Watch The Hearing On Preemption Right Here!
13 CommentsBy Ed Silverman // May 14th, 2008 // 9:50 am
The House Committee on Oversight and Government Reform is holding a hearing today at 10 am EST. The witnesses include some marquee names - actor Dennis Quaid, who is suing Baxter; former FDA commish David Kessler, who opposes preemption and New England Journal of Medicine editor Greg Curfman, another opponent. Joining them will be John Calfee of the American Enterprise Institute, who supports preemption, and FDA deputy commish Randy Lutter.
This fall, the Supreme Court will review preemption, which is the notion that FDA approval supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue preemption exists by maintaining agency actions are the final word on safety and effectiveness. The ruling may likely determine whether patients can sue a drugmaker through state law when a product has already been approved by the FDA. So stop by right now and watch what they say.
Video
Live coverage has ended. We’ll post archived video when it becomes available.
Live coverage/discussion
Don’t forget to take our poll on the Supreme Court stockholdings and preemption!
laura
Ed,
Do you know if there will be any way to rerun the hearing later in the day or if it is being televised? I would love to watch it but. unfortunately, I have to work.
Ed Silverman
Hi Laura,
I believe it will be archived and so perhaps checking with the committee web site later will get you there. I will look into that, meanwhile.
Regards
ed
Justice in Michigan
Good question - I hope it will be accessible later.
So far, people are clearly “up” on the relevant debating points. And some have gone beyond those.
Dan
Preemption Flaws
The Food and Drug Administration approves, for purposes of this article, pharmaceuticals and medical devices for use by American Citizens, theoretically, due to their flawless expertise and excellent judgment regarding the safety and quality of such items, as determined by this Department of Health and Human Services division. Considering the progressive acknowledgement of potentially deadly aspects of such approved meds and devices, more are getting removed from the market or are receiving very strict limitations on their use, which are called black box warnings, the FDA appears to not even exist for its original purpose.
The drug companies, for example, presumably in a rush to get their new med to market because of its patent life limitations, has for close to 20 years now paid the FDA to speed up the approval process with so much money that the pharma industry now provides nearly half of the FDA’s budget. This occurs due to the Prescription Drug Users Fee Act, which began in 1992. In my opinion, this creates a relationship between the two as client and provider. So clearly fallacies exist with the FDA’s approval process, as noted with the damage that has been done by the products it has approved to ideally benefit human health.
Unfortunately, there is a standard, legal, and judicial doctrine called Pre-emption that protects the makers of damaging products from responsibility and exonerates them from any liability from the damage they may have caused to those who used their products.
Here’s why this happens: Pre-emption means that federal law is and will always be supreme over state law due to the U.S. constitution and its supremacy clause, yet the FDA lacks such a clause itself. So what does this term have to do with pharma companies avoid being charged by the victims for the liability from those harmed? The FDA is a Federal Administration. Since the FDA are flawless experts and a Federal Administration, the FDA and the makers of harmful products cannot be blamed for the damage they may have caused others, because the so called experts, the FDA, approved such products. And Federal Law along with the Supreme Court and the Bush Administration agree that the drug makers should not be liable. I smell cronyism with this arrangement.
The FDA has itself admitted it cannot do what it is required to do because of lack of resources, they say, which is to manage, supervise, and regulate with thorough and complete oversight the pharma and med. device companies. This in itself should raise the attention of the government to replenish this association because of their importance to the public. Since this is not the case, the FDA depends on the good faith of the saints of the pharma industry to disclose their product flaws once discovered and immediately. If this was done, then harmful drugs would likely cause less damage to others. Certainly, patients and doctors cannot be completely aware of such risks as the environment described exists presently, as they can be and are uninformed possibly of the knowledge and information of the drugs available.
However, patients do head to court for relief, rightfully so, for compensation from their suffering from such flawed products. A plus to this activity, regardless of its success, is that it becomes a catalyst for discovery and disclosure of the collusive ones, which are the pharma industry and the FDA, one could conclude.
On a more positive note, a recent pre-emption case involving Medtronic came to light which displeased the U.S. citizens thanks to certain media sources free of fear, apparently, so congress has pledged to pass a bill reversing this removal patient rights regarding such situations, which were both announced earlier this year, so the harmed ones can respond without the restrictions of their government, as they should. At the same time, however, GSK and Pfizer won their preemption cases regarding anti-depressant lawsuits just last month.
Our Health Care System is too important to accept wrongdoing and allow corruption regardless of the amount or severity. Awareness and action by U.S. citizens in time, I hope, will not allow such things to occur in the future again of a similar nature. Because presently, it appears apathy is our greatest weakness for such evil to exist.
“Justice shines by its own light.” — Cicero
Dan Abshear
Justice in Michigan
Hi Dan - I don’t know if you’ve followed any of it, but thre has been quite extensive, detailed, and pretty nuanced discussion of preemption on the blog. Some of it may be of interest.
Based on the hearings so far (I’ll soon have to “unplug”), I think the most debated area will be the distinction between grossly criminal behavior (deliberate suppression of info) and the very wide range of ways companies are able to remain technically “in compliance” but use delay, denial, camoflage, etc. in the ways the deal with FDA.
These behaviors actually could be prosecuted as criminal if the DOJ had the goods and was inclined to do so. Short of whistleblowers, however, they virtually never do have such info, nor are they so inclined.
As I’ve predicted, Bendectin just came up! It always does on the pro-preemption side, since it is the one example (perhaps the only example) of a drug that probably should not have been withdrawn but was because of lawsuits.
Catherine
Is there a way to access a detailed transcript of this hearing?
Ed Silverman
Hi Catherine,
Not yet, but it should be available. I’ll try to find out exactly when.
ed
laura
When the live feed is complete, you can watch it from the beginning at http://oversight.house.gov/. The written record will be made public after the transcript is finalized. This may take several months.
Justice in Michigan
Thanks, Laura. You can also get the full statements of each panelist at the committee website which are available now:
http://oversight.house.gov/story.asp?ID=1943
These are longer than the five minutes apiece allowed at the hearing itself. But, of course, they don’t include the colloquy between panelist and committee people.
From the part I saw, up to Curfman, the weakest bit was the assumption that preemption does not apply if there is felony fraud. As we’ve discussed here before, that is not the case as far as I know, and it is definitively not the position of the Department of Justice and FDA.
Justice in Michigan
For the record…
I have confirmed with a “reliable expert” that FDA preemption would still apply, whether or not felony fraud occurred during the FDA approval or post-approval process.
I mention this because there was some discussion at the hearing that suggested otherwise.
Catherine
Any news on the Transcript for the hearing?
IF any nwes, please let me know…
Catherine@wingtip-online.com
Thank you!
Much appreciated.
-Catherine
Ed Silverman
Hi Catherine,
I’ve checked with the commmittee and I’m told the transcript will likely be available by the end of next week, or maybe early the following week. The archived video of the hearing should be available one day next week.
For both, its best to check here…
http://oversight.house.gov/story.asp?ID=1929
and look in the Table of Contents box.
I hope this helps. It’ll show up, but if you need a transcript faster, you may have to pay a service to obtain a copy lickety-split.
ed
Just A Thought
Interesting article, Dan
Thanks.