Oct 082011

A petition was filed in July 2010 asking the FDA to revoke its approval of the Alair® device used in bronchial thermal cautery (thermoplasty).  As of October 6, 2011, the FDA had not made a definitive determination on the petition. So PFIMR has filed a lawsuit in an attempt to compel the FDA to make a final determination.

Federal law allows any US citizen to petition the FDA and the FDA must accept or reject the petition within six months. However the FDA was given an “escape clause.” If a petition requires further data or review or if the FDA is bogged down in other work, it could issue an interim response and give a final response later on. Unfortunately the FDA has taken this to mean that all petitions from the public can be given a “boilerplate reply” saying just that and then the FDA sits on the petition for years. Somehow this does not happen when the petition is filed by a drug company. I have several letters from the FDA where a definitive response was given to the "citizen's" petitioner within six months -- but these were all responses to drug companies and their attorneys.

I am sure the FDA has some way to explain the discrepancy between how they respond to petitions from the public and petitions from drug companies. However this does not seem fair to me. Anyway the District Court in the Central Division of California has the petition now and hopefully the judge will ask the FDA to respond in a timely fashion. The whole process should not take more than six months.

Update: The district court dismissed the petition on the ground that PIMR did not suffer any injury and therefore it has no standing to sue.

Update: The Appellate Court of 9th Circuit has taken up the case and is holding a hearing on February 13th in Pasadena. The Circuit Court will decide if PIMR has standing to sue. If they rule in favor of PIMR, the case will go back to the district court for trial.

Click on documents:




 Posted by at 5:40 pm

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