On this day that shall live in infamy -- the day that God told George W. Bush to sign a bill that got through the Senate thanks to a tie-breaking vote by President Cheney, and got through the house by two votes with arms twisted out of their sockets littering the house floor, the bill that will force working poor people off of Medicaid and make the ones who are left pay money they don't have for doctor visits and pills -- I have come across yet another outrage.
The FDA has recently revised labelling requirements for medications. Good idea, they are now somewhat more stringent. On page 169 of the new rule, which you can read here if you're willing to wait 5 minutes for the PDF to load and then scroll down (it's page 75 of the PDF file, since the document is broken into multiple files), you will read the following:
X. Executive Order 13132: Federalism
We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. Section #a) of the Executive order requires agencies to “construe * * * a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.“ Here, FDA has determined that the exercise of State authority conflicts with the exercise of Federal authority under the act.
What this means in English is that it will be harder for people to sue drug manufacturers. It means that the FDA says that if manufacturers comply with the labelling requirements, they can't be sued under state law for failing to warn people about adverse effects. (State courts don't have to agree with them, but it puts a thumb on the scale.) Here's what Public Citizen has to say about this. Excerpt:
In a further blow to consumers, the final rule now contains a preamble aimed at preempting the rights of patients to sue drug manufacturers if a drug is approved by the FDA. The Bush administration has previously failed to persuade Congress and, with a few exceptions, the courts (where it has filed amicus briefs) to shield drug makers from liability. The new tactic of writing preemption language into federal regulation notices is an attempt to bypass Congress and override consumer protection liability laws, said Public Citizen President Joan Claybrook. The administration has also used such language in recently proposed automobile safety rules.
“This is a sneak attack on consumer rights,” Claybrook said. “President 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.”
And here's what I have to say. I want an FDA that works to protect the people, not to protect the drug companies. I want a federal government that respects the rights of the states and the people. I want a government that isn't run by hypocrites, liars, thieves and, oh yeah, murderers. That's what I want. It's the Christian thing to ask.