Thursday, January 31, 2008

Drug immunity law: politicos jockey for position

Democratic lawmakers have been running into a brick wall trying to repeal MCL 600.2946(5), Michigan's one-of-a-kind law that grants drug manufacturers lawsuit immunity if the federal Food and Drug Administration has approved the complained-of medication.

Sen. John Gleason (D-Flushing), has been leading the effort in the Republican-controlled Senate but to no avail. His repeal legislation is bobbing in the backwaters of the Senate Judiciary Committee.

In her State of the State address delivered Tuesday evening, Gov. Jennifer Granholm took a poke at this state of affairs:

"[C]onsumers in every other state have the right to hold drug companies accountable when their products lead to injury and even death. Michigan consumers should have that right, too."
Interestingly, Senate Republicans, earlier Tuesday, tried to make a little hay with the issue in the legislative session. Sen. John Pappageorge (R-Troy),introduced Senate Resolution 134, which called upon the FDA to toughen up standards for the drug approval process. The resolution impliedly acknowledged the Vioxx situation. The FDA approved the drug, which, it was belatedly discovered, apparently had the disastrous side effect of causing sometimes-fatal strokes and heart attacks. The drug was later pulled from the market.
"Whereas, Incidents of harmful side effects raised concerns that the FDA post-marketing monitoring needs strengthening. Although American drugs are arguably the safest in the world, allegations of detrimental consequences from FDA-approved drugs show that there is room for improvement. Stricter standards for the FDA's investigation and response to consumer reports of harmful side effects should be established to enhance the safety of drugs approved by the FDA and on the market. The FDA must immediately investigate consumer reports of harmful side effects and act quickly to protect the public. In this way, Michigan's tort law and strict FDA standards will ensure that Michigan residents can have confidence in the drugs and medications they take; now, therefore, be it
"Resolved by the Senate, That we memorialize the United States Congress and United States Food and Drug Administration to establish stricter standards for the drug approval process[.]"
Not good enough, said Gleason.

He offered an amendment that would have linked the resolution to Democratic efforts to repeal the drug immunity law by striking this language:
"In this way, Michigan's tort law and strict FDA standards will ensure that Michigan residents can have confidence in the drugs and medications they take"
and replacing it with this:
"We pledge, as the Michigan Legislature, to continue ongoing efforts to remove current statutory obstacles which hinder the ability of Michigan residents to obtain just compensation for injuries caused by FDA-approved drugs."
Sen. Buzz Thomas (D-Detroit) opportunely requested a roll call vote for the amendment, which, predictably, was voted down on party lines but left the Democrats with a paper trail to use against Republicans come election time.

The resolution, sans amendment, passed the Senate on a non-accountable voice vote.

Sen. Gretchen Whitmer (D-East Lansing), was quick to point out what she apparently believed was the resolution's specious nature:
"[L]et me get this straight: Our drug immunity law is based on the FDA standard. The rationale behind that public policy is that the FDA standard is strict enough to protect our consumers, our citizens here in Michigan.
"Now instead of taking action like the other 49 states in the country have to protect our citizens, we are once again advocating and asking Congress to enact a stricter standard because we don't think their standard is strict enough, but that is our standard.
"So it leaves you to conclude that our law is not sufficient to protect Michigan citizens."
To which Michigan drug-injury claimants might wistfully add, "But more than sufficient to protect the drug manufacturers."

The Senate's proceedings on Resolution 134 can be found here (scroll to page 102 or search the document for "Senate Resolution No. 134").

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