companies to decide what the warnings should be. They’ll get it wrong. And I don’t particularly want local courts to decide: They will predictably err on the side of demanding excessive warnings. FDA has a chance of getting it right. In this case, a lot of reasonable people would say they did get it right.

I think I know why: you’re not afraid of the FDA, you had the drug on the market for many years and just let it ride and didn’t want to spend another dime unless it resulted in more sales. Profits over people, sales over safety.