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   “If a firm voluntarily corrects misinformation in a truthful and non-misleading manner and as described in this draft guidance, FDA does not intend to object if the corrective information voluntarily provided by the firm does not satisfy otherwise applicable regulatory requirements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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Weekly Roundup 6.13.14

It is hot.  It is humid.  Mosquitoes have begun to make their presence known.  Thunder and rain showers occur almost daily.  Summer is truly here.  And we are making our way rapidly to my favorite day of the year – the day with the longest daylight is just over a week away. Seems like only yesterday I was lamenting about the lack of daylight.

The summer seems off to a slow start, but here are a few things of note from the week:

  • Cheese – Yes cheese.  It was a main topic for the week.  There was a groundswell of reaction to reports that FDA was moving to disallow artisan cheese makers to use wood shelving when aging their product.  Certainly my Facebook page lit up on both sides of the Atlantic with comments that included a good deal of scorn related to this news.  The reaction reached such a pitch that the agency responded by posting a clarification on its Website stating the following:  ”To be clear, we have not and are not prohibiting or banning the long-standing practice of using wood shelving in artisnal cheese….The communication was not intended as an official policy statement, but was provided as background information…”  Thank goodness, the matter is apparently laid to rest.
  • Fish. Yes, it is all about food this week.  While the cheese issue was being resolved, FDA and the EPA joined together to issue notice that they have concluded that pregnant women, those women who might become pregnant, and young children should eat more fish that is lower in mercury in order to gain developmental and health benefits.  While the agencies had previously cited a maximum amount, they had not cited a minimum amount of fish to consume.  The notice came after an analysis of consumption data showed that out of 1,000 pregnant women, 21 percent had eaten no fish the previous month and those who did were eating small amounts.  The updated advice recommends 8-12 ounces per week.  Lower mercury choices were listed as shrimp, pollock, salmon, cannled light tuna, tilapia, catfish and cod.
  • OPDP Issues Only 4th Untitled Letter for the Year – For those of us watching the edicts of the Office of Prescription Drug Promotion closely, we are left wondering what is going on at that office.  OPDP in 2014 has proceeded with enforcement at a record slow pace, issuing only the 4th letter of the year this week. Normally by this time of the year they would have issued at least twice that many, judging by the past few years.  It is noteworthy because guidances and these letters are two of the only insights that the outside world has into understanding policy from FDA – and there has not been much of either.

That’s it for me this week.  Have a good weekend everyone.

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Warning and Untitled Letters By Therapeutic Category – Oncology

Ever since developing a data base on the Office of Prescription Drug Promotion (OPDP) Warning and Untitled letters, I have wanted to sort the information along various lines to see differences and similarities given different circumstances.  Last year, I produced a White Paper, for example, comparing violations by traditional communications vehicles versus those carried by digital means.  I also did a posting that looked at a particular violation – promotion of an investigational compound – to see what the characteristics of that particular violation.

The data is tracked along a number of fields and one of them is the therapeutic area for which a drug involved in a violation.  Therefore I thought it might be interesting to look at specific areas to profile them against the aggregate.  Today I chose to look at all violations involved in oncology.

First let’s review the overall violations.  There are 390 letters spanning the years 2004-2014, inclusive and covering over 1000 violations.  Here is a table that compares Oncology to the entire group:

How does Oncology differ? One of the surprising things perhaps is that Oncology products account for over half (62.5 percent) of all violations related to promotion of an investigational drug.  Given the fact that there are numerous disease-specific categories, this was a surprise and perhaps sounds a word of caution about pre-approval communications for oncology products.

Also of note, oncology related letters had a lower proportion of warning letters than the general population of letters.  That too is surprising given the serious nature of the drugs involved

As seen below, oncology was also under-represented in terms of the most common violation – the omission or minimization of risk information, but more represented in the category of overstating efficacy.

Finally, there were many more violations in the “other” category for oncology.  This is a hodge-podge of less common violations, with perhaps the most common being a “failure to submit” materials under 2253.

So there are a few lessons about oncology worth noting.  Over time, I will examine other categories of treatment.

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Weekly Roundup 5.30.14

This is just awful.  A whole week without a posting.  Not because I did not have anything to talk about, but because I did not have anything like time on my side.  It was one of those weeks.  I did have time during my dog walks, however, to note that my neighborhood is almost wholly infused with the sublime scent of honeysuckle, reminding me of being a child in my grandmother’s garden.  I have always liked honeysuckle.  It is also a harbinger in my mind that summer is just about here.  As a kid, the period after Memorial Day was the beginning of summer, even though it doesn’t officially begin until later in the month, emotionally speaking – it is summer!

And for those not interested in that, but in FDA, there were a lot of things popping this week and here are a few of them:

  • FDA OKs Test for Identifying Certain Types of Kidney Disease – The agency announced this week that it would allow marketing of the first non-invasive test that would help identify when a specific type of kidney disease is due to autoimmune causes or because of infection.  The condition is called membranous glomerulonephritis (MGN) which is a chronic disease that can cause damage to a cluster of blood vessels in the kidney and which can damage the kidney as it progresses.  The test is called the EUROIMMUN Anti-PLA2R IFA blood test.  Since treatment depends on the kind of disease one is experiencing, the test can help in getting access to treatment according to the FDA spokesperson.  While the test helps determine the cause, the test should not be used alone to diagnose.
  • Agency Approves First Implantable Device with Remote Monitoring to Measure Pulmonary Artery Pressure – There was just no way to shorten that headline.  But speaking of approvals of a first kind for a device, here is another one. FDA approved CarioMEMS HF System which is an implantable wireless device that measures the pulmonary artery (PA) pressure and heart rates of patients with Class III heart failure who have been hospitalized within the previous year.  The goal of having such a system is to reduce possible future heart failure-related hospitalizations by providing data from the home that can be reviewed by physicians who can then make treatment decisions.
  • Draft Guidance on Proprietary Names of Drugs – A not uncommon question about drugs is about the process for naming them.  Here to shed some light on the process is a draft guidance issued by FDA entitled “Best Practices in Developing Proprietary Names for Drugs“.  It focuses on the safety aspects for naming, i.e., avoiding medication errors with similar names and provides a systematic framework for evaluating names before submitting them to the agency for review.  FDA held public meetings in 2003 to discuss the topic and again in 2008.  Interested persons can comment on the draft guidance at www.regulations.gov.
  • Final Guidance on Expedited Programs for Serious Conditions – Drugs and Biologics – After initial publication last year on a draft guidance, FDA issued a final guidance entitled “Expedited Programs for Serious Conditions – Drugs and Biologics” that is intended to speed the availability of new therapies to patients with serious conditions, especially when there are no satisfactory alternative therapies, while seeking to preserve the standards for safety and effectiveness.  Among other things, the Guidance provides definitions for the concept – a serious condition, available therapies, unmet medical need and delineates the differences between Fast Track, Breathrough Therapy, Accelerated Approval and Priority Review.
  • Before You Get in That Tanning Bed – You should probably know that this week FDA moved to reclassify sunlamp products from Class I (low risk) to Class II (moderate risk), requiring the products to carry a visible black-box warning that explicitly states that it should not be used on persons under 18 years of age and added information and warnings to be included in marketing materials.

That’s it for me this week.  Again sorry for the lack of posts this past week.  Busy, busy, busy. Have a good weekend everyone!

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