Top FDA officials opposed rule limiting tort claims against drug companies: report

[JURIST] The US House Committee on Oversight and Government Reform [official website] on Wednesday issued a report [text, PDF] revealing that top Food and Drug Administration (FDA) [official website] officials opposed FDA regulations that preempt consumers’ ability to bring tort claims against drug manufacturers. The report said that career FDA officials objected to a 2006 regulation [text, PDF] revising the so-called Physician Labeling Rule because under it the agency’s approval of labeling preempted conflicting state law, significantly limiting the liability of drug makers. Prominent FDA staffers had maintained that state lawsuits complement the agency’s regulatory function by discovering risks that it cannot. The regulation also made it more difficult for pharmaceutical companies to add new warnings to existing drug labels. The report shows that Jane Axelrad, an FDA research director, expressed reservations about the rationale for lowering label content requirements:

[T]here 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.
AP has more.

The initial Physician Labeling Rule, as proposed in 2000, did not preempt state law. The FDA bolstered labeling restrictions with an August 2008 regulation [text, PDF] stating that manufacturers may not strengthen warnings except when there is "sufficient evidence of causal association with the drug."


 

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