Weekly Roundup 6.10.16

We are finally getting some weather that could be described as delightful.  I hope that you are too. The grass is green, a breeze blows and there is lots of birdsong in the air. For the first time in years, my little shade garden is not embarrassing.

More importantly, on the FDA front, there were a few official developments and here were a few outside of FDA activities that were of note. Here are a few:

  • FDA Sweep on Illegal Internet Sales – Speaking of roundups, there was the annual International Week of Action in the form of Operation Pangea which every year gets a Roman numeral after it and this one was IX. It is the time of year when FDA and other international agencies coordinate to reduce illegal sales of unapproved prescription medications over the Internet. As part of the effort, FDA said in its release that it requested the suspension of over 4400 sites and issued over 50 warning letters. It is perhaps notable that in the release regarding Operation Pangea VIII last year, the agency said that it sent warning letters to operators of over 400 sites, but said that it took action against more than 1000 sites.
  • Another Biosimilar AdComm Set – Another AdComm Calls it Quits - An FDA AdComm has been set for July 13 to consider another New Drug Application for a biosimilar, this time where the reference product is Enbrel. A meeting of the Arthritis Drugs Advisory Committee has been scheduled for July 13 to consider several indication for the biosimilar candidate. And in other AdComm news, FDA announced this week that it was terminating (such a choice of words!) the Transmissible Spongiform Encephalopathies AdComm due to lack of issues and corresponding need for advice on the part of FDA.
  • Vermont Governor Signs Transparency Pricing Bill into Law – Governor Peter Shumlin of Vermont signed into law this week a first-of-its kind bill that would require greater transparency on the part of manufacturers when raising the price of a prescription medication. The press release from the Governor’s office states that there will be a list of the top 15 price increases each year and that manufacturers will be responsible for justifying those increases to the Attorney General’s office.

That’s it for me this week folks. I hope to have some information for you next week to update you on the use of Twitter by pharma. Until then, have a great weekend.

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Weekly Roundup 6.3.16

Weekly Roundups have been in absentia for the past few weeks. Forgive me – it has not been for lack of wanting to get the job done, just time. May began with a serious bout of the flu. While it only had me down a week, there was a lot of catching up, among other things. Even today, the Roundup comes on a Saturday. Moving forward,  I will try to be more assiduous.

Given the lapse, I thought I would turn our attention to a few things that happened of note, both this week and in the last few (to cover for some lost time):

  • FDA Makes Big Move on Nicotine – You would have to be living under a rock, or have a serious bout of flu, to have missed FDA’s action on tobacco announced early in the month. But just in case you missed the deets, here is a synopsis. First, the agency extended its authority over tobacco to include e-cigarettes, cigars, hookahs and pipe tobacco among others and such products cannot be sold by vending machine nor can samples be given. Second e-cigs will no longer be sold to persons under the age of 18 years. Third, the agency said that newly regulated products will have to be reviewed by FDA and that manufacturers will have to file an application with the agency for consideration so that the agency can review ingredients, health safety and whether or not the product appeals to young people. Products that are already on the market will be given continued market time for a period as time to prepare. In short, the pathway from teen to adult nicotine access narrowed significantly.
  • Advances in Detection of Two Different Cancers - June began with the approval of two cancer detection methods for different types of cancers. First as cancer treatments become more and more focused on the type of cancer a patient is facing, the agency announced that a blood test was approved to determine whether or not an important gene mutation exists related to non-small cell lung cancer (NSCLC). The approval means that a treating physician can initially conduct a blood test, as opposed to biopsy, to determine the presence of a particular gene mutation that would be indicative of appropriate treatment. The same day, the agency announced approval of a new diagnostic imaging agent that can be used to detect rare neuroendocrine tumors. The approval had priority status and orphan drug designation.
  • Food Labels are Overhauled – In a long-awaited move, the agency announced revisions to the labels that we read when standing in the grocery aisle trying to decide whether to make a purchase (often while others are trying to get by us). While there area many changes coming to the label, to that end, two stand out. First the agency is making changes to highlight the information around the number of calories and the number of servings contained in a  product, but more pointedly, the agency is making a concerted effort to point up the sugar content in the product.  The date slated for the change for most manufacturers is July 26, 2018.

That’s it for me folks. Hopefully back in the saddle here. Hope you have a good weekend.

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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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