What They Said – FDA Press Releases Mid-2021

It has been a regular feature of the blog to give a read on what FDA has been talking about, at least through the form of press releases. It is not always an easy task because the nature of FDA’s practice in this respect has evolved over time. But here is what we see looking at the first 6 months 2021, and comparing it to mid-years past.

You may recall from the last posting on this topic at the beginning of the year, during 2020, FDA had a lot to say – a real lot, and that isn’t surprising given the agency’s role in facilitating treatments, diagnostics and vaccines to respond to COVID. Last year the agency issued over 400 releases on a range of topics (65 percent of releases were related to COVID-190. And while we are still in the midst of the pandemic, it is somewhat surprising to see that the overall number of releases during 2021 has fallen off a bit – to 153 so far this year (54 percent have been COVID-related), which if this pace kept up, would annualize to only about 300. Of the 153, only 33 of them were translated into Spanish.

It is even more surprising considering that the agency started listing releases under “FDA in Brief” in with its listing of Press Release materials, which serves to inflate the total number of press releases. Consider “FDA in Brief” releases as a sort of press release-lite. They have their own section in the FDA Newsroom and usually involve topics that are not quite press release-worthy by my observation. They generally have a more limited audience and a different format than FDA press releases. And while some, but not all, of FDA’s press releases are also issued in Spanish, FDA in Brief releases do not seem to ever be available in Spanish. It would appear in May of this year, the agency began adding “FDA in Brief” releases into the list of regular press releases, while still listing them separately under their own heading, adding about 20 entries. So what that means, if you backed those out is that the agency actually only put out about 133 press releases by mid-year, compared to last year when FDA put out 218 press releases.

Also by mid-year last year, FDA announced 55 approvals, including several Emergency Use Authorization (EUA) announcements for drugs and devices compared to just 44 approvals, EUA’s, or label expansions so far this year (though the number of new molecular entities is running at a very high pace during the first half of this year). This year 10 of these approval announcements have been in relation to COVID-related medicines or devices, while last year it was 17.

Further, last year FDA introduced regular Coronavirus Updates as part of the press release regimen. Last year during the first half of the year there were 134 such updates. This year there were only 67 Coronavirus Updates in the first half.

With regard to other subject matter, there were 6 alerts issued by the agency during the first half of the year and 9 releases regarding legal actions including seizures, consent decrees and warnings.

There is no telling for the reason or reasons there has been a drop-off. Certainly last year may have been an anomaly given the circumstances. But this year there were also fewer releases by mid-year than in 2019 when there were 155, though on par with the mid-year level in 2018 when there were 126. Any number of factors could be affecting the agency’s output, including the fact that the agency is still working with an Acting Commissioner. As we saw with the “Gottlieb effect”, Commissioners can make a difference in the agency’s approach to communications. We’ll check in again at year end.

Photo by AbsolutVision on Unsplash

Author’s Note: Unfortunately the first automated mailing to subscribers last week did not work out so well and subscribers received a blank email when they should have received a blog posting about an Untitled Letter issued by FDA’s OPDP. Apologies for the misfire, but hopefully we are working more smoothly now. Thanks!

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OPDP Sends Untitled Letter

Upfront Author’s Note: This is the first posting in a while as I have been working to migrate the subscription service to a new provider. As such, some subscribers were lost in the process. Anyone who signed up for a subscription prior to 2019, would need to sign up again. Apologies for the inconvenience and thanks for your patience.

Years ago, a single regulatory action letter issued by FDA’s Office of Prescription Drug Promotion (OPDP) would not have merited a blog posting in and of itself. That is because OPDP used to issue scores of letters each year. In the last several years, however, FDA’s enforcement arm has issued only a few letters each year. Yesterday they posted a new one and as such, it merits some discussion.

Let’s talk first about though enforcement patterns. There have been a total of 4 letters issued this year by OPDP, two of which were Untitled Letters and two of which have been Warning Letters. It might also be noted that this year the four letters involved five different communications vehicles, two of which were Banner Ads (the subject matter of the most recent letter).

Long time readers will know that enforcement by OPDP dropped off significantly beginning several years ago. There has been lots of speculation as to why and many theories. But in 2018 there was some definitive output from Dr. Janet Woodcock, then head of the Center for Drug Evaluation and Research (CDER) which houses OPDP. In one article she was quoted as saying that First Amendment issues curtailed enforcement activity. In the same article, however, she was quoted as saying that the agency would rather let companies sort it out among themselves rather than involve the agency in comparative claims.

Yet that is exactly what seems to have happened with the newest action from FDA. The letter from OPDP to Amgen took issue with statements made in a banner ad which compared delivery systems for Neulasta which the agency said created an impression of a higher risk associated with one over another. While a study was referenced in the sponsored communication, the agency did not find that the relied upon research was adequate to support a claim of greater safety for one delivery system over another due to the limitations of the cited study. The only violation cited in this Untitled Letter was in relation to this claim. So contrary to the earlier indication from FDA, the agency is getting involved in a comparative claim, perhaps because this claim was in regard to an implication of safety over one of efficacy.

In any case, Dr. Woodcock has since moved on (up) the ladder as Acting FDA Commissioner and OPDP has a new acting lead. FDA’s OPDP certainly has held its powder in the recent past when it comes to enforcement and we will have to wait and see if this newest letter is an indication that there is change coming.

Finally, for those who watch this space, FDA took a simple listing of the regulatory action letters issued by OPDP and made it extremely complicated. One used to be able to look at Warning and Untitled letters in one combined list, but no more. You now can view Untitled Letters by year here. To see the Warning letters issued by OPDP during that same year, you must navigate to a different page and perform a sort on “Office of Prescription Drugs” to narrow the list to only those letters issued by that office. But if you don’t want to do all that, don’t worry, I will do it for you and have created a tab (located in the black bar at the top of the posting and underneath the lead logo banner) on the blog site that lists the letters with links to the letters issued so far the year. This list will continue from here on out.

Photo by Goh Rhy Yan on Unsplash

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Virtual Reality – FDA and AdComms

Vaccination has been robust. Cities are opening up. Plans are underway for back-to-school. Travel is robust. Offices are cautiously re-opening. There are multiple hallmarks that, whatever the consequences, we are going back to normal. The age of COVID-19 will likely continue, but with the emergence of a significant proportion of the population with vaccines pumped into them, we headed back on almost every level. Not FDA.

Today the FDA announced an upcoming meeting of the Cardiovascular and Renal Drugs Advisory Committee set for July 15 and once again, it is slated to be virtual. As the rest of the country prepares for Return to Travel, Return to Work, Return to School, this raises the question of “when” FDA is going to get off the virtual dime and migrate back to in-person meetings? One has to think that is is highly likely that nearly all people who attend an FDA Advisory Committee meeting as members are going to be vaccinated individuals. And that while travel might be required, CDC has stated that vaccinated persons “who are fully vaccinated with an FDA-authorized vaccine of a vaccine authorized for emergency use by the World Health Organization can travel safely within the United States.”

At a time when almost everyone is returning – at least partially – to pre-COVID patterns – what signal does it send when the agency responsible for approving the vaccines many of us just took is not? One branch of Health and Human Services (HHS) – the CDC has said – albeit in uncertain fashion and with an indelicate process – that masking is no longer necessary for the vaccinated while another HHS agency stays virtual.

As anyone who has had to sit through the misery of a virtual FDA Advisory Committee meeting can attest, and as recently noted on this blog, there is a significant amount of wasted time and inefficiency with an e-meeting over the old fashioned in-person variety, not to mention pain for those of us having to endure it. Moreover, while virtual platforms (when they work) have been a lifesaving substitute – from telemedicine to online cocktail parties – they lack the important nuances of human interaction as well as that je ne sais quoi that adds quality to the experience.

Also noteworthy, application has been made for full approval by one manufacturer for the COVID-19 vaccine and another will soon follow suit. Presumably there will be an advisory committee meeting associated with those applications – one that might be soon given that the application is a Priority Review. One has to consider that an advisory committee meeting for that deliberation would certainly raise some eyebrows if not held in person. It would be ironic to say the least.

FDA appears to be swimming outside the current. Perhaps there are policy and logistical questions to consider. Thinning out the seating pattern might be one – requiring people to produce evidence of vaccinated status might be another. But the world is moving on. Hey there FDA, think about the optics if nothing else. Let’s get together again.

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Passport Please – An App to Verify Your Status in a World Re-Shaped by COVID-19

This week New York became the first state to make available a means for mobile digital confirmation that an individual has been vaccinated for COVID-19. Popularly known as “immunity passports” they are in fact more than that. The New York app, dubbed “Excelsior Pass” can also carry information regarding an person’s latest COVID-19 test result. The idea has been floated for some time, and while New York is the first state in the U.S. others are poised to follow. And outside the U.S., Israel – much further along in its vaccination process – has implemented their version called “Green Pass” and France is set to launch one soon. We have upon us a new aspect of the pandemic. There are questions that immediately arise.

First, how does it work? It is an opt-in program whereby people can utilize an app to supply evidence of their status if it is needed, just the way you download your boarding pass to get on an airplane – except instead of a seat number, this explains your vaccine status or you negative PCR or antigen test for COVID. When you download the app, you will be directed to provide information to confirm your identity. Once you do, a QR code is posted in your app that can be scanned when you need to provide proof of status. (For those who do not have a smart phone, there is an ability to print out the code which presumes ability to access a computer and printer). Those who are screening will have an app that will read your passport and provide verification. Which leads to the second important question.

Why have this? What is to be gained? Plenty, for both businesses seeking a pathway to recovery as well as individuals who wish to have more normalized access. Emerging from the pandemic, particularly as recovery may be undermined by emergent strains and complicated further by vaccine hesitancy, individuals may want to be reassurance regarding any environment they want to access. This can include a health care provider to a theatre to perhaps even in their own workplace. And therefore it follows suit that in the future businesses may see it as a competitive edge to offer an environment where both patrons and employees all have provided evidence of vaccination. Would you rather stay in a hotel that offers a stay where all staff and guests have been vaccinated or one that could not make that claim?

Who would use it? From theoretical to real – specific uses for the app are already emerging. In the New York announcement it was noted that several venues in New York State were already planning on its use, including Madison Square Garden with statements of support from the New York State Hospitality and Tourism Association, the New York State Tourism Industry Association, the New York State Restaurant Association, the Empire State Restaurant and Tavern Association and the MTA all citing the app as a means to resume in-person events and to return to more normal times. From your gym to your doctor to your employer, the possibilities are vast.

What is the impact? The app is not just about the mechanics of having a “pass” but ultimately in what having it means in one’s life. Some may not choose to participate – it does require one to opt-in. Choice has played a big role in this pandemic, with some seeing it as a choice whether to restrict their movements, socially distance or to wear a mask. And whether or not one gets vaccinated is clearly at this point a matter of choice, but the existence of the app may heavily influence that choice. Someone who is reticent about getting vaccinated may feel passionate about attending a football game. For many, the existence of the app and the requisite for vaccination for entry to multiple venues and services may be more of an incentive than protecting one’s health.

And as foreign countries consider opening up their borders once again, vaccination may be a foundational requisite for entry. In the old days, all sorts of shots were often required as a means for entry into foreign countries. Now your phone will serve just as an important means of entry as your actual passport. The app facilitates decision making regarding access not only to countries, but to many venues and services and perhaps even employment, particularly once the vaccine migrates from emergency use authorization to full licensure in the future. Having an app such as this, or one instituted by airlines, will likely be essential to at least foreign travel. And we all remember the stress of passengers on cruises early in the pandemic.

It almost certainly appears we are about to enter a new vista in the complex terrain of this pandemic and one that will most certainly raise ethical and legal questions as it plays out. But it will also raise practical questions. Will the various states be able to coordinate the technology so that a reading from the Excelsior Pass will be read when going to a sports game in New Jersey or to a government building in Washington, D.C.? Will it be translatable to whatever platform the airlines use. Will hotels be able to read the apps from all 50 states? These questions are all as inevitable as the emergence of the app itself. Stay tuned.

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“Can You Hear Me?” – The (Hopefully) Coming Transition from Virtual Meetings

Today, FDA published notice in the Federal Register of an upcoming meeting of the Arthritis Drugs Advisory Committee that will be held May 6. The meeting will be held virtually.

Last year when the pandemic reality started setting in, like everyone else FDA had to change operations – in some cases shutting down or curtailing activities altogether and moving others to a virtual stage. The last in-person meeting of an advisory committee – by coincidence a meeting of the Vaccines and Related Biological Products Advisory Committee – occurred on March 4, 2020. A meeting of the Non-prescription Drugs Advisory Committee scheduled for one week later was “postponed” with subsequent meetings scheduled for April either postponed or cancelled entirely. A meeting scheduled for May 8 of the Cellular, Tissue and Gene Therapies Advisory Committee was slated to be a hybrid event – with members of the committee participating virtually and FDA staff appearing onsite at the agency campus, but was altered to become an all-virtual event via Adobe Connect.

You get the idea. Afterward there were more cancelled meetings, but by mid-June the agency was moving all meetings to a virtual platform as the realization that the pandemic was going to be long-term sank in. FDA expanded the types of platforms utilized in making the meetings available to view, including use of YouTube. I recently attended all three Vaccines and Related Biological Products Advisory Committee meetings on the COVID-19 vaccine candidates.

Those meetings included multiple exchanges like this:

“Hi. Good Afternoon. Can you hear me now?”

“We can hear you just fine. We are having trouble seeing your slides.”

“I see them. I don’t know why other people don’t see them.”

While the virtual meeting has become a regular fixture now, the exchanges such as the one above are nevertheless common and extremely repetitive and time consuming. In fact, if you added up the time spent addressing technical issues associated with the virtual meeting, you would probably find that several minutes had been eaten up, depriving the conversation of valuable time and thereby eroding the quality of the deliberation. Operating virtually is obviously better than not operating at all, whether we are talking about advisory committee meetings, our offices or even our personal relationships. But it becomes painfully obvious that it is not a substitute for the real thing.

In May the American College of Cardiology will be holding their annual meeting – ACC.21. Originally and perhaps optimistically it was envisioned as a hybrid meeting model – half in- person and half virtual, but has now transitioned to an all virtual meeting, leaving open the question as to who will have the first in-person meeting. As noted in the ACC statement on the switch to an all virtual venue, the decision was made not only based on the continued spread of the virus – and now in the form of a new strain which may be more readily transmissible, but by policies in place by institutions that are restricting travel during this time. You can’t hold an in-person meeting if no one is allowed to come.

So which will come first, the chicken or the egg? As we move from a non-vaccinated world to a partially vaccinated world to a mostly vaccinated world, where will the tipping point? Yesterday the New York Times noted that 26 percent of Americans have had at least one dose of vaccine and that if we continue at the same trajectory, by May 11 (just a few days after ACC.21) we will reach the half way mark of first vaccine dosing, with 9 in 10 being reached by the end of July. In the meantime, what policies will be in place to usher in a new era as we approach mass vaccination? Will there eventually be vaccine requirements imposed for entry to some venues, services or to take public forms of transportation?

We are fortunate in the respect that the pandemic has occurred at a time when we were able to pivot to virtual platforms. Can you imagine had it been otherwise – how much more damage would have been done. But it is time to start thinking about how we engineer the return journey.

There will be a tipping point and it will likely be sometime in the coming months, perhaps the autumn when enough people are vaccinated that it seems safe to go out in the world again.. And when it comes, hopefully we will be spared the pain – and the loss of benefit from in-person deliberation – and we will finally be able to throw the phrase “you are muted…” into our verbal trash bin. And hopefully someday later this year, we will have the first FDA Advisory Committee meeting that is held in person, or at least is a hybrid.

Can you hear me?

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