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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Weekly Roundup 4.8.16

I put the herbs into the garden on a warm and balmy day last weekend only to fall victim to freeze warnings a day later so brought them in the house. Warms up. Put them back outside and then another freeze warning. Bring them back in the house. Warms up. They are outside now but tomorrow there is a prediction for some snow…. Am seriously now thinking of just turning the dining room into my new herb garden….

Wherever you are, I hope there is Spring in your present, if not your near future. In the meantime, some interesting stuff happened this week and here is a little bit of it.

  • Help for Making a Mobile Health App – If you are trying to create a mobile health app you may find yourself needing help in sorting out the various regulatory compliance issues. FTC?  FDA?  HIPAA?  Alphabet soup?  This week, FTC came to your rescue when it posted on its website an interactive tool designed to help you find out which federal laws you need to follow. Produced in cooperation with HHS, the Office of the National Coordinator of Health Information Technology, the Office for Civil Rights and the FDA, the tool sets forth a series of yes/no questions that inform a developer of which laws apply to the project in question.
  • FDA Approves New Biosimilar – For only the second time, FDA announced this week the approval of a new biosimilar for use in the U.S.  Called Inflectra (infliximab-dyyb), it was approved for multiple indications – all of which were the same as the indications approved for the reference product Remicade (infliximab) which includes moderate to severe Crohn’s disease, moderate to severe ulcerative colitis and rheumatoid arthritis, and others. Indicating the need to educate the public about this emergent area of medicine, in its press release, FDA went out of its way to explain the nature of a biologic and a biosimilar and the approval process (though did not explain the naming). You can see the company press release here.
  • Growth in Number of Organic Food Producers – Not an FDA story, but an interesting food story nonetheless – USDA reports that according to data from the Agricultural Marketing Service National Organic Program, he number of U.S. certified organic operations has increased nearly 300 percent since 2002 and 12 percent between 2014 and 2015. As almost anyone who shops for food can tell you the number of stores offering organic choices has certainly increased. In the release on the topic, USDA also referenced a resource – the Organic Integrity Database run by the agency where you can look up specific organic operators and see what products are certified as organic.

That’s it for me this week. On Monday I will be sharing some thoughts with you about an important emerging issue and the real need to be planning ahead of the curve. Until then, have a good weekend everyone.

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More or Less – FDA Press Releases 1st Quarter 2016

There are going to be times when FDA has less to say than at other times. In fact, there have actually been times where the agency has gone weeks without issuing a press release about anything. This quarter was not one of those times, but the volume of material slowed this year compared to the same period in 2015.

Keeping track of what the agency says and when it says it is just one means of monitoring activity. I track the releases and categorize them and have 520 of them going back through 2013. I just went through a lengthy process of updating and correcting entries going back through last year and thought it would be a good idea to provide you with a comparison of last year at this time with the beginning of this year. There were a few things of note:

  • Looking back to the first quarter of 2015, the agency issued 46 press releases, compared with the same quarter a year later when 32 were issued.
  • Perhaps most noteworthy were the announcements involving approvals. In the first quarter of 2015 when it was a record year for approvals, FDA announced 31 during the first quarter – 11 were devices 19 were drugs and 1 was an app. In 2016 during the same period, the agency announced only 13 approvals – 4 were devices and 9 were drugs.
  • Otherwise, the announcements were very much on par with last year. In 2015, there were 6 general type announcements, 7 related to legal issues (seizures, consent decrees, e.g.) and 2 rule/guidance related releases. In 2016 there were 9 general announcements, 6 legal and 3 policy or rule announcements.

Does the drop off in approval announcements for the first quarter of this year signify that this year will not see as many approvals as were seen during the banner year that was last year?  A single quarter is only a short measure in time and lots can change over 3 quarters, but it is an early indicator that we should continue to look at – and will.

(So far in April, there has been another approval announcement.)

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