October 26

Federal Court (Illinois) Rejects FDA-Daniel Troy Preemption Argument

Federal Court (Illinois) Rejects FDA-Daniel Troy Preemption Argument

Fri, 11 Nov 2005

In yet another federal case (Zikis v Pfizer)  involving the company’s failure to warn physicians and the public about the increased risk of suicide effects for pediatric patients prescribed Zoloft, the court rejected Pfizer’s argument that it didn’t need to war if the FDA did not require it to issue a warning.

Some of the key language from the Court’s Order (dated November 8):

“Pfizer has yet to point to any tangible conflicts between the claims in the instant action and the FDCA. For instance, Zikis alleges that prior to December 2002, Pfizer had sufficient information to determine that there was an association between Zoloft and an increased risk of suicide. Zikis argues that Pfizer could have provided the FDA with the information and such information would have caused the FDA to alter its position sooner. Zikis argues that it was Pfizer’s obligation to notify the FDA about the data showing an increased risk of suicide. Pfizer has not pointed to any statutory authority or regulation that would have prevented Pfizer from disclosing the data to the FDA prior to December 2002, and thus has not shown any conflict in this regard. The Amicus Brief provides nothing more than a historical summary of the FDA’s position in the absence of the information that Pfizer was allegedly withholding in order to further the sales of its product.” (P. 7-8.)

“Thus, a drug maker is expressly provided with the authority to unilaterally, without prior approval by the FDA, add warnings that ‘add or strengthen a contraindication, warning, precaution, or adverse reaction. [Cites omitted.] The FDCA was designed primarily ‘to protect consumers from dangerous products.’ [Cites omitted.] That purpose is clearly served by the provision in 21 CFR 314.70(c)(6)(iii)(A), which allows for an amendment to a label without extended delay when a drug manufacturer learns of new dangerous side effects of a drug.” (P. 9.)

“The fact is that Pfizer did not seek to supplement its label, which it could have done in accordance with the regulations.” (P. 10.)

Contact: Vera Hassner Sharav

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