But I would be equally interested (even if I disagreed) to hear from candiates who support preemption. In other words, to have the free, open, public discussion I refer to above.

Nathan asked a few days ago why we don’t hear more about it in the media and elswhere. I think it’s a great question. And I think the answer has something to do cowardice on several sides and parties.

In the end, this is an issue (again, on whatever side) that voters are going to have to _bring_ to the campaigns. Through persistent letters, questions, etc., at every opportunity, of the sort that Dianne listed.

The people whose voices may count the most, as I’ve said before, are those inside of industry who _know_ what FDA compliance does and does not mean depending on who is calling the shots and in what context. Likewise, those in FDA who know the same thing from their side.

Again, though, I am pushing above all for the discussion. How it shakes down is not the point.

But if I was a preemtor, I would also want to keep the issue out of public debate as long as possible. It doesn’t wear well in sunlight.

Sadly this is as far as it went. He did not share his stance on the subject or let us know how he might support us. His lack of commitment on the subject concerns me.

There must be some reason that politicians are afraid to make this a policy issue. I can only assume the worst; that there are some negative political repercussions for taking a stance. It must be that the torte reform lobby is much stronger than the right to due process (constitution). In that case it becomes obvious that politicians will not take the lead on this issue, they will only follow the vote, the money, or the public outcry. They will only make a decision after someone else (the American public) has decided for them. In other words unfortunately some politicians are not leaders they are followers.

They will forevermore have a black mark by their names and suffer for the foolishness of their actions, when they realize the ill-effect it has loosed upon this nation.

Of course we will list their names and alert the world to their devious acts.

But (a) no one would see it through the smog and (b) you would inevitably be shot down (and rightfully so). So that is not a recommendation.

Those of us who care about the issue just have to keep on truckin. It is pretty clear that the last thing the “offical” spokespeople for preemption want is a free, open, and public discussion of the issue.

If I am wrong, and any of them read this, please correct me and let’s work together to find a find the right way to foster that discussion on such a critical policy question.

Contact me at: justiceinmich@gmail.com

Would love to hear from you.

FDA preemption is about to happen. This policy needs to be made known to the American public, right now.

I’ve written Senators Obama and McCain and our representatives and senators. I’ve also asked friends, family and neighbors to do the same. Also, letters have been sent to local newspapers and to TV/radio pundits.

Not a word back, so far. It’s a little scary. Who put the clamps on the media? Why all the hush-hush?

Following are questions I asked Obama, McCain, and our representatives and senators. Please feel free to use them.

● What is your stance on FDA preemption?
● What efforts have you made to protect the health, safety and civil Rights of Americans, who are being assaulted by favors to big business?
● How will you vote on the Waxman/Pallone Medical Device Safety Act of 2008, H.R. 6381?
● How will you vote on the Kennedy/Leahy companion bill, designed to protect consumers of FDA approved drugs and state tort law?

Anyone with an idea of how to inform the public of FDA preemption, please post it here. Thanks.

U.S. House of Representatives - https://forms.house.gov/wyr/welcome.shtml
Ph. (202) 225-3121

U.S. Senate: - U.S. Senate: Senators Home
Ph. (202) 224-3121

It is probably a sign of things to come. When the SC does uphold preemption, as they almost certainly will, we will probably read a bunch of stories that are similarly bungled.

For people interested, google up a recent Colloquy by Catherine Sharkey which is called, “What Riegel Portends for FDA Preemption of State Law Products Liability Claims.”

Sharkey essentially tries to stake out a middle ground between full preemption and the current system by placing the onus on the FDA. If the FDA can show that it adequately reviewed data relevant to the issue raised in the suit, than preemption would prevail. That means FDA would have to keep a thorough record of its reviews (which Sharkey suggests it doesn’t always do). And it obviously means they would have to have the whatever data company had to make such a review.

I mentioned this in another thread. Worth reading, I think.

Looks like someone who doesn’t know anything confused Riegel, of a few months ago, with pre-emption in general, in some sort of poorly prepared brain sandwich.

Don’t believe all you read on the internet. But here is what I received from “Wired.” I guess they’re not …………….

*************

Supreme Court rules States cannot add to FDA regulatons
July 27, 2008

Dallas, Texas (WiredPRNews.com) America is facing a tough call deciding who should hold the final say when it comes to the accountability of pharmaceutical and drug companies. Thus far, the Supreme Court has ruled in favor of pre-emption (i.e. that federal regulations automatically overrule state laws). The Supreme Court case of Wyeth vs. Levine may potentially create a precedent for all future related drug-company liability cases (by placing the FDA above state courts).

The case involves a musician from Vermont, Diana Levine, who lost her arm to gangrene caused by an anti-nausea drug. The drug was injected by means of a method that was not specified in the label (called the IV-push method). After settling with her health care provider, she sued Wyeth (the drug company) and was awarded $6.7 million by a Vermont jury. On appeal, The Vermont Supreme court upheld the ruling and found that the drug company could have been held accountable according to state standards and additional labels validating the risks involved with the IV-push method could have been added (without interfering with the FDA).

Wyeth’s lawyers argued that different states could not hold drug companies to different standards. In addition, the drug company argued that the FDA’s required label was not to be considered a minimum requirement/standard but the best, most effective and most informative. The final and most effective argument was that the State of Vermont could not rule to prohibit the administration of the drug via the IV-push method, as that would interfere with the FDA.

The Supreme Court ruled 8-1 in favor of Wyeth based on preemption and thus further increasing the power of the federal government (as has been the trend since the beginning of the 20th century). The ruling in this case could set a precedence that may shield tobacco and drug companies from liability lawsuits and any state regulation (as such responsibility is explicitly within domain of the federal government not the state).

Legal News Desk