"New" Mobile Apps Guidance Released

I'm using the word "new" in the headline of this blog post in the technical sense that FDA uses for promoting drugs, namely within the past six months, because the new guidance was actually published in February of this year. I didn't notice it at the time, so apologies for the late notice.

I'm blogging about it anyway because the topic is of interest in general (namely what apps are subject to FDA enforcement focus vs. enforcement discretion), and because the update itself is interesting to FDA process geeks like me.

Here's a quick timeline for the uninitiated:

In 2011, FDA released its first draft guidance* about how it would apply its regulatory authority to the realm of mobile apps. Here's my take at the time.

Industry (and Congress) reacted as if FDA were suddenly imposing a new set of regulations on a vibrant and rapidly evolving technology, despite the fact that FDA had been regulating apps for years.** As a result, there was significant pressure exerted on FDA to finalize its guidance.

In 2013, FDA released a finalized version of the guidance. Here's my take at the time.

In 2014, FDA released a new draft guidance about Medical Device Data Systems. As I noted at the time, this guidance significantly downgraded the regulatory status of MDDS, essentially shifting the entire category of apps from the group of apps where FDA would focus its regulatory attention to the group of apps where FDA would exercise "regulatory discretion," i.e., choose not to enforce regulatory requirements.

In addition, this guidance also by extension altered the finalized mobile apps guidance, and though I agreed (and continue to agree) with this decision, I mentioned that this created an odd situation for those relying on FDA's guidance. We had a new draft guidance about MDDS, which was making revisions to the mobile apps guidance, without any indication in the mobile apps guidance itself that it was undergoing a revision.

Instead, FDA is maintaining a separate, real-time listing of apps that it is updating as individual classification decisions are being made.

I applaud this innovation. I think it helps industry tremendously to have FDA maintaining this consolidated listing of decisions, especially because (as the MDDS guidance itself shows), FDA is willing to reconsider these decisions as the technology evolves.

The wrinkle is that you have to keep on top of these process issues closely to understand them. Otherwise, you'd find yourself going to the guidance, which was always kept in its final status, and assume that you were reading FDA's current thinking about a topic without realizing that FDA had released other, newer guidance that contradicted the position from the "final" guidance.

Well, as of February of this year, that discrepancy has been resolved. FDA finalized the MDDS guidance, and at the same time (apparently), released an updated final mobile apps guidance.

In reading through the new version of the final guidance, it does not appear any significant changes have been made to the FDA's classification scheme for mobile apps, or any additional reclassifications have been introduced; however, if anyone finds such changes, please point them out in the comments.

* I'm posting this (and other) guidance on my own site. My sharing these documents 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 and use by others who would like to see how FDA's position has evolved.
**According to both FDA and press, FDA has been clearing (i.e., regulating and accepting apps as medical devices) since at least 1997.

Help-Seeking Guidance Withdrawal Update

Last week, FDA withdrew 47 guidance documents, including the disease awareness guidance that has become so central to ad-promo professionals. As I mentioned at the time, this move left those of us who care about these issues in a bit of a quandary.

It certainly seemed from FDA enforcement activities and other statements that many (if not all) of the principles set forth in that guidance still represented FDA's view, but the guidance itself was technically no longer an official statement of FDA's position.

Since I was teaching a two-day ad-promo class for FDAnews this week, I reached out to OPDP about whether I needed to radically alter my treatment of the topic of disease awareness in light of this development.

I received the following statement in response:
FDA continues to believe that disease awareness communications can provide important health information to consumers and health care practitioners, and can encourage consumers to seek, and health care practitioners to provide, appropriate treatment.  While many of the principles in the withdrawn draft guidance are still relevant, we are taking this opportunity to work on an updated draft guidance that considers new technologies and includes information about social science research to better reflect FDA’s current thinking on help-seeking and other disease awareness communications.
I'm sharing this with the community because I think it provides important amplification on the initial withdrawal statement.

FDA is apparently working on a new updated draft guidance (despite that guidance not being listed on the 2015 guidance agenda). Also, FDA continues to endorse the view that disease awareness communications are important and can improve the public health.

I'm particularly excited to see what FDA has to say about new technologies. The 2004 guidance was silent on the use of the Internet, and as readers of this blog might know, I've been curious about this topic for several years.

So stay tuned. Clearly there's more coming.

How Not to Submit Interactive Materials to FDA

In two recent guidances, FDA has requested that sponsors submit materials "in an archivable format that allows FDA to view and interact with the submission in the same way as the end user (e.g., working links)."*

I understand the need to experience digital promotional communications in their native environment to fully appreciate the communication and ensure its compliance.** However, achieving the stated goal of creating an experience for the FDA reviewer in the submission that is the same as the end user is not practical.

The most common format for submitting materials to FDA for the postmarketing submission of promotional materials is via the .PDF document format. Websites, emails, and other digital tactics are converted into PDFs. Typically, this process is achieved by taking screen shots of each webpage or other unit, gathering those screens into a convertible format such as .jpeg files and combining those files into a single .PDF file.

There are various techniques for doing this, and lots of software out there to assist with both the screenshots and the conversions. Adobe has at various points provided software additions that purported to convert an entire website into a single .PDF file at the click of a button. I've worked with most if not all of these solutions, and none of them work. At the end of the day, the only reliable technique to create a .PDF file that looks like the finished piece is to do so manually.

To convert such a file into a piece that functions in the same way as the original thus requires manually building into the .PDF file individual links that move the user around the PDF in the same way as the hyperlinks behave in the website (or email, etc.).

Depending on the complexity of the original piece, that task can be considerable. For example, a 12-page website probably actually has about 25 pages once error states, index pages, and other miscellaneous aspects are included. Assuming 10 hyperlinks per page (which is low), that's more than 120 individual hyperlinks that have to be created (and checked) prior to submission. It's very easy to introduce an error during that manual build.

And the resulting PDF will never be used other than for a 2253 filing. So, there's a lot of effort to create something that no one (outside FDA and the sponsor company) will ever see. A lot of effort with a high likelihood of error for no benefit.

As if this were not reason enough to avoid creating this file, the timing for its creation could not be worse. Digital tactics aren't like print ads. When I submit a print ad to the FDA for a postmarketing submission, the actual ad itself is unlikely to be on newsstands for several days or even weeks. But a digital tactic will often go live immediately after the materials are submitted to the FDA. Every additional minute spent creating the file for the postmarketing submission is a delay in making the materials available.

This also ramps up the pressure on the ad agency or other responsible party to complete the submission as rapidly as possible. That pressure further increases the likelihood of an error being introduced.

To recap, creating fully functional PDFs that recreate the end user experience of a digital tactic is an expensive, time-consuming, error-laden process that delays the deployment of promotional communications and benefits no one other than the FDA reviewers. This is one time I think industry is likely to ignore FDA's request.

* Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics, page 6, note 7. See also "The website should allow the FDA reviewer to click on links within the website," in Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs, page 31.

** Indeed, a significant portion of my primer on this topic is devoted to the idea that reviewers have to understand and experience the platform to determine its compliance.

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.


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.