Do You Have a Story to Tell?

Giuseppe Randazzo, the Director of the Office of Program and Regulatory Operations, urged the generic industry to tell a story in a cover letter when sending a submission to FDA. Yes, that’s right.  At his presentation in Bethesda at the Association of Accessible Medicines 2017 Fall Technical Conference, Mr. Randazzo explained that a cover letter, with proper background and specific reference to previous communications, helps FDA reviewers, and, in turn, the industry.  He also mentioned that the industry responses to FDA requests should be complete, substantive, and timely.  I must admit that most regulatory professionals have gone through regulatory environments that encourage storytelling to the ones that value facts and would rather keep it short and sweet.  This makes good sense to RA professionals who have been trained to tell a story.

Mr. Randazzo outlined the current Office of Pharmaceutical Quality (OPQ) organizational charts and presented various OPQ achievements such as publishing 7 MAPPs, responding to 220 external inquiries, 371 controlled correspondences, publishing 7 guidance documents, while outlining some of the key GDUFA II changes related to Quality. Some of these include grouping all original ANDAs and ANDA amendments within a single assessment scheme (90% goals), creation of new pre-ANDA program for complex products, creation of new GDUFA II deliverables (e.g., DRLs) etc.  Another interesting update provided during his session is that the guidance for post-approval changes to drug substances is on track to meet the October 1, 2018 issuance date — almost 20 years after the first publication of the draft BACPAC I in 1998 (which was finalized in 2001 and withdrawn in 2006).

Giuseppe provided additional information on the mission of OPQ and the impact that the User Fee Acts have had on the organization. Today, the conference focuses on GDUFA II and its implementation.  We will keep you posted with more highlights from this conference as they arise.