FDA Officials Opposed Preemption Policy

Democratic Congressman Henry A. Waxman released a new report that finds key FDA officials opposed the agency’s shift to favor preemption.

In this context, preemption means that patients shouldn’t be able to sue drug makers in state court for any injuries caused by FDA-approved drugs. (Federal regulation preempts state law, so the argument goes).

The premise of preemption is that the FDA's standard for safety in labels and drugs is the only one that we need. But even the agency says you can't rely on it.

The drug industry and the Bush Administration are supporters of preemption.

Wyeth v. Levine

Diana Levine is at the center of a case that has implications for everyone who has ever taken a prescription medicine.

A Vermont jury awarded Levine $6.7 million from Wyeth, in 2004, finding that the drug's label offered insufficient warning about the danger of that injection method. In 2006, the Vermont Supreme Court upheld the jury's verdict.

On November 3, her case goes before the U.S. Supreme Court. Wyeth claims the ruling should be overturned. It will test whether corporations have blanket immunity from lawsuits when their product is approved by the government.

The case for and against federal preemption is covered in a previous story on Levine on IB News.

While at the ER for treatment of a migraine, in addition to a medication to treat the migraine she was given another medication called Phenergan made by Wyeth to stop the nausea.

It was delivered by an IV push that injects the drug through an existing peripheral IV line. Previously during hospitalizations she had received the drug intramuscularly through a shot in the butt.

The label for Phenergan does not indicate it can be administered by IV push. In the hospital, Levine was still in pain. Eventually doctors removed her hand because of gangrene. In a second procedure they took the right arm up to below the elbow.

FDA scientists weighed the risks versus the benefits of Phenergan, used to treat allergies and nausea, when it approved the prescribing literature, or label, as a guide for doctors. The FDA is aware of the risks of associated with injecting some forms of Phenergran, but the label failed to specifically warn about the technique used in Levine’s case.

Waxman’s office obtained documents rejecting that warning. Jane Axelrad, an associate director for policy at the agency wrote, “We rarely find ourselves in a situation where the sponsors want to disclose more risk information than we deem necessary, she said. “Quite the contrary, usually we find ourselves dealing with situations where sponsors want to minimize the risk of information.”

Two officials, in memos contained in the released documents say it is wrong to assume that FDA-approved drug labels are completely reliable, or that they are based on full disclosure of safety risks by drug makers.

The FDA is yet to provide a complete set of documents that would show communications between the White House and the agency, but some documents suggested the agency and the White House would not go forward with a rule on labeling until the pre-emption changes were added, the report said. #