Shielding Big Pharma

Posted on Thursday, January 26 at 08:34 by Ed Deak
The new rules announced by the FDA last week requiring clearer labeling and more detailed warnings represent a long overdue, pro-consumer change for the FDA-which causes one to wonder what's really up. Whenever the fiercely anti-regulation, pro-business Bush administration sides with consumer advocates, there must be more to the story. And there was. Tacked onto that consumer-friendly drug labeling rule change was another rule change, one that couldn't have been less consumer-friendly if it had been written by Big Pharma itself-which it likely was. It represents nothing less than a multibillion dollar gift to the pharmaceutical industry. The second rule change announced that day would bar state courts from hearing individual or class-action liability suits against drug companies. The reasoning behind this change was that, because a federal agency-the FDA- approves drugs before they can be marketed to the public, only federal courts should hear cases where someone claims they were injured by those drugs. It's called "federal preemption," and, if upheld, it will require anyone wanting to sue a drug do so in federal court. Deputy FDA commissioner Scott Gottlieb explained the logic behind federal preemption. We think that if your (drug) company complies with the FDA processes, if you bring forward the benefits and risks of your drug, and let your information be judged through a process with highly trained scientists, you should not be second-guessed by state courts that don't have the same scientific knowledge. It may come as no surprise that not everyone agrees. "This is a sneak attack on consumer rights," responded Joan Claybrook, president of Public Citizen. "Bush is once again abusing his executive powers, this time in his attempt to protect the big pharmaceutical companies from the consequences of their actions. Thousands of people in this country have died or been seriously injured by drugs approved by the FDA, and this administration is saying it doesn't think people should have any recourse." [Proofreader's note: this article was edited for spelling and typos on January 27, 2006]


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