The Pharmaceutical Research and Manufacturers of America (PhRMA) provided comments to a recent report by the US Food and Drug Administration (FDA) in which the agency assessed its communication and transparency of information with industry for new molecular entity (NME) new drug applications (NDAs) and original biologics license applications (BLAs). The FDA released the report in November 2016 as part of its assessment of agency performance under the Prescription Drug User Fee Act (PDUFA). Part of PhRMA's comments related to the inspection process for drug-manufacturing facilities.
In its comments, PhRMA said it agreed with the FDA's final report finding that "inconsistent availability and communication of information about the status and results of inspections has hindered review timeline transparency and predictability." In its comments, PhRMA noted that the final report states that only 46% of applications received inspections that were completed within the agency's projected timetables. For those that were not completed within the timetables, the majority (87.6%) were due to the late completion of GMP inspections. PhRMA said that it supports the recommendation that the FDA should examine the process for disseminating information about inspections and encourages the agency to improve communication of inspection information between relevant offices within the FDA, divisions, and sponsors. PhRMA said that it supported the agency's undertaking a review of inspection information flow, considering that the final report states that applications receiving on-time inspections received first-cycle approvals over one and a half months earlier than those applications that did not receive on-time inspections.
PhRMA also commented on other aspects of the FDA's review process for NME NDAs and BLAs. PhRMA said it supported the hiring goals in the PDUFA VI Proposed Commitment Letter, in which the the FDA outlines its performance goals under the current consideration of reauthorization of PDUFA. PhRMA agreed that the hiring goals would enhance the FDA’s hiring and workforce management strategy by ensuring that the agency can hire and retain sufficient experts to continue efficiently conducting reviews and managing enhancements to the human drug review program. PhRMA expressed concern over the process and related timelines for the review process for when a "major amendment" is part of the FDA review process. PhRMA said it would like to better understand the FDA's rationale for deeming responses to information requests as major amendments, the timing of information requests that result in major amenments, and what could be done to avoid major amendments. PhRMA recommends that the FDA explore ways to enhance the consistency across review divisions with regard to major amendments, particularly as it relates to decreasing the frequency of goal date extensions due to submission of relatively small amounts of information in response to an information request. Lastly, with respect to overall communication, PhRMA said it encourages the FDA to continue promoting policies and procedures that ensure that such robust engagement occurs consistently at both mid-cycle and late-cycle meetings, followed by timely management input into the content of labeling