From Michael Villanella, Copywriting Intern, Palio

While the FDA and DDMAC are still on the drawing board setting regulations for social media healthcare marketing, we are left shrugging our shoulders.  What can we do?

Social media regulations have been delayed by the FDA to a Q1 2011 draft date, so unfortunately all we can do is sit back and wait, right?  Well, not exactly.

Many pharmaceutical companies are making the push now.  Instead of giving in to fear, companies like Johnson & Johnson are taking small steps to embrace the social media phenomenon.  Thus finding ways it can be done.

Just about a year ago, J&J started a blog on their website called “JNJ BTW.” The blog hits on a very personal level with staff anecdotes and follower feedback.  Although they aren’t talking about any products or FDA regulated issues, they are successful in promoting their brand and making “friends.”

In this intimate community, Johnson & Johnson makes each of their 5,000+ followers feel like an individual instead of a number — something that is often neglected in healthcare.

Of course the fear of adverse event reports is always present in a social media venue, but J&J is looking for new ways to combat this. In a separate community called Children With Diabetes, J&J actively combs over and monitors the bulletins for inaccurate reports. This seems a little taboo but, nonetheless, necessary to penetrate the social media world.

As this develops further, there are a few events to keep an eye out for. The Social Media and Community 2.0 Strategies event will be held on April 4^th-6^th in Boston.  This event focuses solely on brand promotion strategies by means of social media. There was also just recently the ePharma Summit on February 7-9 in New York City.  The ePharma Summit included FDA and DDMAC updates on the regulations.

With these two events and a Q1 draft date (fingers crossed) just around the corner, 2011 is shaping up to be a pivotal year for pharmaceutical marketing. Until then, tread cautiously with your social media endeavors.  Just remember that practical solutions can be made today!

Palio is a full-spectrum global pharmaceutical and consumer advertising, marketing, and communications agency that excels in brand creation and specializes in brand strategy, product launches, global marketing, and digital and integrated media.

From Ian DeMeritt, Senior Medical Writer, Palio

In what may be the first DDMAC letter to focus on Facebook, Novartis Pharmaceuticals was just warned that its use of Share Widgets on the Tasigna (nilotinib) Web site was illegal and that it misbranded the drug. Tasigna is “indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome positive [Ph+] chronic myelogenous leukemia (CML) in adult patients resistant or intolerant to prior therapy that included imatinib.” The Tasigna PI contains a boxed warning and the FDA required a REMS program for Tasigna to educate healthcare providers and patients about proper dosing strategies to avoid serious risks.

The Tasigna Web site contained several Share Widgets. By clicking on these icons, visitors were able to quickly and easily share information about Tasigna on Facebook, Twitter, or other social media sites. A short description of Tasigna (including its indication) and a link to the Tasigna Web site would then appear on the user’s Facebook page visible for all of his or her friends to see. Although users were unable to edit the Novartis-generated text, they could include comments along with the post.

While I applaud this use of social media by Novartis, there was only one problem with this approach that anyone familiar with recent DDMAC communication in this area could predict (except, apparently, the Novartis regulatory team): no safety information was included on the Facebook pages of visitors who shared the link. Even though a link to the Tasigna Web site was present, DDMAC has made it pretty clear over the past couple of years that when it comes to social media, it doesn’t recognize a so-called “one-click rule.”

To my knowledge, this issue was first addressed by DDMAC in the 2008 untitled letter regarding banner advertisements for Diovan; this letter was also issued to none other than Novartis. That letter clearly stated the need to include safety information in on-line communications, and that a link to safety information is insufficient to communicate risk information:

“The [Diovan] banners, however, entirely omit all risk information, including the warnings, precautions, and the most frequently reported adverse events from the PI. We note that a link to the PI and Patient Product Information (PPI) is included at the bottom of the banners. However, this does not mitigate the misleading omission of risk information from the banners.”

Not surprisingly, DDMAC’s position hasn’t changed in the past 2 years. The following wording from the latest letter is nearly a direct copy-and-paste from the letter issued in 2008:

“We note that the shared content contains a hyperlink to various Tasigna product websites, which do contain risk information. However, the inclusion of such a hyperlink is insufficient to mitigate the misleading omission of risk information from these promotional materials.”

Given the previous communications between DDMAC and Novartis, I find it curious that they continue to test the “one-click rule.” Whether this latest misstep was intentional or not, it highlights the fact that the issue of pharmaceutical advertising in social media is not going away. Until DDMAC releases its guidance on social media these issues will continue to surface and DDMAC will continue to issue letters to companies who fail to comply.

Until then, I wonder if DDMAC will accept my friend request.

From Geoffrey Sheldon, VP, Brand Planning Director, Palio

One of the biggest factors in ensuring a successful launch of a new prescription drug lies in a marketer’s ability to generate pre-launch buzz and brand name awareness. Unfortunately, this is often easier said than done, due to restrictions by DDMAC on what can and can’t be said about products in development.

So what are the allowable forms of pre-launch promotion, and what can you do as a marketer to generate that critical pre-launch brand awareness while staying compliant with DDMAC’s guidance on prelaunch promotion?

If you need a quick answer to this question why not take a minute out of your day, and read “The 60-Second Guide to Understanding DDMAC’s Guidance on Prelaunch Communications”

As the title implies; it’s a quick, easy, yet informative read.

[slideshare id=4754845&doc=the-60-second-guide-to-understanding-ddmacs-guidance-on-prelaunch-communication-100714131747-phpapp01]

No Slideshare account?! Download it here – The 60-Second Guide to Understanding DDMAC’s Guidance on Prelaunch Communication

From Joe Baumann, Account Supervisor, Palio

The start of summer generally brings a new energy into the workplace – the sun is out past work hours, colleagues are taking vacations, and weekends are spent relaxing outdoors. The start of summer also brings business planning for the next year. And, of course, along with business planning comes the dreaded tactical plan.

As we all know, the way we reach our target market is changing. Tactical plans are shaped differently than they were 5 years ago. More focus is being put on non personal efforts – most importantly on emerging digital technology. Time is certainly being spent educating Agency brand managers on these new tactical and strategic initiatives. But who is taking the time to educate clients’ Medical, Regulatory, and Legal teams?

Just as the way we reach customers is changing, the regulatory environment is evolving as well. The general feeling is that DDMAC is becoming stricter, so added pressure is being put on client Medical, Regulatory, and Legal teams. This is contributing to an environment in which risk is increased with the idea of trying something new.

Something that can help with these challenges is to involve the entire Client team from start to finish with your important communications planning efforts. Traditionally, these teams are only brought in after the Agency develops materials. They are somewhat blindsided by a new tactic or channel to reach the target audience. Why not educate them along with your Agency brand managers? Not only will you gain a better understanding of regulations, but you’ll be creating a stronger working partnership between the Agency and the extended Client team.

At the very least, hold a concept review to get an idea of how a new space or technology can be utilized, instead of putting a developed piece in front of your team for comments. For a concept review, I’ve found it best to include the following in one document for review:

• Marketing Objective
• Description of the channel and tactic
• Target audience
• Examples of where it has been executed in the past (if possible)

In my experience, these steps create a collaborative effort where the Med/Reg/Legal team will begin to champion the idea instead of figuring out ways to shoot it down. This won’t always guarantee you’ll be able to execute on your plan, but it should eliminate an atmosphere of “Us vs Them” and hopefully turn potential foes into friends.

This business planning season, I encourage you to challenge your brand managers to reach out to the extended team prior to Agency development.

From Jim Mittler, Medical Director, PhD, Palio

We’ve all seen bad drug advertisements – confusing concepts, poorly written or too much copy, disconnected visual elements, etc. The FDA is now stepping up their monitoring for bad ads, but not for the creative aspects or connection to the brand. (Although, in some cases I wish there was an organization that could pull poorly executed creative.)

Last week, the FDA announced the launch of the “Bad Ad Program,” which is an educational outreach effort to encourage physicians to do what the Division of Drug Marketing, Advertising, and Communications (DDMAC) can’t necessarily do – monitor what is communicated during face-to-face interactions with pharmaceutical representatives. Traditionally, DDMAC reviews promotional materials developed by pharmaceutical companies (eg, journal ads, TV commercials, sales aids, or slide kits) to ensure that information is on-label and accurately portrays the efficacy of a drug while clearly stating the potential risks so that physicians can make informed prescribing decisions. Through the Bad Ad Program, DDMAC will seek to educate HCPs on what constitutes inappropriate promotional activities and will encourage HCPs to report possible violations. So not only is the content of promotional materials monitored, but by using HCPs as their agents, how these materials are used and the information articulated can also be monitored by DDMAC.

What this means is that verbal communications that occur in promotional settings such as sales representative office visits and industry-sponsored dinner and speaker programs could be under scrutiny. In the current conservative environment, sales reps are careful not to discuss off-label use or overstate the efficacy of a drug. Now, glancing over the safety data in a sales aid or the Important Safety Information slide during a presentation is frowned upon, as it should be. However, the increased scrutiny by HCPs could deter sales reps from deviating from a predetermined script and they could lose meaningful conversations out of fear that they could misspeak or be misinterpreted, and subsequently be reported to DDMAC. It may be difficult for DDMAC to determine what was discussed in a private meeting; however, according to FDA officials, if there is systematic misrepresentation, FDA reviewers will be able to spot similar complaints about a drug coming from multiple doctors, which would signal DDMAC to investigate.

The question remains if HCPs will take the time to report anything they feel is misleading or inappropriate. Additionally, will this enhanced surveillance lead to increased enforcement? The FDA has gotten tougher on promotional materials developed by drug marketers. Issuance of enforcement letters is higher than it has been in the past, with 31 warning letters already issued by DDMAC through May 2010 (which is on pace to exceed the 41 letters issued in 2009 and tops the 21 letters issued in 2008). However, if a high volume of complaints arise, there are questions regarding how the FDA will be able to investigate and issue timely corrective action due to the limited resources within the FDA. Regardless, even if DDMAC enforcement is logistically problematic, the Bad Ad Program could be a deterrent and improved compliance to DDMAC regulatory principles on the part of the pharmaceutical companies is sure to follow.

From Ian DeMeritt, Senior Medical Writer, Palio

“What’s in a name? That which we call a rose by any other name would smell as sweet.” – Romeo and Juliet (Act II, scene II)

What if that rose didn’t have a name, yet claimed that it smelled sweet?

Late last week, DDMAC issued several regulatory letters to pharmaceutical companies, bringing the total number of letters it has issued so far in 2010 to 22, already topping the 21 letters sent in 2008. Of interest was a letter addressed to GlaxoSmithKline for an unbranded, single-page ad (also shown above) placed in the Journal of Clinical Oncology last December.

The simple ad announced that a “New Treatment Option for Refractory Chronic Lymphocytic Leukemia (CLL)” was “NOW APPROVED.” A footnote clarified the treatment was for CLL “refractory to fludarabine and alemtuzumab,” and a disease-specific Web-site address (www.cllinformation.com) and the GSK logo were included on the bottom of the page. That’s it. No efficacy data were included, no overt promotional claims were made, and no fancy images of happy people walking along a beach were present.

Most importantly, however, no safety information was contained in the ad, despite its unbranded nature.

Even though the name of the treatment was not provided, DDMAC considered the ad misleading because “the characteristics of the product promoted in the ad can only describe Arzerra,“ the only drug recently approved by the FDA to treat refractory CLL. Because the promotional material could only apply to a single product, the ad was effectively considered a branded advertisement requiring full disclosure of safety and risk information.

In our line of work, the response to what we perceive as unfair feedback from a client’s regulatory team is often jokingly along the lines of “can’t we just turn this into an unbranded campaign?” thinking that by simply removing the branding elements, the regulatory requirements will also magically disappear.

However, one of the important lessons to be learned from this letter is that a pharmaceutical brand comprises more than just a logo and color pallete. The totality of the message being conveyed must also be considered a key branding element, especially in the eyes of the FDA.

This latest DDMAC letter provides a useful reminder that failing to call a rose by its name doesn’t make it any less of a rose.

From Ian DeMeritt, PhD, Senior Medical Writer

As printed promotional materials are continually being replaced by flashier electronic detail aids and on-line content, it is not surprising that DDMAC continues to cast a regulatory eye on digital presentations of pharmaceutical advertisements. Last April, DDMAC fired a resounding shot across the bow of the pharma world that sent a clear message that it was well aware of the goings-on in the digital realm and that it meant to enforce on-line media as diligently as that in print form. The more recent FDA hearings on social media, the FDA’s new “transparency blog,” and the recently-launched “FDA basics” Web site demonstrate a growing commitment to their online presence.

The watchful on-line eye of the FDA was again demonstrated just recently when DDMAC warned 2 pharmaceutical Web sites for making false and misleading claims. While these new letters do not contain any new or groundbreaking information regarding DDMAC’s interpretation of the advertising laws as they apply to Web-based content, they do serve as a useful reminder of some pitfalls to avoid when designing Web sites for a pharmaceutical product. In addition to the familiar “Unsubstantiated Claims” castigations, warnings related to speciously presentated risk information were a key component of each letter.

Both products cited (Isovue and Visipaque) are intravascularly administered contrast media indicated for imaging of the cardiovascular system. Both product labels contain boxed and bolded warnings cautioning against a laundry list of severe and frightening risks including death, convulsions, cerebral hemorrhage, coma, paralysis, and brain edema, among others.

Despite these warnings, the GE Healthcare Web site describing Visipaque boasted an “excellent safety profile” and declared that it was “designed for patient safety and comfort.” The only risks listed on the Visapaque Web site were general cautions against blood clotting, thromboembolic events, and use in certain patients. While the Isovue Website (which presents the results of a head-to-head clinical study against Visipaque) did mention the possibility of severe reactions, the potential for fatal adverse events was not disclosed. This stark omission of important risk information did not escape the notice of DDMAC reviewers and these letters serve as a reminder that all relevant risk information, regardless of the implications to the brand, must be presented to balance promotional claims.

Furthermore, these letters reiterate that the placement and presentation of risk information is just as important in electronic format as it is in a printed piece. The Visipaque risk information was located at the very bottom of a long page of text, hidden below the references. Despite headlines heralding “Product Highlights” and “Product Description,” the risk information was not marked in any way to indicate to the reader that it was either present or important. Similarly, the risk information on the Isovue Web site was portrayed in a smaller font size than the promotional copy and without any headers to indicate its importance or presence.

It should be noted that both Web sites contained a link to the full prescribing information. However, as previous Warning letters have demonstrated, DDMAC is no fan of the so-called “one-click rule.”

While these new letters reveal no momentous changes in DDMAC policy concerning Web-based content, they do reinforce several lessons to keep in mind when creating, designing, reviewing, or reading pharmaceutical-based Web content:

Lesson 1. Safety Information must be clearly labeled as such and be given prominent placement on a Web page

Lesson 2. Risk information must be presented in a similar font size and appearance as promotional messages

Lesson 3. The FDA does not consider any pharmaceutical product with a boxed or bolded warning to be “safe” and any promotional messages to this effect are at risk

Lesson 4. All relevant risk information must be presented, regardless of how scary it might sound or the potential implications for the brand

Lesson 5. A “Please see…” line and/or a link to the PI is not sufficient to replace missing risk information

Lesson 6. The “one-click rule” is still dead