Weekly Roundup 7.4.14

Happy Independence Day for America.  This week also so Canada Day.  So while a week where work productivity may have dipped, enjoyment factors probably drove up – at least in North America.  The season is marked by hot, humid days and stormy nights, especially now as Hurricane Arthur takes an excursion along the Southeast coast in the Atlantic.  So many things going on.

And here are few from this week that caught my eye related to FDA, pharma and communications:

  • Accelerated Approval for a New Drug – Always noteworthy, FDA announced this week the accelerated approval of Beleodaq – a new treatment with orphan status for a type of Non-Hodgkin Lymphoma called peripheral T-Cell lymphoma (PTCL) – one of the ways in which lymph nodes can become cancerous – from Spectrum Pharmaceuticals.  The drug works by stopping an enzyme that contributes to T-Cells becoming cancerous and is the third drug approved since 2009 for PTCL, according to FDA and FDA took the unusual step of listing those in this press release.  Accelerated approval, it should be noted, allows approval based upon surrogate endpoints which would be reasonably likely to produce a clinical benefit.  Accelerated approval is one of four designations that can alter the approval pathway timing and course and differs from Fast Track.  Here is an FDA Web page that provides an overview of them. And here is the Guidance on Expedited Programs for Serious Conditions.
  • More Information on Regulation of Compounders – In 2012 and throughout 2013, in response to highly publicized adverse events associated with compounded products, policy actions were taken to increase FDA’s authority over that sector resulting in a series of new steps to help define the environment regarding compounding.  Eye on FDA has a tab for compiling a historical timeline of many of these actions.  This week, FDA announced a series of steps to move the process along, including (1) a draft interim guidance on maintaining current Good Manufacturing Practices (cGMP); (2) a new proposed rule that would revise the list of drugs that may not be compounded; (3) a Final Guidance on the practice of compounding and regulatory actions related thereto; two Federal Register notices – one a list of bulk drugs that may be used in compounding according to one section of the regulations and another for a second section.
  • Legal Actions – FDA announced two legal actions that provide insight into different regulatory oversight – the first was against a California company in which the agency was seeking a permanent injunction because FDA said was selling products that were actually over-the-counter (OTC) drug products without approval.  The second action related to a dietary supplement manufacturer where the agency obtained a consent decree due after the agency issued warnings about a product being sold that contained ingredients in the form of controlled substances that were not included in the ingredient label.

Time to fire up the grill!  Happy Independence Day to U.S. readers; Happy Canada Day to Canadian readers and the rest of you – have a wonderful weekend.

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Weekly Roundup 6.27.14

Well, I am late again with the Weekly Roundup and I once again seek forgiveness. I didn’t even get much time to tweet!  It has been a rowdy few weeks and the summer is shaping up to be unruly.  We began summer in earnest this week and are already sitting on the cusp of the July 4 holiday.  Everything in the garden is growing like weeds, especially the weeds. The grass I never planted sits in a bag in the shed, waiting now for the fall planting.  It is just that kind of summer.

Hopefully you have a few moments however to kick back and look at a few of the things that happened this week:

  • Diabetes Drug Afrezza Gets FDA Approval – The top approval news this week belongs to Mannkind’s Afrezza, a form of insulin to treat Type 1 and Type 2 diabetes that is administered through inhalation.  The inhalation powder is a fast-acting insulin that is inhaled at the beginning of each meal, or within 20 minutes after starting a meal.  The approval has been long-sought and is an example of a company coming back after receiving a Complete Response Letter from FDA, not once but twice – in March 2010 and again in January 2011.  The agency announced the approval on Friday, stating that Afrezza would have a Boxed Warning regarding the potential for acute bronchospasm in patients with COPD and a REMS program regarding informing physicians of same.  In addition, there are post-marketing studies slated for the drug.  You can view the company press release here.
  • New Device Approval for People with Spinal Injury – FDA also announced approval of the first motorized device that is intended to act as an exoskeleton to be used by people who have lower body paralysis due to a spinal cord injury.  Named “ReWalk” – the device is worn over the legs and extends to part of the upper body.  The agency said in its release that ReWalk is for people with paraplegia due to spinal injuries at specific sites.  In order to use the device, patients and their caregivers will have to undergo training in a program designed by the manufacturer – Argo Medical Technologies which will also be conducting a post-marketing clinical study that will consist of a registry to collect data on adverse events related to the use of the device and to assess the training program. A film news report is available here.

Time to go enjoy the summer weekend.  Have a good one everyone!

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How a Watch Can Result in More OTC Switches

Remember when your phone was just a phone?  You flipped it open and made a call.  It also may have told you the time, but you primarily used it for talking to people.  Today you actually use it in ways so that you don’t have to talk to people.

Instead, you can use your phone to text, IM or send an email, but you don’t have to make a call.  You can check the weather, news, sports.  You can play music – even watch a movie. You can use it as a compass or to provide you with a map and directions.  It can be a fitness partner to track your progress – a dietary guide and oh – did you know that you can take pictures of yourself and post them to Facebook?  And you can even do things like take your blood pressure, look at X-Rays and there are numerous diabetes apps.  (If you are interested in more along the lines of medical apps, here is a dandy resource.)  In fact, your phone has evolved to the point where it is highly likely that one of the things you use it for the least is to have it be a phone.  It is now more a personal assistant.

Your watch has pretty much always been there to tell you the time (though now your phone does that).  Yesterday was the “pre-launch” of a new “smartwatch” in an ever expanding line to make news.  The watch comes with a built in heart monitor and will pair with other devices and will be a tool in managing fitness, among other things.

At some point, one simply has to assume that the smartwatch, along with the smartphone, will be able to help drugs that are sitting behind the prescription pad to make their way to the OTC counter.  For many drugs, such as statins, the inability to monitor one’s own liver functions and cholesterol levels has meant that attempt to switch statins from RX to OTC have failed.  (I attended most, if not all of the AdComms.)  But as our technology advances and becomes more accessible, and our watches and phones stop telling us the time and making our calls in favor of providing us with ever expanding amounts of information about ourselves, at some point it is likely that the watch and the phone will help us do things that we can only do with our doctors now – and hence opening up a bit the vault of drugs that can be switched from RX to OTC.  Just “watch”.

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Guidance on Two Social Media Fronts from FDA’s OPDP

For four and half years now FDA’s OPDP has endeavored to devise answers to 5 questions raised during a public hearing on the Internet, Social Media and Pharma and Device Manufacturers held in April 2009.  Finally, on a day when I am travelling, the agency poses at least some partial answers to those questions in the form of two guidances. Ed Silverman at Pharmalot broke the news (“Tweet This:  FDA Finally Proposes Social Media Guidelines”).

FDA’s approach to the guidance materials is not to lay down commandments.  Rather, the agency presents their thinking or principles in a section labeled “Background” and then to provide examples that lend insight into how a company might consider approaching a situation.  There are, I think, some real surprises for companies.  I will note them below.

Here is my first take on the contents of the two draft guidances, with the proviso that what is rendered herein is not legal or regulatory counsel, but rather observations about the impact of the guidances in communications considerations and any regulatory or legal question should be posed to counsel:

1. – “Correcting Independent Third Party Misinformation About Prescription Drugs and Medical Devices” provides some very useful information, both direct and indirect.

  • Companies CAN Correct Misinformation. The first surprise is this. Companies can correct misinformation.   “If a firm voluntarily corrects misinformation in a truthful and non-misleading manner and as described in this draft guidance, FDA does not intend to object if the corrective information voluntarily provided by the firm does not satisfy otherwise applicable regulatory requirements regarding labeling or advertising…”  Up until this point, I believe that many firms believed that correcting misinformation on a third party site was not an option.  Apparently it is.  That is part of the principle laid out in the background.
  • Guide for Making Corrective Comment. FDA made specific recommendations for going about a correction.  Corrective comment has to be relevant and responsive to the misinformation and tailored to it specifically.  A corrective message should apply to the indication being discussed in the original commentary, not additional indications for the product that were not mentioned. It must not be promotional in nature, tone or presentation and must be accurate and consistent with the label, supported by evidence and should disclose that the person posting the correction is affiliated with the product manufacturer.  These are the standards by which a correction will be assessed by FDA.
  • Companies Can Host Discussions. Another point the agency makes is that when the firm itself is responsible for the product communication that contains the information, then the guidance does not apply.  So, no surprise there – I think everyone understood that they are responsible for content that they generate. However, here is another reveal – in providing examples as to how a firm is responsible for its content and where the draft guidance would not apply – one example involves a firm that is hosting a discussion group on its own website – and is monitoring that discussion and in the course of it, removes some of the unflattering comments or postings and adds positive postings.  Obviously that content is under control of the firm and so is not something covered by the guidance.  But the interesting part here is that the example seems to take for granted that most firms would do this in the first place, but I think that is most definitely not likely the case. And here is a statement I bet most did not know – “Firms are generally not responsible for third-party UGC (User Generated Content) about their products…regardless of whether the firm owns operates the platform on which the communication appears.” In the example of a firm hosting a discussion about an FDA approved product on their corporate website where they have provided a clear message that they are not controlling content and did not create the content, then the “firm is not responsible for the information that is posted by independent third parties and can, if it so chooses correct misinformation according to the guidance.”  Now comes a very big BUT.  What does it mean that a firm is “generally not responsible”?  In other words, the firm is not responsible for misinformation, one supposes – but what if a participant in such a circumstance starts talking about an adverse event.  Here the guidance is silent – and presumably that is the subject of another guidance perhaps yet to come.  But I believe that most in industry would not hold such a discussion on their corporate site in the first place, so the example is murky here.
  • Not obligated to correct. FDA also uses an example of a blogger supplying misinformation and states that a “firm may decide to attempt to correct misinformation, but is not obligated to attempt to correct it.”  That raises an interesting point to this for manufacturers.  If there is misinformation out there, they may correct it, but in doing so, must follow guidelines for doing so and they could mis-step.  That means that there is some inherent risk in correcting misinformation, but there is no obligation to correct misinformation.  In that case, many conservative regulatory cultures are possibly going to take the position that misinformation should not be corrected as a matter of taking the safest policy course.  That means, in essence, that in seeking to address the public health concern about misinformation, the guidance may fall short of the mark.
  • Correcting a Part of a Website Does not Obligate One to Correct All of the Website. A company should correct all of the mistakes in a posting, but in doing so, is not obligated to correct misinformation that appears on other pages of the site.  To many, that will be welcome news.

There is more to the guidance, such as the fact that companies can contact the original author to suggest corrective information (once again, which is corrective and not promotional in nature).  Companies are not responsible if, once contacted, the author of a piece does not issue a correction.

2.  The second draft guidance “Internet Social Media Platforms with Character Space Limitations – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices” is a title that I am pretty sure is over 140 characters.

This guidance addresses the situation where a communications platform is of limited space and therefore poses a challenge for communicators regarding medical products where benefit information about the product has to be accompanied by information on risk. Previously through regulatory action letters, OPDP has taken the position that inclusion of the risk information by link is not sufficient.  With this guidance, OPDP appears not to have changed that position.   This guidance addresses primarily microblogging platforms (Twitter) and sponsored link promotions.  For my purposes, I am going to focus on the news medium – Twitter.

And here is the rub on this guidance regarding Twitter.  Prior to the guidance, Twitter – a major communications hub in healthcare – particularly at medical meetings – was essentially off limits for branded information about pharmaceutical and medical device products specifically. There are many pharma Twitter feeds addressing everything from recruitment to corporate news, but product-specific efforts are extremely rare, though there is at least one product-specific Twitter feed run by a pharma company.  However, a company could not tweet about the approval of its product by naming the product and the indication and a link to full information without running the risk of regulatory action from OPDP.

In other words, if FDA would tweet a drug approval – “XYZ Drug approved by FDA for diabetes Type 2″ – the manufacturer would presumably not be allowed to re-tweet the FDA’s announcement.  After this guidance, nothing has changed.

In the upfront section of the guidance, FDA outlines the traditional regulatory parameters that any promotional labeling that makes claims about a prescription drug product must include the risk information conspicuously, present fair balance, contain risk information in each part, as necessary to qualify any representation about the product, etc.

General factors that go into the equation – first of course, the benefit information must not be misleading, which means that material facts about the use of the product such as limitations to an indication or patient population must be included.  Further, the information must be accompanied by risk information within the character-space-limited communication.  A link should also be provided to allow direct access to more complete risk information about the product.  Finally, the brand name and the generic name need to be included.

The agency then sets up some hypothetical example to construct a tweet using a fictitious drug called “NoFocus” which is indicated for mild to moderate memory loss .  Further profile of the product – it has no boxed warnings and no known fatal or life-threatening risks in the PI. The most serious precaution is that it may cause seizures in patients with seizure disorder. The chemical name of NoFocus is remembrine hydrochloride, but scientific abbreviations may be used for a chemical ingredient name so it could be  written as HCI instead of hydrocholoride).  Now, how does that translate to a tweet in compliance?  Here was FDA’s result:

“NoFocus (remembrine HCI) for mild to moderate memory loss-May cause seizures in patients with a seizure disorder www.nofocus.comrisk” – 134 characters, with 140 the limit.  While presumably you could cut this down by making patients “pts” and making with “w/” there is essentially little to no room left for any news, such as including the words “FDA approves” before the tweet which would take it to 146 characters and allows for no link to the press release about the approval.

Yet twitter is a news forum.  The way that the example is constructed in the example is nothing more than an advertisement – not a communication particularly appealing in the Twittersphere and in fact, might backfire.  The inclusion of so much information in the text of the tweet and the link being consumed by the link to fuller risk information leaves the tweet nearly unmanageable from a news point of view and would require a lot of review internally by a company to ensure compliance.  So in the end, while product specific information was nearly impossible before the guidance, nothing has changed with the guidance.

In the end, that may be the lesson of both of these guidances.  After such a long wait, little may have changed.  While technically firms are allowed under the first guidance to correct misinformation, there is regulatory risk if the parameters for doing so are not met and therefore the most conservative course of action is to not correct.  Remember, there are two pathways to getting regulatory guidance – the first is guidances and the second is warning letters when the nuance of the guidances is misread.  And for the matter of the second guidance, while twitter was not a medium that appeared friendly for product-specific discussions by manufacturers, that would appear to continue to be true.  Still, only time will tell.  At least the guidances do offer some new insights but there are still outstanding questions and there remains work to be done.

Since beginning this posting, the WSJ has published another piece on the guidances that can be found here.

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Join Me for a Webinar – Communications Implications of the Sunshine Act Data

I don’t usually do adverts here on the blog – in fact never, but you may remember a posting I did a few months back on the communications implications of the Sunshine Act implementation.  There is room to be expansive upon the topic beyond a blog posting and so that end, I will be giving a Webinar on the topic this Thursday, June 19 at 12 noon Eastern.

At the end of September, the government is scheduled to publish financial data it has been gathering to create greater transparency on the financial relationship between industry and prescribers.  Manufacturers, teaching hospitals, physicians and medical societies are all stakeholders.  What kind of stories can be expected as a result and what should be done now to prepare?  I’ll be sharing some thoughts on the matter.

The Webinar is free and if you would like to join us, here is the link.

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