The Fourth Quarter Will Have Little Oxygen – Implications for Healthcare Milestones

Given the state of things in 2020, a lot of us are already thinking about when it will end. Moreover when it does end, it will be good riddance. That said, this difficult year will not go quietly into the night. For those seeking to have a share of voice during the final quarter of the year, they may find it drowned out by circumstances and events.

First of all there is the obvious factor of the election cycle that means that the fourth quarter of the year will be different, and more intense than the previous three. Leading up to the election there is not only going to be the usual focus on political issues and the electoral milestones such as debate between the candidates. It is also likely that we going to witness an unprecedented stream of drama – as we have seen with suggestions of election postponement this week. That alone promises a good deal of media attention – both traditional and social. Additionally, the stakes along so many lines are high and intense. That includes the issues themselves – healthcare and the handling of the pandemic to diversity and social justice. As well, the balance of power is very much more in play this season with a much stronger possibility than there was at the beginning of the year that the Senate could change hands.

Secondly there is the pandemic itself, likely to be a frequent subject in the swirl mentioned above in addition to producing its own news. Transmission in the U.S. is out of control and a de facto policy that appears to favor waiting it all out in the hopes of a coming vaccine – a course that appears costly in human and economic terms. Not only will media be covering the political aspect of COVID already mentioned, but the deliberations that have begun as back to school decisions are made, or not made, among various jurisdictions. And it is during the fourth quarter that we will see the fallout from those actions. And that doesn’t even get into other ongoing debates, such as the existence and enforcement of mask mandates and new efforts to utilize old medicines.

Thirdly, there is the economy. The stunning negative developments are jaw-dropping and recovery is not only uncertain at this juncture, but given the transmission rates seen in most of the country, there could be further retrenchment. While another extensive shutdown may not happen, there will certainly be discussion for the need and that discussion itself may have an impact.

Finally, there is that vaccine thing and the data and regulatory milestones associated with it as well as public discussions about safety and efficacy. Vaccine candidates are already entering Phase III trials and are being conducted in impressive numbers of people. Preliminary results from those trials are going to start coming in during the fourth quarter. Not only will that be happening on the COVID-19 front, but there will also be the possible emergence of new treatments as FDA gets closer to a decision on approving the use of a treatment with convalescent plasma and wider use of such a treatment would be the subject of media scrutiny.

A smart colleague of mine did some analyses of media coverage during the early days of the pandemic. Needless to say, the events of this year have commanded (and demanded) a huge amount of attention. The final quarter of the year stands poised to really suck out almost all of the oxygen in the room, so to speak, with implications in healthcare for data milestones of non-COVID-related treatments as well as corresponding regulatory developments, such as approvals or FDA acceptances of new drug applications and, in turn, presents a challenge for medical meetings occurring during the second half of the year as well as any launches of new medicines.

Anyone seeking to gain some earned media coverage should at the very least be considering a strategy, is possible, that combines a social presence with some paid promotion. It at least will afford a pathway for gaining some of our attention. Holding that attention will be another thing.

It will be good to see 2020 step aside.

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Look Back – Drug Approvals First Half of 2020 Amidst the COVID Challenge

As the year began, no one really thought that within a few months, the systems upon which we rely on for just about everything would be so severely disrupted and tested by the presence of something we cannot even see with the naked eye. But of course, that is what happened. By March we were remaining at home, including people who worked at FDA who assess new drugs for approval. What would the impact be on the approval process?

In response to written questions submitted in March, FDA indicated that the situation was fluid and could not say with certainty whether new approvals might be delayed, and also indicated that the agency was considering virtual advisory committee meetings. In April the agency reinforced the potential for disruption when it issued a statement saying that while it was meeting its PDUFA date obligations, it was uncertain that the agency could sustain its current work performance given the demands of the pandemic.

Now after six months of the COVID-19 pandemic, one might have expected that the approval of new medicines by the Food and Drug Administration might have been negatively impacted as a result. In fact, did everything that was going on – or more to the point not going on – did all that make a dent?

Looking to the approvals of new molecular entities, it appears not. In fact, so far, 2020 is doing rather well. Below is a chart comparing each year since 2015 at the 6-month mark of the hear. Not only is 2020 doing well, it is doing better by mid-year mark than any of the previous 5 years.

Mid-year comparisons are not always telling. For example, in 2018, there were only 20 approvals as of June 30, behind the number of the previous year when there were 23, but by year end new approvals in 2018 set a record at 59, far outpacing the previous year.

Another factor that might have adversely impacted the number of approvals for this year (though to a far lesser degree) are the number of FDA Advisory Committee meetings. Last year by June 30, FDA had held 9 meetings to consider new approvals. This year there were meetings either postponed to a date uncertain or cancelled altogether, while a few have been held virtually. During the first half of 2020, FDA AdComms were scheduled to discuss 8 NDAs, BLAs or sBLAs.

As far as upcoming PDUFA dates, I have fewer on my list for the second half of this year than I had last year at 45 NDAs or BLAs, at least 11 of which are Priority Review. In any case, with the number of approvals during the first half of the year, it suggests that this year will be at least on par with prior years.

While approvals are going along at a good clip during the first half despite COVID-19 challenges, this is occurring in an environment where patients are consuming fewer health services. That includes prescription medicines fueled in part by the fact that physician/patient interactions declined. Either because they have lost insurance and therefore their access, or because they feel unsafe in a medical care setting out of fear of COVID-19, patients are making fewer visits, getting less care, and engaging in diagnostics less. In the end, that leaves this a good news/bad news proposition. In spite of the challenges posed by the shutdown and distancing, the agency is nevertheless still approving NMEs at a healthy pace. But conditions in the greater environment mean that launch and uptake of these newly approved medicines will not be as robust as they might have been under different circumstances.

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FDA to Hold Virtual AdComm

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.

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Time for FDA’s OPDP to Fill the Gaps on Digital and Social Media

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.

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Webinar on the Medical and Legal Aspects of COVID-19

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.

You can register for the free Webinar here.

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