FDA Reform Bill Hits Snag On Preemption
3 CommentsBy Ed Silverman // September 17th, 2007 // 4:35 pm
As House and Senate staffers try to reconcile their competing versions of the FDA reform bill, sources say a new roadblock has emerged - preemption. What is preemption? Essentially, this gives companies immunity against product-liability claims, because the FDA has already deemed a product to be safe. As a result, drugmakers say state judges and juries don’t have the right to supercede a federal regulatory authority.
Why is this an issue in FDA reform? The Senate bill contains language that would require a drugmaker to obtain FDA approval before updating product labeling with new safety info (if you go to the Library of Congress site, type in S1082, click ‘bill number,’ and the click version 3 before scrolling to section 506D, subsection B). The bill would require the FDA to react to a proposed change within 30 days, but what if that doesn’t happen? In other words, this would create an additional line of defense for drugmakers to argue they should be shielded from state claims because their hands are tied.
“This is the issue of the day,” a source familiar with the topic tells Pharmalot. “And it’s a billion-dollar issued that’s buried in the legislation. This diminishes the likelihood that lawyers will look at a safety issue and think they can win a case. And it’s causing a high-stakes game on the floor, because now the FDA is saying it will lay off workers later this week if a bill isn’t passed.”
To date, the pharmaceutical industry hasn’t been terribly successful in using preemption to ward off product-liability lawsuits, and the Supreme Court appears likely to sort this out, anyway. But if the proposed language were to become law, such lawsuits may be easier for the industry to deflect.
Mike in Dallas
The only reason there would be reluctance to accept responsibility for drug side effects, damages, and deaths is the cumulative history of errors, criminal acts, and criminal neglect on the part of the pharmaceutical industry. If preemption were allowed as an excuse for product liability (which is as weak a defense as telling the traffic cop that you did not know the speed limit because you can’t read), the result would be allowing these criminals to continue with injustices. The victims are real people; our relatives, friends, and ourselves - all innocently accepting the marketing instead of being provided real scientific facts.
In other words, it is stupid. We know the FDA has a history riddled with corruption, with employee’s hands in the pockets of drug companies. We know that there are 2 drug lobbyists for every member of Congress. We know that they have a Billion dollars a year to carefully court favors. Enough is enough! Hold them responsible regardless of FDA approval.
The FDA should be there to side check their science. It is not a removal of responsibility to have objective review. We need a new FDA, one with transparent inspection available and accountability to the public, not to drug companies.
Congress FDA Bill Includes Reforms « The Pump Handle
[...] companies immunity against product-liability claims if the FDA had approved their products. (See Pharmalot for more on this particular provision, or this post for more on why pre-emption is problematic.) Â [...]
Congress’s FDA Bill Includes Reforms « The Pump Handle
[...] companies immunity against product-liability claims if the FDA had approved their products. (See Pharmalot for more on this particular provision, or this post for more on why pre-emption is [...]