When the Going Gets Tough – FDA AdComms in 2022

Posted on January 17, 2023 by Mark Senak

Through its Human Drugs Advisory Committee process FDA has a vast array of outside experts to consult on matters related to product approval as well as questions about policy or safety issues concerning approved products. The mechanism provides an open and transparent process whereby people can see and hear the deliberations and have input during open public comment as well as through a docket established for that purpose.

But for those who have spent years watching – one thing has become clear. FDA Advisory Committees (AdComms) ain’t what they used to be.

First of all, they are all still virtual. At the beginning of the pandemic, FDA moved to staging virtual meetings. For anyone who had to suffer the onerous security ritual at FDA’s campus where the meetings were generally held that may be good news. In-person FDA AdComms were not really fun. The parking lot was light years from the entrance, the security screening was slow and laborious and once you were in, your eating options were quite limited. The switch to virtual meetings has meant that you can now watch and participate from the comfort of your own home – where presumably you can get whatever you want to eat. Ultimately, the virtual meetings certainly get the job done in terms of the exchange of information – even if you do have to put up with a lot of people needing to be reminded to unmute. But certainly the meetings have lost the personal touch lost in all virtual re-setting. You could see who showed up and who talked to who. I can recall a sitting U.S. Senator walking into a meeting to confer once. And there were many open public comment periods that were quite moving as a result of patient presentations in a way that they might not be in a virtual setting. The networking that used to occur – the informal interchanges – those are not happening. So that is one – albeit small – way in which AdComms have changed. But there are others.

Second, and perhaps more important, there have been fewer of them. In 2012 there were 35 meetings held by FDA for the purpose of considering new drug approval which is almost 3 meetings a month. By contrast in 2021 there were only 10 (see blue bars below in the chart tracking meetings from 2017 – 2022).

Yet in the midst of that range, the number of new molecular entities approved by FDA actually increased. Looking at the second chart below, one can see that the number of AdComms since 2018 peaked in the same year FDA approved a record number of new molecular entities (NMEs). But if you look at more recent history, you will see that during years of robust approvals for NMEs in 2020 and 2021, the number of AdComms went down considerably. That means that as FDA was approving more drugs of first impression it was consulting with outside experts through the transparent process of Advisory Committee meetings with less frequency.

As has been speculated here in the past, the drop-off may be a result – at least in part – of the rise of new pathways for drug approval such as Breakthrough Therapy Designation which promise enhanced access to FDA decision-makers, thereby perhaps diminishing the need for outside consultation.

During 2022, the number of AdComms held to consider new products rose a bit over the previous year to 19 scheduled meetings. However, with 4 of them cancelled, there were only 15 applications considered this year through the AdComm process. Pre-pandemic numbers were consistently higher. But conversely, in 2022 the number of NMEs plummeted.

Third, AdComms aren’t as approving as they used to be. In terms of votes for recommendations of approval for new drugs, the track record was a little brutal this year. Of the 15 applications for new drug approvals in 2022 that went to AdComm consideration, the committees gave a thumbs up to only 4 (the green bars) – and in one of those FDA’s decision went against the approval recommendation of the committee and the sponsor received a Complete Response Letter. Moreover, of the 4 approval recommendations, none of them were unanimous votes in favor of the application. On the flip side – there were 11 votes on applications that failed to get a recommendation for approval (the red bars) and one of them was unanimous. In addition to the more negative tone as expressed by fewer approval recommendations, during 2022 there was an increase in meetings that were either cancelled or postponed.

So in sum, over the past few years, AdComms have been consulted less frequently while more NMEs were being approved. And when they were consulted, the outcome has been increasingly negative. Does the COVID-19 pandemic figure in here? It certainly seems that there is a difference between pre-and post- COVID patterns. Perhaps the virtual means for these meetings has an impact beyond the obvious in the deliberation. Or perhaps it is a coincidence. For those having an AdComm in 2023, we will watch and see what happens.

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Tick Tock re Tik Tok and FDA’s OPDP

Posted on October 19, 2022 by Mark Senak

Tik Tok was first released in 2016. While slow out of the starting gate with emergent media opportunities, in 2022, pharma is embracing the platform in both unbranded and branded efforts. While historically, a lot of Tik Tok use has been comprised of individuals releasing videos of them showing off dance moves and physique, the time for embracing the platform by institutional users appears has arrived. This is a familiar pattern, echoing back to the time when bloggers, Facebook and Twitter were dominated by people talking about what they had for lunch, who they were dating and where they were standing. Then commercial interests moved in changing the complexion and makeup of those platforms entirely, with pharma taking up the rear. The emergence of pharma on TikTok signals another facet in the evolution of healthcare communications and a similar pattern.

But while FDA’s Office of Prescription Drug Promotion (OPDP), the office responsible for a FDA’s regulatory approach to promotional speech by the pharmaceutical industry, has recently announced research that is aimed at uncovering more about the role and impact of influence of endorsers, that research is covering more mainstream channels , namely television. Earlier research, the agency says, shows that different types of endorsers have different levels of influence, with physicians coming in highest and celebrities coming in lowest. In the newly announced research, the agency will compare reactions among different subsets of viewers by age and education level. What that research will not tell us is, with its extremely high level of viewership, what might the impact of endorsers be on TikTok?

FDA’s OPDP began considering an approach to regulating social media long before Tik Tok came into being. The agency has always maintained that the principles underlying its approach to addressing promotional speech was somewhat platform agnostic – that a video that plays as a commercial on broadcast television is guided by the same principles as those on YouTube. Communicators and marketers would love black and white answers about concrete platforms. But OPDP speaks not in black and white, but gray. And they believe that the principles laid out to date cover pretty much any communications platform.

But in fact, that is not the case as evidenced by the fact that the agency has different approaches for print than broadcast, indicating the medium does, in fact, matter. And FDA made tacit acknowledgement of the fact when it held a public Part 15 meeting in April 2009 to put forth a framework for the discussion of regulating social and digital media, with the aim of developing a guidance related to the unique challenges offered up by new media shortly thereafter. That did not happen and in fact, it was many years before any draft guidance documents emerged and then there were principally two of them that addressed some of what was discussed in the 2009 framework – on Character Space Limitation and on Correcting Third Party Misinformation.

In fact, the medium does matter. In general, social and digital media have begged new and emergent questions related to regulatory oversight than exist within the confines of traditional print and broadcast. For example, the fact that the very basis of social media is sharing content and providing comment on it make it different in terms of impact and perception. More specifically with regard to Tik Tok presenting a myriad of videos varying greatly in subject matter, quality and taste, it is not an unusual for a user to scroll through videos quickly. It is a process that can often result in partial viewing. Many users get just the intro past the viewer before – whoosh – they are gone. So if on a branded Tik Tok risk information is at the end of the vid, how many people will never see it? Once you get the benefit – why stick around for the risk. What is the impact of that? Does FDA know? Should they? How does the medium impact the goal of fair balance, a key principle for FDA’s OPDP.

Another factor in play is that TikTok is content is most likely delivered to individuals, particularly younger people, on mobile devices. Small screens. So what I’m viewing in the way of benefits – and the impact – may be very different from the presentation of voluminous risk information.

Tik Tok aside, the issue of risk presentation somewhat related to the long-outstanding issue of optimizing websites for mobile, about which FDA has said nothing. Yet for many, mobile is the primary access means for Internet use – and therefore health information-seeking behavior. That means the use of links and in particular, their use in optimizing a web site is taking on increasing relevance in relation to mobile sites or video. And yet use of links has never been addressed fully addressed by the agency, even though it was one of the five principle questions posed by the agency in the 2009 public meeting – the only meeting held on the topic of digital and social approaches. FDA spends a good deal of effort in research aimed at how different communications mechanisms impact perception of risk and benefit, where the research is lacking is telling us whether or not the fact there are varied perceptions of risk and benefit actually matters. Given that there is a learned intermediary – a prescriber – between the patient and the product, what is the real issue at hand when communications about the product may result in varied understandings of risk?

As noted in a recent posting, FDA research has been largely focused on traditional media platforms. But the eyeballs have moved on, it is perhaps time OPDP does as well. OPDP has not produced any draft guidance documents in recent months that are relevant to these issues nor has there been much available in the way of enforcement (only four letters issued so far in 2022) to illuminate the many dark areas. The problem is, it is within those areas in which increasing numbers of us reside and consume our information.

To that end, FDA should consider:

  1. Holding another public information gathering meeting on Social and Digital media such as the one held in 2009 to gain further insights into patterns of use and gain a re-focus on the regulatory agenda that results, particularly given the migration of audiences and emergence of new platforms;
  2. Directing more research to discover the important nuances thereto, such as how the ability to scroll before the end of a branded video (where risk information might be) impact perceptions of different types of consumers (FDA is conducting research now into how adolescents perceive risk and benefit) and whether or not impacts on those perception actually presents any greater risk;
  3. Direct attention to the development of additional draft guidance in the 2023 guidance agenda for CDER – it is noticeable that there were no Advertising/Promotional guidance potential guidance documents in the 2022 agenda. Along with the lack of enforcement, this leaves a big gap.

That is a start. We are a long way from knowing how Tik Tok influences health behaviors. But one thing is for sure. Studying DTC on broadcast television isn’t going to get us there and an approach to regulating promotional speech in social media is increasingly not platform agnostic. Just wait till be get to the metaverse. If OPDP is going to stay relevant to its underlying principles and purpose, the agenda needs to move more quickly. Tick. Tock…..

Photo by Solen Feyissa on Unsplash

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OPDP Outlines New Research

Posted on September 27, 2022 by Mark Senak

FDA published notice recently that the Office of Prescription Drug Promotion (OPDP) was proposing some new research related to the promotion of medicines by pharmaceutical companies. The research was new (kind of) but the direction was more of the same old focus – direct-to-consumer advertising (DTC).

First, just a note on why the research is of importance at all. OPDP engages in a fair amount of formal study related to various aspects of its mission to protect public health by ensuring that prescription drug promotion is truthful, balanced, and accurately communicated. To that end OPDP employs a broad range of methodologies to explore the impact of various aspects of promotional practices and speech to evaluate impact. The resulting outcome is a body of evidence that (1) can influence either the development of new guidance, or (2) the revision of existing guidance or (3) inform patterns and priorities of enforcement by the agency – and that is why we take note.

Research that is currently underway spans a number of topics, including the use of animation in DTC promotion, the impacts of disease awareness and prescription drug promotion on television, the use of superimposed text in DTC promotion, to name a few. A full list can be found here. And here are the latest being added by OPDP:

  1. Endorser Status and Actual Use in Direct-to-Consumer Television Ads – We have all seen ads on television where a person endorses a medicine. Are they effective? Who do we listen to? In fact, OPDP has already conducted one study to determine how different types of endorsers in print or internet settings and the impact of disclosure of payment status influenced audiences. The agency also noted that prior research has shown that different endorsers have different impacts – with expert physicians and pharmacists being the ones most likely to lead to purchase intentions, with consumers falling behind them and celebrities bringing up the rear. The new research will focus specifically on television advertisements to assess the impact of the disclosure of payment in an ad by an endorser. OPDP will examine endorser type (patient, physician) and will look at the impact of actual use disclosures. The agency is going to examine whether there is a difference of perception by age and education level.
  2. Perceptions of Prescription Drug Products with Medication Tracking Capabilities – There have been multiple approaches to supporting patient adherence to taking prescribed medications, ranging from pills with ingestible sensors to mobile apps. OPDP states that there is not much known about the perceptions of patient and health care providers that track medication use or work with a software element to track use. Specifically, OPDP is looking to know when a promotional communication conveys the information about ability to track use, the agency is seeking to assess how that fact may impact the perspective of the audience around risk and benefit.
  3. Targeted Mechanism of Action Presentations in Prescription Drug Promotion – When a drug promotion contains the term “targeted” OPDP wants to know if that has an effect on a person’s perception of the safety and efficacy of the product. This is based on a 2014 focus group of healthcare professionals in which OPDP even admits, there was a diversity of opinions but where some may have expressed a tendency to view a product more favorably if the term were used. OPDP is now conducting a survey that looks at how physicians and consumers might interpret a number of terms, including “targeted”. Now OPDP will engage in a study to assess the influence of “targeted mechanism of action” language and use of graphics related thereto in promotional communications.

As one can see, OPDP meticulously follows a thread, sometimes over years, to add definition and context to promotional communications, often highly nuanced. However, the agency has been largely entrenched in its research in traditional communications vehicles – DTC in print and broadcast, for example, without embarking more broadly on research that would provide insight into digital communications. Given the 2009 framework for addressing the regulatory issues associated with digital and social communications and the huge migration by consumers to those platforms and the vigorous use of the Internet in health-seeking information, it would make sense for the research to follow suit. That is particularly true given that the 2009 framework has only been partially addressed by the agency. But for now, we wait.

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What They Said – Looking Back the First 6-Months of FDA Communications

Posted on August 17, 2022 by Mark Senak

Periodically I write a posting to look back at what FDA is talking about to get some perspective. Each individual press release tells us something, but looking back at the aggregate can also provide insights. Not long ago, a retrospective look that compared the ratio and trend of COVID versus non-COVID related news out of FDA suggested that not only was COVID becoming less of a topic for the agency, but also presented the possibility that there was increasing room for other topics. Soon, we may have a new dominating topic in Monkeypox. So let’s take a look:

  1. Volume – Let’s look first at the numbers of releases issued by FDA for the first six months of the year. It is down – mum has been the word. Below is an annual comparison looking back the past few years, compared to where the agency was at mid-year. You can see early in the chart, FDA maintained a very low volume of communications, and at mid-year in 2017 had issued only 52 releases, rising to 166 for the year. This year at 128 mid-year, the agency is at the lowest level since then. You can also see that the numbers rose significantly starting mid-year 2017 through 2019 which coincides with the tenure of FDA Commissioner Gottlieb, reflecting his outgoing communications style. Then the agency began quite commonly issuing Statements from the Commissioner. Prior to that time, such statements were rare. The current downturn in volume could also be attributable in part to the fact that FDA has once again altered somewhat a past communications practice. For many years the agency conveyed news that was not exactly press-release worthy by issuing a separate communication called “FDA in Brief“. This year, the agency stopped issuing news via this mode, and instead began issuing regular releases under Press Releases called “FDA Roundup” that similar bundles news together. One might expect the addition of another regular release from FDA to inflate the volume of releases, but one could also make the case that the bundling of such news created less of a need for individual releases.
  2. Content – Next up – what did FDA talk about? In a February blog posting I noted that by January 2022, the proportion of press releases that were issued by the agency regarding COVID was decreasing in proportion, meaning that there was more oxygen available for other topics. The trend is even more stark today and clearly FDA has moved on to talking about other things. So first observation, volume is down, but volume of COVID news (represented in red below) coming out of the agency appears way down. Some COVID-related developments are covered in the newly launched FDA Roundups, but as stated earlier, that tends to group items together that are not quite newsworthy enough for stand alone releases. During the first half of the year, the agency issued 20 COVID-related releases, compared to 93 during the first half of 2021.

Apart from COVID, of the 145 releases issued during the first half of the year, over one-third were the FDA Roundups. Only 20 were about product approvals or label expansions, compared to 46 the year before (the drop in NME approvals was covered here not long ago).

All in all, it would appear that less talk about COVID and with fewer new approvals, the overall output from FDA has gone down with respect to major announcements. One thing that appeared to get a good deal of attention by FDA involved updating the public with regard to developments around the shortage of baby formula experienced in the U.S. this year. We’ll report back after year-end to look at the year and see if there are any changes.

Photo by AbsolutVision on Unsplash

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Here We Go Again – Monkeypox Communications Challenges

Posted on August 8, 2022 by Mark Senak
Source: CDC

In February 2020 I published a blog posting – Emerging Pathogens, Communications – that encapsulated my observations and learnings from my years work in the early years of the HIV/AIDS pandemic in the early 1980s. As we sit, possibly, on the cusp of another large scale medical challenge with monkeypox, it seemed like a good idea to revisit the topic. When there is a new and scary thing we are facing, medically speaking, there are some truisms regarding the communications environment that can inform strategic thinking about how we talk about it.

  1. Facts are low, speculation is high – And nature hates a vacuum and there will be many who are willing to fill the void with misinformation. People want facts, and the fact is, facts are in short supply.
  2. Numbers don’t mean a lot – First of all, they change quickly – and are changing very quickly with monkeypox. In addition, there is often a lack of accurate reporting for many reasons.
  3. Points of reference will change – What we know, and what we don’t know, will change over time as we get more experience and gain wider understanding. That might seem like a good thing, but in fact, changing stories undermine credibility.
  4. Fraud potential is high – There are people who will take advantage of the situation and exploit it for political and/or financial gain. That, too, impacts credibility and can confuse people.
  5. Policy is likely to be ham-handed – Policies may be developed quickly and without adequate information and be based on emotion and bias more than facts. This is another factor that strains credibility.

Monkeypox is not COVID, and COVID was not AIDS. They each present distinct challenges and evoke particular fears and concerns. There are big differences between the three. But they are all viruses. And when it comes to communications challenges there are many commonalities.

First and foremost, in the absence of facts, fear can drive actions. And when a pathogen is newly emerging, facts are greatly outnumbered by questions. The degree to which companies, educators, businesses and service providers may want to prepare to deal with those challenges may depend on where they are, who their stakeholders are, and how big or small they are. At this stage though, better to consider the challenges that may lay before you know, before they present themselves.

Source: CDC

Analysis

It may be that monkeypox is contained early if we are lucky. There are reported signs that transmission may be slowing in the U.K. and the trend in the graph above appears to show some deceleration. That said, the numbers have increased quickly on an extremely steep curve. That means there is an increasing amount of virus out there. The virus has mainly spread among men who have sex with men and transmission is being attributed to skin contact. But the higher the numbers go the greater potential there is for more lateral spread. A presumptive pediatric case was reported last week in California. It is also a virus that can move between people and animals.

Containment depends on systems that are able to screen, test, treat, and prevent (both by means of avoiding circumstances that can enhance transmission and by vaccination). To that end, many things are not in our favor. An extremely splintered approach at federal, state and local levels impacts the coordination of a public health response. We have COVID fatigue in the extreme. And in terms of tools, we do not have a means for screening, meaning we do not know who is infected before they exhibit symptoms which may take several days; the testing situation is complicated because there is no quick, at-home testing like there is for COVID and may be best applied when there are lesions. But people may have other symptoms such as headache, chills, muscle aches, swollen lymph nodes and exhaustion. The only FDA-approved drug to treat is approved for smallpox, but no Monkeypox and has been difficult to access. In terms of prevention, while a vaccine has been developed, supply is very short and it, too, has been hard to get.

Additional challenges include the fact that the course of illness runs two to four weeks. If a person must self-isolate for that length of time it is not only difficult, but there may be collateral consequences. With men who have sex with men comprising the overwhelming majority of cases, a diagnosis is the equivalent of coming out. For many gay men that is not a problem. For many others, who may have wives and children, it can be a very large one, facing a situation that may have both personal and professional peril.

At the present time, there are some states which are reporting higher numbers than others. If the numbers do continue to climb, then a larger number of geographies will be impacted and most likely a wider circle of people, raising the chances that large employers, those in specific sectors, may face communications challenges sooner rather than later such as:

  • Travel and hospitality
  • Schools and universities
  • Hospitals
  • Institutional settings such as daycare centers, rehab and nursing homes (a case of a daycare workers was reported in Illinois last week)

What to Do

Every business, service or place of public accommodation is different. There is no one-size-fits-all approach to preparation. One must consider the size of the enterprise, the stakeholders and the level of physical contact and interaction with surfaces. That said, there are echos from both AIDS and COVID that shed light into how people may react to the emergence of another communicable condition. A few things to consider:

  • Review policies and assess what may need to be changed or amended; this is not just COVID return-to-work policies, but discrimination policies as well. Re-think many of the things you have had to communicate about a virus transmitted by air, and re-fashion to think about surfaces. Monkeypox will present distinct challenges.
  • Consider the questions and issues you may face. Can we catch monkeypox using the toilet? Trying on clothes? Do I have to sit next to the gay man? My co-worker says it is eczema, I’m afraid it is Monkeypox. Depending on your business, your clientele, there are different sets of questions that may arise for different settings. Think about what they might be and to what degree you are the one to have to provide the answers.
  • Assess the triggers for potential fear and conflict between employees, customers and users of any service.
  • Communicating in an environment where what we know changes, and what was certain yesterday may be uncertain tomorrow is always a strain on credibility. Therefore consider integrating reminders to that effect in your messaging. What we know now is….
  • Gather reliable resources – the obvious ones such as CDC, FDA, and Departments of Health at the state and local levels, but also consider credible grassroots organizations, particularly ones that may resonate with stakeholders, particularly those dealing with gay-related health issues and key medical societies such as the American Society for Microbiology and others.

Many people think that preparation during such a nascent phase of the outbreak is over-reacting. I hope they are right. But having lived through AIDS and COVID, and seen early numbers quickly spell a different story over a very short period of time, one may be well-served to think it through now.

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