Before filing a lawsuit against FDA, I often get asked by clients whether FDA will retaliate by, for example, delaying review times or more closely scrutinizing applications. My response to this question is always the same – no. FDA understands that its decisions are complicated and important. And, as long as you are not making frivolous arguments and litigate in a professional manner, FDA will respond professionally and will not hold the lawsuit against you. In fact, despite suing FDA on multiple occasions, I have always maintained a good and professional relationship with FDA and have never experienced any animosity.
But, is there a limit to FDA's tolerance for being sued? Maybe. Mihael Polymeropoulos, CEO and co-founder of Vanda Pharmaceuticals, certainly thinks so. In fact, in a recent interview, he stated that he believed that FDA was in fact retaliating against Vanda and treating it differently as a result of the multiple lawsuits that Vanda has filed against FDA.
If you have been keeping score at home, it would be an understatement to say that Vanda has been very active in filing lawsuits against FDA the last few years. Vanda stands out as perhaps being the most aggressive company in recent memory, filing separate suits challenging, among other issues, FDA's partial clinical hold on human testing for one product, a denial of a fast track designation, and a failure to schedule a hearing relating to an unapproved ANDA. Vanda has launched two separate suits challenging FDA's ANDA approval decisions – one of which challenges FDA's failure to require a generic label to have braille labeling and another that challenges FDA's bioequivalence finding. Vanda has even filed multiple lawsuits to require FDA compliance with FOIA requests.
Is FDA actively retaliating against Vanda in response to these lawsuits? That remains to be seen. But, in the meantime, my advice to companies considering a lawsuit to challenge an improper FDA decision will remain the same.