Mark S. Senak's Blog, page 7

The Pharmaceutical-Biotech-Devices Industries Face a New World Post-Pandemic

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.

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The Language of “Recovery” in the Age of COVID-19

There have been many parallels drawn between this pandemic and the AIDS pandemic that began in 1981. And in fact while many obvious differences exist there are many valid comparisons. Moreover, there are some common threads that run through crises involving a communicable disease and here were a few from this writer back in February 2020. But as many turn their attention to a “recovery” phase for this pandemic, there are also some lessons learned from the experience of HIV/AIDS that might be applicable today.

It begins with the very term – recovery. On the grand scale this word refers to the desire to address the economic impact that has been wrought by the pandemic and the necessary measures of social distancing to contain it. On a more individual level, recovery signifies getting our lives back – having people over, going out to a restaurant, receiving or giving a hug. For the former the yearning has led to policies put into motion that will relax containment measures, leveraging economic gain with potential human loss. For the latter, it may lead to easing up and going to get that haircut or have one’s nails done or getting that hug. For both, the outcome may be perilous. Time will tell.

Language is important. The word “recovery” sets up an expectation that things – business, the economy, our personal lives, will go back to “normal” or that there will be a “new normal” that is different – though undefined despite the fact that the term is increasingly used. There are many scenarios of what may happen with the COVID-19 pandemic, but one of them is that the recovery is represented less by a definite demarcation – a turning point or represented by straight lines – to one represented by wavy lines, where infection rates go up and down. In the absence of a vaccine, this scenario has a strong basis, perhaps particularly as social distancing is relaxed in a patchwork fashion across the nation. A “new-normal” could be a state of being where there is no new normal.

From 1981 through 1997, I worked in HIV/AIDS and in the early days of the 1980s was the Director of Legal Services at the Gay Men’s Health Crisis in New York City, providing legal support to people – helping battle insurance companies, devising immigration solutions, bringing discrimination actions and doing endless wills – many in hospital rooms suited up in protective garb of caps, gowns, and masks. Almost every day I got “RIP sheets” delivered to me naming my clients who had died. I had about 3000 clients at any given time and there were 3-4 names per sheet of paper. On some days, the RIP sheets ran 20 pages long. Many co-workers died; many friends died (once 2 in a day); my partner died. It would be many years before there was an effective treatment that would bring change. Every day represented a yearning for recovery – hopes that rested on the possibility of either a cure or a vaccine. It bears noting that we are still waiting for either one. And all that happened nearly forty years ago.

My point is this. Recovery experiences that are so life-changing is very subjective. It is not a blanket return to normal. Something you quickly learn going through this sort of thing is that it is not a crisis that comes and goes, it is bigger than a crisis. Tectonic plates shift. Things re-order. Recovery implies an ability to forget about what has happened and to move on. But in fact, when the magnitude of what you go through is so large, expansive and pervasive, you don’t forget, you learn to live with it. Or you don’t. It became a mantra of mine in those days. You don’t forget this, you learn to live with it. And that takes work.

And so in the context of today’s pandemic, what we are going through – economically, politically and personally – invites a sort of examination of our strengths on a very subjective level. A promise of “recovery” in the traditional sense is perhaps setting ourselves up for failure. Moreover, this does not happen from the top down. It cannot be ordered by policymakers, either those in government or those in corporations, organizations or other institutions. It is not directed, it is inspired. And it will have to come from within – from the people living in states, the people working in companies, and those serving in institutions. And forty years from now, it may well be those who discarded the notion of “recovery” in favor of concentrating on the ability to adapt who have a perspective that helped them survive.

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Impact of COVID-19 on FDA Enforcement and Approvals – Part 5 – FDA Provides Update to Shape Expectations on New Approvals

In response to written questions submitted last month regarding the potential for delays, FDA had stated that “CDER remains fully capable to continue daily activities, while responding to the public needs of the current COVID-19 outbreak.” In a subsequent blog posting this month, it was noted that FDA was devoting personnel to focus on COVID-19-related review efforts and that it was certainly possible that this might be a factor in delaying new approvals of non-COVID-19 medicines and devices. Yesterday FDA provided an update which affirms the possibility of delay. The fact that there was such an update would seem to indicate that the agency regards delays as increasing in likelihood.

Of note in yesterday’s statement the agency stated – With many staff working on COVID-19 activities, it is possible that we will not be able to sustain our current level of performance indefinitely. Our staffs are working at full capacity and we are striving to ensure that the drug programs continue to see minimal interruptions during this time. However, if there is an increase in drugs shortages and supply disruptions, we will be ready to reprioritize more of this work, as necessary.

And respecting devices, it seems to appear a little more certain that there will be delays: Additionally, with many staff in CDRH working on COVID-19 activities related to pre-Emergency Use Authorizations (pre-EUAs), EUAs, and Immediately In Effect (IIE) guidance documents, it is possible that we will not be able to sustain our current level of performance indefinitely. However, this will be assessed on an ongoing basis.

In the current environment, the only thing that can be said with certainty is that we are dealing with a great deal of uncertainty. The statement from FDA does not absolutely say that there will be delays, but that there are factors at play that make it more possible that there may be delays. It bears keeping in mind that not all new drug and new device applications are equal – in other words, while delays are possible and even probable, there are likely variables at play that will be highly influential on whether a particular application is delayed. But the communication from FDA underscores the possibility.

For the present it is a wait-and-see moment for each and every product in the pipeline. And in the longer term, to see what impact that this year will have on the future course of approvals as well as the standards by which products are reviewed.

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T-Minus COVID-19 – Impact of Pandemic on New Medicine Launches

As the coronavirus pandemic began to unfold, focus on the pharmaceutical and biotech sectors was on the most immediate and apparent concerns – the impact on the supply chain for drugs that are currently in the market and on the regulatory process for approving new ones. More distant in time, but also of extreme importance is the effect on the launch of new medicines that have been approved.

Drugs coming to market are important in several respects. First, they may represent advances in either safety or efficacy over previous treatments – or they can even be bringing new treatments in a category where there are very few or no viable treatment options. Second, they represent hope to patients whose needs are not being met in the current treatment environment. Third, they may have a financial impact for the company and they set shareholder expectations for return. Finally, they underscore the innovation of a company that is vital to its brand.

But a new drug launch in the time of COVID-19 comes with definite challenges. Recently in the U.S. Bristol Myers Squibb stated in its press release announcing FDA approval of the company’s treatment for multiple sclerosis that the commercial launch would be delayed due to the COVID-19 situation. And in Europe bluebird bio announced that it would delay the treatment of the first patient in Germany with its new approved gene therapy until the second half of 2020.

Why would COVID-19 affect a drug launch? Some of the factors involved include:

Risk Associated with Routine Medical Visits – There has been an observation that catheterization laboratories have seen a steep drop in utilization since the pandemic began, which could indicate that people are avoiding going to the doctor right now out of fear of contagion, even when experiencing something as serious as symptoms of a heart attack. In particular, patients who are older or who are experiencing a serious illness that might put them at increased risk may avoid going to the medical office for a routine visit. Since healthcare providers are the gatekeepers to prescriptions, it necessarily would impact uptake of any new medication. Loss of Insurance – Millions of people are losing their jobs, and often with it, their access to health insurance not only for the care, but to cover the cost of new prescriptions. The magnitude of job loss is going to seriously impair the ability of people to access their existing medicines, much less be evaluated for new (and likely more expensive) treatments. Concerns Related to Starting New or Switching Therapies Now – Switching a therapy to a new medicine, or starting any new medication, may require follow up evaluation. If people are avoiding non -urgent medical care based on fear of COVID-19 transmission, their desire to switch medications that might necessitate follow up is likely to dampen any desire to start a new therapy. Physician Practices Under Stress – Many practitioners are on the front lines or are in institutions that are under siege, dealing with issues from the inherent lack of personal protective equipment to patient need to demands for tests that are not available. This is not to mention their own health status and those of their families. Many individual practices are not seeing patients. Company Sales Forces Operating in Virtual Environment – Prescribers are introduced to new medicines and learn about their many aspects through visits from sales representatives. By necessity, these are occurring in a virtual environment, but it’s a conversion that will take time to establish itself, with the technical side being only part of the challenge. It is one thing to take a discussion of orders online, it is quite another to master the art of developing a relationship in a virtual setting.

While the challenges are many, there is one counterweight that may address some of what might otherwise impede access to care – the increasingly rapid facilitation of access to telemedicine. Every day the the impacts of the pandemic take on new aspects. And each day we are without a vaccine means these effects are going to linger. While telemedicine is not a panacea, it is one means of addressing the issue of access based on concerns that patients have for stepping into the healthcare environment. There is little question that the pandemic has motivated the healthcare system to turn to telemedicine as a solution and to have payers firm up efforts to reimburse for its use. Hopefully as we collectively travel through this new terrain, over time we will address the loss of access to healthcare due to financial constraints. There is no question that delay of new medicine launches for now may be a short-term necessity, but we are going to have to deal with the fact that we are in the midst of long-term problems to every aspect of the healthcare system on which we are going to rely.

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Principles for COVID-19 Healthcare Communications – 2 – The Virtual Medical Meeting

Virtually everyone is going virtual. Even in February, which seems like a very long time ago, many organizers began either postponing or canceling major conferences and meetings. This has included major medical meetings and given that large gatherings will be the last type of activity to resume some sort of normalcy in the future, it is quite likely that many more will make announcements that meetings are going to be virtual in the foreseeable future. There are many communications issues associated with this new way of having a major medical meeting.

The coronavirus pandemic is a challenge to medical meetings on two fronts. First medical societies must address the logistics of a virtual meeting. But given the realities of conducting clinical trials in a time of contagion the exchange of future data may mean that meetings will contain less information than in the past, if held at all. Here is a great resource providing an overview of clinical trial disruption on a company-by-company basis.

Medical conferences are dynamic in nature fulfilling a number of important purposes. First and foremost of course they are the venues for the exchange and presentation of scientific data. Results from clinical studies for new treatments are presented not only for the practitioners in attendance, but for media and patient organizations. This provides a finger on the pulse of progress, representing not only scientific advancement and positioning companies vis a vis their investors, but hope for those whose future may rely on the advances in science and medicine. They are also a venue representing multiple commercial opportunities. And it is a place where networking occurs – where patients, investors, innovators, scientists and companies can engage in dialog and even protest. It is all reported out by media, both top tier and trade. So how does all of that happen virtually?

Virtual conferences have had to happen in short order and it seems apparent that those organizing such events are building the bicycle while riding it. There is no guidebook or established set of best practices for this. The various ways for stakeholders to participate – from presenters to patients – is likely going to vary and over time, the experience is likely to improve. There are, of course, any range of virtual tools available and platforms by which information can be exchanged. Tools used by participants obviously should include multi-media press kits that contain as many separable and shareable components as possible such as podcasts and videos. Here is where stakeholder organizations that have invested in their social media muscle will see some of that work payoff. And it is also where those who have established lines of digital communication with stakeholders – some of whom will be key opinion leaders and patient organizations – will also experience the wisdom of that investment. While always an important factor, having others to carry your water for you – your messages and content – beyond the venue is even more essential in a virtual setting than it was in a more traditional one.

But of course one of the most important aspects of data presentation is the media who write about the data. These days COVID-19 is taking all of the oxygen out of the mainstream media room. But for trade media, it is still important news. I asked some colleagues to reach out to a few reporters and ask them about operating in this virtual environment. Here is some of the wisdom that was captured for both meeting organizers and presenters:

Pre-meeting materials. A big, long, in-person meeting is being compressed into a short-time window on a computer screen. That makes it even more important to help reporters plan and prepare before a meeting starts with advance access to materials such as abstracts. Embargoed updated data. While pre-meeting materials play an important role they can be out of date by time of the presentation starts. Sharing embargoed data in an email or with a link the day before a presentation facilitates reporters’ ability to get the story right. Prior Access for Interviews. Ideally both presenters and executives who can provide some context for the data beyond the study should be available before a presentation rather than after. Accessible and Digestible Materials. Posters and slide decks should be made available online at the time of the presentation either through link or QR code. The maximum time for a webinar should be 3 hours in length with breaks built in for each hour as reporters are still required to be available to others during the time spent covering the conference. Virtual Press Room. There should be a meeting place for the reporter and interviewee with such a venue allowing for both to dial into a virtual press room and enter a private chat for conducting an interview.

These are obviously only meant to be thought starters, but come from the perspective of a few trade reporters. Not only should the pharma, the medical and professional societies organizing medical meetings should take note, but FDA as well as the agency undoubtedly is involved in planning eventual virtual Advisory Committee meetings.

Eventually the bicycle will be built and once done, there will be many ways to improve it. What becomes the central question now, given the wrinkle in future data, is for how long?

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Impact of COVID-19 on Regulatory Enforcement and Approvals – Part 3 – FDA Adds Resources to Facilitate COVID-19 Research

With the COVID-19 impact making itself apparent on a daily basis as the numbers climb and organizations respond, the effects on the pharma and biotech sector also shifts. Yesterday FDA announced a new concentration of agency assets to be focused on enhancing the development of new treatments and presumably vaccines for COVID-19 called the Coronavirus Treatment Acceleration Program (CTAP).

According to the press release from FDA, Health and Human Secretary Alex Azar was quoted as saying that FDA would be “redeploying staff” in order to review potential new therapies. Staff from CDER and CBER will both be working to triage and provide support quickly with the underlying goal of maintaining FDA’s standards for evaluation of safety and efficacy on a fast-track basis.

There is certainly an urgency to develop strength in a “four-legged stool to address the pandemic. One leg involves the development of treatments that address symptoms of COVID-19 – both bringing new ones to market and assuring continued access to existing ones; one leg involving new therapies that directly address COVID-19; one additional one that is centered on vaccine development; and finally one that addresses diagnostics with rapid, reliable testing. The last has moved quickly in development. The others must move quickly.

Needless to say the current environment demands that COVID-19 development be priortized and facilitated. However, along with the pervasive interruption to clinical trials of non-COVID-19 therapies in research and development, the shift in resources to CTAP also signals that it may not be business as usual in the coming months with respect to the pipeline. This is true even where non-COVID-19 approvals occur as evidenced by the announcement last week that the approval of a new compound for due to the COVID-19 pandemic.

In addition to shifting regulatory focus, research and development within industry is being deployed to the important task of the four-legged stool. The devotion of both research and regulatory assets and resources is extremely important but also factors in the equation when it comes to assessing the impact of this pandemic on the pipeline of new treatments – on research, regulatory review and even launch.

As noted in the last posting on this topic, I will continue to monitor and report out on developments.

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Impact of COVID-19 on Regulatory Enforcement and Approvals – Part 2

Empty FDA Advisory Committee Meeting Room

Earlier this month I published a blog posting that raised questions related to the potential for disruption of approvals in the wake of FDA actions to limit inspections due to the COVID-19 pandemic. Subsequently I had the opportunity to pose questions to FDA regarding the impact of the current circumstances on future approvals and the ability to meet PDUFA dates in a timely manner. The Center for Drug Evaluation and Research (CDER) responded as specifically as they apparently could under the circumstances. Bottom line – it would appear that while disruptions to the approval process are possible, the agency is operating and attempting to put into place measures to mitigate disruption. And while virtual AdComms are not a certainty, it would also appear to be something that is possible – at least they are thinking about it.

Here is what they said verbatim:

What is the expected impact on approvals of the recent decision to postpone inspections? On 3/18/2020, for the health and well-being of our staff and those who conduct inspections for the agency under contract at the state level, and because of industry concerns about visitors, we announced that we have temporarily postponed all domestic routine surveillance facility inspections. These are facility inspections the FDA traditionally conducts every few years based on a risk analysis. Importantly, all domestic for-cause inspection assignments will be evaluated and will proceed if mission-critical. We will continue to respond to natural disasters, outbreaks, and other public health emergencies involving FDA-regulated products. Importantly, during this interim period we’re evaluating additional ways to conduct our inspectional work that would not jeopardize public safety and protecting both the firms and the FDA staff. This can include, among other things, evaluating records in lieu of conducting certain onsite inspection on an interim basis when travel is not permissible, when appropriate. Does FDA plan on attempting virtual advisory committee meetings? As this remains a dynamic situation, we will continue to assess and calibrate our approach. Where possible the agency will leverage technology to host meetings allowing for remote participation. We thank you for your patience. In considering necessary steps for protecting public health, including our sponsors, our committee members and our workforce, we are cancelling or postponing all non-essential meetings through the month of April. We will reassess on an on-going basis for future months. Where possible the agency will leverage technology to host meetings allowing for remote participation.Is there an expectation that PDUFA dates will be missed, or will they be extended due to the crisis? CDER is fortunate to have existing policies on the use of flexible workplaces, as well as the IT infrastructure to support a large number of staff simultaneously working offsite This gives us the ability to ensure the safety of our workforce and the continuity of our important public health mission during government disruptions. CDER remains fully capable to continue daily activities, while responding to the public needs of the current COVID-19 outbreak. As this remains an evolving and very dynamic situation, the FDA will continue to be flexible and transparent as possible. Will new drug applications be considered during this time when presumably the FDA workforce is working remotely? CDER continues to perform our drug review activities as well as contribute to other vital functions of the Agency. As you may know, we are working around the clock to monitor and mitigate emerging coronavirus-related issues with our federal partners, international regulators and medical product developers and manufacturers to advance response efforts to combat the coronavirus disease (COVID-19) outbreak. Our application review teams remain focused on their work, and we are doing everything possible to maintain continuity of operations in a very dynamic situation.

What do we know from this? The situation we are presented with means that certainties in any conversation are off the table given the situation we are facing. But what this tells us is that the FDA workforce is equipped to work remotely. It does say the agency is striving to find alternative means to do what it cannot do in person and to meet the necessities of the review process. It does foreclose the possibility of delays, but affirms that efforts are going into getting work done as usual. That means that we will not really know for certain until upcoming PDUFA dates come and go. To that end, I track all the dates of which I am aware and record decision dates and will let you know that tells us as we tread further along in this environment.

Be well. Be safe. Be kind.

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Principles for COVID-19 Healthcare Communications – 1 Keep it Simple, Keep it Organized

On February 21 I published a piece on LinkedIn – Communications Considerations for Medical Manufacturers as the COVID-19 Epidemic Emerges – that provided an overview of some of the communications considerations for pharma, biotech and device manufacturers related to the COVID-19 pandemic. It seems a good idea to look at some of those things I discussed in the piece a little more close up – and so I am thinking a series of postings here on the topic.

A frequent communications pattern with emerging pathogens is going from too little information to a deluge of information, sprinkled in with a dose of misinformation. We have all been receiving in our in-boxes emails with updates from everyone in business – banks, airlines, car rental companies, even my hardware store. It is a lot to digest and it is coming at us during a time of stress. Moreover for those in healthcare there are special considerations to communications given the range and impact of topics that must be covered – from supply chain to workforce to business continuity and even eventually, recovery.

Let’s begin generally, however. I reviewed a missive today sent by a healthcare manufacturer that was long and thick with narrative. The range of topics was pretty vast, covering everything from managing business continuity to financial impact on current sales to products in the pipeline and the status of clinical trials. It was all important information. But it was long and thick narrative.

In crafting communications about the very important range of things about which medical manufacturers must communicate, it may be good to borrow some common tips from media training about organizing messages for the spoken word and apply them to the written word. A long press release or statement with paragraph after paragraph is a lot to ask of people – especially now. Another thing I stress in media training is that you have a person’s full attention for the first few minutes you speak – and then minds naturally begin to wander.

Therefore in creating either general statements, or ones that are geared to very specific audiences, here are some guidelines:

Plan your messages – It is always important to define what the goal of the communication you are writing actually is – what do you want audiences to walk away with? If you don’t craft the communication with those goals in mind – and shape it so that the audience walks away with the three most critical things you want them to remember – then it is not likely the audience will get their on their own. Lead with the important messages – Given that people may not read the whole communication – lead with your most important messages – and may it be suggested that in this time, at least a part of that be centered on the impact of what you are doing on peopleList topics – If you are covering a range of things, organize your messages and sort it out for the audience. Guide their eye to the material which interests them. Not every audience needs to read every single thing in the release and the presence of a long narrative may discourage a thorough reading rather than promote it. Parsing your messaging into categories allows the audience to sort out what is important to them – and it doesn’t overwhelm them. Flag the really important message – If there is something you really want to have stand out, flag it for the audience. This can be done visually with bold-face and italics and underscoring (or any combination thereof) or by including it upfront in a quote from a CEO or agency lead with very pointed language – “The most important thing we want people to know….”

These are straightforward tips and communications at its most basic – no rocket science here. But in a time of crisis it is sometimes easy to overlook some basic principles because there is so much to say and that must be said urgently. But when that is the case, what often happens is that in our zeal and need to push messages out, we do so in a way that undermines the ability of our audiences to absorb them. And so we begin with this simple reminder.

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FDA Guidance on Clinical Trials During COVID-19 Pandemic

Much attention has been paid to the impact of the COVID-19 pandemic on the supply chain for medicines we rely on, but there has been less focus on the impact of medicines yet to come. The advancements in cancer care alone during the past few years have been breathtaking. The medicines pipeline is the focus of many who need and hope for a new treatment for a life-threatening condition.

This week FDA issued a new guidance document entitled “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic“. This would seem to set a record for the development of any guidance document from FDA, some of which take years to cultivate through the draft stage. In it, FDA concisely enumerates some of the many obstacles to conducting a clinical trial in our current circumstances – quarantines, travel restrictions, sites that are under lockdown, supply chain of the investigational compound to name a few.

There has already been a lot written about it providing explanation already and there is no point in recreating the wheel and here is among the best courtesy of the Regulatory Affairs Professional Society. But briefly, FDA encourages sponsors to consult with Institutional Review Boards (IRBs) very closely and sanctions also the deviation from protocols of the trial may be initiated unilaterally in order to protect health and well-being of study subjects. It is a worthy goal, to be sure, but where there are such adjustments made by study sponsors, one can imagine that it will later ultimately complicate the assessment of the trial when it comes to the approval process.

FDA also stated that sponsors should be prepared to assess patients for safety from a distance given the potential of travel restrictions. This most certainly means the use of the telephone, but makes the case – as the pandemic does across many areas – for creativity when it comes to exploring virtual means for exchanging information. That goes from telemedicine, to the release of data at virtual medical meetings.

Much of the document is geared to considering the impact of the pandemic on the role of study participants. But there are also likely to be issues where those who are involved in conducting the trial itself – the investigators – are also negatively affected, impacting the collection of data.

In short, FDA has injected more fluidity to respond to circumstances into the process. While important, it is not likely enough to overcome absolutely all the obstacles to conducting clinical trials in this environment. And once this is over, there will be more complications as these trials are assessed for approval and as the gold standard for consideration of new medicines is preserved during this difficult time.

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Impact of COVID-19 on Regulatory Enforcement and Approvals

Atrium at FDA

The impacts of the COVID-19 pandemic bring change shifts the status quo on a daily basis with both breadth and depth. Everything we as individuals and as a society would normally do is undergoing change. FDA regulatory oversight is one of them. And some of them are likely to impact timelines for the approval of new products.

Last week, FDA took the profound step of announcing that the agency would be “postponing” foreign inspections of facilities given the realities of the pandemic stating that this would be in effect until the end of April. Acknowledging that the decision would impact product application reviews, the release stated that “most” foreign inspections would be postponed and that those deemed mission-critical would be considered on a case-by-case basis. The agency cited as a factor in its decision the confidence had in the use of alternative methods and tools of enforcement. The term “mission-critical” was not defined. As the virus spreads domestically, it also calls into question how the agency will be forced to further pull back its activities.

For example, regarding advisory committee meetings and other public meetings, the alternative methods and tools do not appear to be available. One wondered if the agency was equipped and ready to conduct these meetings virtually. After all, if university courses can be taught virtually is there ability to conduct an interactive session among the advisory committee members with input from the public. The answer at this time would appear to be not. The word “postpone” is the watchword of the day. And in fact, the FDA calendar there have begun to appear notices that meetings are being postponed.

A meeting of the Non-Prescription Drugs Advisory Committee that was to have been held March 11 was postponed. On the meeting notice page, there was a message inserted that said that the meeting would be postponed until further notice due to extenuating circumstances. A second advisory committee meeting – the Blood Products Advisory Committee – to be held April 3 is also postponed, but a meeting set for April 16 has not yet been postponed nor have any meetings scheduled after that date. Meanwhile there are workshops that are scheduled for as soon as March 23, and one presumes that they, too, will be postponed, but there is nothing up on the site as of yet.

The impact of the inspections issue and the postponed advisory committee meetings are both likely to impact the ability of the agency to meet approval commitments. But an unknown factor is the capability of the agency to support its large workforce to work remotely, which would obviously affect the consideration of new drug applications where there are not advisory committee meetings being held, among other things. Domestic enforcement efforts also becomes a question. This year had seemed poised to bring out a robust number of new medicines, but that is now in some reasonable question.

FDA has a lot on its hands right now and emphasis is obviously on facilitating the production and use of test kits for COVID-19 and doing everything to speed and encourage treatments and vaccine development. That said, the communications around the regulatory process and approvals here in the U.S. needs clarification, and should be consistent and credible. Specifically does

How much impact will the inspection issue have on approvals? Does FDA plan on attempting to conduct advisory committee meetings virtually at some point in the future? Will PDUFA dates be missed, or will they be extended due to the crisis? Is the FDA workforce working remotely and if so, how well-equipped is the agency to accommodate that? Hopefully in the coming days, the answers will be available.


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