Vanda says FDA ‘unlawfully’ delaying hearing

Vanda Pharmaceuticals (VNDA) stated that “FDA bureaucrats have committed to delay Vanda’s request for a hearing on the approvability of tradipitant for gastroparesis. Rather than take accountability, FDA bureaucrats identify a new scapegoat: newly appointed Commissioner, Dr. Martin Makary, and reductions in force.” Dr. Mihael Polymeropoulos, Vanda’s President, CEO and Chairman of the Board, said: “Vanda has fought for ‘transparency and common sense’ for years because rational innovation can only thrive in a democracy and not in a bureaucracy. It is time for FDA and DOJ to stop fighting innovators like Vanda, focus on what is broken and listen to ideas of how it can be fixed, and usher in a new era of rational and transparent decision making.”