Street Cred: Dog Days at the FDA

In this episode, Rick Weisseinstein of Cowen Washington Research Group speaks with Mike McCann, Founding Partner at Provisions Policy.  

They discuss current events at the FDA including virtual advisory committee meetings and interesting applications with upcoming deadlines. They also speak about the state of drug manufacturing inspections amid the pandemic, a recent cluster of FDA complete response letters, Trump’s executive orders on the drug rebate rule, import policy and the international pricing index (IPI) and whether an advisory committee will be required for a COVID-19 vaccine. 

Press play to listen to their conversation.

Transcript

Speaker 1:                       Welcome to our new podcast series Street Cred powered by Cowen’s Washington Research Group. Our resident policy pirates are planning to release interesting, insightful episodes weekly, spanning key issue areas. We landed on the title Street Cred since Cowen’s Washington Research Group lives at, and you could argue lives for, that all important intersection of Wall Street and K Street.

                                         In the coming weeks and months you’ll hear regularly from Jared Siebert hosting the aptly named Tip [00:00:30] of the Siebert, Rick Weissenstein conducting your monthly checkup, and Chris Krueger as the dashing leading man in Nightmare on K Street. Since we’re covering health and biotech, financial and housing, trade and tax, as well as political analysis, you could say that this new podcast series will keep you healthy, wealthy, and wise, but only if you rate, subscribe, and tell a friend about Street Cred.

Rick Weissenste…:          Welcome everyone to our second podcast for Cowen Washington Research Group. I’m Rick Weissenstein, [00:01:00] a healthcare analyst. And like everyone else, we are here and trying to ramp back up again after some downtime due to the pandemic. We call this podcast The Monthly Checkup and we hope to make it a companion piece to the Weekly Checkup written product that Eric Assaraf and I do for Cowen Washington Research Group. The Weekly Checkup looks at what’s upcoming in healthcare on Capitol Hill and the administration. And each month we want to do the same thing, taking a look at what’s upcoming at the FDA and [00:01:30] in the pharma bio space for the next month, along with discussing some other issues of importance to drug makers and the drug supply chain.

                                         I’m overjoyed to be joined again, again being the second time, both times, maybe both times, second time, either way, by Mike McCann who’s a founding partner of Provision Policy, which covers the FDA and all things biopharma for a number of clients. Mike and his two partners, Cole Werble and Ramsey Baghdadi, all cut their teeth at the legendary biopharma newsletter The [00:02:00] Pink Sheet where Mike was the editor for 20 plus years. And I say this all the time, mostly because I think it aggravates Mike, but Mike has really spent most of his adult life covering the FDA and the pharma bio space. That’s the part that aggravates him because it makes him sound old and I’ll throw at the end there and there’s really nobody better at this than him so then he doesn’t get mad at me anymore.

                                         With that great introduction-

Mike McCann:                 Rick, I got to jump in there though and just point out at least you’re acknowledging that I’m an adult. So I’ll take that as a compliment.

Rick Weissenste…:          So you’re one up on me already. [00:02:30] So let’s dive in. Our first segment, which we’re calling the State of Play at the FDA. In the coming month the most interesting, and in fact, the only ad comm that the FDA is planning on holding is on tap for August 13. Even if this was not the only one it would still be one we would focus on if only out of morbid curiosity because the first virtual ad comm was a bit of a mess. Mike, can you run us through what to expect at the meeting for Ryoncil, which I’m hoping I’m pronouncing right. [00:03:00] Probably not, but-

Mike McCann:                 Your guess on the brand is probably as good as mine at this point, but we’ll hear it live or we hope we’ll hear it live on August 13th. And you’re correct, it’s the second time the oncology drugs advisory committee will be trying out a “virtual advisory committee meeting” and it’s really a teleconference. Turns out they don’t even bother at this point trying to do the sort of Zoom calls we’ve all gotten used to with video.

                                         The first one, I think as you alluded to back in July, was [00:03:30] a near disaster or maybe we could almost call it a disaster from a technical perspective. All kinds of trouble with really a pre-recorded sponsor presentation that they couldn’t quite get to work. And then all kinds of audio problems throughout the day for what was actually a fairly straight forward review in the end with a GlaxoSmithKline breakthrough application for myeloma therapy and clearly in hindsight the purpose of the meeting was to highlight an unusual risk profile, [00:04:00] not really to question whether it should be approved and sure enough it was a unanimous vote for approval when they finally got to the point where people could vote.

                                         This meeting sounds like it’s going to be a lot more complex in every way and it’s a company called Mesoblast, an Australian firm within allergenic cell therapy and it’s for a very dire condition, severe pediatric graft versus host disease. So [00:04:30] transplant rejection is, of course, a life threatening risk. The agenda outlined in the federal register for this meeting is a full day agenda. The first meeting was only supposed to be a half day, but it took a full day because they had so much trouble. So they’re more ambitious right out of the gate for this one.

                                         And it starts specifically saying that the morning session is going to be focused on issues related to the characterization and critical quality attributes of this [00:05:00] cell therapy as it relates to clinical effectiveness, which is both a topic that I would think would be a challenging advisory committee conversation in the best of settings and also probably an ominous topic for a sponsor where you’re hoping the focus is just on safety and efficacy. Then the afternoon is going to be devoted to what sounds like the more typical discussion of what’s the clinical benefit and is it good enough for approval?

                                         So this is [00:05:30] an unusual application and there’s obviously a lot to talk about with it. The sponsor’s presentation of the data publicly, if you believe it at face value, is very impressive. They have a single arm trial with matched controls and they assert that there is a 28 day response rate in this dire condition of 70% versus 43% in the control arm and even a survival benefit, 100 day survival [00:06:00] rates of 74% versus 57%. So for me, just as an observer, this is the kind of application where I think if FDA was completely confident in that level of efficacy they would not be going to an advisory committee, they’d be trying to accelerate the approval as best as they could. So they obviously have some issues that they’re looking forward to talking to with the committee.

                                         Just another layer of sort of public interest in this application, the sponsor is simultaneously testing the cell therapy as a treatment [00:06:30] for acute respiratory distress syndrome associated with COVID-19. They actually have a trial running and again, they are projecting that they’ll have some data potentially available at the end of August. So there could be a layer of sort of public interest underneath all this that has nothing to do with the proposed indication that’s under review.

                                         So this will be a fun test, both to see how the virtual technology works on the … will actually be the third advisory committee [00:07:00] using this format and the second oncologic drugs meeting and if they can actually get the technology to work well. And it’s also a pretty interesting application that clearly has a lot to talk about. So it should be an interesting day on the 13th.

Rick Weissenste…:          And Mike, you’ve talked about the first one that happened and one of the things you pointed out was normally you get FDA leadership there, or people that matter at the FDA there, who will discuss something or speak out or you can get the body language or at least have a chance to see how they’re reacting [00:07:30] to things. You don’t really get that in this situation or for a sponsor like this, which in this particular submission, that might be a big deal, right?

Mike McCann:                 Yeah, definitely and the first meeting was sort of the classic ODAC and Rick Pazdur, the head of the Oncology Center of Excellence, was kind of the host of the meeting, but said nothing during it and it’s not unusual for him to sit quietly if he thinks the meeting is going the way he wants it to, but he’s also very famous for just sort of stepping [00:08:00] in, in the middle of the discussion and telling the committee they’re off base and they should think about something else.

                                         The second meeting, it was actually a cardiorenal committee meeting, was where it really stood out to me where you had the senior FDA officials who normally relish engaging in debate with the committee and sometimes, frankly on side issues that probably aren’t that important, but usually you leave those kinds of meetings with a feeling that the senior management was either favorably or unfavorably inclined and bought or [00:08:30] didn’t buy what the committee was saying. And here they just introduced themselves at the start of the day and they said nothing for the rest of the meeting and you were left wondering, “Does that mean they agreed with everything they heard? Does that mean they were called into another meeting and didn’t even pay attention?” There’s nothing you can learn from that. And in that particular case the meeting ended in a split vote.

                                         So it was eight, seven and I’m sure as the sponsor you would love to have some clue whether the division director and office director were more persuaded by the yeses than the nos, but there’s just [00:09:00] no information to be gleaned from it. So it’s definitely a very different experience. And here you have clearly going to be some complex discussions. There’s going to be the biologics group presumably rather than the drug team that’s running the meeting or at least discussing the application and it might be very difficult for the sponsor to get a read on what the decision makers are actually hearing and taking away from the meeting, which after all is what really matters. So that’s something we’re all going to have to adjust to for as long as [00:09:30] this strange pandemic period continues. And it also seems like FDA is being really sparing in using their advisory committees as well.

                                         So at least they get some public feedback, but I think probably everyone is eager to get back to those in-person meetings once it’s safe to do so after just the first two experiences were probably enough to learn that.

Rick Weissenste…:          Yeah. I think they have to be upset after that first one and all the troubles that they had. I mean, [00:10:00] that did not put them in the best light far as that goes. I’m sure they’re happy to move on. There are also a number of applications with decision deadlines in August. So let’s move on to our next segment, which we’re calling second opinion. There’s about eight or 10 of them that are up later in the month. So Mike, which of the applications do you want to highlight as being particularly interesting?

Mike McCann:                 Yeah. There are a lot and it’s funny for me, you’ve been so [00:10:30] kind to reference how long I’ve been doing this, but once upon a time August was real quiet and like everyone else in Washington DC went on vacation in August. In the kind of modern user fee era, August turns out to be a really busy month because if you’re trying to get something filed at or near the end of the year, a lot of the deadlines end up falling into August and you end up having often these sort of clusters of very interesting applications coming up all at once.

                                         One thing just to point out, [00:11:00] there would be probably twice as many new molecular entities with decisions coming up in August, except that the oncology group at FDA has already approved almost all of them that were filed. They had August deadlines, but that group works months ahead of schedule. That’s just kind of an interesting side point. But I would call out there is at least one of the oncology group reviews that’s pending, which is that GlaxoSmithKline myeloma drug was the subject of the advisory committee review. It has an August [00:11:30] deadline. Certainly based on the unanimous recommendation for approval, one assumes approval will be forthcoming.

                                         And I think what most people will be watching on the investor side and everywhere else will be what the label says in terms of this unique risk it has for an ocular toxicity and how strict are the controls to make sure that that’s appropriately screened for. And then what, if any, commercial implications that ends up having. [00:12:00] And I guess we’ll also see if having to take it to the advisory committee and discuss it first leads to what would be a very unusual situation where they actually have to extend the deadline. I don’t expect that, but it would be an interesting just test case if they end up having to actually delay a decision for once in that oncology group just because of the getting through this advisory committee process.

                                         To me though probably the most exciting and interesting application with an [00:12:30] August deadline is a potential first hemophilia gene therapy from BioMarin. The deadline date is August 21st. We are hopefully on the cusp of a wave of really potentially curative gene therapies for rare diseases. Obviously hemophilia A is a very interesting and important one and this is an application that has a lot of interesting regulatory wrinkles to it. [00:13:00] It’s presumably going to be an accelerated approval for a gene therapy and so a lot of us will be interested in seeing exactly how FDA translates its guidance in this area into an actual approval and what the confirmatory trial obligations look like and so forth. I think, should it be approved, it will also be a really remarkable test case sort of commercially for gene therapy as well.

                                         Obviously the potential of a cure in hemophilia could be one [00:13:30] of the most extraordinarily valuable medicines ever compared to the cost of clotting factors and so forth that’s used in treating the disease now. This therapy does not appear to be a cure in everyone and maybe not in anyone. It might wear off over time. And I suspect there’ll be a lot of interesting conversations should it be approved around what the best way is to price it and the best way is to contract for it in a way that captures the value [00:14:00] depending on how it actually performs in patients. So this is one that I think, both as a regulatory story and then looking forward as a reimbursement and coverage story, could be fascinating for the months and years ahead. And I guess I’ll just call out two other very different sorts of applications that are resubmissions that just will maybe give a sense of where FDA is on some old topics.

                                         There’s a company called Trevena that has a novel opioid [00:14:30] pending for pain and it was rejected the first time around and the resubmission is in with an August 7th deadline. Obviously the opioid class been one of the toughest and most difficult areas for FDA and I guess for the whole country, before the pandemic anyway, and hadn’t gotten any better since. So that will be one to watch and just see if there’s any sign that FDA’s kind of hard line on getting any creativity in the opioid space is still in place or if there’s been any change in [00:15:00] thinking there. And there’s also a resubmission for a novel testosterone formulation from Lipocine that comes up on August 28th. And again, there was a lot of regulatory agita around the so-called low T claims for testosterone therapies, safety issues in the class, a lot of work done on trying to relabel them and really sort of restrain what FDA started to view as out of control [00:15:30] use of these products.

                                         This application was submitted in the middle of all that and a reformulation of testosterone should be a relatively straightforward decision that either mirrors other approved products or it doesn’t, but it got kind of caught up in a lot of those safety concerns and the fear of overuse of these products. So again, it’ll be an interesting test case come August 28th about whether that climate has changed at all and FDA is a little more comfortable [00:16:00] allowing new entrance in this class going forward. So, as I said, there’s tons more, but those are just a few to wet the appetite for the month ahead.

Rick Weissenste…:          I do long for the days when August was nice and quiet and everybody sort of unilaterally disarmed and went home and we didn’t have to really work very much. Much different climate now, that’s for sure. Mike, let’s move on to our next segment, which we’re calling diagnosis. The idea here is we want to look at an [00:16:30] issue or issues in a bit more depth. And this month I want to ask you about two important topics. The first is a state of play on manufacturing inspections. At the outset of the COVID lockdown, it was feared that inspections would be halted completely, but it’s really played out as not being all that bad, at least as far as we can tell. And I know the FDA recently released some new guidance on inspection. So really where are we now?

Mike McCann:                 Yeah. Certainly. I mean, the agency [00:17:00] did halt certainly all international inspections and then most domestic inspections. They always made an exception for “mission critical inspections,” which they never quite defined. But what they’ve been able to do, starting in March through the present really, has been to accomplish the goals of particularly things like pre-approval inspections by other means.

                                         You’re able to work with sponsors to collect [00:17:30] paperwork remotely without having the physical site visit by the inspector. They’ve clearly relied a lot on cases where other global inspectors have been able to visit a facility, even if FDA can’t travel there and so forth. And remarkably through this period, there’ve been really just a tiny handful of applications where it seems like the lack of an inspection became a hurdle to actually making a decision [00:18:00] on time and for the most part FDA has just been moving forward. They did announce a policy to resume and to resume “routine inspection activity in the US starting July 20th,” but it’s routine in the sense that they’re going to now be visiting facilities, not necessarily based on a preapproval inspection, but to do their normal checkup as it were, but there’s nothing routine about it.

                                         All inspections, [00:18:30] even in the US right now, are pre-announced. I think that’s a safety measure that everyone understands. They can’t just have a group of people show up unexpected at a site at this time. And it’s also kind of an odd and not overly transparent set of metrics that FDA is applying. They’re making clear that they’re going to prioritize these inspections. So if they’re coming to visit a facility it’s for a reason, it’s been a long time since they’ve been there or they have [00:19:00] some underlying questions that they’re trying to answer, but they’re also following their own sort of guidebook on where and when it’s safe to travel, even within the United States, which I guess is in its own quiet way an indictment of the federal guidelines as they exist because it appears the FDA has come up with its own set of metrics that will decide when a certain part of the country is safe enough to inspect and when it’s not.

                                         And as far as I know [00:19:30] those are not public, they’re FDA’s own secret sauce as it were. So there’s presumably some inspection activity has resumed, but boy are we a long way from being back to a “normal inspection activity” and I think it will be interesting to watch over time and one of the things I would flag in the near term is when FDA does go and inspect a facility, if they do find something wrong, I think there’s going to be a tendency to try to make [00:20:00] an example, draw as much attention to the errors as they can in the hopes of getting the attention of all the people they can’t inspect. That’s kind of normal reaction by the agency when they’re feeling constrained on their ability to inspect. That will be balanced against a very strong desire to do nothing that harms access to medicines during this pandemic.

                                         So it’ll be interesting balancing act there. When we do get back to normal inspections, so say hopefully a year from now. Maybe [00:20:30] if you’re optimistic there’ll be a vaccine and travel will be more or less acceptable almost anywhere. I think they’ll then be kind of a look back on all these products that were approved without the usual preapproval inspection. And there may a learning that what FDA did during the pandemic can work just fine in the future. It’s clearly more efficient not to send inspectors to every plant every time. And if it turns out that that worked really well, that could be [00:21:00] a new normal going forward.

                                         And the flip side being, if they find a case or two where they regret not having done any inspection up front, you might see a period of clamping down on flexibility, on preapproval inspection matters for a while too. And that’s just something to watch if and when we do get back to normal travel. So anyway, where we are now is at least there’s some inspections that are happening. I still think for the most part review [00:21:30] decisions will be made, even if they can’t inspect in a normal sense. And then we’ll all wait and see where this shakes out a year or two from now.

Rick Weissenste…:          Great. The second question that has cropped up I think with investors is that there’s been a rash, if I can call it that, a small rash anyway, but a rash nevertheless, of complete response letters coming out of the FDA. There’s some concern that maybe this is [00:22:00] something new at the FDA or is it really just happenstance that these four really came up all at roughly the same time or do you think this is a sign of change at the FDA?

Mike McCann:                 Yeah. It’s definitely a question that comes up and it comes up whenever there’s one of these sort of weird clusters that happens to affect applications that investors are focused on because obviously there’s this refuse to file actions and complete response letters all the time and a lot of the time it’s you never [00:22:30] even hear about them because no one’s really paying attention.

                                         They’re not commercially or no one seems to think they’re that important, but you get a couple where they feel surprising and they’re being followed by the street and it’s human nature to then tie together a broader pattern. My immediate instinct is always to say, “This is really just kind of a statistical cluster and nothing more, particularly when you look at the overall backdrop of FDA’s performance.” I mean, [00:23:00] we could set a record for new molecular entity approvals this year. Not sure we’ll get there, but we’re on pace for close to 60, which is extraordinarily productive in terms of the output from FDA and actual NDA approvals, not just the new molecular entities is also at or near record levels. So overall most applications are still kind of cruising through the agency.

                                         At the same time, it’s worth [00:23:30] at least keeping a close eye on things because we are now six months into this incredibly disruptive period. FDA employees are disrupted just like everyone else. Even without that, you do have a transformation, the review divisions at FDA, and then an expansion of the number of divisions, which means some newer leaders who are less experienced in the job. That doesn’t mean they’re incapable, but it [00:24:00] may be that at least in some cases they haven’t always learned some of the hard lessons about the difficulties of communicating with sponsors. Nine times out of 10 when there is a problem with an application it basically comes down to FDA told the sponsor one thing and they heard another and you can always blame either side for that if you want, but the truth is as people at FDA learn where the pitfalls are they become much better at communicating and making themselves clear.

                                         [00:24:30] And then some sponsors will always miss the message if they can because they have other agendas in mind, but be that as it may. So I guess from where I sit, Rick, I’m still inclined to say, “This is kind of a random cluster of a few specific circumstances.” Some divisions at FDA are better and worse than others. We talked about oncology. If your application is rejected by any oncology group, my ironclad assumption [00:25:00] is it’s because you did something wrong as a sponsor because the oncology group is falling all over itself to do everything it can to keep applications moving. There are other divisions where I don’t feel that way. We mentioned opioids. The pain analgesia division has been struggling with an incredible workload around opioid policy. Really an impossible workload.

                                         And they’ve now had layered on that they’re responsible for a lot of critical care medicines that are in short supply. So it’s not surprising to me [00:25:30] if in that division sometimes maybe a sponsor has trouble getting the attention they might otherwise get and need to have a successful interaction. There is going to be some variability and I think we should all just keep a close eye on whether over time the same division seems to keep running into the same obstacles or if it really is just now and again an application’s going to go off the rails and it’s nothing more well.

Rick Weissenste…:          Wow. And that division that deals with opioids, of course, has also been [00:26:00] the center of a number of hearings on Capitol hill, et cetera, where you usually get the normal amount of grand standing and in some cases even attacking the FDA. So one could understand certainly why they would be perhaps a bit more gun shy than some of the other ones.

Mike McCann:                 Yeah. And they even just had a leadership transition of their own where the division director and other senior person had left. So it’s kind of a perfect storm of that would be not surprising that a sponsor might have some difficulties in that division. [00:26:30] And the flip side being, if you are a sponsor trying to work with that division, you should be prepared for what you’re getting into and over communicate accordingly.

Rick Weissenste…:          I can’t imagine that as somebody new at the FDA who gets assigned to that division say, “Woo-hoo. Boy am I happy.”

Mike McCann:                 Yeah. [crosstalk 00:26:49].

Rick Weissenste…:          Divisions.

Mike McCann:                 I don’t have any data on this, but I got to believe that that would be the least popular division to be assigned to in the agency.

Rick Weissenste…:          Yeah.

Mike McCann:                 And [00:27:00] the flip side is there certainly are people where that’s their specialty and their passion. But boy, it’s a thankless job. I mean, it’s a thankless job. There’s no right answer on these opioids unfortunately.

Rick Weissenste…:          Yeah. Isn’t that the truth? So this brings us to our last segment, which we’re calling prognosis. The idea here is to look at some upcoming events outside the FDA that could have an impact on the drug sector. Having said that, I have two things to ask you, one of which actually [00:27:30] is the FDA so I’m already lying, but we’ll move anyway. Mike, I wanted to ask you about the recent executive orders out of the Trump administration and what you think they mean for the dialogue on drug pricing going forward and what you think we’re really going to see. Obviously the two of interest where the rebate rule and then the fourth one, the one that they haven’t really released, appears to be discussion of the IPI. Certainly with the rebate rule anyway, [00:28:00] the clause in there is saying that it can’t increase spending or increase premiums would seem to be an iron clad poison pill, unless I’m missing something.

                                         So what do you think about those and do you really think these are any kind of threat whatsoever to the industry at this point anyway?

Mike McCann:                 Well yeah, Rick. I think now president Trump has finally done it and he solved the drug pricing problem. So we’re set. Okay.

Rick Weissenste…:          Right.

Mike McCann:                 As you allude to, all the ideas, and I would also just mention the import policy [00:28:30] executive order as well, only because that’s the one where there is a proposed rule that was issued in the comments we’re due in March just before the pandemic came. And that does fall in FDA’s bailiwick. I think, left to their own devices, the agency would happily focus on other priorities, but the executive order should remove any doubt. They’ll issue a final rule at some point and then the state of Florida will be able to apply for permission to import.

                                         Anyone else who wants to can [00:29:00] to, but I have a feeling that the state of Florida is the most important applicant there. I doubt anyone’s going to be importing drugs wholesale before election day, but I would be shocked if the rule itself doesn’t come out before election day since I think the president wants to deliver that. The rebate rules is definitely a much bigger deal for the industry and how drug pricing works, but it was fascinating to just see the entire debate over the rebate rule seem to play out [00:29:30] exactly the way it did in 2019 in the course of about 48 hours when the president was going to sign these executive orders and he was going to put the rebate rule in there and it was out and it back in and then as you allude to it’s back in there with the caveat that HHS secretary Azar will basically have to put in writing that he thinks his own actuaries and the congressional budget office are completely wrong when they say that this rule would increase premiums and federal spending.

                                         I [00:30:00] suppose he could do that. It still comes back to then you still would have to somehow get a final rule out the door. And even if they did got it out, say tomorrow, it’s too late to implement the policy in 2021. The Medicare plans, the bids are in and you can’t really just tear it up and make them start over. So this is something that clearly will be decided after the elections and I [00:30:30] personally don’t think secretary Azar will be back after the elections, even if president Trump should win. So not so sure we’re ever going to see a final rebate rule. And then you mentioned the last one is this invisible ink executive order that is the international pricing index or most favored nation or something else.

                                         And apparently was signed mostly with the intent of getting the drug companies [00:31:00] to come back into the White House for a photo op similar to what happened way back in January of 2017. And the drug industry said, “Thanks, but no thanks.” And I guess chose not to take that threat seriously right now. And that probably tells you at least how they’re handicapping the election at the moment. So a lot of time between now and November. So I guess, yeah. I would say that there’ll be some interesting [00:31:30] precedent set, certainly by that import rule should it come out in final form, but I kind of don’t think we got this drug pricing problem moved really even one inch forward yet heading into election.

Rick Weissenste…:          I think that’s fair and I would completely agree with you on that. Interesting the Florida re-importation from Canada waiver, which they’re looking for the other state that has been public about wanting to do that is New York. And I [00:32:00] looked it up and New York and Florida added together have more people than Canada and in the US they use significantly more drugs per person than Canada. So unless Canada’s basically going to send us all of their drugs, this would seem to be … which they’ve said they’re not interested in doing, surprisingly enough. Again, this would seem to be more of a political maneuver than something actually aimed at reducing drug prices.

                                         I will ask you one last question and then we’ll let you go. The FDA seemed [00:32:30] to suggest very recently that they might not need an ad comm for COVID vaccines. That’s kind of an interesting turn. Can you tell us a little more about what their thinking is there and where you think that’s going?

Mike McCann:                 Yeah. Great question and it’s good to bring us back. We can go full circle and get back to advisory committees where we started, which is fun. This was a CDC advisory committee meeting, the ACIP, Advisory Committee for Immunization Practices. They’ve been proactively [00:33:00] preparing for COVID vaccines and many, many important issues about who’s going to get them and how quickly and in what form. There’s an FDA official from the vaccines group who serves kind of as an ex-officio member of ACIP and spoke up at the most recent meeting to talk a little bit about the FDA approval process and of course, everyone is worried about, will the agency be put under political pressure to approve a vaccine?

                                         The October [00:33:30] surprise theory to get a vaccine out ahead of election day and allow Trump to declare that the virus has been defeated. So I think the broader context is an attempt by a career FDA official to assure ACIP, this external committee, that FDA does things by the book and follows the process and falls in the science. In doing so [00:34:00] they’re also trying to do it as quickly as possible. They recognize obviously this is the most important probably public health application potentially ever that they would have to review and you don’t want to waste any time on unnecessary steps.

                                         And we just talked about how difficult some of these virtual meetings were, even an in-person meeting is logistically difficult. And I think less to themselves, the vaccine group at FDA would just assume review and if appropriate approve, [00:34:30] or authorize, take the first step, of an emergency use authorization before the full application is ready, without the extra time and burden of preparing for an advisory committee. I think that’s where sort of the agency career staff is and it’s a very logical place to be. Just to be determined is, number one, will Congress impose some kind of legislative mandate? Certainly Democrats in Congress have already [00:35:00] proposed that there should just be, as part of the next COVID bill, a requirement that FDA cannot approve a vaccine or even authorize one under their emergency use procedures without first hosting a meeting of their own vaccines committee. Those kinds of mandates, the FDA never likes them.

                                         You get all kinds of problems like what if there’s a power failure on the day of the meeting and suddenly you can’t host it like you plan? [00:35:30] Do you really want to waste another week or two getting it ready? That being said, I think the political leadership of the agency will ultimately decide this and whether they recognize that public confidence in an eventual vaccine is as important as a successful vaccine itself. And so I think they’ll read the tea leaves when the time comes. If they feel like there’s a risk that they’re making a decision, say in October, [00:36:00] and everyone’s going to suggest that this is being done purely because the president wants it done, they may be more likely to hold an advisory committee then so that the public can see their own thinking and try to provide some measure of public assurance that they aren’t moving that quickly just because of political pressure.

                                         Flip side is if, as is probably more realistic, there’s no vaccine that’s ready for approval until after the election. Wouldn’t surprise me if they do skip the step just to save time. [00:36:30] But we’ll see, obviously, as we get closer and like I said, Congress could take that decision away from FDA between now and then.

Rick Weissenste…:          Well Mike, you are gracious in saying that I had any clue that I was actually bringing this full circle to talk about ad comms at the end here. I wish I had thought that. That would’ve made more sense, but I’m going to take it anyway. Mike, really appreciate your time. A lot to cover here as there always is. Thanks everyone who ends up listening to this. Really appreciate it. And if you have any feedback, this is only the second one. [00:37:00] As I said last time, I’m not a huge podcast fan. So please, if this is the worst one ever, I’m blaming Mike. If it’s not the worst one ever I’m taking total credit for that. But if you have any feedback, things you want to talk about, things we could do better, please pass them along. So thanks everyone and Mike we’re out.

Mike McCann:                 Thank you very much.

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