Pharma Twitter Activity

I recall a time when the head of a regulatory department of a pharmaceutical company told me that the company would never, ever, ever under any circumstances be involved in social media. By my count, today that company has twenty-one different twitter feeds running, nine of them in the U.S. and the rest around the world. It is not an atypical history when it comes to pharma and social media. In the beginning there were few. Today there are many.

For some time now, I have monitored the activity of pharma across several social media platforms in a database that tracks what companies are doing on Twitter, Facebook, YouTube, Pinterest, Google+ and Periscope. An activity gets logged and characterized as I become aware of it and during regular concerted efforts to discover activity and log it in. Therefore the database where I store this information is not perfect, and has some rough edges – the numbers should not be construed as absolute, but they do serve as a healthy observation and characterization of activity where we can sort by company, country, frequency of updates, and purpose for which the activity is undertaken.

Recently I worked to update the Twitter feeds and added in about 40 of which I had not been aware. Nearly all of them are listed here on my Twitter list of pharmas.

  • How many? Looking first to numbers – the numbers have grown even if the strategy may not seem all that apparent. The total number of Twitter feeds in the data base is 335 being run by 69 companies making prescription products – removing those that are aimed at supporting over-the-counter products. Obviously there are some pharma company brands that run multiple feeds. Some run over 20.
  • How busy? One of the fields tracked is how often the feed is used and only 201 had “regular” or “daily” updates with another 8 having rare updates. The balance were inactive/dormant accounts. (See posting “Abandoned Properties“) Of the active feeds, the pharmas are following about 190,000 others and being followed by 2.7 million, though it should be noted that this census represents numbers from last summer as those numbers are only recorded once a year.
  • What for? The feeds in the data base are characterized by primary purpose. Of the active 201 – what is the activity?  Overwhelmingly the purpose is a corporate one with 141 of the Twitter feeds serving some direct corporate purpose, including corporate social responsibility (CSR) – of which 9 appear directly related to CSR and about another half dozen could be characterized as being involved in advocacy. There are also a fairly large number that have been devoted to the issue of a disease or condition (39 overall, 23 among the active). A few are even dealing in product-specific work to varying degrees. Finally, there are a number of Twitter feeds devoted to recruitment. Looking for a job?  There are 36 such feeds and you can see just those recruiting tweets here.
  • Where are they? What may surprise some is that 58 percent of the active Twitter feeds were outside of the United States. That appears largely because many of the multinational firms have developed feeds that are country and language specific.

The FDA guidance and/or lack thereof and the FDA OPDP enforcement and/or lack thereof, may have chilled entry into the Twittersphere by many, but that has not lasted. The numbers have increased, but industry may be a ways off from finding its stride here entirely, But Twitter is a news platform see my updated list of Healthcare reporters on twitter) –  it reports news and drives traffic. While many companies are still not there, others realize that engagement here is important. In short, pharma has emerged on Twitter in healthy numbers. In the next phase, many companies will likely be working to more closely coordinate their efforts while others may still contemplate whether to take the plunge.

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Weekly Roundup 6.17.16

We are enjoying more respite from heat here in the mid-Atlantic. Certainly a difficult week that brought reflection and sadness for many. And so we’ll get right down to some of the things that happened FDA-related that were noteworthy:

  • Tragedy in Orlando and FDA Blood Policy – In the wake of the Orlando tragedy that so heavily involved the LGBTQ community, most members of the community were barred by FDA policy from donating needed blood to help treat survivors. In a guidance document issued last year, FDA had revised its extreme policy of defacto deferral of all donations from gay men to one that deferred donations from gay men who had had sex within the past year. (See “The Guidance that Dare Not Speak its Name“).  Other countries have followed suit. The tragedy drew scrutiny on the latest deferral policy raising question as to whether or not the new construct was in fact justified. From an issues management perspective as well as a policy perspective, FDA would do well to convene another public forum on the matter and cast the net widely for input.
  • FDA Approves Cholera Vaccine - This week FDA announced approval of a new vaccine to protect against cholera. Called Vaxchora, it had fast track designation and priority review status and is the first such FDA approved vaccine. While the FDA release states that the vaccine is intended for travelers, in fact cholera can occur in settings where there has been a breakdown in sanitation, such as in the wake of a natural disaster.
  • Device to Treat Obesity Approved – A tube that is surgically inserted into the patient that drains a portion of stomach contents after every meal was approved this week by FDA.  The approval is meant to provide another device/surgical alternative for patients who do not respond to non-surgical means of weight loss and the release states that it is intended for use in adults with a body mass index between 35 and 55 over the age of 22 years. According to the FDA, the device will allow patients to remove approximately thirty percent of the calories that were consumed during the meal when used 20-30 minutes afterwards.

That’s all for me this week. I had intended to have a posting with an update on pharma and twitter use, but it is now scheduled for next week. Until then, be well and be safe.

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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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