This morning the Supreme Court is hearing testimony on the subject of pre-emption in Levine vs. Wyeth.  The case promises to be one of the most important issues of our day. In its simplest form the question is: Does the fact that drugs are regulated by the federal government preempt drug companies from being sued in state court?

Both sides have been lining up on this issue.  But in the end this may be a moot point as the case is based on statutory law, and with the new Congress and President, the notion of preemption may go by the wayside.

A report by the Legal Times: High Court Case Turns Political Spotlight on Pre-emption

outlines how if the Supreme Court rules against the plantiff and in favor of pre-emption that the trial lawyers will devote a significant sum to petition Congress to change pre-emption via statute.

In preparation for this morning's testimony, the House Committee on Oversight and Government Reform released a report including internal FDA documents which show high-ranking career officials repeatedly warning about the dangers of not allowing drug companies to add additional warnings to their labels without FDA approval. 
 

The report cites Dr. John Jenkins, the highest official in FDA’s new drug review process, writing:  “Much of the argument for why we are proposing to invoke preemption seems to be based on the false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis. We know that such an assumption is false.” The release of the report was to influence the court and show that companies should not be subject to pre-emption.

A good editorial on this issue was in the Washington Times outlining how pre-emption supports innovation.  And another good read on this is Journal of Life Sciences: Preempting Innovation.

Key Documents

Legal Times: High Court Case Turns Political Spotlight on Pre-emption

House Committee on Oversight and Government Reform: FDA CAREER STAFF OBJECTED TO AGENCY PREEMPTION POLICIES

Washington Times:  FDA and Drug Pre-emption

Journal of Life Sciences:  Preempting Innovation