I don’t usually publish the scheduling of an AdComm with a blog posting. But this one merits one.
With fewer than the usual minimum of fifteen days’ notice, FDA has scheduled an FDA Advisory Committee meeting of the Cardiovascular and Renal Drugs Advisory Committee to discuss a new drug application (NDA) for terlipressin, lyophilized power for solution for injection for the proposed indication of the treatment of hepatorenal syndrome. The meeting will be held on July 15 from 8 AM to 5 PM and it will be a virtual meeting.
Normally before an advisory committee meeting, FDA opens a docket for the submission of public comment prior to the meeting at www.regulations.gov – and while they are opening one for this meeting, it will only accept comments until the end of day July 14, 2020, but only those comments submitted before July 10 will be submitted to the committee for review.
The reason for the lack of time between publication of the notice and holding the actual meeting was stated to be unspecified “technical problems”. The agency sates that it will make the background materials available no later than 2 business days prior to the meeting. Hopefully no technical problems there. These should be found on the FDA website at the Cardiovascular and Renal Drugs Advisory Committee meetings page.
The agency states in the Federal Register notice that the meeting will be conducted via an “online teleconferencing platform” but does not say which one. The notice refers people with questions to the standard FDA Advisory Committee webpage about in-person meetings. So you can find out how you get lunch in an in-person meeting, but there is no information about how to access the virtual meeting or how it will work. Bad show, FDA. Presumably this will become apparent in the meeting materials that will be posted prior to the meeting.
We are in the seventh month of this pandemic and it has been clear for at least five of them that virtual advisory committee meetings were likely. FDA needs to deliver a better product here for the sake of credibility in the approval process moving forward.
At mid-year, it has been a custom here at Eye on FDA to look back at a few categories of activity by FDA at the first half of the year and discern what it tells us about future directions. This year the unprecedented circumstances presented by the COVID-19 pandemic make it particularly interesting this year. A good place to start is with regulatory enforcement of the Office of Prescription Drug Promotion (#OPDP).
In the now distant past, enforcement from this office, then called the Division of Drug Marketing, Advertising, and Communications (DDMAC) and later re-named OPDP, was robust, with the office issuing scores of letters a year (156 were issued in 1998). However that number begin to trend downward and in the past several years, the number of letters issued has dwindled ranging from as few as 5 to as many as 11 over the past five year period.
There are potentially many reasons for this drop in enforcement, which could be the subject matter of its own for a blog posting. But this year, enforcement is particularly lull. There has been a single letter (1) issued this year, issued in the nascent days of the pandemic on February 21.
The interesting thing in connection with that is that in May – in the midst of the COVID-19 pandemic – FDA held a Webinar on the “Bad Ad” Program – a program that deputizes healthcare professionals to assess promotional communications and report potential violations to the agency. By holding the Webinar, OPDP is presumably to solicit greater participation of healthcare professionals but in spite of the fact that visible regulatory enforcement is at an all time low. But truly, one has to wonder in the midst of a pandemic that is gripping and challenging the healthcare system just how much spare time healthcare professionals might have to participate in a non-reimbursed activity in this regard. Moreover, how much of a priority is enforcement given the track record of the past several years?
This year’s single letter was a Warning Letter, the more serious type of regulatory action letter issued by OPDP. The communications vehicle that incurred the violation was a sponsored link that appeared on Google. The drug in question is Schedule II drug and bears a Boxed Warning on its label, yet the link contained no risk information about the drug, despite the fact that there was present information about the benefits of the drug, according to OPDP’s letter.
OPDP has indicated in the past that the use of sponsored links without risk information is a no-no. Notably in April 2009 the agency issued 14 letters regarding 45 brands all related to the use of sponsored links – going after a practice known as the so-called “one-click rule” which was not a rule at all, but the common practice in promotional communications of having risk information just one-click away in a promotional communication. The agency had never said that this was not a permitted practice and only made it clear by issuing the letters, rather than having enunciated the parameter through a guidance document about digital communications.
Then as part of the agency’s effort at putting together a regulatory stance regarding the unique questions posed by the huge migration into digital and social communications, FDA later that year posed a series of five questions to inform the regulation of this burgeoning environment during a public meeting held that same year. One of them was about the appropriate use of links. FDA said they would produce a guidance by the end of 2010, but did not. Only in 2014 did the agency issue guidance documents addressing some of the questions they posed in their framework, but have not issued anything since and have left many questions unanswered while new ones have emerged. For some years CDER published its Guidance Agenda to include a guidance on the use of links to third party websites by pharmaceutical companies. This item disappeared from the agenda, however, and no draft guidance was issued.
As we muddle our way through the COVID-19 pandemic, one of the emergent truths is that virtual and digital life is taking on a much greater presence than is real life. We are on Zoom calls, FaceTime cocktails and our use of the Internet has apparently surged. Utilization of the services of physicians and other healthcare providers, on the other hand, have plummeted. It stands to reason therefore that use of the Internet for health-seeking information is likely on the rise during this time. Telemedicine is ascending and patients are going to be relying on what they access online over what they access in a doctor’s office, or from television for that matter.
Yet the focus of OPDP seems to continue to be on traditional communications vehicle, while leaving the work on digital and social undone. Recently, FDA published in the Federal Register intent to study the promotion of multiple indications in Direct-to-Consumer television advertisements. In fact, the OPDP research agenda has a focus that is heavily tilted to traditional avenues of communication over digital and social, despite the fact that it is the latter to which people are turning for healthcare information. Several aspects of digital and social guidance are in need of attention – from designing a website for mobile use to the appropriate use of links. The pandemic certainly presents one not only with the opportunity to provide clarity on these and other aspects, but the overwhelming need for such attention. It is difficult to say what enforcement will look like for the balance of the year but it certainly seems like a good time to focus on some gaps.
Any pandemic is a medical crisis first, but it is also a social crisis and in the case of COVID-19, it has been a financial crisis. On top of that, emerging pathogens push new legal issues into the forefront. Currently with COVID-19 we are at a great crossroads where businesses and services are opening up while at the same time the virus is surging out of control in several states. That points to another reality, we have had a patchwork approach to the pandemic, and we also have a patchwork of state laws to contend with.
In re-approaching the workplace and places of service and public accommodation in the wake of COVID-19, there are a number of tools in the toolbox. Obviously testing for COVID-19, the wearing of masks, appropriate distancing, temperature screening and there has been discussion of using antibody tests as a means to screen and categorize people and even terming a positive status as an “immunity passport”. Ultimately there may be a vaccine.
But in the United States, there are also an array of anti-discrimination laws; there are health privacy laws at both he federal and state levels; and there are regulations that guide what constitutes a safe workplace. And there are people who have religious beliefs that may be asserted related to medical care. If you shuffle this half of the deck with the half outlined above, what do you get? It is not as uncomplicated as one might think.
On Monday, June 29 at 1 PM Eastern Time, I will be moderate a webinar to discuss the medical, legal and ethical aspects of COVID-19 at this particular juncture in the pandemic. Join me as I discuss the issues with an infectious disease specialist and a legal expert in workplace issues.
Given my background as a lawyer for people with HIV/AIDS in the 1980s, I witnessed first-hand how a pandemic pushes new legal boundaries – and that sometimes we are so focused on the medical side of the equation, we think of the legal side only when it is too late. I hope you can find the time on Monday to hear this discussion.
COVID-19 was a shock to the system unlike anything that had been anticipated. Even prior to the shutdown, health-perceptive people were starting to avoid public venues and there were declines in the numbers of people going out to eat at restaurants, to public functions, visiting with friends and also going to the doctor’s offices.
When it comes to healthcare, that has translated into multiple stress points to our system of care spanning both health and economics with people avoiding care for both their chronic and acute medical needs. Medical personnel themselves have been consumed by COVID-19 duties to care for patients and many have themselves fallen ill. Many medical and dental practices have shut down or have reduced greatly the number of patients being seen and then, only under specific circumstances. That means that not only will there be a backlog of patients, but they will be coming in for care when they have progressed in their illness or made its treatment more complex. Moreover, they may have lost their insurance. The interruption of services has brought financial peril to practices, particularly small ones. Cracks that existed in the healthcare system prior to COVID-19 have widened while new ones have appeared. As with all venues – work, restaurants and healthcare, a return is going to be premised on multiple factors, but many of which will rely on communications.
My colleagues at FleishmanHillard’s TRUE Global Intelligence – the in-house research arm – fielded an online survey of 600 adults in the U.S. aged 30-75 on May 4-5 to provide insights into the perceived risk people have of returning to healthcare offices and moreover, what will make them feel safe.
What they found was that concern is widespread, far-reaching and multi-faceted. Overall nearly forty percent of consumers surveyed felt either “not very safe” or “not at all safe” in going to a dentist and nearly 1 in 3 (28 percent) stated that they did not feel very safe or not at all safe in a physician visit. Moreover, 41 percent stated that they would not feel very safe or not at all safe in going to a hospital for a diagnostic test, while even greater numbers stated they would not feel secure in going for elective surgery either as an outpatient or inpatient. Women felt a greater sense of unease than men by far in each of these categories, and naturally because of the risk of co-morbidities with COVID-19, the older a person was, the less inclined one was to feel safe. Overall, only one-third felt that it would be considered safe to visit their physician in the coming months. You can view and download the complete survey report here.
Concerns were not limited to the physical premises, but also centered on ancillary issues. For example, 69 percent of respondents said they were either “extremely concerned”, “very concerned” or “moderately concerned” about someone not being able to attend a procedure with them, or to be able to stay with them during recovery. Additionally, 58 percent were concerned that they would not be able to have someone to take care of them once they were home, and nearly half feared not being able to find someone to take them to and from a procedure – sentiments that were particularly concerning to younger consumers.
What will it take to be ok? The bottom line for consumers (80 percent) was that there needed to be some clear way of communicating the parameters of safety in a healthcare setting, but consumers are guarded about the motivation behind those communications, with 63 percent worried that a drive to get patients to return may be driven by financial reasons. They overwhelmingly (88 percent) expressed a desire for clear and simple communications about safety in returning to the healthcare setting but 80 percent feel that there currently are no clear signs.
Clear communications on this front will not be easy. The survey revealed that one of the most reassuring messages to patients was that healthcare staff are being routinely tested for COVID-19. But the real challenge is that as people seek certainty and security, the solid facts about COVID-19 are still being discovered. And no one entity is in charge of the message complicated further by a politicization of the issue. The survey also revealed that the voice of the physician is more important than that of elected officials or governmental bodies.
In short, it is likely to be communications from healthcare providers – both individual practices and large institutions, medical societies and perhaps ultimately those without a direct financial interest – such as patient organizations – that may ultimately shape perceptions about that risk. That makes this more of a grassroots effort than communications that comes from the top-down. That, in turn, means that efforts may vary regionally and even by locale. Above all, it will be essential to strike the right balance of message with the appropriate messengers and the correct times. And above all, it will be a process, not an event.
There is going to be a time in the not too distant future, when the fuller picture of the healthcare impacts of COVID-19 come into sharper focus. When that happens, it is not likely to be pretty. In large part, this is because a very large portion of the population has moved into a state of unemployment. With that reality come a labyrinth of consequences that alter the healthcare landscape on a seismic scale, particularly in the United States where access to healthcare relies largely on being employed. For the pharmaceutical, biotech and device industries, this impacts everything from from philanthropy, to sales force mindset and approach, to the development of strategic partnerships. There are going to have to be changes. And moreover, there are likely to be new expectations.
Here are just a few realities:
We will be sicker. First of all, people have put off care across therapeutic categories, in many cases likely exacerbating their existing conditions. In addition, illness that may have been prevented through early detection and treatment will not have been. Icing on this particular cake is that everyone is stressed resulting in substantial acute mental health needs – and we don’t really have a good mental health system of care in this country. In fact, we don’t even have a system.
We will be poorer. Just when we need access to the healthcare system more urgently, more broadly, and with more needs, as a result of unemployment we will have less ability to do so. Insurance that was employer dependent will have evaporated for many, savings will be consumed and with a resulting increase in indigence (which means food and nutrition insecurity), there will likely be a huge and unprecedented migration onto Medicaid.
We will have fewer options. Healthcare practitioners have taken it on the jaw and a number of practices as well as institutions, such as rural hospitals, may be in shorter supply. In addition, healthcare workers have been on the front lines and many have been stricken and died. And there will be those who will not want to continue in their profession given this experience and the new demands placed on them in a post-COVID world. Some will just understandably burn out. That means that even for those lucky enough to retain their insurance, the options at hand for accessing medical care may be far less than they were before.
We will be more on our own. Non-profit patient support organizations provide a great deal of support for all types of patients. During the early days of the AIDS epidemic these organizations filled the many holes that were in the system of care providing everything from counseling to food support to dentistry to name a few in a long list. There exist a multitude of patient organizations providing support and advocacy for their constituent groups. They are all charitable entities that rely on donations. With so many fewer people employed, donations will be much more competitive and in much less supply. They are going to need help to survive.
Naturally it is not up to the pharmaceutical, biotech and device sector to solve all of these problems, but there may be a very real expectation that they are huge part of the solution in areas where they have the ability to make the greatest impact.
In September 2019, a Gallup poll was released that showed that the pharmaceutical industry had hit rock bottom when compared to other sectors, with a positive rating of just 27 percent of the population and a negative rating of 58 percent. Now, as we universally experience a pandemic that has threatened our health and our wealth, attitudes may be shifting. Some have speculated that this crisis presents industry with an opportunity to change public perception. This was evidenced in a analysis conducted by my colleagues at True Global Intelligence, the in-house research practice of FleishmanHillard. In a survey of over 6500 people conducted globally in six markets, people were asked how important various entities were in responding to the pandemic. Pharmaceutical companies had the second highest ranking (93 percent of respondents), just behind the role of national government, ahead of local government, employers and well ahead of other major corporations.
In other words, there is a great expectation of industry. Fulfilling it may mean adopting new approaches to supporting health care professionals as they grapple with the pent up medical demand for non-COVID conditions. It will likely require a more holistic relationship between providers and companies through their sales force; the development of new and expanded patient assistance programs to address the needs of the newly indigent and those lacking insurance; providing beefed up support for patient organizations seeing to the ancillary needs of their constituents, and more. It requires proactive planning now, not reactive patchwork later.
There are going to be a lot of pieces to pick up and put back together. From adversity there is always present opportunity. This is not just a medical crisis, it is a humanitarian one. And unlike the AIDS pandemic that was horrific but narrow in scope, this one touches every single person in critical ways. That means an approach in a post-pandemic world must also be humanitarian and must be comprehensive. People expect the pharmaceutical, biotech and device industries to step up and bring this pandemic to its knees with treatments, vaccines and tests (antibody and viral presence), but the expectation is not likely to stop there. When everything else is somewhat broken, the industry will likely still be standing tall. The future perception of the industry may hinge more on its presence in the aftermath of COVID-19 in helping shape a new and better environment than it will be by innovation expressed during the pandemic that eventually may bring an end to it.
My name is Mark Senak. I’m a lawyer and I work at the international communications firm FleishmanHillard in New York. For the past several years, I have been consulting with pharmaceutical and biologic companies that are engaged in the process of bringing new drugs to market.
I am an authority on regulatory aspects of communications and medical products, with particular emphasis on pre-approval communications; strategist to help pharma and biotech companies prepare best case for advisory committee approval; and counselor in issues and crisis management. I am a frequent speaker on various aspects of same - drug development, promotion, reimbursement and new media in a highly regulated environment. Author of books, newspaper and magazine pieces related to drug marketing and promotion as well as HIV specialty pieces. And of course... blogger!
About This Blog
Eye on FDA is published by Mark Senak of FleishmanHillard's Washington, D.C. office. The thoughts and ideas in this blog and postings are strictly my own and are not screened by my employer. Everything posted on this blog is my personal opinion and does not necessarily represent the views of FleishmanHillard or its clients.