The Office of Generic Drugs (OGD) has taken great pride in meeting all of its GDUFA goals (including most, if not all, ANDA review goal dates). But, Houston, we may have a problem!
Here are some facts that may have the OGD worrying into the future:
- December is typically one of the largest months for submissions. We don’t know yet how many ANDAs the Agency received this December, or what they are doing with those submitted after the beginning of the shutdown (which started on December 21, 2018). What we do know is that the OGD (or other UFA paying applications) cannot be submitted prior to the government obtaining authority to collect the money (i.e., after the appropriations bill is signed, funding the FDA).
- With many of the December ANDAs coming in at the wire (i.e., the very end of the month) as firms close out their calendar year for submission, and with the shutdown coming on the 21st of the month, at least one-third of the end of year submissions never made it into the gateway for acceptance. Depending on how long the shutdown lasts, when the gateway opens up to receive fee-paying submissions, there will be a huge bolus of ANDA (and likely NDA, BLA, and medical device applications, etc.) flooding into the Agency.
- That bolus will place a tremendous amount of pressure on user fee goal dates that will mostly be set for ten months after the filings. Just to get a feel for the numbers, over the last six years, with the exception of 2015 (the elemental impurity debacle), the OGD averaged 187 ANDA in December and 60 ANDA for January (with the same 2015 exception). If the shutdown goes on until March (another big month that averaged 128 [same exception]) as that is the end of India’s FY), then we will really have a problem as there may be over 500 ANDAs awaiting submission, there will be no carryover money left, and the FDA will essentially be shut down. We all hope that does not happen.
- How will the Agency be able to meet its user fee goals when more applications will arrive in a thirty‑day period (perhaps more than the FDA has ever seen before)? All hands on deck, folks, we are in for a wild ride. Let’s hope the ship does not sink before Congress and the President come to their budgetary senses and execute their responsibility appropriately.