FDA AdComm Agenda Covers the Bases

First of all, we are having a bit of a crisis with our crisis. As we appear to be moving into yet another wave of COVID-19 infections, and as research into a vaccine is aggressively underway, we also see serious drawbacks. Apart from the increasing numbers of cases in the United States, there has been a strong perception that the process has been politicized which in turn has brought on an increasing skepticism or crisis in confidence on the part of the public to embrace the outcome. And now, three agencies that have seen an erosion in public confidence – FDA, CDC and NIH, will participate in an FDA Advisory Committee meeting that will discuss vaccine development.

The agenda has been posted for the October 22 meeting, and the discussion will be available to view on YouTube, according to FDA Commissioner Hahn. One had to wonder what the meeting would actually be discussing since there was no candidate vaccine to consider for approval and given the fact that FDA has already issued guidance to provide a framework of understanding for how the agency will approach approval.

The order of the day includes presentations from all three stakeholder agencies – CDC, FDA and NIH and appears to be designed to add a little more meat to the bones on how each will play a role and to lay out some of the mechanics of the process. in the day they will establish a level playing field for understanding COVID-19, followed by the various key agencies explaining their part in the process, beginning with NIH, followed by BARDA with CDC discussing that agency’s role in monitoring use after either early use authorizations (EUA) or final licensure and CBER will follow up describing post-marketing surveillance systems. Another CDC presentation will discuss vaccine distribution and tracking, which is an important topic about which there are many questions, followed by a discussion on “vaccine confidence” presented by the Reagan-Udall Foundation. There will be a specific discussion of the manufacturing and control as well as the clinical considerations for EUAs and licensure. In short, broadly all the categories in which there are questions seem to represented in the agenda.

Apparently as well, they are expecting a higher degree of public participation in the Open Public Comment period, usually reserved as a 60-minute window, but which is cast for 90 minutes for Thursday. Presumably if that is the case, participation will be limited to a set number of minutes. The number of comments added to the docket that had been set up for the meeting numbered 34 as of yesterday and included two stakeholder companies engaged in clinical trials.

Hopefully what will come out of the discussion is not only the broad understanding of the background and mechanics of approval and distribution, but answers to a good number of the questions regarding the nuances of actual approval, distribution and uptake. Whatever is going to be offered up during the presentation from the Reagan-Udall Foundation about confidence, this meeting will actually be an important factor related to the confidence levels of people, particularly health care workers, in taking a vaccine once there is one to take. This meeting cannot settle for perfunctory presentations and must take the questions that were raised in the docket comments, and those that will be raised during the Open Public Comment period and respond to them in some way subsequent to the meeting. We are in unprecedented times that require unprecedented transparency, planning and sound communications that has so far been largely lacking. Meetings are often perceived as an event – but this one is the beginning of a process.

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After a Vaccine – What? The Shift from Research and Discovery to Communications

Vaccines for COVID-19 are the focus of the moment – politically and scientifically speaking. On the political front, there has not only been jockeying to try to squeeze the square peg of a vaccine development timeline into a round hole of political convenience, there is also skepticism expressed by a wary public that the process has become politicized – an unfortunate impression to be sure. Scientifically, there was the big news that a vaccine trial had experienced a serious adverse event bringing a pause to bear in its continuation, likely throwing further cold water on the political side of the equation. But eventually vaccine candidates will likely emerge as successful, developed and evaluated according to the FDA guidance laid out on the subject. What then? Who will take the vaccine and at what rate?

That question has been the subject of numerous polls which have found widely varying degrees of willingness among the public to the idea of taking a vaccine – an opinion that may be further influenced by the emergence of adverse events in the clinical trials. One poll found one-third would not take a vaccine; another found fewer than half; and one that found that only one in five would take a vaccine.

There are perhaps three major categories of vaccine outlook: (1) Those who will be early adherents and seek and get vaccinations as soon as the distribution guidelines allow for it; (2) those who will hang back and wait to see what happens but may eventually take a vaccine; and (3) those who are committed anti-vaxers who will refuse to take a vaccine under any circumstances. You do not need to expend resources on the first category and you will likely waste them expending efforts on the third category. It is those folks in the middle who are the most important to communicate with. It is their sentiments, motivators and beliefs that need to be examined.

The New England Journal of Medicine published an important Perspective piece – “When Will We Have a Vaccine? – Understanding Questions and Answers about COVID-19 Vaccination” that explored two primary parts of the question – when will there be a safe and effective vaccine and when it does become available, who will take it. With respect to the latter, the article points out that to achieve the societal aim of ending the pandemic, then uptake will have to be strong to achieve the goal of herd immunity, even when combined with the huge numbers of people who have already been infected. While noting that a range of trusted people may be utilized as trusted messengers to promote vaccination, healthcare professionals are likely to be among the most persuasive. And moreover, the article makes clear we need to think about the role of communications.

When it comes to that, some additional insight comes from a Gallup poll also published this week which looked at regard for business and industry sectors. Last year the pharmaceutical industry was ranked at the very bottom. This year there was movement and the industry is now the second-lowest regarded industry, just above the federal government, with 49 percent of respondents viewing the industry negatively and 34 percent having a positive outlook, a net negative of 15 percent. However, of note was the change in the ranking of the healthcare industry which went from the third-lowest ranking last year to somewhere in the middle with a 13-point increase to 51 percent favorability. It was the first time in the 20 year history of this Gallup poll that the healthcare industry was viewed with more positivity than negativity. It is perhaps a direct result of the extreme effort and sacrifice that has been witnessed by healthcare workers in the face of the pandemic.

Bottom line – communications planning needs to be taking place in earnest and assets should be cultivated now that will allow for credible outreach to that middle group of people who may be uncertain. The surveying of sentiment needs to be targeted and precise and consistent. The underpinnings of any campaign need to be evidence-based. Just as we can’t afford to miss the target with respect to the vaccine itself, we do not have the luxury of missing it with communications efforts around the vaccine. And the message is not only important, but so is the messenger. Looking to the rankings of the Gallup poll mentioned above, with the great advance made this year among healthcare workers and other indications that people do not want information about the pandemic coming from government officials or non-scientists, health care workers emerge as the obvious messenger. That needs to be coordinated now. Health care workers who have been on the front lines and bravely witnessed and endured the very worst this pandemic has had to offer may be the most credible. To that end, among others, medical societies should be going out of their way to finding them and to be prepared to offer communications guidance to their membership related to vaccines. Additionally, the next likely most credible source of convincing information will be the experiences of friends – friends who have been vaccinated. They will have influence both in-person and via social media. Their voices will need to be amplified. That means outlining a very cohesive, convincing and comprehensive social media strategy. Because while the main battle today is the one in science – to jump the hurdles of research and discovery, the next effort will be in convincing people to use the vaccine and that will be a communications effort. Like the science, it is best grounded in research and evidence. And like the science, the research and development of communications should be taking place now.

Photo by Markus Winkler on Unsplash

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For FDA and CDC and the Rest of Us – The Stakes Have Never Been Higher

Since last week’s posting regarding FDA credibility being on the line, there has been a swirl of activity and commentary around the evaluation of vaccine research for COVID-19 that would seem to have exacerbated the problem.

For context, last week the President issued a tweet stating that people were operating within FDA to slow progress on a vaccine without supplying any evidence, credible or otherwise, to support that. Subsequently in a speech on Thursday the President stated a pledge that there would be an approved vaccine by end of year “or even sooner” signaling urgency to the effort. But later in contradiction to that sense of urgency, the President has also re-tweeted a message that the number of deaths due to coronavirus has been greatly exaggerated – a tweet later deleted by Twitter.

More importantly, there have been new developments involving the FDA and CDC that are noteworthy.

  • First, FDA’s Commissioner appeared to walk back some of the statements made during the announcement of the Emergency Use Authorization (EUA) for convalescent plasma.
  • Second, he also apologized for the characterization.
  • Third, FDA let go of staff and a consultant reportedly involved in both the announcement and apology.
  • Fourth, FDA announced that there would be an October 22 meeting of the Vaccines and Related Biological Products Advisory Committee to discuss the developments and study around research related to a vaccine for COVID-19, without specificity to a particular company’s effort. Typically these announcements include a docket number so that the public can submit commentary into the docket, however this author found no such link in the announcement.
  • Fifth, the Centers for Disease Control issued recommendations regarding testing saying that people who were asymptomatic need not be tested, later changing it to “may be considered” – generating headlines about creating confusion.
  • Sixth, in turn, the former head of NIH expressed the sentiment in an opinion piece in the New York Times entitled “It Has Come to This: Ignore the CDC“. Just let that one sit there for a moment.

That is a lot to unpack. And those are just a few of the highlights.

There are so many moving parts, it is difficult to put it together into a coherent picture. As noted last week, the credibility of these agencies would seem to be vital to the end goal – an uptake of vaccine once one is approved. There needs to be confidence in the process and for that there needs to be confidence in the agencies involved.

Regarding the meeting of an FDA Advisory Committee, one has to ask oneself what exactly it is in the way of data that will be examined and discussed? The study subjects in vaccine trials are still getting the investigative vaccines administered to them (some require two doses – spreading out the inoculation to even greater periods of time). Subsequent to that, they have to be followed for their exposure to the virus and then assessed as to whether or not they were protected. Meanwhile, effects – both safety and efficacy will likely be sketchy at best and the effects on outliers would likely be yet non-emergent. Will people be willing to take a vaccine that has been granted authorization before the clinical trial data has been fully collected, must less examined?

In last week’s posting, I cited two surveys of people related to willingness to take a COVID vaccine. Since then, STAT published a survey that revealed that three-fourths of Americans believed the process for vaccine approval was driven by politics and not science. There may be some who say that there is a crisis of confidence in science – a high degree of skepticism, but it is far more likely that there is an even higher skepticism of politics. All that being said, the survey also found that most people would take a vaccine, even if authorized prior to the election. There were many critics of the Russian approach to approval, but the door is at least open for a very rushed process here as well.

Two questions stand out among the many that remain. First, is there actual political benefit to rushing an approval? That is not immediately clear. Will the shortcomings in managing the pandemic so far in the United States evaporate as an issue because of the early use authorization of a candidate vaccine? And second – and more importantly, what are the long-term effects of an erosion of public confidence in the gold standard set by FDA for the approval of new medicines. How will it impact confidence in future approvals – not just of these vaccines, but of all drugs? And if there is growing doubt about the integrity of FDA, will people begin to look to European regulatory authorities more readily than those in the U.S? The next few weeks will be critical in providing the answers.

Photo by Glen Carrie on Unsplash

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FDA Credibility on the Line

In normal times, when there is no pandemic threatening our lives and livelihoods, it is essential for FDA to maintain the traditional “gold standard” in relation to the decision-making process for the approval of new treatments. That standard is even more important now, as we approach a time when critical clinical data will be emerging around the various vaccine candidates now being studied. That is especially so since a successful vaccine – and the generous uptake of that vaccine by a skeptical public – is a cornerstone to getting out of this mess.

That is why – pre-pandemic – I wrote this blog posting in December – Remaining Aloof from Politics – citing the action by the FDA press office to issue a press release that took on a political cast, using the name of the president in the headline and sounding like a cheerleader rather than an independent government agency when appearing so might compromise the agency’s all important credibility.

Since then, and almost at the outset of the pandemic, a number of FDA actions have caused further concern for the agency’s credibility.

Now, over the weekend, FDA issued an emergency use authorization for the use of convalescent plasma with the issuance of a ham-handed, politicized headline on the agency’s press release – “FDA Issues Emergency Use Authorization for Convalescent Plasma as Potential Promising COVID-19 Treatment, Another Achievement in Administration’s Fight Against Pandemic“.

The approach in this approval and the communications around it raises concern as we enter a phase in the process whereby critical data from vaccine trials will begin to be collected and preliminary effects assessed. Already there are many within the public who are not part of the anti-vax movement who are skeptical about the vaccine. One recent poll by Gallup showed that one-third of Americans say they will not take the vaccine while less than half indicated they would in an NBC poll. Muddying the waters even further are the tweets insinuating the existence of a “deep state” effort to stymie progress.

It is in our public health interest, as well as our collective economic interest, to have viable vaccines not only developed, but utilized by the public. That means that as much as possible, there must be confidence in the end product, supported by the process of assessment and approval. There must be confidence in FDA that is supported, not inhibited by the Executive Branch. Credibility is nearly as much as a key factor as the science. Even the appearance of political pressure for a specified outcome should be avoided at all costs. We can only hope that when the time comes, the Administration and the FDA both do a better job of it than they have with the issuance of this emergency use authorization.

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What They Said – A Look Back at FDA Press Releases First Half of 2020

Each year, midway through it all, I take a look back to see what FDA has been talking about and compare it to the year before to see how things may have changed. I’m a little late at getting to it this year due to all the COVID-19 distraction. But it is not likely to surprise anyone that the first half of 2020 has caused not only an increase in communication from FDA, but a focus as well.

During the first half of the year, FDA issued a record number of press releases and nearly two-thirds (64 percent) were about COVID-19. The first release related to the pandemic appeared on February 24 to inform us about what steps the agency would be taking with respect to foreign inspections. FDA acted early and relatively often after that. The agency now issues daily updates on the topic.

FDA issued a record number of press statements, two-thirds of which were about COVID-19

Let’s first examine the profile of all the releases, and then focus on those just about COVID-19.

Approvals – There were 54 press statements regarding approvals so far in 2020, comparing to 42 approvals announced in 2019. The big difference, however, is that a big slice of approvals in 2020 involved Emergency Use Authorizations (EUAs) for COVID related products. In fact, there were 16 EUA announcements in 2020, which if you subtract that from the total of 54, leaves you with 38 non-COVID announcements which would lag just a bit behind last year.

The breakdown of those approvals between drugs and devices is also skewed this year due to the fact that the overwhelming number of EUAs about which statements were issued involved devices – usually diagnostic testing associated with COVID. Fully 15 out of the total of 16 EUA announcements involved devices – with only one involving a drug announcement (the EUA for remdesevir). So for the total number of approvals, including EUAs in 2020, the split among the total of 54 approval announcements in2020 were 33 drugs and 21 devices, comparing to 2019 when there were 29 drug approval announcements, 12 devices and 1 gene therapy. If you back out the COVID-related EUAs for 2020, it would be 32 drug approval announcements with only 9 device approvals for 2020, which would have it behind last year at this point.

Alerts – Normally there are not too many alerts in a given year, but 2020 has been an alarming year to say the least. The agency sent out 9 alerts during the first half of the year, 4 of which were related to COVID-19, including one for the off-label use of anti-malaria medications. During 2019, the agency had issued 10 alerts related releases. And so the impact of COVID-19 on alerts did not increase the volume, but were involved in the subject matter of almost half of them.

Guidance/Policy Announcements – There has been more guidance from the agency this year, again due to COVID-19. During 2020, the agency issued 13 releases involving guidance announcements or policy changes, 11 of which were related to COVID-19 compared to the first half of the previous year when there were only 5 Guidance document-related releases. The non-COVID related guidance for 2020 was in relation to e-cigarettes and were issued during the first quarter. Everything subsequent was COVID related, indicating how the pandemic has consumed the focus of the agency.

Legal – These announcements include warnings to companies and court actions such as consent decrees. During the first half of the year, FDA issued releases about 14 legal actions, somewhat less than last year when it issued 19. Of the 14 issued this year, half of them were COVID related in some way, including the announcement regarding the agency’s revocation of the EUA for use of hydroxychloroquine as a treatment for COVID. A sidenote – it does not appear the agency issued a release regarding the issuance of the EUA for hydroxychloroquine. The legal announcements were almost entirely centered on drug related products, with 3 related to tobacco and only 1 for a device.

General Announcements – This is the largest category and the place where “other” goes, i.e. anything not in the above categories. It is the place for agency updates on various topics and providing information that is not specific to an agency action. It includes statements from the commissioner and various division heads. During the first six months of the year, FDA issued 51 general announcements, 30 of which were related to COVID. These covered subjects ranging from calls for blood donations to updates on policy developments to statements regarding the passage of legislation. This compares to 114 that were issued during 2019. While that would seem to be a lot fewer, in fact there has been a real diversion to talking about COVID. In addition to these general announcements, FDA has issued 72 Coronavirus Daily Updates which carry a miscellany of compiled updates on the agency’s activities that are not circulated via a stand-alone press release.

In short, the volume of what is coming out of FDA has increased significantly. This happened when Dr. Gottlieb took over the agency and began handing out Commissioner Statements like crazy. It has happened again because public health circumstances. But there is more to communications than volume, and in an upcoming posting, I’ll take a look at content and assess how well FDA is doing with regard to the content.

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