Ever heard of FDA preemption??

[NGinpa]

Ever heard of FDA preemption?? Do you trust that every drug and every device approved by the FDA is safe?? Do you think the FDA review process is above board and always fair and adequate? If you are injured by such drugs/devices which were FDA approved, do you think you should have any legal recourse. Well the Bush Administration and now its/the Supreme Court thinks you should not. You see, government healthcare actions are not all good, as it depends on that same old issue of who is in power and what are their views about government purposes!

See this information about the Supreme Court Ruling on about 2/21/08. Some interesting info quoted below from the sole dissenter.

Justice Ruth Bader Ginsburg, the solitary dissenter, said the court had misconstrued Congress’s intent in adding the pre-emption clause to the 1976 law. The purpose, she said, was to prevent individual states from imposing their own premarket approval process on new medical devices. Devices were not regulated under federal law at the time, and California and other states had stepped in to fill the vacuum by setting up their own regulatory systems.

That was all that Congress had in mind, Justice Ginsburg said, not “a radical curtailment of state common-law suits seeking compensation for injuries caused by defectively designed or labeled medical devices.” She said that Congress had passed the 1976 law “to protect consumer safety,” not to oust the states from “a domain historically occupied by state law.” The decision was at odds with the “central purpose” of the 1976 law, Justice Ginsburg added.

Here are more background links from a Google search of FDA preemption:

States Barred from Protecting Consumers Hurt by Faulty Medical Devices, Says Supreme Court

Ruling on Devices Could Signal ‘Big Win’ for Drugmakers

FDA Final Rule on Prescription Drug Labeling

So I guess some folks would say the usual conservative line that too much restrictions on Drug companies will stifle innovation. I suppose if the drug approval process was truly independent and adequate, we might see some wisdom in FDA supremacy and preemption. However given the constant accusations that the FDA is in bed with these drug companies, and that the drug companies in the past only had to release the favorable studies, and that the Vioxx type drug problems did actually happen, this FDA preemtion is more of a license to kill than a green light for innovation, IMO! Related links:

Report Assails F.D.A. Oversight of Clinical Trials

July 11, 2007 - FDA REFORM BILL STRENGTHENS DRUG REVIEW PROCESS AND SHINES LIGHT ON CLINICAL TRIALS USING MARKEY PROVISIONS

Lawmaker Says F.D.A. Held Back Drug Data

Do Pharmaceutical Companies selectively report

In conclusion, how do folks here feel about all this. If you have a government administered single payer system, what recourses should be available to injured patients that don't cripple the innovation of the system but also don't encourgage greed killing and maiming?

[NC_Nurse]

1. The FDA is fraught with issues and conflicts of interest.

Big Pharma has WAY too much influence in how drugs are reviewed.
I'm sure it's gotten worse with the Dubya effect too, laying waste to every govt agency.:(

[MannyGoldstein]

2. This Actually May Not Be As Bad As You Think

I happen to be in the medical device industry, and here's how I see it.

Realistically, it's always been tremendously difficult to sue device manufacturers and drug companies. "The FDA said it was OK" is a very, very powerful defense.

Generally, plaintiff's only have a good shot if the manufacturer messed with the FDA - lied, hid stuff, didn't follow procedures that they were supposed to follow, etc. This SCOTUS ruling still allows people to go after device makers if they messed with the FDA.

This is not a general defense of the FDA or of medical device makers - they both have good and bad points.

[NGinpa]

4. When I read that in the

past the FDA did not require all trial data to be reported, but that drug companies could selectively report only the better results and that was all legal, then this preemption becomes an endorsement of caveat emptor (buyer beware) greed induced policies. If the approval process was fair, objective, comprehensive, and INDEPENDENT, and with ongoing quick methods of getting out new data to the public, then maybe this premption makes some sense from an innovation spurring point of view. However, that has not been the process, so I am against taking away state safeguards and other safeguards at this time!

[MannyGoldstein]

5. I'm Pretty Sure That All Data Has To Be Reported At Submission Time

I believe that the gamesmanship with data comes after approval - which is still clearly awful. Fortunately, steps are being taken to stop this.

The big problem is the FDA - some parts are good, some are badly broken.

[fasttense]

3. The dancing supremes just dancing for their masters.

Next thing you know they will be coming out with a convoluted legal rationale for giving corporations the right to torture all plaintiffs for information.