OPDP Outlines New Research

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

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

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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Speaking of Medicine – Mid-Year OPDP Enforcement Review

There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceutical companies; one is through the issuance of guidance documents, the other is through enforcement.

But when it comes to enforcement things have changed greatly over the years. In 1998, there were 156 letters issued in a single year. By 2002, the number had dropped to 28, reviving somewhat by the end of that decade when it reached 52 in 2010. And since 2014 the Office of Prescription Drug Promotion (OPDP) has broken double digits only 3 times, producing only 6 letters in both 2020 an 2021. So far this year, we are at 4, which is a pretty good clip these days.

While it is difficult to discern trends with such a small number, an examination of recent warning and untitled letters reveals some possible shifts in priorities and emphasis that may be worth noting. That is particularly true since we have a new FDA Commissioner, a new head of the Center for Drug Evaluation and Research (CDER), and a new head of OPDP.

The 4 letters issued this calendar year:

  • Involved 3 Untitled Letters and 1 Warning Letter – a profile not out of proportion given that about 33 percent of letters issued since 2004 have been Warning Letters. One of the letters came to attention of FDA reviewers through the Bad Ad Program.
  • These 4 letters related to 5 different communications vehicles, 4 of which involved digital forms of communications – 2 were videos, 1 was a web page and 1 was an Instagram posting, one of the rare letters involving a social media platform. If you would look back to 2008, when digital and social media were in ascendancy by pharmaceutical companies, and compared enforcement involving traditional means of communications to those on digital platforms, letters from OPDP more commonly involve traditional means of communications (brochures, DTC print ads, etc) over digital (web pages, social media). While these most recent letters represent a small sampling, the fact that digital is over-indexed here potentially signals a heightened scrutiny involving digital platforms.
  • It should also be noted that one of the videos involved an oral statement made by the CEO of a company which was posted to a third-party site. The characterization of investigative data resulted in a violation related to promotion of an unapproved compound. This perhaps emphasizes the role of media/message training prior to public-facing statement (at all stages of development).
  • The single letter involving a traditional communications platform was a printed information sheet directed to physicians.
  • Violations this year so far were 9 and included risk presentation deficits (3 letters) Superiority Claims and Unsubstantiated Claims (2 each) and Promotion of an Unapproved Drug (1).
  • Some of the triggers included
    • The use of studies in relation to a claim where the studies were unrelated and conducted in different patients for different lengths of time and were limited in design and analytic strategy;
    • Risk information that was presented in small bring, out of balance to the claims presentation as well as another risk presentation that offered risk in a fast-scrolling video that was out of sync with the benefits information;
    • A claim related to efficacy that did not more narrowly define the intended population as reflected in the label

When you view enforcement activity through a broader lens to get more examples to analyze, a few things stand out. Most notably, while promotion of an unapproved drug is a relatively rare violation, comprising only 2 percent of all the letters issued since 2004, it is 13 percent of all letters issued since 2016. Correspondingly, the instances of promotion of an unapproved use has diminished and was last named as a violation in 2019.

Finally, one characteristic of the regulatory action letters issued by FDA’s OPDP over the past several years is that they have principally involved smaller, lesser-known companies. It was very rare to see a company in the top 25 companies cited for violations. But this year and last year we saw Lilly receive two letters, Bausch receive one, and Amgen receive one. It may be an anomaly or it may signal a shift. For any trends to become apparent, there will need to be more enforcement actions. And for that, we must wait.

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New Approvals in 2022

We are at mid-year, a good time to check in and see how we are doing on a number of fronts – including where we are with new drug approvals. Over the years, Congress has acted to enhance the ability to bring more new treatments from test tube to medicine chest more quickly. Most notably in 2012 the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law, bring to bear among other things, breakthrough therapy designation. Since that time, there has been a healthy output of new treatments.

But recently in the larger environment, there have been several factors that may have inhibited the flow of the medicine pipeline. The most obvious impact is that of COVID-19 to recruiting and maintaining clinical trials. And then there is the fact that a number of clinical trials were being conducted either in Russian or in Ukraine prior to the outbreak of the war. On top of that, COVID-19, while representing a good deal of medical progress, also represents a tremendous diversion of resources in time, money and effort that might have been otherwise utilized. Finally, COVID also impacted FDA’s ability to manage the regulatory process itself. Advisory committee meetings have been far fewer and observationally speaking, FDA seems to be extending PDUFA dates quite regularly.

So how are we doing? There are a few things to look at.

  1. New Molecular Entity Approvals – The most obvious is to see how we are doing on new molecular approvals – those approvals representing entirely new treatments. Looking at past years and where we were at the mid-year point and where we ended up each year, can give us some insight into this year. The news is not so hot. By the end of June this year, FDA had approved only 16 novel drugs. By this time last year, there were 27. Below is a chart that compares year by year the rate of novel approvals as of the end of April and by the end of year.

This is not to say that the balance of the year might not make up for the slow first half. by mid-year 2019, there were only 13 approvals of new entities but the year netted out with a respectable 48. It all depends on what’s in the pipelineSo let’s look at PDUFA dates.

2. PDUFA Dates– PDUFA dates are proprietary and FDA does not publish a list of upcoming dates. Still, one can compile a list by capturing public announcements of new drug or biologic applications with FDA, many of which mention the specific PDUFA date and many that allow a guess based on counting from the date of a press release. Subtracting out applications for supplemental applications, there do not appear to be an overwhelming number of upcoming dates, which might undermine any recovery in the second half of the year to a more robust number of approvals of new molecular entities.

3. AdComms – Finally, as noted in a prior posting, the number of advisory committee meetings that FDA has been holding has diminished considerably overall. That means that the agency is utilizing outside counsel less frequently, perhaps due in some part to the advent of breakthrough therapy designations which means that the agency is having a higher level of interaction with drug sponsors that may negate the need for an AdComm. But one could also surmise that AdComms are reserved for circumstances where FDA wants outside counsel because an investigative compound is exploring new territory. In any case, the only recent advisory committee was one of the Cellular, Tissue, and Gene Therapy Advisory Committee which by its nature, is likely to be in regard to a new molecular entity.

In short, the outlook for output this year does not appear at this juncture to be promising. But there are many moving parts and when and if they do move, it can change the picture considerably. Certainly there have been years past where at mid-year, there was not a robust output, but which ended up much improved over the final half of the year.

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