Weekly Roundup 4.29.16

Goodbye April. It was nice knowing you.

There were a lot of noteworthy developments this week and I would like to write about them all, but as usual, will pick only a few from the bunch.

  • FDA Issues Complete Response Letter for First Digital Medicine – In September 2015, two companies announced they were submitting an NDA for the first “digital medicine” – a combination product of an FDA approved medication with an embedded sensor. In this case, the medication was ABILITY, approved for the treatment of several mental health conditions and it was being combined with a sensor that would, among other things, measure adherence.  This week FDA issued a complete response letter regarding the application, according to the companies, indicating that the agency would like to see further data regarding the performance of the product under conditions in which it would be used.
  • Lawsuit Brought Regarding Advisory Committee Redacted CVs - Public Citizen announced this week that the organization had brought a lawsuit regarding redacted Curricula Vitae of FDA Advisory Committee members. As any regular reviewer of these CVs will know, information regarding specific details of an individual advisory committee member’s information is often redacted – some of it personal information, some of it associated with grants. Public Citizen makes the point that confidential information is not generally included on documents that are in fact meant to be shared.
  • First Commercial Zika Test Approved – There will be an increasing amount of news about Zika in the coming months. Ironically while this week there was the first U.S. death reported in the media attributed to infection with Zika occurring in Puerto Rico, there was also an announcement that the FDA had authorized the first commercial test for Zika for emergency use. Until now, testing was only available through the CDC and using specified labs but the new test will be made broadly available next week throughout the U.S.

That’s it for me this week. Have a good weekend everyone.

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What Pharma’s Are Doing on Periscope – Update on the Landscape

If you have Periscope on your phone, you may find yourself doing something and all of a sudden, hear a little whistle that is the sound cue to let you know that someone you follow has gone live. I set up an EyeonFDA Periscope handle quite a while ago, with the idea that it might be fun to interview people at conferences or even Advisory Committee meetings or to film the actual Advisory Committee vote. I haven’t used it yet, but I do have 178 followers!

Back in November I did a check in on how involved pharma was on Periscope (See Upscope! Pharma, Periscope and Some Regulatory Questions). I examined the top 25 companies by sales and found that 10 of them (40%) had developed a Periscope handle. Now instead of just doing a check, I have included them in the data base I started that tracks what pharma is doing in social media across several platforms, including Twitter, Facebook, YouTube, Google+, Pinterest and now Periscope. Here is what I found about pharma and Periscope use after going back to the top 25 companies.

  • There has not been a huge increase in the number of companies – I found 11 of the top 25 pharmas have created Periscope capacity – or 44 percent – not quite half;
  • Of those 11, 3 of the companies had multiple Periscope assets, including one that had 5, bringing the total of Pharma-related Periscope handles to 17
    • The company that had five is also a company that has multiple Twitter feeds, so it makes sense;
  • The number of followers ranged from a low of 1 to a high of 978;
  • And this one was a surprise, though it should not have been – it appeared that about half of the Periscope properties were from outside the U.S. – the reason that is not surprising is that of the 294 pharma Twitter feeds I follow, only 128 are U.S. based.
  • There was no finding of a Periscope handle for FDA, despite the many Twitter handles FDA has (you can see them all at work here).

So it does not appear that there has been explosive growth in the development of Periscope feeds, there is a continued dabbling by pharma. As for the regulatory issues raised in the November posting, no movement there.

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Weekly Roundup 4.22.16

A few weeks ago it was snow, now it is pollen – laden everywhere. Dogs, cars, outdoor seating, all covered in a fine yellow haze. Or is that me?

I have had such a busy week that the result has been no postings between the last Weekly Roundup and this one and for that I am sorry. Sometimes life just speeds up. Here are a few things I did note in passing however:

  • FDA Biosimilars Page – In the wake of the second approval of a biosimilar (covered a few weeks ago in EyeonFDA), the agency has been gearing up to educate stakeholders about the category. Currently on the landing page of the FDA website carousel is a link that takes you to a page entitled “Biosimilars: More Treatment Options Are on the Way“.  The page contains an overview of the most recent approval, a resource to sign up for updates, and also links to learning more about biosimilars. One of the links is to a page entitled “FDA 101: Regulating Biological Products“, including a delineation between CDER and CBER overview,  but no mention of the naming issue regarding biosimilars and it appears the page has not been updated for a long time. So more organization around education of biologics given a new potential era of biosimilars, but the material is some old/some new.
  • Agency Launches Smokeless Tobacco Campaign - FDA announced this week an expansion of a campaign called “The Real Cost” in 35 markets aimed at white, rural youth to carry warnings about the consequences of smokeless tobacco use, highlighting risks of gum disease, tooth loss and oral cancer. The campaign is integrating its approach including paid traditional media approaches as well as a social/digital effort. The campaign is part of a broader effort to educate at risk youth on tobacco use.

That’s it for me this busy week. I hope things slow down a bit. And by all means, have a good weekend.

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Weekly Roundup 4.15.16

It seems safe to say we are officially done with snow. Winter is finally at our backs. In the rear view mirror. Yes, we have shifted gears into that very, very short time of the spring – at least here in the Mid-Atlantic region – when you can wear a smart cotton sweater. Earlier it was too cold. In a few weeks it will be too hot. So this is the very narrow fashion window. It is a new day.

But it is the old week and we are at the end of it. This week we had a new approval in oncology, reports of a banner year in generic approvals, and an update to Zika news and new progress against an old killer.

  • FDA Approves CLL Treatment - The agency announced the approval of Venclexta (venetoclas) for use in the treatment of patients with chronic lympohcytiuc leukemia (CLL), one of the most common forms of leukemia in adults, who have a chromosomal abnormality called 17p deletion, ascertained through an approved companion diagnostic test, and who have been treated with at least one other prior therapy. The drug targets a protein that supports cancer cell growth and is overexpressed in many patients with CLL. Venclexta had breakthrough therapy, priority review, and accelerated approval as well as orphan drug status.
  • Banner Year for Generic Approvals – The good folks at the Regulatory Affairs Professionals Society (RAPS) reported this week that with over 700 approvals and tentative approvals, the ok for generic drugs hit an all-time high during 2015. As is well known, the more generics in a category that are on the market, there accordingly is a downward pressure on the price and as RAPS noted in their piece, generic drugs account for 88 percent of all prescriptions written on the U.S. This follows a year in which approvals for new drugs was also in full gear.
  • Zika Developments of Note - As regular readers may deduce, I believe that as we approach summer, the unfolding developments related to Zika are important to note and so from time to time here, newsworthy updates may be provided in the Weekly Roundup. This week, comments from CDC indicated that understanding of the impacts of Zika were unfolding and that more clearly demonstrated links between the virus and potential effects on those it infects, including the phrase that Zika was “scarier than initially thought”. More evidence appeared regarding the sexual transmission of Zika.
  • NIH Maps Gene for Pneumocystis – In the earliest days of the AIDS epidemic in the 1980s, there was no test for infection and one of the signs that gay men everywhere tried to self detect was whether or not they were experiencing a shortness of breath. That is because it was a symptom of one of the worst opportunistic infections brought on by a compromised immune system, pneumocystis pneumonia. As one of the more prevalent opportunistic infections, it killed thousands but culturing it in the lab to research it evaded science. This week NIH announced that it had sequenced the genome which, the agency said, could facilitate efforts to culture the organism, facilitating the pathway to screen for effective treatments.

That’s it for me this week folks. We are in store for a beautiful weekend and I hope wherever you are, your’s is as well, indoors and out.

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Serious Communications Planning Needed Now for Zika

Election cycle aside, it is going to be a rough summer. As things stand, this will likely become the summer of Zika as the country faces a growing potential for dealing with transmission inside the U.S. and abroad.  As the stage for a new emerging pathogen is being set for this country, now is the time for all types of institutions to be planning how they are going to communicate around this issue. There are many reasons to do so.

While last year’s Ebola outbreak in west Africa raised issues in the U.S. from a public health policy perspective, public involvement with Zika is likely to be much more ubiquitous among the American public than Ebola. Not since the prospect of an avian flu outbreak a decade ago has there been greater reason for institutional stakeholders to begin thinking about planning for the potential consequences of widespread concern over Zika. In February I wrote a posting “From HIV to Zika – The Role of Communications” discussing broadly some of the truisms in communicating around an emerging pathogen. It is also time to think about it less broadly – not just as a public health issue, but a business communications issue.

In the U.S., federal agencies have been building a set of policy underpinnings to help prevent transmission and protect the blood supply and begun planning efforts. In mid-February FDA announced guidelines meant to reduce transmission of Zika through the blood supply from becoming a source of transmission, followed in March by additional guidelines on protecting against transmission from use of human cell and tissue products. On April 1, the Centers for Disease Control and Prevention held a one-day Zika Action Plan Summit which provided guidance for states in their planning efforts.

Time is short. The primary means for transmission of Zika is through mosquito bites and we sit on the seasonal cusp of mosquito transmission. The virus epicenter has been South America, but it has been making its way north.  In March the first cases of transmission were reported in Cuba and Domenica. According to the CDC, in the U.S. there have not yet been any mosquito borne cases, but there have been travel associated cases.

Solid understanding may be in short supply. In February, the Annenberg Public Policy Center conducted a survey to gauge American understanding and perceptions of Zika and what causes it. Nearly two-thirds of those surveyed felt confident that a vaccine would be developed by the end of summer. While two-thirds also could correctly identify sexual intercourse as a means of transmission, one in five mistakenly believed that Zika could be transmitted to another individual by sitting next to someone infected and many people – thirty eight percent – believed that contracting Zika could prove fatal.

A good deal of the focus of prevention effort has been on mosquito control. But people – through intercourse, blood and tissue – can spread it as well. Given that, if mosquito infection does begin to occur in the U.S., the reservoir of infection in people will also rise. While not fatal, a number of those people will not know whether or not they are infected and some may have symptoms.

Where does communications come in? Apart from the obvious role for public health authorities to help the public understand what is known, and not known, about Zika, many other stakeholders need sound planning as well.

Employers of all sizes, schools from daycare to university, communal care and living facilities such as nursing homes and hospitals – will all face questions specific to their own operations and policies. How will the infected be treated in each of these contexts? As a blood screening test has gotten provisional approval for use to screen blood, will it be used under any circumstance to screen people – and to what effect? And as we saw with SARS, not only will specific industries such as the travel and hospitality sectors likely be a focal point, but specific geographies as well.

In short, communicators within each of these sectors and institutions need to be thinking now about how Zika may impact their operations and cause very particular questions to be posed to them. Communicators need to think strategically about the ways that an epidemic could play out. This can, in part, be based on models from the past – HIV, SARS, Avian flu. But it should also be consider the unique challenges presented by Zika.  What policy questions need to be considered? What will constituencies demand? To what standards will you be held?

It is always a train wreck when policy development and clear communication are attempted in one swift effort. Communications is more complex where emotions run high and where points of view may be based on misinformation. Where a large part of the population believes Zika may be fatal and where a very vulnerable population such as newborns are concerned, communications challenges are going to be steep. And as we saw in HIV, the legal and regulatory frameworks which may lend guidance sometimes have to catch up to real events on the ground.

The far more prudent path ahead for everyone concerned is

  1. To engage as soon as possible in an organized and strategic process to consider the questions that are going to come up in advance specific to your own operation and
  2. Develop the  the means for the messaging ahead of time and recalibration later, and
  3. By all means, always be based and rooted in what is known to public health authorities.
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