The FDA decided to protect drug-makers from state-court liability suits by offering drugs their approval. Basically, you can’t sue a drug-company for a drug approved by the FDA. This practice has been on-going for the past few years.
However, this policy is apparently fought against from within FDA ranks. One of the most recent cases, Wyeth vs. Levine, has forwarded such proof. During the Supreme Court case, Congressman Henry Waxman brought forward as evidence a couple of internal memos exchanged between a few of FDA’s top executives. The memos were straight-forward and showed that the executives were clearly fighting against the decision made by the FDA and the Bush Administration. They were of the opinion that an FDA approved drug was not necessarily fully reliable. FDA’s policy is not the only anti-lawsuit one that the Bush Administration has openly supported – it extends to a high number of other regulatory agencies.
In the words of John Jenkins, Drug Approval Department official, “we are proposing to invoke preemption based on the false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis”. Jane Axelrad, a former FDA associate, assessed preemption as not being “consistent with the agency’s role in protecting the public health.”
The internal memos are one of the best weapons the Congress has to fight the Bush Administration anti-lawsuit policy. Even after the Wyeth vs. Levine case is resolved, the argument over the preemption policy is far from being settled. One example of the Bush Administration controlling regulatory agencies and their policies is provided by a document which attests the Administration wanted to block one of the FDA’s rules on drug labeling.