July had some fireworks early in the month, and when the smoke cleared on July 15th, the OGD reported twenty‑nine full‑approval actions and seven tentative‑approval actions (thirty‑six in total). If this pace continues, the OGD should surpass seventy total approval actions again this month. For the nine months already officially in the books, six of those months saw more than seventy approvals, with a high in May of ninety‑four (eighty‑four full‑approval actions and ten tentative‑approval actions).
In FY 2021, the OGD surpassed seventy monthly total approval actions seven times, and all came in the first seven months, with a high of ninety‑three total in October 2020 (seventy‑eight full and fifteen tentative‑approval actions) and a low of forty‑nine total in September 2021, the last month of the fiscal year (thirty‑nine full and ten tentative‑approval actions). With three months to go in FY 2022, the OGD might tie or beat last FY’s “7 months above 70” total approval actions.
We will report further on the unofficial numbers after the month closes; we await the official numbers that will be reported sometime in early to mid-August. As we move closer to the end of this fiscal year, uncertainly regarding the User Fee Authorization bills loom heavy on the Agency as failure to pass this “must‑pass legislation” could mean that the FDA has to lay off staff currently funded by the user fee programs. Guaranteed if that happens, it will make the number of approval actions look like a submarine making an emergency dive!
