March 2020 has got to go down in the history books as one of the most disruptive months of the last forty-four years (that is how long I have been in the pharmaceutical arena). COVID-19 is running rampant across the country. Many states are in lockdown and social distancing seems to be the new norm. Most people are working remotely (including most from FDA) and restaurants, if you can find one open, are doing take out only. Toilet paper is the new Bitcoin, and hand sanitizer and disinfectant wipes are like gold. Two things that appear to be working overtime are the FDA and Netflix.
The OGD, despite working mostly by remote means, has been able to keep approval actions moving through the system. With numbers unofficially reported through March 23, 2020 (here), the OGD has issued forty-two full approval actions and thirteen tentative approval actions for a total of fifty-five thus far. The official averages for these two metrics through the first five months of FY 2020 are 55.8 and 11.8. With five days left in the month, the OGD is poised to meet or exceed those averages in March.
What is unusual is that the February set of full metrics has not been updated yet, and we are very close to April. The updates usually occur by the second week in the following month. You notice that I used the word “usually” in the previous sentence? Well, there is nothing “usual” about the month of March in 2020, and I expect it will be a few months before any semblance of order is returned to the FDA’s or the rest of our lives. Once the February metrics are updated, and, after the first few days in April, I will update you on where the OGD numbers stand. Till then, stay safe and healthy!