Help-Seeking Communications Guidance Withdrawn

FDA announced today (technically tomorrow) that they are withdrawing nearly 50 guidances.

One of these guidances has become a staple for ad-promo professionals who have turned to it repeatedly in the more than 10 years since its initial publication.

The notice in the Federal Register provides the following rationale for the withdrawal of these guidances:

Many of these draft guidances were not finalized most often because of higher priorities and resource issues. However, over the years, because of new information, scientific developments, and emerging technologies, a number of draft guidances have become outdated and therefore, should be withdrawn.

No further explanation is provided for the individual guidances listed.

Ad-promo professionals will be surprised to see the Disease Awareness Guidance on this list.* Since its publication in 2004, poring through this guidance has become a rite of passage for ad-promo professionals. The guidance itself has always been something of an odd bird in that it sets out a category of communications over which FDA does NOT have authority.

The basic idea is that FDA has authority solely over the communications that promote or provide instructions for use of drugs. FDA does not have authority over all other communications. Sometimes, companies are cited by the FDA for engaging in communications that the FDA deems to have been product promotion but which the company itself clearly intended to be some other form of communication.

This guidance sets out many of the criteria that FDA identified in 2004 as crossing the boundary from non-regulated to regulated speech.

Based on the limited information in the Federal Register, there's no way to know why FDA has chosen to withdraw this specific guidance document.

It is worth noting that there is not currently anything on the CDER Guidance Agenda that touches on this topic, so it appears that people promoting prescription drugs will be left without any guidance about what FDA considers inappropriate in this area.

* I'm posting this guidance on my own site because I'm assuming that FDA's site will no longer host the guidance as of May 6, 2015. My sharing this document should not be construed as endorsing the views set forth in it, nor should it be taken as a sign that these views represent FDA's current position. This link is merely being provided for historical research purposes.

Why professional associations matter

The following remarks were delivered to the Temple University QA/RA program during their 2015 career night. I'm providing here the prepared remarks, which differ slightly from what was actually presented.

I’m Dale Cooke, the president of PhillyCooke Consulting, which is an FDA regulatory consulting firm that helps pharmaceutical companies and technology platforms make information about FDA-regulated products available via new and emerging technologies.

I also serve as the co-chair of the local Regulatory Affairs Professionals Society (RAPS) chapter, and it’s in that capacity that I’ve been asked to speak to you.

Specifically, I’ve been asked to speak about the importance of professional society involvement in your ongoing career development.

So, here it is: It’s really important to be involved in professional societies.

Seriously.

What’s in it for you?

Well, first, you get to meet other people outside of your specific company. The value of having those contacts is very high. I like to say that when you hire someone you’re also hiring their Rolodex.

For those of you who have never heard of a Rolodex, it’s a mid-20th century technology, kind of like an offline LinkedIn.

And the reason you want to hire someone’s Rolodex is that no matter how talented you are, there’s always something you don’t know. There’s nothing wrong with that. It’s just a fact of life, and when you’re facing that area where your own knowledge is lacking, it’s important to be able to reach out to other people who can help. Not to mention that at some point, you hope your company will be expanding, and when you do so, the first place you turn is your (and your team’s) Rolodex to look for more talent.

So, professional societies are an important means of extending your brain to tap into the larger community of professionals who also work in your field.

Second, professional societies keep their membership up to date on the latest developments. If you’ve been paying attention to the news, you’re certainly aware that Congress has been completely gridlocked and absolutely nothing is going on in Washington…except for FDA.

In the past few years, there have been several landmark pieces of legislation passed to address issues such as the supply chain, compounding pharmacies, and generic drug development, just to point out a few items that are near and dear to my heart.

Two days ago, new draft legislation that would drastically overhaul the FDA was released. I don’t know whether it’s going to pass, but if it does, I’ll be turning to RAPS, the Drug Information Association, and Food & Drug Law Institute (I’m an active member of all three) to find out how it affects me, my job, and my clients.

For example, next week, the local RAPS chapter is hosting an event with Jay Crowley, the godfather of UDI, about how the Unique Device Identification system is being implemented. This is a massive challenge for medical device manufacturers (i.e., some of the people you might be working for).

So, perhaps there’s some value for you in learning about it. Maybe?

By the way, if you want more information about the event, stop by our table to pick up a flier.

Finally, actively participating in professional societies enables you to demonstrate to your current and future employers your commitment to your career. It looks good on your resume.

If on a Thursday night, you choose to go the Maggiano’s in King of Prussia to hear Jay Crowley speak about UDI, instead of playing Quizzo at a local watering hole, then you’re showing how highly you value staying at the top of your game in your chosen career.

And serving actively in your local chapters is a further demonstration of that commitment. I always say that if you have two hours a month to volunteer with RAPS, then I’ll find a way to have you help the chapter in those two hours. If you have 10 hours, we’ll give you an award.

In addition, actively participating is fun. If I weren’t involved with RAPS, I’d never have met Linda Bowen [Editor's Note: Linda was in the audience], and Linda’s a hoot.

So, my advice to you is to get involved with at least one (and preferably several) professional societies. They’ll help you expand your network, stay on top of the latest developments, and demonstrate your commitment to current and potential employers, all while having some fun.

New 21st Century Cures Act Removes Social Media Provision

The House Energy and Commerce Committee have released a new draft version of the 21st Century Cures Act, which would significantly change how the FDA operates.

An earlier version of this bill included a provision that would basically have written a version of the one-click rule into law and required FDA to

"review each regulation and guidance that applies to the dissemination by means of the Internet (including social media platforms and character-limited applications) of information about medical products" and "treat hyperlinked information ... as if the information" were part of the initial communication.

In essence, Congress was mandating that FDA permit some version of the one-click rule, and revise or withdraw all guidances and regulations that prevented them from doing so.

This language has been completely removed from the latest draft legislation. I haven't seen any coverage of why this provision was dropped, and I was never able to determine where the initial language came from.

So, for now, the idea that legislation will drastically alter the landscape for using social media has taken a set back. But once draft legislative language is out there, it tends to crop up again and again.

Using Periscope for Regulatory Updates

Twitter released a new app a few weeks ago called Periscope. Periscope enables users to broadcast live from their mobile devices. Depending on how the broadcast is shared, you can either make the broadcast available to everyone or only a select few people.

I've been playing around with Periscope to get a feel for how people are using it and also to see what if any interesting regulatory issues it raises.

It's possible to create a distinct identity on Periscope from your Twitter identity; however, I'm using Periscope as @PhillyCooke.

One way I've seen Periscope be adopted by the larger non-pharma community is to provide additional "behind the scenes" footage from television performers, specifically people who host interview programs. I've also seen it used successfully for Q&A sessions because viewers can type responses, feedback, and questions into the app, and those comments are then seen by everyone viewing the broadcast including the presenter.

Next week, I'll be broadcasting the Philadelphia RAPS chapter meeting. We're having Jay Crowley speak about UDI.

Jay spent more than 25 years at FDA and is widely regarded as the godfather of the Unique Device Identification system, so we're extremely excited to have him speak. Another chapter chair asked whether we could turn the event into a webinar or otherwise make Jay's talk available to a wider audience, and that's when I decided to leverage Periscope.

So, start following @PhillyCooke on Periscope, and tune in next Thursday, May 7, at 6:30 to listen in to Jay's talk.

Brief Summary Guidance Digital Application

Five Things to Notice About FDA's Electronic 2253 Filing Guidance

Today, FDA produced its long-awaited guidance of submitting promotional materials electronically.

As ad-promo guidances go, this is a hefty one, weighing in at nearly 40 pages. For comparison, last year's two social guidances released on social media guidance day totaled 30 pages combined.

Rather than trying to provide a comprehensive digest of the guidance, I'm going to here provide a framework for understanding the guidance and point out some the items that leapt out at me on a first reading.

1. What is this guidance about?

Up till now, FDA's two primary groups responsible for overseeing the promotion of prescription drugs and biologics, the Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER) and Advertising and Promotional Labeling Branch (APLB) in the Center for Biologics Evaluation and Research (CBER) have had different policies about accepting electronic filing of promotional materials. APLB accepted them; OPDP didn't.

Moving forward, both agencies will accept promotional material submissions electronically, and they will do so using the common eCTD format used for all other electronic submissions, such as NDAs and BLAs.

2. Which submissions are affected?

This guidance affects only submissions of promotional materials to the FDA, and such submissions are either voluntary or mandatory. All promotional materials for any prescription drug must be filed with FDA at the time of initial dissemination or publication (though see here for an important exception regarding social media). In addition, a small class of products (call subpart H or E) have additional mandatory submissions.

In addition, companies sometimes request voluntarily that FDA provide feedback (so-called advisory comments) on draft promotional materials. Companies do so to minimize the likelihood of receiving an FDA enforcement action, since the worst situation a company can find itself in is having spent money to develop promotional materials only to have FDA take enforcement activity that requires the company pull the existing materials and lose the time and money of creating all new materials. Voluntary submissions of promotional materials primarily include requests for advisory comments from the FDA on a newly approved product in its launch phase, TV spots, new messaging, or perhaps as a result of previous enforcement activity.

Because all submissions of final samples of promotional materials include a completed copy of Form 2253, these submissions are typically referred to as 2253 submissions. Though note that APLB requires that companies include Form 2253 for voluntary submissions of draft materials for advisory comments; and that difference will continue even in the new eCTD submissions as proposed in this guidance.

3. Guidances are usually voluntary; but this one isn't (sort of)

Right now, everything in this guidance is voluntary; and the guidance itself is in draft status. There is no requirement that any company begin adopting the procedures set out in this guidance today.

HOWEVER, after this guidance is finalized by the FDA, then parts of the guidance (the parts addressing mandatory submissions of promotional materials) will become mandatory 24 months later.

So, even after the final guidance is released (and there's no way of knowing when that will be), only parts of this guidance will represent mandatory changes; but the mere fact that some parts of the guidance are mandatory is itself a significant difference from most other guidances.

4. But aren't TV spots required to be submitted for review 45 days prior to use?

No. PhRMA's guiding principles on DTC television advertising recommends that companies submit them to the FDA with sufficient time for FDA to review them, but this is not a regulatory requirement. It is only binding on PhRMA signatories, and even then, the companies are not required to submit the materials for advisory comment, just to give FDA time to comment, should the Agency choose to do so. 

Also, FDASIA granted FDA authority to mandate that TV spots be submitted to FDA 45 days prior to airing for FDA to comment, and FDA issued a draft guidance about how it would implement such a program. However, as this new guidance states repeatedly, that guidance has not yet been implemented, and FDA does not want companies to follow those procedures currently. The process itself is deeply problematic, as I pointed out in an appendix to my primer on the topic.

5. Is there any glaring change from current 2253 submission processes?

This guidance provides far more extensive discussion of the submission of promotional material than previous direction. Most of the discussion will sound familiar to ad-promo professionals. One item that leaps off the page in the section on final samples submission is this passage:

Firms are also encouraged to submit annotated versions of the promotional material(s) cross-referenced to the product labeling and references, if applicable. (page 6)

Standard final samples submissions do not include references, and this "encourage[ment]" appears in a section of the document that otherwise will cover mandatory changes. Adopting this change would be deeply problematic for most promotional materials.

In the standard review and approval process, the references are only included for the initial medical legal regulatory (MLR) review, and then deleted from subsequent check-changes, and final samples submissions to the pharmaceutical company. Adding references back for the final 2253 submission would create significant additional expense, and would create additional possibility for error during the most time-sensitive portion of an elaborate process. 

New Video Lecture Available

The Digital Health Coalition, where I serve as one of the Digital Scholars, has created a new online resource called the Digital Health Coalition Academy. At this online destination, they are providing a series of short videos about topics of interest to people working in the digital health space.

I am pleased that they asked me to create one of the inaugural presentations. I chose to update and slightly expand on the presentation I previously delivered at the FDLI enforcement conference. 

I've previously asked on this blog how much value people get from the slide decks I post on SlideShare when there's no corresponding audio because I sometimes post unaltered decks that were not created as standalone pieces, but were intended to be accompanied by my narrative.

I've also previously declared my intention to start making more video content available, and though this presentation isn't on my YouTube channel, which remains woefully inadequate, I hope the DHC partnership will jump start that process.

Please provide any feedback in the comments or privately about whether you find the presentation useful, especially whether it was significantly more valuable than just the slides alone on SlideShare.