Upcoming Speaking Engagements

The conference season starts up in February, and I have a few engagements (listed in the right hand column as always) coming up. If you follow this blog, then keep in mind that I sometimes have discounts available and will send you the info if you register for updates or send me an email using the form that is also in the right hand column.

First up on Tuesday, February 10 is a webinar I'm delivering with LSTI on the current state of social media guidance. This is an updated version of the webinar that I presented in the fall on the same topic. Since that initial presentation, the comment period has closed on the two social media guidances from last summer (though of course, it's always permitted to send comments even after the docket is closed).

The following week on February 18-19, I'll be leading an exciting panel on leveraging innovative technologies at DIA's Marketing Pharmaceuticals conference. Here's the official description of the conference:

The importance of understanding the complex regulations regarding the marketing of pharmaceuticals, veterinary products, biologics, and medical devices has never been higher. The DIA Marketing Pharmaceuticals 2015 conference will explore drug and device marketing in an evolving environment while serving as a vital forum for all stakeholders involved with the marketing, advertising, and promotion of a wide range of health care products.

Featured Topics:

• Latest enforcement actions and policies issued by the FDA
• Leveraging innovative technologies compliantly
• How other companies are complying with government regulatory requirements
• Best review and approval practices with industry colleagues
• Novel promotional tactics trending in the pharmaceutical industry 
• Emerging issues in the oversight of marketing materials

The panel I'm leading will feature participation by AstraZeneca, J&J, Twitter, and YouTube. Here's the description from the conference webpage:

Consumers and health care professionals rely on the Internet and their mobile devices as essential tools for finding information about health care, medicine, and other treatment options. Makers of prescription products have been lagging behind in the uptake of these tools. This session provides the hands-on experience of some of the people who are leveraging YouTube and Twitter at the time and in the platform that people are using.

You can see the full conference agenda and get registration information here.

The week of February 23 will see me back in DC for the final session of the ACDRS program. This is something I started doing last year and really enjoy because of the intimate classroom setting of working with a group of professionals who have spent more than a year following the development of prescription drugs and studying the regulatory requirements. It's an intense program, and I speak in the final session dedicated to commercialization and (no surprise) the need to understand and leverage new and emerging communication channels.

Before that travel gets started, I'll be attending the local Philadelphia RAPS chapter meeting next week on Thursday, January 29. Gary Buehler from Teva Pharmaceuticals will be speaking about the Citizens Petition process and ways companies use it to delay introduction of generic versions of products. Gary spent nearly 10 years at FDA's office of generic drugs before moving over to Teva four years ago. It should be a great topic, and I hope you'll join.

But whether you're also in the Philadelphia area, will be traveling to one of these events, or joining a webinar remotely, please stop by or drop a line and say hello.

DTC Perspectives Article Out Now

Apologies for the lack of posting.

It's been a busy few months. I have, however, been writing, just not posting stuff to the blog. Some of the writing is for a longer book project.

I did, though, publish a column over at DTC Perspectives giving my take on what I have dubbed "Social Media Guidance Year." This of course comes on the heels of the new national holiday, June 17, which shall henceforward be known as Social Media Guidance Day.

Check it out: http://www.dtcperspectives.com/dtc-news/social-media-guidance-year.html

Master Class Early-Bird Discount Expiring Soon!

There are still spaces available in the November 12 & 18 sessions of Using Social Media Compliantly in Princeton, NJ, and Boston, MA, respectively.

These classes will go beyond the information presented in my recent articles (available here and here) about the FDA guidances, and focus on the key decisions that need to be made on the top three platforms (Facebook, Twitter, and YouTube) to use these platforms compliantly.

Right now, there is a $100 early-bird discount available, but that is about to expire, so if you're interested in attending, register now!

"Reminder-like" Promotions

This week at the Food & Drug Law Institute's Advertising & Promotion Conference, FDA made a subtle, but vital, clarification in the context of discussing the scope of its guidance on space-limited contexts.

The clarification came on the penultimate slide* of FDA's presentation about the space-limited and correcting misinformation guidances. On that slide, and during that portion of the corresponding presentation, FDA noted that the guidance explicitly set aside any discussion of reminder advertising, and addressed the prohibition for use of the reminder ad format by sponsors of black box drugs.

FDA then proceeded to note that although reminder advertising and promotion is prohibited for black box drugs, the FDA has long recognized in traditional (i.e., offline) communications the ability of sponsors of black box drugs to engage in "reminder-like" promotion.

The key distinction for reminder-like promotion vs. reminder promotion is that reminder-like promotion must have an"[a]ccompanying PI or brief summary" and a statement to "Please see..." the accompanying PI. Reminder promotions do not have such requirements.

At this point, it's useful to briefly recap the traditional reminder advertising/promotion requirements:

As I discussed in my article on search engine marketing, traditional reminder advertising has only a few required elements:

1. brand name (if any)
2. generic name of the product and/or active ingredients

All other elements are optional. Quoting directly from my article, the optional elements are:

1. quantitative ingredient statements (e.g., 20 mg)
2. dosage form (e.g., tablets or capsules)
3. quantity of package contents (e.g., 30 pills per bottle)
4. price
5. name and address of the manufacturer, packer or distributor
6. other information so long as it makes “no representation or suggestion” about the product use

So, FDA is acknowledging this week the existence of a separate category of communication with a distinct set of requirements. For reminder-like promotion, the required elements appear to be:

1. Brand name (if any)
2. Generic name of the product and/or active ingredients
3. "Please see..." statement directing people to the PI or Brief Summary
4. Provision of a PI or Brief Summary immediately accompanying the advertisement

This presentation was a welcome clarification for many reasons. Perhaps the most important reason is that many people in industry have been concerned that FDA's guidance provisions make it impossible for sponsors of black box products to engage in communication channels with space limitations.

Second, many of the communications that seem most appropriate in social media, and other space-limited contexts would most likely make use of formats that fall under the category of reminder or "reminder-like" communications, such as sending a Tweet to a customer who is asking where she/he can find information about the most common side effects associated with a drug.

There are, though, still many questions to be answered about these "reminder-like" communications. Among those that leap immediately to mind are:

• What are the rules about what you may or may not include in a reminder-like promotion? 
• Are you permitted to include all of the same information in a reminder-like promotion as in a traditional reminder ad for a drug without a black box?
• Are there any additional requirements for the reminder-like ads beyond the link or physical accompaniment of the prescribing information?
• When engaging in reminder-like promotion online, must the link to the PI be a direct link, or would it suffice to have a link to page where a link to the full PI is presented along with additional information?
• Is it permitted (or required) to mention that the product has black box warnings in the reminder-like promotion?
• If either, is there specific language that should be used to describe those warnings?

These last few questions are particularly important for the context of space-limited contexts explicitly addressed by the guidance because the current Google Black Box ad format makes use of the following phrase, which sponsors are not permitted to alter:

"Click to see full safety and prescribing information, including boxed warning. More info"

Many people (including me) think that this language is confusing in consumer-directed promotion because consumers probably aren't familiar with either a PI or the phrase "boxed warning." 

So, although that language is appropriate for HCP advertising, it seems as if a more consumer-friendly version should exist. 

For example, "Click to see full product benefit and risk information, including all serious warnings. More info"

I hope this recent presentation by FDA furthers the conversation about how sponsors of black box products can make use of space-limited contexts while remaining compliant with FDA promotional regulations.

* Note that I'm not sure whether the slides will be available for non-FDLI members and non-conference attendees. There does not appear to be any log-in requirement to access this link. FDA generally makes their public presentations available, so if the link is blocked for any users, contact me and I'll let you know when FDA posts the presentations.

Podcast with PharmaGuy

I was interviewed for PharmaGuy's podcast today. One of the primary topics was the FDAnews Ad-promo workshop that I'm teaching October 15-16. It was a fun time, and here's the archive.

  

Check Out Business Podcasts at Blog Talk Radio with Pharmaguy on BlogTalkRadio

New Speaking Engagements

I have accepted an invitation to speak at the DTC Point of Care Conference on October 1st in Baltimore. Mukesh Mehta of PDR and I will be talking about the explosive growth in EHRs and the need to engage this new communication channel compliantly for providing patients the information they need while ensuring compliance.

Also, I have partnered with FDAnews to prepare a two-day workshop for ad/promo professionals. This workshop will present the basic principles that apply to all promotional communications. In addition, I'll be focusing on some of the areas that have been subject to recent clarification and guidance, including social media and product name usage.

FDAnews is offering a discount exclusively to readers of this blog. To get the details, fill out the contact form in the right rail and ask me for the discount code.

An Underutilized Phrase in SEM?

I suspect that "FDA-approved," "FDA-cleared," "approved by the FDA," and similar phrases are not fully appreciated by marketers of prescription products.

There is a tendency of marketers of prescription products to put on their blinders and see themselves and their product's performance solely in the context of other prescription products. Who's one slot above us on the IMS Health Rankings and who's one slot below? Are we gaining or losing ground?

But for consumers (and even HCPs for certain conditions), the decision set (your actual competitors in the marketplace) include many non-prescription, and even non-drug treatments. Dietary supplements, homeopathic remedies, and even home cures are legitimate considerations for treating many conditions, and many consumers don't distinguish between all of these categories as rigidly as people in the pharmaceutical industry.

However, the public in general holds the FDA in high esteem, and though criticism of the FDA certainly exists, most consumers consider the fact that the FDA has reviewed and approved (or cleared) a product as a guarantee of the product's quality and overall safety.

As such, the phrase "FDA-approved" can have significant value in a context (such as search engine marketing results), where the competition includes many products that are not reviewed, approved, or cleared by the FDA.

As part of FDAMA's passage in 1997, the prohibition on using this phrase was removed from the FD&C Act.

Since the implementation of FDAMA, FDA has not taken any actions for including the phrase "FDA-approved" or its variations in what otherwise would qualify as a reminder ad, and although FDA has never explicitly endorsed the phrase as being compatible with the reminder ad format, it certainly seems to qualify.

A reminder ad may not include any "representation or suggestion relating to the advertised drug product." 21 CFR 202.1(e)(2)(i) And the phrase "FDA-approved" certainly does not seem to violate that prohibition.