Meetings, Clinical Trials and Supply Chain Disruption from a Virus We Never Heard of Until New Year’s Eve…

The world changes quickly. A few weeks ago, I published an article on LinkedIn “Communications Challenges for Medical Manufacturers as COVID-19 Epidemic Emerges”. It was meant to outline some thinking for the potential for the disruption of medical meetings, of clinical trials and of course, the much talked about potential for supply chain disruption.

We are no longer talking about potential. In the few weeks since then, the European Society for Radiology which was to have its annual meeting starting next week, postponed the meeting and HIMMS 2020 was also cancelled. At least one pharmaceutical company, one which by the way got FDA approval for its multiple myeloma product just last month, has indicated that sales will be impacted and clinical trials may be impacted which would in turn, have a negative effect on the bottom line. And the government of India announced that the export of 26 pharmaceutical ingredients would be banned for export, likely to have a direct effect on the production of some specific categories of medicines including generic medications and over-the-counter pain relief.

That raises many problems for pharmaceutical and biotech companies. Of those, let’s concentrate on three:

  1. Meeting Cancellations – Companies will have data milestones in the coming months with the possibility that the traditional venue for unveiling and discussing such milestones – i.e., the medical meeting – may either be cancelled or attendance may be diminished. Medical meetings are a primary avenue of communications for the exchange of scientific information regarding new therapies and understanding the latest developments in specific therapeutic categories;
  2. Media Environment – Companies will be dealing with a media environment that is not particularly interested in new therapies, unless they happen to apply to COVID-19. A colleague of mine wrote an article, also on LinkedIn, that took a look at coverage in the New York Times over the past few months and he makes some solid recommendations. The viral pandemic (let’s call it what it is) is grabbing headlines, ink and reporter attention;
  3. Tough Questions – Companies that are lucky enough to be engaged with media during this time are likely to face questions and scrutiny over supply chain continuity, and to a lesser degree, clinical trial timelines and of course, profitability.

There are no magic bullets. But there is strategic thinking. Here is are a few thought starters related to the above considerations:

  1. Direct to Audience Communication – It is time to brainstorm over ways that companies can achieve at least some of the communications goals that would be associated with large medical meetings by employing digital means for conveying messages. If there was to be a poster presentation for a meeting, put it on video and make it available. In the absence of a meeting venue, develop and conduct webinars to cover presentations that were to occur. Think of every way possible to go virtual and execute upon it, then get the contents pushed out to patient groups, members of professional societies and investors.
  2. Focus on Trade Media – With COVID-19 taking up all of the ink in mainstreams, there is going to be a diminished capacity – and even a diminished interest by reporters – for non-COVID-19 news and data milestones – particularly those for non-life-threatening conditions – may get far less traction (or even none) by traditional means. For trade media, however, it is still their primary focus. Shift primary focus to these outlets and utilize bloggers and target online influencers more heavily and skillfully.
  3. Plan, Plan, Plan. The basis of planning is information and the situation is rapidly changing and doing so hourly. It is extremely important to know what is going on with respect to the numbers and the developments – both the medical and the policy ones – on an on-going basis and to consider their impact on one’s own operations. As the organizers of medical meetings grapple with whether or not to hold a meeting, individual medical manufacturing companies are imposing their own restrictions on employee travel and meetings. While data milestones are going to take a back seat, media scrutiny on supply chain flow will heighten. Scenario planning and messaging around worst case scenarios that considers both health implications and corporate reputation needs to be robust and recalibrated almost daily. Some pharmaceutical companies have reassured concerns about supply chain flow – but the situation on the ground can change quickly. Planning needs to be extensive.

For many, it is important to feel ahead of the curve. Under the current circumstances, there is no real curve as we catch up to determine the real extent of the outbreak and then can assess its real impact. There are many uncertainties – but one thing that is certain – traditional communications approaches are likely to require adjustment.

Photo Source: C.S. Goldsmith and A. Tamin

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Emerging Pathogens, Communications

In June 1981 I graduated from law school. One month after that an article appeared in the New York Times with the headline “Rare Cancer Seen in 41 Homosexuals” on page A20. These two events would end up pretty much defining the rest of my life. I became the chairperson of a group of lawyers volunteering time to provide legal help to people with this new disease and later became the Director of Legal Services at the Gay Men’s Health Crisis (GMHC) where I provided wills and advocacy on insurance and immigration matters, landlord/tenant issues, and discrimination in jobs and public accommodation. I also emerged as the spokesperson for the agency on important public health policy matters both at GMHC and in the 1990s at AIDS Project Los Angeles. This included commenting on important milestones such as actions by legislatures (or lack thereof), regulatory matters, and high profile developments such as Rock Hudson, Greg Louganis, Brad Davis and Magic Johnson, and more. In short, I got to know media and communications in the face of an emerging pathogen. During past outbreaks of emerging pathogens, I have written postings on this topic. As I watch the media report on the new Wuhan coronavirus, there are some lessons from that time that bear noting and repeating.

  1. Facts are low; speculation is high – In the earliest reporting on Wuhan, human to human transmission was regarded as a low likelihood though transmission is now regarded as more likely than either SARS or MERS. So little in the earliest stages of an emerging situation that there is necessarily a good deal of speculation, often on which opinion gets based. Early reporting referenced the fact that mortality seemed concentrated in the elderly with co-morbidities, but news outlets also reported the deaths of young medical workers. In short, speculation or casual observation is often presented as fact and policy actions are sometimes based on that. But the only fact is that we don’t know much about this and only time and experience will tell.
  2. Numbers don’t mean a lot – The number of Wuhan cases reported climbed dramatically within only a few days. In the early days of an epidemic, numbers are frequently subject to change. The number of diagnoses represent only those people infected who are showing symptoms, not the number of people infected who may not be symptomatic but who may be able to transmit. Second, the method and nature of counting (and testing) can change, as it did for COVID-19 when the methodology for counting cases caused a spike in the numbers. Third, there is always under-reporting. A communications focus should rely less on numbers than on solid principles of public health and on the business facts that are at hand. Numbers are indicative, but not certain.
  3. Points of reference will change – In the earliest days of the AIDS epidemic the disease was referred to as GRIDS (Gay-related Immune Deficiency Syndrome) and then AIDS. When finally discovered, the virus was HTLV-III and then became called HIV. In short, it takes time for the nomenclature and framework to become established, which can add to confusion. The situation can remain very fluid well into an epidemic. The coronavirus became COVID-19. It will be essential to monitor and educate stakeholders, both internally and externally, in any organization.
  4. Fraud potential is high – Not only will homespun remedies emerge, but on a more unpleasant note, there is a high potential for products to appear accompanied by unapproved claims. There is also a high potential for the emergence of counterfeit products. This is where FDA and FTC have a role to play.
  5. Policy can ham-fisted – With so few facts in hand, policymakers often react in ways to make it appear that something is being done to address an outbreak when in fact, policies being enacted may not support public health goals, necessitating vigilance in monitoring and considerations for how organizations respond. Some may be benign while others may be truly ill-advised.

Under fast changing circumstances, it is difficult to get a good grasp of the total picture along with all the nuance represented therein. As events unfold, and there is a greater demand for communications from stakeholders such as public officials, companies and health authorities, it is important to keep in mind some truisms during the early days to help us keep our bearings and develop perspectives.

Information Resources

Photo credit – NIAID-RML

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The Side Effects of a Coronavirus Epidemic for Pharma

There are a lot of important facts on the FDA’s Web Page set up to provide information about the novel coronoavirus (2019-nCOV) outbreak, now dubbed COVID-19. But there are three sobering statements that stand out:

  • There are no FDA-approved diagnostics for COVID-19
  • There are no FDA-approved vaccines to prevent COVID-19
  • There are no FDA-approved drugs to treat COVID-19

Statistics about the numbers of people who have been infected vary greatly. It is far too early to tell what will happen with this outbreak. It is not to early to prepare for it. Without the ability to readily diagnose, prevent or treat the condition – things that cannot be readily done – the main thing that can be done is planning.

When we think of an epidemic, we naturally think of the obvious concern – the safety of ourselves and those we care about. But there are consequences in store beyond that for many industries – most obviously the travel industry. And there are also dynamic concerns for the industry that makes our medicines.

  • API – First there is the potential for disruption of the production of medicine due to a lack of active pharmaceutical ingredients (API), a large portion of which are manufactured in China. While there are non-Chinese API producers, many of them are in China and it stands to reason that disruption is a distinct possibility. That would have an impact on everyone relying on medicine not only to treat infections, but also to treat chronic conditions such as diabetes, blood pressure and cholesterol levels.
  • Manufacturing Disruption – In the event of a widely spread contagion, it stands to reason that social isolation practices – i.e., not coming to work – could become necessary and thereby interrupting the actual manufacture of finished medicines. While API can be obtained from various sources, the manufacture of many medicines is specific to established sites.
  • Medical Meetings – The effects of the outbreak on large meetings is already becoming apparent with high-profile companies pulling out of the Mobile World Congress set for Barcelona this month resulting in the cancellation of the meeting. At the very time when collaboration is essential, there may be a disruption to medical meetings commonly held around the world at which clinical data is presented and cutting edge research is discussed. A disruption in the course of research-related discourse could impact the speed of development of new medicines.
  • Regulatory Oversight – Media reports this week mentioned that visitors to the campus of the Food and Drug Administration were being asked upon entry about foreign travel. Social distancing also means that regulatory meetings such as FDA Advisory Committee meetings may be put on hold – as well as the review process itself – considerably slowing down the approval of new medicines.
  • Blood Supply – As anyone connected with the early days of the AIDS epidemic can attest, when you have a communicable disease where there are no diagnostics for screening, the blood supply becomes particularly vulnerable, resulting in the potential for severe shortages to emerge.

These concerns are not new with COVID-19. The circumstances were very similar during the Avian flu outbreak during the first decade of the 2000’s and extensive planning around the supply chain was undertaken by the pharmaceutical industry. We find ourselves again with an imperative to not just plan appropriately but to consider how to effectively, accurately and compassionately communicate what needs to be considered in a time of crisis. In that way, industry can minimize some of the potential side effects that are possible as we see our way through this.

The World Health Organization puts out daily situation reports that are highly detailed and comprehensive. You can access them here.

Photo – Centers for Disease Control

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FDA Takes A Number of Actions to Enhance the Market for Biosimilars – A Process Not an Event

There is a policy interest in driving the biosimilar market. Among other reasons, increasing the number of generic drugs and biosimilars on the market addresses another policy priority – having an impact on the high cost of medicine. The approval of generic drugs has been at record highs the past few years, and FDA is also doing all that it can to facilitate the market for biosimilars. This is one of the few things FDA can actually do to address the issue of price, even if in the totality of things it is only nibbling away at the edge of a much larger issue.

So far in 2020, FDA has taken a series of actions designed to enhance the market for biosimilars.

The approval and marketing structures have been primed by FDA to facilitate approvals and uptake of biosimilars. But there are certainly other impediments. For example, currently due to patent issues, several of the biosimilars that have been approved are not brought to market. A study published last year in the AMA Journal of Ethics (AMA J Ethics. 2019;21(8):E668-678. doi: 10.1001/amajethics.2019.668) of the 17 biosimilars approved, only 7 had made it to market. It is an example of only one of many issues that have consequences for uptake.

The more on the market, the merrier (for price). For generic drugs, the rule of thumb has been that the more that are on the market to treat a particular condition, the lower the price for treatment. But for biosimilars, we are not yet a point where there are enough on the market to have a significant impact on pricing. When it comes to biosimilar entries impacting price, we are looking at a process, not an event. FDA has worked to facilitate the process. The effects, however, would appear to be something for which we should be prepared to wait.

In the meantime, there are more near-term consequences for biosimilar marketing. The joint announcement by FDA and FTC not only sets up the guardrails for communications in the industry, it also is a signal of intent. The agencies will be watching closely and likely looking for a circumstance by which enforcement can stress the existence of the guardrails even more keenly. Despite the fact that enforcement by FDA with regard to promotional communications has been at historic lows, they agency seems to be saying pay attention. So pay attention.

Photo by Amir-abbas Abdolali on Unsplash

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Sorting it Out – FDA AdComm Review for 2019

Has FDA been holding enough AdComms? There have been a large number of drugs approved in the past year, but there has not been a corresponding increase in the number of advisory committees staged by FDA. Late in 2019, I had a posting about the fact that it looked like FDA was headed to a year where it held fewer FDA Advisory Committees than it had in years past. However, it was premature. FDA did manage to squeak in a few more meetings in December and brought the total up, though it was still well below the number of meetings held during many of the years between 2012 and 2019.

More about the volume of meetings in a moment. First let’s look at those that were held – what they considered and what the outcomes were. How man meetings, how many about drug approvals and how often was FDA in agreement with committees – and more…

  • There were a total of 28 meetings for the 2019 calendar year
  • Of the 28 meetings, 23 were held to consider an approval of a medicine, seven of which were sNDAs or sBLAs while the balance were NDAs or BLAs – the other five meetings were to discuss specific issues of safety or policy issues
  • Of the 23 NDA/BLA/sNDA/sBLA meetings, committees recommended approval for 17 medicines, did not recommend approval of 5 and 1 of the meetings was cancelled;
  • Of those 17 drugs that Advisory Committees approved during 2019, FDA approved 12 of them; however three of them that got committee approval were instances where FDA decided against the recommendation of the committee and did not approve the application; and there are two applications where a decision has not been announced;
  • In fact, there were a total of 4 examples of FDA going against the recommendation of the committee – 3 where FDA declined to approve against a recommendation (mentioned above) and 1 where FDA approved the drug in spite of the committee’s recommendation against approval – that would mean FDA disagreed with the Advisory Committee recommendation just over 14 percent of the time
  • Four of the meetings involved joint sessions with the Drug Safety Risk Management Committee, only one of which was to consider an NDA for a new product
  • The committee that met the most was the same as in 2018 – the Oncologic Drugs Advisory Committee met six times this year, though that was down from nine last year; the next highest level of activity was also the same as last year – the Antimicrobial Drugs Advisory Committee met five times (three of them product-related) down from six meetings last year.

In addition to having a few more meetings at the end of the year, FDA approved a bunch of new molecular entities in the closing weeks of 2019 and in fact, is approving drugs more quickly, which was an aim of the policy changes made by Congress. Also, lately there has been some question regarding the higher rate of new approvals versus the lower number of FDA advisory meetings held. There have also been some approval decisions made by the agency that have also attracted criticism and concern. It is possible that this kind of scrutiny on the process could result in the staging of more advisory committees in 2020. We’ll have to see.

Photo by Laurynas Mereckas on Unsplash

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