§355f Extension of exclusivity period for new qualified infectious disease products

Summary

Drugs that get a special label as a "qualified infectious disease product" get five extra years of market exclusivity added to whatever 3-, 4-, 5-, or 7-year exclusivity they already have. That extra five years is added on top of any other extensions the drug might get. The extra time does not apply to certain approvals, including supplements to an application already covered, new applications for changes that create a new use or form (like a new dose, route, device, or strength), products that do not meet the special-product definition based on their approved use, or applications filed under section 262(a) of title 42. A drug maker can ask for the special designation any time before filing its approval application. The Secretary must decide within 60 days. The designation usually cannot be taken away unless the request included a false material fact. The Secretary had to adopt final rules within 2 years after July 9, 2012, using a public notice, at least 60 days for comments, and publishing the final rule at least 30 days before it takes effect; interim guidance is allowed and eligible drugs can be designated before the rules are final. The Secretary must keep and publish a list of "qualifying pathogens" (serious drug-resistant bacteria and similar threats, such as MRSA, resistant gram‑negative bacteria, multi‑drug resistant tuberculosis, and C. difficile), explain how the list is made, consult experts, and review the list at least every 5 years. Definitions: "Qualifying pathogen" — a listed germ that can seriously threaten health. "Qualified infectious disease product" — a drug or biologic that acts on bacteria or fungi (or their products) and is meant to treat serious or life‑threatening infections, including resistant or listed pathogens.