Food and Drug Administration Preemption Rules Based on False Assumptions
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On Monday the Supreme Court will hear arguments on the case of a Vermont woman who sued Wyeth after she lost her right arm below the elbow following a high-volume injection of the drug Phenergan. The injection accidentally punctured an artery, prompting gangrene to set in. Diana Levine argued that the company had a duty to warn her and other consumers that such injections could have devastating consequences. The state courts agreed, awarding her nearly $7 million. Wyeth appealed, saying it was protected from such suits. It argued a state court cannot overrule the FDA's judgment on label warnings.
Wyeth’s argument stems from 2006 and 2008 FDA rules which restrict the authority of manufacturers to add safety information without first receiving FDA approval. The FDA regulations also work to trump stricter state law standards, potentially making it harder for consumers to hold drug manufactures responsible for the mislabeling of drugs and other medical devices. The FDA said in its 2006 rule and in a 2008 rule that state suits could encourage drug makers to propose unnecessary labeling, and such labeling could result in scientifically unsubstantiated warnings and less use of beneficial treatments.
However, a new report released by the United States House of Representatives Committed on Oversight and Government Reform found these recent regulations were based on false assumptions. The Committee obtained internal documents which opposed the new regulations because they were not based on real-world workings of the FDA.
Dr. John Jenkins, the highest official in FDA’s new drug review process wrote,
“Much of the argument for why we are proposing to invoke preemption seems to be based on a 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.”
In addition, the Committee did not find evidence of manufactures over-warning their consumers of potential hazards. Instead, Jane Axelrad, Associate Director for Policy in the Center for Drug Evaluation and Research, wrote, “there are continued references to sponsors ‘disclosing too much’ risk information and its adverse impact. … We rarely find ourselves in situations where sponsors want to disclose more risk information than we think is necessary. To the contrary, we usually find ourselves dealing with situations where sponsors want to minimize the risk information.”
In the end, the report found that the Bush Administration pushed regulations that worked to shield drug manufactures from litigation and ran counter to the longstanding view of the FDA “that private litigation can provide an additional layer of protection against unsafe drugs.”