The draft guidance from December , called “Providing Submissions in Electronic Format—Summary Level Clinical Site Data for CDER’s Inspection Planning,” aims to assist drug applicants in the voluntary submission of trial site information and clinical datasets summarizing the characteristics and outcomes at each site. The submissions will help the FDA select and conduct their inspections of sites run by sponsors, CROs (clinical research organizations) and IRBs (institutional review boards).
PhRMA (Pharmaceutical Research and Manufacturers of America) expressed particular concern about the potentially duplicative nature of the information submitted by sponsors that can cause inspections to be delayed. Requests from the FDA’s OSI (Office of Scientific Investigations) routinely place “unreasonable burden on sponsors to re-format and resubmit information” already provided in the application in conformance with relevant ICH (International Conference on Harmonisation) guidelines, PhRMA said.
The FDA also needs to clarify “the mechanics and specifics” of e-submissions and data standards so the agency and sponsor “can focus on reaching agreement on scientific issues during pre-NDA/BLA [New Drug Application/Biologic Licensing Application] meetings,” PhRMA said.
In addition, OSI’s current practice of contacting investigators without sponsor involvement “has caused a great deal of confusion and unnecessary delay in inspection planning and conduct because all responsible parties” are not notified of an inspection, according to some PhRMA member companies.
The draft also risks “significant confusion on how the ‘voluntary’ nature” of the data submissions should be interpreted because the failure to submit data can be considered a reason for FDA’s CDER (Center for Drug Evaluation and Research) to delay the review of an application.
PhRMA said it “strongly disagrees” with the notion that failing to submit can be considered a reason to delay the review of a PDUFA application.
Meanwhile, BIO (Biotechnology Industry Organization) said it believes OSI has developed a three-part standard information request currently distributed to sponsors and calls for the public release of such a request. The group also has asked the FDA clarify its stance on the voluntary nature of the draft and e-submisisons.
The draft guidance, according to PhRMA, should be amended or even scrapped because it does not clarify FDA’s position regarding what to submit on all clinical sites and manufacturing facilities, and undermines agency-wide data standardization because it only focuses on CDER’s inspection planning.
PDUFA V Issues
The draft guidance also could “undermine” and “hinder” requirements from recently passed FDA legislation, called PDUFA V (Prescription Drug User Fee Act), because the draft merely references “the FDA website for technical specifications documents and other resources that are subject to change without notice,” according to BIO.
Without the security of technical specifications, BIO claims that both industry and FDA “are inhibited from undertaking long-term planning decisions and making the necessary technology investments” for an efficient review process.
PhRMA and BIO’s comments, posted Monday , were submitted as part of an open comment period on the draft guidance. The deadline for comments was Feb. 19.