The US Food and Drug Administration (FDA) on Monday issued a draft questions and answers guidance intended to provide drugmakers with more clarity about its qualified infectious disease product (QIDP) designation.
The QIDP designation was created by Congress to spur the development of drugs to treat infectious diseases in the Generating Antibiotic Incentives Now (GAIN) Act, which was passed as part of the Food and Drug Administration Safety and Innovation Act (FDASIA) in 2012.
The GAIN Act incentives include an additional five years of marketing exclusivity for drugs approved with QIDP designation, and an automatic priority review for a product's first application for approval. Drugs granted QIDP designation are also eligible for fast track designation, but sponsors must specifically request the designation from FDA.
The new draft guidance comes less than a year after a report by the Government Accountability Office (GAO) called FDA out for not fully detailing its expectations for new antibiotic drugs or how drugmakers could access the incentives awarded to QIDP designated products.
In the draft guidance, FDA clarifies that QIDP designation "applies to a specific drug product from a specific sponsor for a specific use for which it is being studied," and does not cover an active substance in general or its uses beyond the qualified indication.
FDA also says it interprets the term "serious" in the same way it does in the context of its other programs to expedite products for serious 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," FDA writes.
While the language of the GAIN Act specifies that products must be "intended to treat serious or life-threatening infections," FDA said that it interprets the term "treat" to include products intended to diagnose or prevent such infections.
The guidance also details when certain QIDP designated products are not be eligible for the five-year marketing exclusivity, such as when an efficacy supplement is being submitted for an application that has already received a GAIN Act exclusivity extension.
Additionally, the guidance clarifies that some information, while helpful, is not required to qualify for QIDP designation. For instance, data demonstrating that a product is intended to treat an antimicrobial resistant pathogen can be helpful, but is not strictly required to qualify for the designation.
For sponsors seeking fast track designation in addition to QIDP designation, FDA says those requests can both be made in the same letter, but notes that while requests for QIDP designation can be made before an investigational new drug (IND) application is submitted, requests for fast track designation may only be made during or after an IND submission.
FDA also notes that QIDP designation can only be applied to drugs, and that biologics approved under section 351 of the Public Health Service Act and medical devices are ineligible for the designation or the incentives it provides.
FDA anticipates about 33 QIDP designation requests per year, according to the Federal Register.