While Americans sit mesmerized by Sarah Palin clapping into the microphone and rambling on about Greek Columns while her daughter wipes down her youngest child's hair with her own spit, they are utterly unaware of yet another attempt by the Republican machine to steal even more of their civil rights and liberties. As if the "Patriot" Act wasn't enough, the war mongerers now want to take away your civil rights in the form of redress in the event that you or your family are damaged by dangerous prescription drugs. And while the fear mongerers are hyping the "War on Drugs" and making chemical attacks against Columbian farmers, they aren't drawing attention to the fact that three times as many people die from "legal" prescription medications every year as from illegal drugs, and that the government is getting ready to remove your right to have any recourse for the harm that is done to you by a pharmaceutical company.
That's right, "preemption" is coming soon to a theater near you. Preemption states that if a drug is approved by the FDA, that approval "preempts" the rights of citizens to litigate in state courts. The good people of Michigan have been living with this ludicrous law for the past decade. People from Michigan who had a heart attack on Vioxx lost their right to have their day in court. That is because preemption says that "if the FDA approved it it is OK," ignoring the fact that scientists have been saying that Vioxx causes heart attacks since 2000, and the FDA literally had to be beaten over the head before they came along six years later. Ditto for suicidality with antidepressants; it took a strong stance by the British organization for the regulation of prescription medications before the FDA "reopened" their files and changed their opinion on the issue. In the case of Levine v. Wyeth Pharmaceuticals, involving a musician who lost her right arm as a consequence of a medication administered to her for migraine headaches in an emergency room, the US Supreme Court will soon rule on whether FDA approval "preempts" the rights of citizens to receive any form of redress in state courts.
Prescription medications are often found to have dangerous side effects after they are approved by the FDA. That is because it takes time and the treatment of many patients before uncommon, but potentially dangerous, side effects come to light. Even members of the FDA don't want preemption; they see civil litigation as complementary to the FDA. Since the passage of the Prescription Drug User Fee Act (PDUFA) in 1992, a law that allowed drug companies to pay a fee to the FDA to speed up the approval process, there has been a decline in the resources that the FDA has to monitor drugs after approval. That is because PDUFA requires a 3% yearly increase in the budget for new drug approval. Since Congress hasn't increased the FDA budget, that means the money went from monitoring approved drugs to approving new drugs.
Preemption isn't good for anyone except for the drug companies. And they are unable to come up with a coherent reason to be in favor of it, other than it will provide more money to develop "life saving drugs," and we've heard that malarkey before. If you are tired of the erosion of your rights as a US citizen, take action.
Doug Bremner MD is author of Before You Take That Pill