The Drop in OPDP Enforcement

Back when the Office of Prescription Drug Promotion (OPDP) issued regulatory action letters on a regular basis (either Warning Letters or Untitled Letters) regarding what the agency saw as infractions in the course of promotional speech, I would post a quarterly summary. While guidance documents provide contour, warning and untitled letters add body to what is known about some of the boundary lines for product promotion.

In the past, many years often saw robust enforcement with the issuance of scores of letters a year. But last year, there were so few letters (nine total) that a quarterly summary was pointless.  Rather a single summary provided an overview of the letters that had been issues during the entire year. As you can see from the chart below, enforcement has dropped off dramatically.

This year is no better. This past quarter, OPDP issued a grand total of two letters, maintaining the pace of last year which also marked a record low in annual enforcement. As one can see, in 1998 the office issued over 150 letters. In 2010 it had dropped considerably to about one-third of that with 52. In 2014 and 2015, the number issued was only 9. And so far in 2016, after four and a half months, there are only 2.

The drop in enforcement naturally raises questions. Has industry gotten really really good with compliance?  Has OPDP lost interest? In articles from January 2016 on the topic – here and here, FDA was quoted as saying that OPDP was using a “risk-based approach to carefully allocate its resources among these activities to have the greatest beneficial public health impact.” Furthermore an agency spokesperson wrote that “it is apparent that one cannot get a complete picture of OPDP’s program area by looking at a snapshot of time for enforcement letters.” Finally, the agency spokesperson stated that merely looking at one year “does not take into account the work that OPDP does on the other priorities to assist companies with compliance.”

That explanation may raise more questions than it answers. What is the “risk-based approach” and where is the activity that has the greatest public health impact?  Is this to imply that other activities beyond enforcement may yield greater benefit?  If so, in the interests of transparency, would we not be entitled to know what they are? And as to not getting a complete picture of OPDP’s program with a snapshot – two and a half years of data is hardly a snapshot – it is more like a real landscape portrait.

What that picture, combined with the scant information offered by OPDP’s spokesperson, is that enforcement appears to be a lower priority than in the past – or takes up resources needed elsewhere. Which is fine, but somewhere – in FDA-Track perhaps – we should get to know what they are.

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More Space on Twitter – Does it Change Things for Pharma?

This week media carried reports that Twitter was going to making a shift in policy regarding space. Until now, you have been limited to 140 characters in your tweeting which included space for your – albeit tiny – URL and/or a photograph. That meant sending a tweet with a photograph embedded or a URL included ate up some of your 140 character limitation. But in the near future, that apparently will not be so.

URLs, while not a requirement for a tweet, are practically essential from a consumer point of view. Social media, after all, is about engagement and a tweet that does not drive traffic somewhere – or give people something to share – is someone just talking about themselves. And we’ve all been on that date. Ultimately, it isn’t very interesting. Driving traffic – back to a website or a blog posting or any other platform – is really a key function of Twitter.

Photos are, of course, are not required, but similarly make a Tweet more interesting and there has been ample commentary that use of photos drives engagement with a tweet, outpacing engagement in the mere text tweeting.

So how much space are we actually talking about saving now that photos and URLs are not eating up our 140 characters? The answer depends on whether or not you are using both, or just one. In the case of using either a photo or a URL, you are eating up about 22 characters – or about 16 percent of your Tweet. If you are using both a photo and a URL in your tweet, you are of course then saving 32 percent of your tweet.

Does that make a difference for use of Twitter by pharma? The answer is yes and no.

First the no. It does not change the regulatory parameters in which companies are operating when contemplating a tweet that contains a brand name product. While adding a total of 32 percent to a tweet sounds substantial, we are really only talking about 44 characters, not enough to cram in the added risk information required and to meet the requirements laid out in the FDA draft guidance on using platforms where there are character space limitations.

And for the yes part. On the unbranded side of things, the new space permitted in your tweet does allow you more space to say more of interest to help set the context of any picture you want to send or any link you want to include.  (By the way, you can see all things FDA and social media on the tab on the blog by the same name.) Having the extra space available may encourage the greater use of photos which, in turn, generates greater interest in your tweet.

And there is an added benefit in terms of coverage by third parties. Using photos without a space penalty may encourage reporters to utilize more images in their tweets. Twitter has given birth to a whole new world of “micro-journalism” giving a platform for reporters to write about news and issues they otherwise might not have covered in pre-social media days. Many reporters have demonstrated a lot of creativity in use of photos and more may do so in the future now that their use is liberated from the character space jail.

This is by no means scientific or conclusive in any way, but going to my Twitter list of pharma companies that are tweeting (the list has 229 companies on it) and counting the last 10 tweets, it was noteworthy that only 2 had pictures. Going to my Twitter list of healthcare reporters on Twitter, 6 out of the 10 had pictures. We’ll see if the new space liberation encourages more photo use. Get out your phones and start snapping.

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Which Way on the Public Health Narrative on Zika?

Back in February in a post entitled “From HIV to Zika – The Role of Communications“, I listed several of the hallmark characteristics involving the communications environment and emerging pathogens, drawing not only on recent observations with respect to Ebola, Avian Flu and other public health threats, but from deep experience in HIV thirty years ago.

One of those hallmarks – the first actually – was that in an environment where more is unknown than known – conflicting information can thrive.

A singular focus of many in public health has been the staging of the 2016 Olympic games. We are 85 days away from the opening ceremony. And of course, Brazil has experienced an outbreak of Zika infection, the consequences of which have been shown over and over again in news reports.

This week the Harvard Public Health Review carried a special commentary – “Off the Podium – Why Public Health Concern for Global Spread of Zika Virus Means That Rio de Jeneiro’s 2016 Olympic Games Must Not Proceed“.  In it, listing five reasons as the basis for its conclusion, the article states -

“Simply put, Zika infection is more dangerous, and Brazil’s outbreak more extensive, than scientists reckoned a short time ago. Which leads to a bitter truth: the 2016 Olympic and Paralympic Games must be postponed, moved, or both as a precautionary concession.”

Also this week, The Lancet published an editorial “Zika Virus at the Games: Is it Safe?” Citing four specific reasons for its conclusions, the editorial concludes -

“…unless new data emerge before August, we can say that compared with the risks usually associated with travel, such as gastrointestinal infections (on which we have written previously), traffic accidents and falls, Zika virus represents a minimal threat to games visitors.”

Both articles articulate a convincing case and demonstrate the challenges that non-experts, as well as experts, are going to have in educating members of the public about the potential threat posed by Zika – in Brazil during the games and in the U.S. during the summer and beyond. Beyond the games, policy will have to be developed – both by federal, state and local governments and in the private sector – and that policy will be reliant on the opinions of public health experts. The fact is the task of policy-making may be vastly more complicated given there may not be absolute agreement in assessing the risks. A lack of clarity may make it harder to shape a public opinion which may be informed by mis-perceptions, misinformation and among some, a real skepticism about yet another public health threat.

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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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