FDA’s Response to a Petition Does Not Constitute Final Agency Action When the Petitioner Requests FDA’s Reconsideration

March 13, 2007

In July 2004, the Coalition for Mercury-Free Drugs (the Coalition) filed a citizen petition with FDA requesting that the agency prohibit the use of thimerosal and other mercury compounds in vaccines and drugs.  In August 2006, the Coalition went to court claiming that FDA had unreasonably delayed responding to the Coalition’s petition.  Shortly thereafter, in September 2006, FDA denied the petition, thereby effectively mooting the Coalition’s claim.  To prevent dismissal of the case, the Coalition amended its complaint to challenge the substance of FDA’s decision.  However, one day earlier, the Coalition had filed a petition with FDA requesting a stay of action, asking FDA to reconsider and modify its response to the original petition.  The Coalition’s petition for a stay of action contained new information and documents that FDA had not reviewed.  Although the Coalition styled the petition as a petition for a stay of action, in reality it was a petition seeking reconsideration of FDA’s response to the original petition.

By filing a petition for a stay in which the Coalition presented new information, the Coalition essentially transformed FDA’s decision into a non-final agency decision, thereby resulting in the dismissal of the court case.  By filing the petition for a stay, the Coalition effectively sought FDA reconsideration, as well as judicial relief of the substantive decision.  As the United States District Court for the District of Columbia noted in its March 1, 2007 memorandum opinion, “plaintiffs cannot simultaneously seek administrative consideration and judicial review of the same order.”  In essence, the Coalition was asking the court to review FDA’s decision regarding certain materials that the agency did not have an opportunity to review. 

By Riëtte van Laack

Categories: FDA News