Statutory Interpretation and Proposed Factors for Consideration. (Comment 1) One comment criticized FDA’s interpretation of the statute that not all treatments for infections caused by qualifying pathogens will be eligible for QIDP designation, and that ‘‘the development of a treatment for an infection caused by a pathogen included on the list of ‘qualifying pathogens’ is neither a necessary nor a sufficient condition for obtaining QIDP designation’’ (78 FR 35515 at 35167). The comment first expressed concern that, because the terms ‘‘serious’’ and ‘‘life-threatening’’ are not separately defined by statute, their meanings could change in the future. The comment contrasted this alleged uncertainty with the statute’s detailed definition and identification process for ‘‘qualifying pathogens,’’ asserting that the collective term ‘‘serious or life-threatening infections’’ includes infections caused by qualifying pathogens. Thus, the comment asserted, Congress intended the qualifying pathogen list to provide ‘‘some certainty and transparency’’ regarding which products may be eligible for QIDP designation. (Response) FDA agrees with the comment that the term ‘‘serious or life- threatening’’ is not explicitly defined in the statute. Nevertheless, the Agency has been interpreting and applying these terms in the context of other programs under the Food, Drug, and Cosmetic Act intended to expedite the development of drugs and biologics to address unmet medical needs for several years. ‘‘Serious or life-threatening’’ is used in section 506 of the FD&C Act, in the context of expedited programs, including fast track designation. The term ‘‘serious’’ is further defined in a 2006 FDA guidance for industry, ‘‘Fast Track Drug Development Program— Designation, Development, and Application Review (which will be superseded by the draft guidance for industry, ‘‘Expedited Programs for Serious Conditions—Drugs and Biologics,’’ when finalized) and in the preamble to a final rule pertaining to accelerated approval (57 FR 58942, December 11, 1992). The term ‘‘life- threatening’’ is defined in 21 CFR 312.81(a). The provisions related to QIDPs in GAIN similarly seek to incentivize the development of drugs to meet an unmet medical need and, indeed, QIDP-designated applications are eligible for both priority review and fast-track designation (see section 524A of the FD&C Act and section 506(b)(1) of the FD&C Act, as amended). The Agency intends, therefore, to interpret serious or life-threatening in a similar manner with respect to GAIN as it has in ...
