Well, I am back from three weeks of traipsing around South America and ready to hit the blogging trail again.  Thanks to all my Lachman colleagues who took up the charge and did a great job in my absence.  However, while away, I tried to keep up by reading the trade press when I had access to the internet, and one story, by Derrick Gingery at the Pink Sheet, caught my eye: Generics Approvals Will Decline, US FDA Predicts, But Supplement Work May Grow (here, paid subscription required).

In that article, the FDA is cited as predicting a lower number of approval and tentative approval actions in FY 2020 (900) and FY 2021 (850).  According to the first four month of FY 2020 (see number here), the FDA has issued 277 total approval (228) and tentative approval (49) actions, which straight line to 831 for FY 2020 if the trend stays the same.  This is even further below the FDA estimate for FY 2021 of 850, which is likely to give industry some significant concern.  Thus far in February, the OGD has published thirty-one full-approval actions and seven tentative-approval actions with just five business days (and about ten reporting days still to go), so another slow month.  Totals are expected when the official numbers come out for the month.

The Agency also predicted a rise in new ANDA receipts to 1,000 in each of FY 2020 and FY 2021, compared to the FY 2019 total of 909, and, so far, that prediction of an increase looks correct as the FDA has already received 324 (annualized for the FY 2020 to an estimate of 972, slightly below the FDA estimate of 1,000).

For complete response letters (CRLs), the FDA predicts a drop, and from the FY 2019 number of 2,310, that appears to be the case, with an estimate of 2,271 for the full FY based on the first four months of FY 2020.

The Agency also predicts an uptick in supplements for the next few years and that prediction seems pretty solid as the FY 2019 numbers for CBE and PAS supplements were 8,017 and 889, respectively.  The four‑month extrapolation for FY 2020 predicts 8,976 and 1,136.

All in all, the numbers can vary significantly, but the FY 2020 numbers so far will likely pique the industry’s positions and expectations going into the negotiations for GDUFA III (which should kick off soon).  I still don’t get how the approvals keep going down!  Stay tuned!