Complete Response Letters Not for Judicial Review: Court

Drug companies that receive complete response letters on their submissions cannot circumvent the agency’s hearing process to petition courts for redress. So says the Washington, DC Court of Appeals in a 6/3 decision that rejected a Nostrum Pharmaceuticals request for the court to hear arguments on the company’s complete response letter on a supplemental ANDA for generic theophylline, a drug used to treat asthma and other respiratory conditions.  

Because the complete response letter does not constitute a final rejection of the application, “we lack jurisdiction to hear Nostrum’s petition and therefore dismiss it,” the court ruling said. Such letters are not orders of the HHS Secretary that refuse approval of an application, rather they are an interim step in FDA’s consideration of an application, and therefore there is no court jurisdiction to hear such matters, it concluded.