New Landscape for the Old Pandemic

Posted on March 30, 2022 by Mark Senak

Tectonic pandemic plates are shifting respecting the COVID-19 pandemic. For weeks now we have been watching caseloads in the United States broadly fall. It feels as if we are indeed shifting gears. There are other moving parts that are in motion as well. It is a fundamental re-shifting of the landscape. And there are consequences.

First, government funding supporting access to vaccination and treatment for COVID has run out and so far, is not replenished. The government established program to fund access for the uninsured has stopped accepting reimbursement claims for treatment and will stop shortly for vaccines (on April 5). For the insured and affluent, not much of a problem. For those without, it can become a major roadblock. And if you need therapeutics, the same problem, but with harsher consequences, especially once the federally purchased stockpiles of therapeutics and vaccines are gone.

Second, next week an FDA Advisory Committee had scheduled a meeting for April 6 (the day after the government program will stop accepting claims for vaccines) to consider whether or not to authorize use of two of the COVID-19 vaccines as a “second booster” or actually a fourth shot, either for people over 50 years or for everyone. Then on March 29, FDA issued an authorization for use prior to the meeting of the advisory committee, quickly followed by a supporting update for providers to permit access from CDC. A fourth shot will likely be authorized by CDC, though access may be different than in the past, especially after the government stockpile recedes.

Third, the BA.2 sub variant 0f Omicron is poised to cause an increase in U.S. caseloads as it has in other parts of the world, thought it is not certain when. According to the Centers for Disease Control (CDC) it is now the dominant strain. After weeks of falling caseloads, some areas like New York City and New York State have seen the rates per 100,000 start to rise again and the 14-day change in cases has risen 92 and 78 percent, respectively as of yesterday, and have been increasing for the past several days. With the fourth booster in hand, those most vulnerable might opt to take it now (while there is stockpile) only to see it wane if the BA.2 wave in the U.S. does not happen until later in the year.

Fourth, the rise in availability of home testing is likely masking (pun intended) the actual numbers. Whole families may be find they are feeling unwell, testing and finding they are sick, but never getting sick enough to get medical attention. So they are completely under the radar when it comes to the numbers that we are counting and upon which we are basing policy decisions, like mask requirements.

Fifth, the masks are dropping. Attending a theatre performance this weekend I was double bagged – a KN95 underneath and a second (more fashionable) cloth mask over it. But I was in the minority by far. The lowering of mask requirements and inclinations may spur the emergence of the sub variant, or future variants.

Sixth, speaking of new variants, in places around the globe where there large numbers of people are being infected there is a potential fro the development of new variants.

In short, we are being dealt a new hand. A more spreadable virus is among us just as our vigilance is waning. More vaccine doses are authorized, but access is narrowed. Cases are increasing while mortality – a lagging indicator – has dropped. And perhaps most important, we are not assuring widespread access to vaccines and treatments to the most vulnerable, we are not accurately counting, and we are not taking precautions. From a policy perspective, perhaps we needed a new hand, but one thing remains – in the face of on-going infection, access to vaccines and therapeutics remains essential. While we are looking at a new landscape, we are also facing certain obstacles.

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Are We Moving On From Covid?

Posted on February 22, 2022 by Mark Senak

Mask mandates are dropping like flies. Restrictions are being lowered. In my observation, it feels that they are going to the wayside not only because of dropping caseloads, but also because people are just more than ready to move on. There may be some complacence – a feeling that the ubiquitous Omicron has fostered a feeling of inevitability about exposure and eventual infection. But mostly, we are just tired – there is a strong sense of COVID fatigue, not just among people, but it seems even institutions.

Even perhaps FDA. In a recent blog posting, I looked back at the profile of FDA press releases over the period 2013-2021 (See What They Said 2021 – An Overview of FDA Press Statements). In it we saw that FDA had a good deal to say in 2020 putting out over 400 press statements, but that output fell considerably in 2021.

Not only was the agency saying less, it was saying less about COVID. Communications regarding aspects of agency work vis a vis the pandemic fell in 2021 compared to the year before, despite the number of developments in vaccines and therapeutics during the year. Looking at it on a month by month basis, you get a real impression of how much oxygen COVID-19 took of FDA’s communications.

COVID-related releases are indicated in orange while non-COVID are in blue. Looking to the right axis of the graph above, one can see that during 2020, COVID was over 50 percent of the discussion nearly all of the time. In April 2020, COVID-related statements comprised three quarters of FDA’s public facing releases, and it never went below 50 percent during the rest of the year. By contrast during 2021 there were some spikes, but the overall profile of COVID talk fell below the 50 percent mark during several months. And the first month 2022 (not a big month for press statements from the agency in general) saw a steep decline. The overall trend is definitely downward.

Why is this important? It may not be, but it also may be a signal from a communications perspective that it may be easier to get back to some of the topics – and some of the science – that we have maybe pushed aside for the past two years. Maybe there is opportunity to talk about the cancer moonshot, or the goal of ending HIV/AIDS or other pressing issues from which we were distracted#C.

Perhaps the pandemic is becoming normalized, perhaps we are just tired, or could there be less actually happening? Maybe it is a combination of all three. It is likely too early to tell. Certainly there are many mysteries remaining with respect to what it means to have COVID, to prevent it and to treat it and many more with respect to what it has done to us as individuals and collectively. But it would be nice to get back to other topics. We will have to see.

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OPDP Issues First Regulatory Action Letter of 2022

Posted on January 26, 2022 by Mark Senak

FDA’s Office of Prescription Drug Promotion (OPDP) issued the first regulatory action letter for 2022. This one has some notable characteristics.

As has been frequently noted, enforcement actions by OPDP have diminished considerably over the years. Another characteristic of recent enforcement actions over the past several years is that smaller, less well-known companies have mostly been the recipients of letters from OPDP. That said, the last two letters – the final one of 2021 and the first of 2022 both went to the same company – Lilly. Here are a few other facts to put this letter into context:

  • This one, as was the last one, is an Untitled Letter, considered the less serious of the two types of letters sent out by OPDP;
  • The product involved was one for diabetes, one of 7 letters issued since 2003 by OPDP regarding a diabetes product covering 10 different communications vehicles (in 2009 GSK received a letter covering 3 sponsored links for separate products);
  • The communications vehicle that was the subject of this letter was an Instagram Post, one of two social media violations related to diabetes over the past several years (the first was a Facebook posting for Mannheim’s Affrezza);
  • It is the second time FDA has taken action in relation to an Instagram posting, the first having been issued in 2015 regarding a product for morning sickness.

So why did OPDP act upon this Instagram post? According to the letter, the agency noted first of all that the video that was part of the Instagram post stated that Trulicity could “lower A1C along with diet and exercise” but that the Medication Guide specifically states that the drug is used for people with type 2 diabetes. There were additional limitations to the use of the drug, including that it is not recommended for people with severe stomach or intestinal problems, nor should it be used in people with type 1 diabetes. Therefore, the agency said, the indication was not adequately communicated. Moreover, when it came to risk information, OPDP noted that the benefits of Trulicity were emphasized through “attention-grabbing” and fast-paced video, but the the risk information was presented was included in a small window that was difficult to read and therefore presented a challenge in comprehension. In addition, one of the side effects regarding hypoglycemia that was in the Medication Guide did not appear in the posting, leaving the overall presentation minimizing risk associated with use. FDA noted that the product has a boxed warning and that there have been past advisory communications from FDA have expressed concerns.

It is perhaps worth noting that while this violation involved a communication via a social media platform, the issues addressed in the letter were not because it was a social media platform. Essentially, OPDP said, a video lacked balance and omitted some material issues. It was not the medium, it was the message.

As you may recall from recent postings, last year FDA decided to remove Warning Letters, considered a more serious infraction, from the list of OPDP regulatory actions. The above chart portrays a combination of Untitled Letters and Warning Letters. However, FDA now lists Warning Letters in a searchable part of the FDA website that lists all Warning Letters issued by any part of the agency, while the OPDP portion of the website now only lists Untitled Letters. This means that in order to get an understanding of all the actions taken by OPDP, you now must consult two different parts of the FDA website. Confused? Well, yes, it is in confusing. Warning Letters can be found performing a search here, while Untitled Letters are listed here.

Eye on FDA maintains a database that contains the results of Warning and Untitled letters issued by OPDP going back through 2003. It includes 352 letters covering over 450 communications vehicles and over 1100 violations. The database tracks disease area, type of communications vehicle, whether or not the product had a boxed warning, whether or not it involved a Warning or Untitled Letter, whether it was a digital or traditional communications property and of course, the violations cited in the letter.

Note: In a prior posting reviewing 2021 regulatory actions, it was stated that FDA issued 5 regulatory action letters for the year. Since that writing, FDA posted another letter in mid-January that was sent to a company on December 19. That posting has been updated to reflect the late addition from FDA.

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What They Said 2021 – An Overview of FDA Press Statements

Posted on January 12, 2022 by Mark Senak

Each year we look back to take stock of how the agency has been communicating in the course of the previous year and assess how that might compare to years gone by. In fact from year to year, there is a good deal of change that occurs. When Dr. Scott Gottlieb took the reins of FDA as Commissioner, the amount of communications material put out jumped enormously. And it did so again last year when the agency would have a lot to say about COVID-related activities.

This year, however, not only was the agency putting out less, the number of releases this past year represents a somewhat inflated number. In prior years, the agency statements under a heading called “FDA in Brief“. These are statements that differ in format and nature from a traditional press release. They are more general announcements than they are news. Press Releases announce approvals, for example, while FDA in Brief statements can be used to “remind industry” or to announce that the agency will be holding a meeting. Press releases are often (though not always) released in English and Spanish, while FDA in Brief statements are not. These statements were housed on the FDA website separately from press releases. This year, however, the agency not only listed the FDA in Brief statements under their own heading, they also begin listing them in with the press releases they agency sends out. Since they did not do this in years gone by, that means that the number represented in the press release category is inflated. This year there were 43 “FDA in Brief” statements included in with press releases. If you actually removed them from the count, then the actual number of traditional press releases from FDA this year is 241, meaning the agency issued about 57 percent of the releases they issued during 2020.

Why the plunge? Certainly there was a good deal going on related to COVID, and the agency also approved a solid number of new molecular entities during, falling just a few shy of last year’s record number. One possibility may be the presence (or not) of a full time commissioner. The arrival of Dr. Gottlieb certainly saw an impact in volume. During nearly all of 2021, FDA has been under the direction of an acting commissioner.

In any case, here is what FDA talked about this year.

  • COVID – 144 announcements were COVID-related in 2021, compared to 274 such announcements during 2020;
  • Approvals – there were 77 announcements related to approvals this year, 22 of which were COVID-related announcements. In 2020 there were 40 COVID-related approval announcements. There were 43 drug and gene therapy approval announcements in 2021 (7 of which involved EUA announcements), 24 device approval announcements (7 of which were COVID-related) and 8 announcements related to Vaccines;
  • Alerts – there were 9 Alerts issued by the agency this year, 4 of which were related to COVID – this compares to 16 Alerts issued in 2020, 7 of which were related to COVID;
  • Legal – there were fewer releases related to legal issues in 2021, with only 12 issued regarding warnings issued by the agency or consent decrees compared to 21 in 2020;
  • General Announcements – this category includes statements from the commissioner or from various division heads and here is where there the greatest numerical difference existed between 2020 and 2021. In 2020, there were 251 such pronouncements while in 2021 there were 156;
  • Translation – Sometimes FDA communications are issued in both English and Spanish, sometimes not. There is no discernible rhyme or reason to it. There is also no indication why all communications are not translated. The translation rate appears roughly the same for the past two years – in 2021, 57 of the 284 releases (20 percent) were translated into Spanish, compared to 88 of the 420 last year (21 percent).

As far as what 2022 will bring, given the events of the past two years, it is hard to say. If the pipeline continues to produce in spite of the pandemic, there will be new approval announcements. There will certainly be new COVID developments. And the existence of so many products authorized under emergency use authorization is certainly an issue that will have to be dealt with. When will the products be fully approved? And while the imprint of the communications style of a new commissioner is something that might be anticipated, we are getting a commissioner who we had once before in 2016-2017, a period where the quantity of communications was not robust. And new in 2022, FDA has occasionally begun issuing something called “FDA Roundups” but have provided to date no new “FDA in Brief” statements. Something to keep an eye on.

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FDA OPDP Look Back at 2021 – The Yawning Gap

Posted on January 10, 2022 by Mark Senak

Once again it was a quiet year with respect to the FDA’s Office of Prescription Drug Programs (OPDP). As noted in the past, there are two primary means for understanding the agency’s latest thinking with respect to promotional communications from pharmaceutical companies – the content and pattern of enforcement and the issuance of guidance documents to shed light on the parameters that exist. In that respect, 2021 was not a banner year.

The Numbers: Looking first at the quantity of enforcement, the numbers were low. This year there were 6 regulatory action letters issued by OPDP, the same as the previous year. The only other time in the past 24 years when enforcement was this low was in 2017. This year there two were Warning Letters and four were Untitled Letters.

The 6 letters issued involved 7 different communications vehicles for a total of 13 violations that were cited by the agency as reasons for the action.

The Substance: What triggered the enforcement actions? Back in 2009 you may recall that FDA issued 45 Untitled Letters aimed at 14 companies regarding the use of banner ads/sponsored links where clearly benefits of a branded product were available, but risk information only ascertainable by clicking on a link. This was a clear direction from the agency that risk information could not be incorporated by link. This year, three of the communications vehicles involved in enforcement actions were either banner ads or sponsored links where risk information was not included. One of them involved the more serious Warning Letter action, possibly because the product associated with that communication had a Boxed Warning in its label. The other communications vehicles involved DTC videos. Of the 9 violations that were cited in the 5 letters, 4 were for risk minimization or omission, 2 involved superiority claims, 1 unsubstantiated claim and 2 failure to submit Form 2253 to review.

Guidance Docs: As far as I can see, there have been no new relevant guidance documents, wither in draft or final form, that are focused on digital and/or social media and promotional communications. In the latest published guidance agenda from the Center for Drug Evaluation and Research, the advertising and promotion category had no slated guidance efforts listed.

Research. To a degree OPDP signals where it is headed in terms of enforcement and guidance by telling us what research it is conducting around promotional communications. Of the 13 projects currently underway by OPDP, 2 of them are focused on aspects of television DTC ads. There is one study comparing physician interpretation of information from scientific publications versus promotional materials. And curiously, one study is focused on assessing medical conference attendee observations about prescription drug promotion even though medical conferences have largely been virtual for the past two years. None of the studies underway are aimed at uncovering data that would be helpful in providing additional guidance related to the use of digital and social platforms by patients, prescribers and pharma companies.

Why This is a Fail. The way that patients and prescribers learn about medicine has changed significantly over the past 15 years. People do still watch commercial television, but in fewer and fewer numbers. Digital and social media are a primary resource for getting healthcare information and discussing treatment, especially now in the age of COVID. It is a continually evolving environment – there have even been an abundance of articles about how pharma companies should be using TikTok. In particular, for people who do not have access to computers, mobile access is the primary means of getting information. How websites are optimized for mobile is therefore important. FDA has traditionally taken the view that if it is wrong on television DTC, then it is wrong on TikTok. But these are all new platforms that have a lot of nuance to the use of the platforms, in addition to the fact that different populations may have different approaches to digital consumption as well as varied skills. There may be vast comprehension differences in digesting communications from digital sources than from traditional DTC television advertising. It is way past time for the agency to have applied effort to understand the role of that nuance and to make more detailed studies – and therefore guidance – on the best uses of digital media. And of course, there is the fact that FDA never really finished providing guidance related to social media inaugurated by the public meeting the agency held in Washington, D.C. in November 2009. At that meeting, the agency posed five questions as a framework for developing a guidance the following year. Guidance did not come for five years and then did not follow the framework, leaving the questions only partially addressed by two guidance documents – one on use of platforms with character space limitations and another on correcting misinformation posted by third parties. This leaves quite a bit of work not done as it relates to social and digital media, the source from which growing numbers of people get health care information.

FDA Changes Display of Warning/Untitled Letters. Finally, FDA has made it harder to get a view of the regulatory actions with respect to promotion. All letters, Warning and Untitled Letters used to be listed in chronological order. This year, for reasons that are incomprehensible, FDA moved the Warning Letters from the list of OPDP actions and lumped them into all of the other warning letters issued by the entire agency. Now to assess the activity of OPDP for the year, one must visit the list of Untitled Letters and then sort through the list of agency-wide warning letters.

One thing that did happen this year is that OPDP has new leadership. It takes a long time to steer any ships within an agency as large as FDA and to bring about true change. The gears grind slowly. But there is a yawning gap between communications realities on the one hand and the agency focus when it comes to promotional communications. One hopes that the agency will consider the shifts in communications that have taken place and the impact those shifts have on the decisions that patients and providers make with respect to treatment. Hopefully 2022 will bring greater attention to addressing the many deficits that exist in the current approach to enforcement by conducting more research that is appropriate to the communications environment.

Note: Following the original publication of this posting, in mid-January OPDP posted a letter dated December 19. The original of this blog posting has been updated to reflect that late addition to 2021 letters.

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