Pharma: Where Innovation Comes with an *Asterisk

All the buzz from SXSW Interactive this week -- plus this NPR article about Facebook COO Sheryl Sandberg -- got me thinking about innovation in the pharma industry.

Per the article, apparently there are posters around Facebook's headquarters that encourage employees to get things done. To take risk. To fail:

"Move Fast and Break Things"

"Done Is Better Than Perfect"

"Fail Harder"

"What Would You Do If You Weren't Afraid?"

One may have questions about if these mantras have really worked for Facebook as a company.

But I love the spirit of them, and the idea of them plastered around the walls as motivation. As an agency whose motivation IS innovation, I can see how these daily reminders help drive people to think differently. To ask the tough questions. To steadily, relentlessly seek solutions. Even if it means bucking the status quo.

Which got me thinking about the inherent dichotomy of innovation and the pharma industry.

• Imagine if, while composing an NDA submission for a major new compound, the submission team took the approach of “done is better than perfect.”
• What if a rogue marketer decided “to hell with FDA regulations” and instructed his promotional team to “move fast and break things.”
• Are pharma CEOs – nervous about what healthcare reform could mean to their bottom lines – telling their companies to “fail harder?” I think not.

But we have seen innovation happen in the industry. We have seen changes taking place. Even failures in the industry are a step forward, because from those failures come information and learnings. We live in a modern society, after all, with life-saving medications that would not have come to fruition if not for countless failures in the labs.

I encourage you all to keep moving. To take risk. To fail harder and faster.

Within the pharma industry, for better or worse, these mantras come with an asterisk:
* Innovation must not come at the risk of patient safety.
* Innovation must not come at the risk of corporate responsibility or ethics

Did I miss any?

Facebook is one thing. Human health is another. But I choose to live in a world where I believe  innovation is possible anywhere.

FDA Targets Website Search Results

In case you missed it, an FDA warning letter issued late January addressed the issue of how website searches associate keyword searches with search results. In other words, when a visitor to a compnay's website searches the website for a certain condition such as cancer or diabetes, if a product name displays in the results, then this is an implication that the product treats that condition. According to FDA, the company that owns the website can be liable for this association.

The letter was issued to “MDR Fitness Corp,” a vitamin and supplements company that, according to its website, applies “the latest discoveries about nutrients and how they benefit the human body.” MDR, by the way, stands for “Medical Doctors Research.” The warning letter cited additional problems such as a failed facility inspection, the promotion of supplements for conditions which cause the products to be drugs, and overstated personal testimonials.

Buried in the letter – but highlighted by this article from Forbes– was this information:

“ … typing the key word “cancer” or “diabetes” into your product search field located on your website brings up your product lists to include Fitness tabs for Men, Longevit – E and others, implying your products are intended for use in the diagnosis, cure, mitigation, treatment or prevention of such diseases. Your products are not generally recognized as safe and effective for the above referenced uses, and therefore, the products are “new drugs …”

The site search at MDR.com is still active, but the offending search results seem to have been disabled. The site, after all, is an ecommerce site for the company and likely a revenue generator. It’s not known if the website search functionality was custom-built (and therefore strategically manipulated) or driven dynamically by a tool like Google, but it raises an issue that, to my knowledge, hasn't been addressed by FDA in the past: Are companies liable for the way every single possible search result displays on their site? If so, this could be problematic. What if, for example, a search for the word "infection" yields results with a link to product prescribing information that warn patients NOT to use the product if they have an infection? Is the mere association of the condition or symptom with a product name enough to imply a claim?

The Forbes article headline reads, misleadingly, “FDA Regulates Internet Search” This was NOT a warning letter related to Internet search engines such as Google or Bing. (However, if you’re new to the pharma marketing landscape, a slew of letters related to search engine marketing have been issued by FDA in the past.)

MDR is not a pharmaceutical company. And I can say that clients I’ve worked with would not even consider manipulating a search so that over-hyped claims or off-label information appeared with certain searches. If you read the letter, MDR Fitness was clearly operating in a manner well outside the realm of FDA law in a number of ways.

But there certainly can be implications for pharmaceutical and medical device companies. Site search functionality is an important component for a positive user experience, especially on content-rich sites. On-site search shouldn't be an afterthought.

What search tools do your websites use? Even if the results are dynamically generated, have you tested the various combinations?

If not, it might be time to take a gander.

Did off-label promotion just become legal?

On Monday, a court in New York ruled free speech prevails over off-label discussions.

Wait. Whaaaaaat?

It was this news nugget that prompted friend and compliance/regulatory attorney Darshan Kulkarni of Kulkarni Law Firm to tweet this to me:

What happened? A summary

On Monday, a federal appeals court in New York threw out the conviction of a pharma sales rep for promoting off-label use of a prescription drug. The court found the sales rep’s First Amendment right to free speech had been violated. Judge Denny Chin wrote:

"In the fields of medicine and public health, where information can save lives, it only furthers the public interest to ensure that decisions about the use of prescription drugs, including off-label usage, are intelligent and well-informed.”

The ruling essentially follows the notion that "The more information available to everyone, the better. If physicians can discuss alternative uses of drugs, others should be able to do the same.”

So far, not surprisingly, FDA has not commented on the ruling.

Darshan and I co-presented in September on the topic of FDA's recent guidance, "Responding to Unsolictied Requests for Off-Label Information About Rx Drugs and Medical Devices." Back then, and to his credit, Darshan predicted this to happen, referencing the IMS Health v. Sorrell case where a Supreme Court decision stated the governement cannot limit free speech.

Interestingly, Darshan expects it's this sticky issue off-label promotion that is precisely the reason FDA is holding off on providing social media guidance. If off-label promotion is protected by free speech, then they have to go back and look at everything all over again.

“To be clear, this isn’t law of the land, just of that specific jurisdiction,” he wrote to me in a tweet Monday. It “will likely involve some negotiation. But (this) will have HUGE implications.”

[If Darshan, an attorney, were writing this blog he would insert some legal disclaimers here as reminders that this is not legal advice and this does not setup an attorney-client relationship :-) ]

 

What does it mean?

What does this mean for FDA? Essentially, they’re in a pickle. Forbes sums it up this way:

“This appellate decision, if it stands in the long-run, forces the FDA into a corner. It must either grant greater leeway for pharmaceutical manufacturers to market off-label uses of their products or restrict the ability of doctors to prescribe medications for anything other than agency-approved uses, an approach it has been loath to take.”

I'm not a lawyer, but Darshan is. And he pointed out to me that this last part isn't exactly true. FDA can't regulate physicians' prescribing of medications because they are instead regulated at the state level - by the state Boards of Medicine. Either way, FDA is in a bit of a bind.

What does it mean for patients? That likely depends on whom you ask. Empowered, informed patients comfortable with their physician relationship and their/their doctors' decision-making abilities may welcome the opportunity for more free speech around alternative uses. There are many drugs that are regularly prescribed off-label, providing valuable treatment and relief. Of course, there is tremendous mistrust of this industry. Some patients understandably may not like the idea of pharma reps and marketers having a quintessential "free for all" when speaking around product use and safety. And some pharma company representatives may not handle this new freedom wisely or responsibly. It really comes down to who has the most influence and decision-making power in each pharma-physician-patient dynamic.

What does this mean for pharmaceutical companies today? Will it embolden them to begin regular and blatant off-label promotion? That's not likely, given the billions in settlements various companies have paid FDA for off-label promotion in recent years (though those settlements themselves may be called into question). Perhaps the aversion to risk will be somewhat lifted. But most likely, it will come down to how much a company stands to gain or lose. And again, if history is any indication, that could be billions.

If any change is to come from this, I expect it to be slow. It’s definitely something to keep an eye on. And this is just one court's decision. Future decisions for similar cases, as well as escalation to the Supreme Court, may further solidify the situation one way or the other.

It may eventually open up more ability for pharma companies to communicate about their products.

It may also just tie up any further FDA marketing guidance in a legal quagmire.

Additional headlines and perspectives

• Forbes: Appellate Ruling Exposes Long-Running Tension In Pharmaceutical Regulation
• Pharmalot: What The Off-Label Ruling Means: Piety Explains
• Reuters: U.S. Court Voids Drug Rep's Conviction, Cites Free Speech
• New York Times: Ruling Is Victory for Drug Companies in Promoting Medicine for Other Uses
• Pharmalot: Free Speech: Off-Label Conviction Overturned
• Medical Marketing & Media: Court says off-label decision against Jazz rep ran afoul of free speech protections
• John Mack: What's at Stake in the Off-Label Promotion Debate: It's NOT Free Speech!  

Special thanks to Darshan Kulkarni for his opinions and insights for this post. Visit his firm's website for information on how to contact him for more information, or reach him on Twitter at @FDALawyers.

Pharma's First Branded Facebook Ad?

I was goofing around on Facebook last night when I noticed what looked suspiciously like a branded pharmaceutical advertisement:

It was indeed an ad for Axert, a Janssen migraine treatment, and one click took me to the home page for Axert.com. It's possible I'd "liked" a  migraine page on Facebook in the past and that's why it was targeted to me. (I "like" a lot of pharma/health-related pages on Facebook; my friends must think I'm a hypochondriac.)

I've noticed ads on Facebook that recruit for clinical trials, unbranded ads promoting pharma-sponsored Facebook pages, and other unbranded mentions, but this is the first branded Facebook ad that I could recall. Have you seen any others?

A colleague asked about the risk of this ad ending up on a page that mentioned the indication (migraine), and if that was a problem because the ad didn't include fair balance. In my mind, that equates to many display ad purchases available today for WebMD and other condition-related sites. I've never seen FDA give a warning letter for that. However, I do know companies have shied away from branded ads in social spaces because they see places like Facebook as "the Wild West" ... where anything could happen. The branded ad could appear next to a user-generated overstated claim, a comparative claim, or any number of other "violations" that patients unknowingly state about the drugs they use.

FDA pays attention to what is and is not within the control of the pharma company when they engage in promotional activity. Janssen has clearly decided that this is a safe thing to do, and they're putting money behind it. Whether Facebook ads work at all is a different question. And whether consumers will welcome pharma advertising in their stream alongside kittens and kids is yet to be determined.

The question was also raised in discussions here at Intouch... if the ad doesn't have the indication/condition, why would anyone even click on it? Of course, I clicked out of curiosity. But we can't count on those outside the industry to do the same. Janssen must be hoping for some level of awareness to already be in place.

Janssen is not a client, so I can't speak to any decisions made behind the scenes. But I applaud their branded move into the social space. It's crazy to me that it took this long for someone to try it. This industry always needs more trailblazers willing to take a chance!