Weekly Roundup 9.5.14

After a surprisingly mild August, September begins with summer in full force – heat, humidity and a mosquito rally that is immensely annoying.  Forecasts however predict that we only have one more day of this and then a break to temperatures that appear to be much closer to the gentle welcome of autumn.  I hope.

I also hope that you enjoyed the short week as a result of the Labor Day holiday.  In the meantime, here is a bit of what happened this week (short week – short roundup):

  • Approval of Keytruda (pembrolizumab) for Advanced Melanoma - FDA announced this week the accelerated approval of Merck’s new treatment for patients with advanced or unresectable melanoma who are no longer responding to other drugs.  Keytruda is a humanized monoclonal antibody andis the first approved drug that works by blocking a cellular pathway known as PD-1, which restricts the body’s immune system from attacking melanoma cells, but is the sixth melanoma drug approved since 2011.  Keytruda was granted breakthrough therapy designation by FDA based on the agency’s assessment that Keytruda may offer a substantial improvement over existing therapies.  The company’s press release can be found here.
  • First Test for Assessing Risk of Developing Acute Kidney Injury - The NephroCheck Test System was cleared for marketing by FDA - a first-of-a-kind laboratory test to help determine if certain critically ill hospital patients are at risk of developing moderate to severe acute kidney injury.  Currently tests can only assess if a patient may already be experiencing acute kidney injury, however this test assess the patient’s risk of developing the condition within 12 hours of the administration of the test.

Have a good weekend everyone.  Next week is a long one!

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Tracking 10 Healthcare Beat Reporters on Twitter

It is not news that social media has fundamentally changed the way we communicate. Today, we share news, we don’t just read it.  A news cycle is every moment of every day. We rely on people to pitch news to their own networks of other people.  You get the picture.  The fact that communications has changed is not really news anymore.

Twitter, more than any other social media platform, is a news platform.  It is a news feed that is constant and on-going.  It is less social than it is media.  It even sometimes provides us with news and pictures from places and events where there is no other way to get news out.

And since the nature of the way we communicate has changed, so has journalism.  Ever since 2009 when news events started generating pictures of breaking events over Twitter every reporter realized “I need to be on Twitter” (and some realized it before that) .  A reporter who used to file maybe one story a day, can now file several mini-stories.  A reporter who used to have to cast a wide net with a story or a report can now report on something very granular.  And a reporter can drive traffic back to his or her story with a link to followers and the follower’s followers.  There used to be only macro-reporting – now there is micro-reporting.

So I wanted to get a feel for the environment around Twitter and healthcare reporters.  I picked 10 reporters who I consider to be those who would regularly report on significant data milestones or on FDA advisory committee outcomes or FDA decisions.  They spanned broadcast, print, wire/news service, magazine and newspaper.  I think what I found was interesting.

Of the ten I examined (no I am not telling you who they were) – they ranged quite a bit in terms of frequency of tweets and number of followers.  Some had a rather anemic output on Twitter – sending out a tweet only every other day or so and rarely re-tweeting.  You could tell that they don’t embrace the medium fully.  Others were prolific, sending out as many as several tweets a day.

Followings ranged quite bit as well, with some having only a few thousand followers while others went into the stratosphere.  Some had relatively low KLOUT scores, while others had very high ones – though not quite in the Lady Gaga realm.

And I was surprised to find that many of them re-tweeted others and in fact, some were prolific re-tweeters.  Moreover, not only were some prolific re-tweeters, but some retweeted others regularly from other outlets, not just their own.  High profile reporters re-tweeted material from other high profile healthcare reporters.

So what, you may ask?  The so-what is this.  While it may be very important to get a print story above the fold in a traditional paper, or even to get a nice mention in an online edition, there is something to be said for knowing your beat reporters and their Twitter profile. I have said before, a media list that has the name, phone number, email and outlet name on it is yesterday’s list.  Just as one might prepare for a news milestone by doing some macro-analysis of the media environment, it is probably important to be doing some micro-analysis as well.

I think it is time that today’s media list includes a Twitter profile that includes following, KLOUT score and that you have an understanding of who they follow and who they retweet.  It is good to be above the fold in print – but it is also good to be in the know on the digital side.  Cover the macro.  Cover the micro.

I have created a Twitter list of some key healthcare reporters and if you like you can follow it here.

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FDA Looking for New Head of CDER Communications

For those who have had the pleasure of working with Julie Zawisza in the past, the news is that she has moved on to a new role at FDA.  That means her former position in communications at the Center for Drug Evaluation and Research is open and FDA is looking for someone to fill it.  Wishing Julie well in her new position, here are the deets on her old one in case you, or someone you may know, is interested and note – the official job posting will be up next week.

Description of Duties:

FDA’s Center, for Drug Evaluation and Research (CDER) is searching for exceptional candidates for the position of Director of the Office of Communications (OCOMM). The Office currently has over 100 employees. OCOMM is the central hub for communication expertise, in CDER, focused on the development of consistent messaging to inform and educate the multiple audiences. The Office has a variety of responsibilities including the planning, coordination and evaluation of the policies, procedures, programs in the strategic outreach and communication about drug-related requests.

The incumbent serves as Director, Office of Communications (OCOMM) for the Center for Drug Evaluation and Research (CDER). The Director provides leadership and direction for all Center internal/external communications. The Director is responsible for the creation of a climate for cooperative work relations, and support and understanding of the CDER program objectives. Additionally, the Office of Communications Director advises and counsels the Center Director and CDER leadership on external and internal communications relative to the exchange of information and is the liaison external groups.


Applicants should possess an advanced degree in Communications, Marketing, Public Relations, or Public Affairs.

Successful candidates are those that have experience working closely with highly-credentialed people. They must have substantial experience in Communications, Marketing, Public Relations, and/or Public Affairs. Knowledge of pharmaceuticals is a plus. The candidate should be persuasive, influential, and have the ability to ask the right questions.

Location: Silver Spring, Maryland

Salary: GS-15, $124,995-157,100 Salary is commensurate with qualifications and experience. A full Federal benefits package is also available including: leave, health and life insurance, retirement, long term care insurance, and Thrift Savings Plan (401K equivalent).

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Weekly Roundup 8.22.14

For the past few years here in Washington, the summer ended in August seemingly with the flip of a switch following Labor Day Weekend.  The daily threat of storms abated, the high humidity retreated, air conditioners were switched off in favor of open windows and there was a hint of chill in the air each morning.  The brown grass starts growing green again.  We are still two weeks away, but I, for one, am counting the moments.

And here are a few other things that some may have been counting on that happened this week:

  • FDA Approves Drug for Gaucher DiseaseGenzyme won FDA approval for Cerdelga (eliglustat) for the long-term treatment of adult patients with Type 1 form of Gaucher disease.  Gaucher disease is a rare genetic disorder that results in a person producing an insufficient amount of the glucocerebrosidase enzyme which causes fatty materials to collect in the spleen, liver and bone marrow. Cerdelga inhibits the metabolic process that produces the fatty materials.  Cerdelga received orphan drug designation from FDA.
  • FDA Allows Marketing of New Type 1 Diabetes DiagnosticThe agency announced this week that it would be allowing the marketing of the first zinc transporter 8 autoantibody (ZnT8Ab) test to help diagnose Type 1 diabetes, the most common form of diabetes diagnosed in children and adolescents.  ZnT8Ab is produced by the immune system of many people with type 1 diabetes and the test detects the presence of the antibody in a patient’s blood.  The device was reviewed by the agency through the de novo premarket review pathway which is intended for low-to-moderate-risk devices that are not substantially equivalent to an already legally marketed device.
  • Plan Related to Diversity and Clinical Trial Data Released – The agency released a plan and had an accompanying blog post from Commissioner Hamburg related to diversity in clinical trials.  It is called the “FDA Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data“.  The Action Plan follows a report issued last year on the topic and includes 27 different action items that the agency is putting on its “to-do” list that the commissioner states is designed to meet three primary goals – (1) improving quality of data collection regarding sub-groups (the term used by the agency related to diversity); (2) to identify barriers to greater participation among diverse populations; and (3) to make the data collection more transparent. The plan is to be executed by a steering committee and the blog posting states that a website has been set up to track progress, but there was not a link to the website provided.

That’s it for me this week.  Enjoy the waning August days.

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DTC and Regulatory Enforcement

FDA’s OPDP views nearly all industry communication – whatever the venue and intent – through a lens of advertising.  Certainly a big focus of regulatory enforcement has been direct-to-consumer advertising and for a long time, there has been guidance available for both print and broadcast.

From time to time, I have used this space to look at different communications platforms to look at OPDP enforcement patterns consulting the Warning/Untitled Letter database that I have put together.  As a reminder the database spans the years 2004-2014, inclusive. There are 294 letters covering over 1000 violations over that period and among other items tracked are the company involved, the product name, the treatment area, the type of communications vehicle and of course the violations, among others. I have pulled together an overview of those letters involving direct-to-consumer advertising.  Here are a few of the factoids:

  • Of the 294 letters in the database issued since 2004, 58 (19.7 percent) of them involved DTC communications vehicles making it the largest category of communications vehicles involving a letter, followed by Webpages/sites – 56 (19.1 percent) and then Sales Aids – 30 (10.2 percent);
  • Of the 58 letters regarding DTC advertising, 22 were Warning Letters (38 percent) which is slightly higher than the ratio of Warning versus Untitled Letters for all letters issued in this time frame (33 percent);
  • There were 18 letters involving Broadcast (either radio or TV) while there were 40 letters involving print ads (including Journal Ads);
  • The 18 letters for Broadcast DTC had a total of 46 violations (2.5 violations on average) while the 40 letters involving print ads had a total of 107 violations (2.7 violations on average).

The most common violation cited in Warning or Untitled letters is Risk Omission or Minimization.  Here is a profile comparison of  proportions for each:

One can see that Risk Minimization or Omission was the primary violation for DTC as well as all letters, but that the second highest  number of violations in DTC were superiority claims while the second highest for all letters was Overstatement of Efficacy, which may lead one to consider that DTC ads as a communications vehicle may be particularly susceptible to a presentation that implies superiority more readily than most other promotional communications vehicles.

Next time I do a comparison, I’ll look at Websites, the second most common communications vehicle involved in a violation that triggers a Warning or Untitled letter.

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