As of this morning’s postings on the FDA “All Approvals” report (here), OGD has issued 62 full approvals and 15 tentative approvals. That is a total of 77 approval actions, and we have 8 days of reporting left for the month still.
If the torrid pace of approvals continues for the rest of the month, we may even see a record-breaking month not only for GDUFA II, but for all of GDUFA. With Kathleen (“Cook”) Uhl, Director of the Office of Generic Drugs (OGD) announcing her retirement coming up in February 2019, the review and approval process appears to be humming along; perhaps this makes it easier for Cook to leave, knowing that the program is running well, and turning out approvals and other actions at record pace.
Hopefully, additional improvements hinted at by the Commissioner (moving to a data-driven review format rather than a narrative format) when implemented will result in increased efficiency in the review and approval process and permit a significance rise in first cycle approvals. That certainly would brighten the spirits of the generic drug industry as they are under pressure from all sides to be the solution to the drug pricing issues so prevalent in the news. They certainly will have a hard time being the solution even with more approvals, if there continues to be a squeeze and pressure on prices in the supply chain, not to mention the threat of foreign drug imports to “help” lower prices.