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

Summary

Gives an extra 5 years of market exclusivity to certain antibiotics and antifungal drugs that are officially labeled as "qualified infectious disease products." It adds five years to the specific 3-, 4-, 5-, or 7-year exclusivity terms already in law. That extra time is added on top of any pediatric exclusivity. It does not apply to supplements while an extension is in effect or has expired, to later applications for changes that create a new indication or change how the drug is given (like route, dose, form, device, or strength), to products that don’t meet the qualified infectious disease product definition based on approved uses, or to applications under section 262(a) of title 42. Drug makers can ask the Secretary to designate a drug as a qualified infectious disease product any time before they file an application under section 355(b) or section 262(a) of title 42. The Secretary must decide within 60 days and generally cannot withdraw a designation unless the request included a material false statement. The Secretary must issue final rules within 2 years after July 9, 2012, using notice-and-comment rulemaking (at least 60 days for comments and final rules published at least 30 days before they take effect), but may give interim guidance and must still grant designations before the final rules if the drug meets the definition. The Secretary will keep a public list of "qualifying pathogens" (examples include MRSA, VRE, resistant gram‑negative bacteria like Acinetobacter, Klebsiella, Pseudomonas, and E. coli, multi‑drug resistant tuberculosis, and C. difficile), explain the method for the list, consult experts, and review the list at least every 5 years. A qualified infectious disease product is a drug or biological for people that acts on bacteria or fungi (or their products) and is meant to treat serious or life‑threatening infections, including those caused by resistant or listed pathogens.