§355f Extension of Exclusivity Period for New Qualified Infectious Disease Products

Summary

If the FDA approves a drug that was given a "qualified infectious disease product" (QIDP) designation, the drug’s existing market-exclusivity periods of 3, 4, 5, or 7 years are each extended by 5 years. That 5-year add-on is extra to any other extension the drug might get under section 355a. The extension does not apply to supplements to an existing approval, to later applications that only change the drug’s use, dose, route, form, device, or strength, to products that as approved do not meet the QIDP definition, or to biologic applications filed under 42 U.S.C. 262(a). A drug company can ask the FDA to designate a drug as a QIDP any time before it files its approval application. The FDA must decide on that request within 60 days. Once given, the QIDP designation generally stays in place unless the request included a false, important fact. The FDA had to issue final rules within 2 years after July 9, 2012, using normal notice-and-comment steps (proposed rule, at least 60 days for comments, and a final rule published at least 30 days before it takes effect). The FDA can give interim guidance and must designate drugs that meet the QIDP definition even before formal rules are finished. A "qualifying pathogen" is a germ the FDA lists that could seriously threaten public health. Examples include certain drug‑resistant bacteria (like MRSA and VRE), multi‑drug resistant gram‑negative bacteria (such as Acinetobacter, Klebsiella, Pseudomonas, and E. coli), multi‑drug resistant tuberculosis, and Clostridium difficile. The FDA must keep a public list and explain how it makes the list, consider public‑health impact and resistance trends, consult experts (including CDC and FDA), and review the list at least every 5 years. A QIDP is a drug or biological product for people that fights bacteria or fungi (or their products) and is meant to treat serious or life‑threatening infections, including those from resistant, new, or listed pathogens.