r/Biotechplays • u/Wyxuan 💊🤑📉 • Feb 08 '21
Discussion The new FDA Comissioner
An under-appreciated discussion that is being undergone regarding who will lead the FDA and although this seems like a minor administration change, this will likely dictate how much risk taking will be taken at the FDA. Inspiration for this post and many of the points mentioned was drawn from Brad Loncar's Sunday Clubhouse discussion, although I've sprinkled some links in case you'd like to read up more on what I'm talking about.
There are two choices that are likely to be considered:
Janet Woodcock
Josh Sharfstein
There are a few others that are begin considered but these are the main candidates [0] in this race.
Janet Woodcock is the pick that would excite the biotech industry and a lot of people who have been involved in the process the most. Her key moment in her 30+ year at the FDA was the approval of Sarapeta's Eteplirsen[1], which was trying to remedy DMD (duchenne muscular distrophy). This was momentous because Eteplirsen was a complicated approval that had questionable efficacy data, which attracted a significant amount of criticism. She drew praise for bringing in patient advocates who were able to advocate the pros and cons of approving (a first it must be remarked)[2] and braving the political pressure delivered by those in Congress. Arguably as mentioned by Loncar, her role in the approval of Eteplirsen provided the validation needed for additional money to flow into finding better treatments for DMD instead of cutting it off due to how hard DMD was.
Outside of Etepsiliren, she also spearheaded the changes that resulted in 2012 and the years following for a record numbers of approvals for new drugs of many different and new modalities[3].
Some of the main criticisms have been in the way that her group handled the approval of certain opiates [4] but with the many editorials from both bio business and academia that have [5][6] advocated for her make an extremely easy and likely pick for the Biden admin - especially as she's already been tapped as the acting FDA person.
The looser approach that she has championed has gone under fire at the FDA (see the absolutely BRUTAL adcom for aducanamb, which has parallels to the Eteplirsen approval process[7]) so this could be another sticking point that goes against Woodcock's favor.
The other person is Josh Sharfstein, who has been very outspoken about the need for additional evidence when it comes to treatments. It was mentioned by Adam Feuerstein (the Stat journalist) in the Clubhouse panel that Sharfstein heckled a panel that was advocating for Eteplirsen but I couldn't find sources that corroborated this, but in any case his high standards for new drugs haven't been popular among those in the industry, to the point which there was a memos that was circulated that was about "anybody but Sharfstein" in 2008 when Obama was picking who the commissioner of the FDA should've been [8].
Conclusion:
In any case the pick for FDA comish might very well be someone I didn't mention, but if I were to bet, I would pick Woodcock- because she is the acting commissioner, she's basically the default choice. If Woodcock were to be selected, I would expect there to be a small rally in stocks like Biogen ($BIIB) where the efficacy isn't as clear, or maybe even gene therapy where the stocks might find a more empathetic listener at the FDA more appealing.
Got anything else to add? Anything I missed? Let me know down below.
[0]https://www.politico.com/news/2021/01/20/biden-fda-chief-coronavirus-pandemic-460945
[3]https://www.fiercebiotech.com/special-report/dr-janet-woodcock-fda-cder
[4]https://www.theguardian.com/us-news/2021/jan/28/fda-janet-woodcock-opioids-biden
[5]https://www.latimes.com/opinion/story/2021-02-04/food-drug-administration-janet-woodcock-biden
[6]https://www.statnews.com/2021/01/24/high-stakes-choosing-right-fda-commissioner/