On September 11-12, 2013, the Generic Pharmaceutical Association ("GPhA") in coordination with FDA and the United States Pharmacopeia ("USP") hosted an ANDA Labeling Workshop/USP User Forum in Bethesda, Maryland. The first day featured FDA speakers from FDA's Office of Generic Drugs ("OGD") who focus on labeling and filing/approval issues, and the second day featured speakers from USP.
Peter Rickman, M.S., Director, Division of Labeling and Program Support, OGD, kicked off the program, noting that OGD had a lot of challenges implanting the efficiency goals of the Generic Drug User Fee Act of 2012 ("GDUFA"), including their new 10-month review goals. Rickman stressed that for OGD to meet those goals, abbreviated new drug applications ("ANDAs") will need to be high quality, which is why FDA is spending time educating industry about quality.
Rudy Wu, Pham. D., M.P.H., Team, Leader, Labeling Branch, OGD, explained that labeling reviews can take longer when a consult is needed, i.e., checking with another FDA office for labeling acceptability, including the Office of Chief Counsel ("OCC"), Office of New Drugs ("OND"), surveillance, epidemiology, pediatric, and other centers. When a consult is requested, OGD must wait for the other entity to respond, which may create additional delays. Wu said there are many reasons why labeling reviews may take longer than expected: waiting for a final United States Pharmacopeia standard to issue or be met, standardizing the generic risk evaluation mitigation strategies ("REMS"), consults, citizen petitions, pending regulations or guidances, new clinical experience, patents and exclusivity may cause generic applicants to submit formulations that differ from the reference listed drug ("RLD) or include labeling carve-outs, and nomenclature differences. For example, regarding nomenclature, Wu said sometimes the RLD may use non-compendia-standard terms where the Orange Book uses another term, and FDA is concerned that both the RLD and the generic versions include labeling to ensure that pharmacists understand that they are substitutable for one another.