The US Food and Drug Administration (FDA) has issued draft guidance, Qualified Infectious Disease Product Designation Questions and Answers, to provide a resource for information on the FDA’s policies and procedures related to the designation of a qualified infectious disease product (QIDP) under the FDA Safety and Innovation Act, called Generating Antibiotic Incentives Now (GAIN).

QIDP designation offers certain incentives for developing new antibiotics, including a five-year extension of the data exclusivity provisions under the Hatch-Waxman Act and priority review of the new drug application when filed.

The draft guidance clarifies that the QIDP designation applies to a specific drug product from a specific sponsor for a specific use for which it is being studied. The designation is granted only to the sponsor making the request, and it does not apply to a drug substance in general or beyond the specified indications.

In the draft guidance, the FDA also clarifies what qualifies under the term “serious” in reference to diseases. It says sponsors may wish to refer to the definition of “serious” that the agency has used in the context of other programs intended to encourage the development of drugs to treat serious and life-threatening diseases or conditions. “Whether a disease is serious is a matter of clinical judgement, based on its impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one,” the guidance says.

The draft guidance also says that some QIDP-designated products are not eligible for the five-year marketing exclusivity. Specifically, this occurs when an efficacy supplement is submitted for an application that has already received the GAIN exclusivity extension, where the subsequent application is seeking approval for a change that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength.

The draft guidance also clarifies information regarding how to request fast track designation in addition to the designation and what information is not necessary to qualify for the designation.

Source: FDA