PETER ROST: PHARMA MARKETING EXPERT WITNESS. AWP, MEDICAL DEVICE EXPERT.: My position on federal preemption of state law as it relates to the FDA.

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Peter Rost, M.D., is a former Pfizer Marketing Vice President providing services as a medical device and drug expert witness and pharmaceutical marketing expert. Judge Sanders: "The court agrees with defendants' view that Dr. Rost is a very adept and seasoned expert witness." He is also the author of Emergency Surgery, The Whistleblower and Killer Drug. You can reach him on rostpeter (insert symbol) Please read the terms of use agreement and privacy policy for this blog carefully.

My position on federal preemption of state law as it relates to the FDA.

Federal preemption generally refers to the effect that federal law has on a conflicting or inconsistent state law. For instance, express preemption exists if a federal statute explicitly states that it preempts state law.

When it comes to the abuse of federal “preemption” to eviscerate state laws providing stronger public health and safety protections, replacing them with federal laws that favor corporate special interests, I'm strongly against this.

The FDA and other state agencies are never all knowing, with a full set of facts, and can't and shouldn't play God. Any legal process may bring forward facts that were unknown by a federal agency, and hence, an FDA decision should not preempt i.e. a lawsuit in state court.

I think that federal preemption of many state-court lawsuits related to FDA-approved products shields drug and device companies inappropriately when they market unsafe or mislabeled products.

Today the FDA and the industries it regulates are too closely tied together for the agency to be counted on to protect the public health adequately. This is the reason the public trust in the FDA needs to be restored.

For more on my positions on issues related to the FDA, please see my interviews with eDrugSearch and BNet.


Anonymous Anonymous said...

A tip of the hat for taking the "right", if unpopular with pharma, position on this important issue.

Anonymous Anonymous said...



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