During the February 3rd meeting of the IVD Town Hall that OHT-7 has been hosting since early on the pandemic Office Director Timothy Stenzel proudly proclaimed:
We have also really have ramped up our decisions. So we are currently over the last week averaging about nine decisions. That’s N-I-N-E, nine a day.
While we were initially encouraged by this update from Dr. Stenzel, we reserved judgment till we could look at more data. We waited two months since the town hall in February to do a look back at Q1 2021 and the state of the play for IVD EUAs.
At the onset of our review we were puzzled. We are being told that the Agency was making up to 45 decisions a week, but why have we not been seeing more EUAs on the market? The answer, in part, is in the rest of Dr. Stenzel’s description from that same town hall as to what counts as a decision.
And some of these are of course new original authorizations…Many of them though are also supplements and amendments to existing EUAs…Also we consider a decision in our accounting when they issue and close out a pre-EUA feedback. And then of course there are negative decisions and those we don’t publicize typically… So not all of our decisions are publicly seen easily or at all…[W]e are working harder and faster than ever with more people whereas in the beginning of the pandemic…when we had an application making maybe one decision today. We’re now making nine decisions a day.
The monologue above raises a few key points that we will address individually.
1. Not all decisions are authorizations.
How many of the decisions are Authorizations? Let’s take a closer look at the data from 2021:
Table 1 – Positive Decisions on OHT-7 EUAs during Q1-2021
| 2021 | Serology | Molecular | Antigen | Total |
| January | 6 | 28 | 2 | 36 |
| February | 3 | 25 | 2 | 30 |
| March | 10 | 29 | 9 | 48 |
What we can glean from the data is that the first quarter of 2021 was once again dominated by RT-PCR reviews. If the pace of nine decisions per day held true through the first quarter of the year, one would expect nearly 200 decisions per month. As can be seen in the table above, OHT-7 never exceeded 50 positive decisions in a month. The data in this table includes both new EUA authorizations and re-issued authorizations via the approval of supplements. This means that the overwhelming majority of decisions that the office has made in the first quarter of 2021 was to close-out PEUAs or render negative decisions on pending EUAs.
2. Not all authorization are new products
Let’s remove the decisions for supplements to existing EUAs and look at brand new authorizations. Many of these decisions listed above fall away and we are left with the following:
Table 2 – New EUAs Authorized by OHT-7 during Q1-2021
| 2021 | Serology | Molecular | Antigen | Total |
| January | 5 | 4 | 1 | 10 |
| February | 1 | 10 | 1 | 12 |
| March | 4 | 10 | 6 | 20 |
When distilling down OHT-7’s track record in Q1 2021 to the new authorizations, we see that the pace of authorizations has slowed to a crawl. Over the first three months of the year OHT-7, on average, authorized a new EUA every 1.5 business days. This does not bode well for companies that are in the process of submitting new EUA as less than half of all positives decisions are to bring a new device to market.
3. Is OHT-7 working faster than the beginning of the pandemic?
Let’s compare new EUA authorizations from the most recent quarter to the first three months of the pandemic:
Table 2 – New EUAs Authorized by OHT-7 during the First Three Months of the Emergency
| 2020 | Serology | Molecular | Antigen* | Total |
| February | 1 | 2 | 0 | 3 |
| March | 4 | 20 | 0 | 24 |
| April | 9 | 25 | 0 | 34 |
The declaration of a public health emergency was not made until January 31, 2021. The first EUAs were starting to trickle in during the beginning of February so it is expected that the first month of the pandemic shows slow progress. Additionally, the number of review staff dedicated to reviewing EUAs was only a fraction of the current review staff for COVID-19 response team as the scope and scale of the pandemic was not yet understood. Similar to Q1 2020, new PCR authorizations were dominant and higher than in Q1 2021. The number of serology EUAs authorized is still higher in the first three months of the pandemic than Q1 2021 even when taking into account FDA’s policy in March 2020 to allow serology tests on the market without prior FDA review. The only category where 2021 outperforms the first three months of the pandemic in new authorizations is with antigen tests. The first antigen EUA was not authorized till May 8, 2020. In light of the above, at the beginning of the pandemic OHT-7, on average, authorized a new EUA every business day.
During the first few months of the pandemic OHT-7 tried to walk and chew gum at the same time by reviewing EUAs and completing their normal review work as required by MDUFA. This was the strategy employed when the emergency was declared for the Zika virus back in August 2016. Similar to the Zika emergency, at the outset of the COVID pandemic review staff were not pulled from other divisions and the additional review work brought on by the EUAs was handled through the approval of overtime for existing staff. However, once the significantly greater scope of the COVID pandemic became clear, the number of review staff dedicated to reviewing EUAs increased dramatically.
When taking into account the significantly higher EUA staffing levels in Q1 2021 than 2020, a full year of review experience with the EUA process, and a full workload to maximize output the pace of new device authorizations is far below the 2020 numbers. With the data on hand we cannot confirm Dr. Stenzel’s claim that OHT-7 is working faster than ever on EUAs is true.
FDA needs to increase transparency within their review process by publishing key metrics:
- We recommend that FDA publish the average time with standard deviation from EUA submission to reviewer assignment stratified by technology (Serology, Molecular, Antigen) and Indication
- We recommend that FDA publish the average time with standard deviation for the authorization of a new EUA stratified by technology (Serology, Molecular, Antigen)
- We recommend that FDA publish the average time with standard deviation for the authorization of an EUA supplement stratified by technology (Serology, Molecular, Antigen)
- We recommend that FDA publish the average time with standard deviation to receive PEUA feedback stratified by technology (Serology, Molecular, Antigen)
- We recommend that FDA not include negative decisions in their metrics
- We recommend that FDA publish the number of pending EUAs and PEUAs
- We recommend that FDA publish the current number of review staff dedicated to IVD EUA reviews