Quick. Word association. What are two words from the FDA that healthcare marketers and communicators almost universally fear and dread?

The answer: Warning Letter (but I’ll admit “not approved” is also at the top of the list!)

For those unfamiliar, the FDA, and in this case the Office of Prescription Drug Promotion (OPDP) issues warning letters when a company or organization insufficiently or inaccurately communicates a medical product or device’s benefits and risks. This includes not fully describing the side effects associated with a product or using language or visuals that imply a product treats a certain condition which the FDA has not approved. A warning letter is what it sounds like; a cautionary notice – “Strike 1” to use a baseball analogy – from the FDA that a company should consider revising its communications to avoid enforcement action.

Of course, Warning Letters can be viewed through different lenses, with the chance for confusion. It’s like the batter who thinks he’s received ball four when the umpire calls strike 3. Different interpretations and views of the information, and the warning letters themselves, in healthcare communications can seriously impact future marketing efforts much like disagreements over the strike zone can affect a game’s outcome.

Luckily, the FDA does not issue warning letters without explanation or allowing for questions. Today at 11:30 a.m. ET, the OPDP will host an Enforcement Webinar that lets viewers directly communicate questions on Warning Letters and Untitled Letters November 2012 through March 2013.

During this time, the FDA issued six Untitled Letters for misleading claims about the efficacy or risks associated with products treating a variety of diseases and conditions.

Here are the three questions that I’d like the OPDP to answer today:

  • Looking forward, do you have a sense of particular areas of concern when it comes to trends you’ve seen with drug promotion? For example, are you seeing more violations in terms of overstating efficacy claims or understanding potential risks?
  • There was only one online letter dealing with a company’s web site and podcast. What are your primary concerns regarding potential violations on digital platforms? Where do you see the biggest risk for sponsors?
  • How do you plan to include the information you’ve used for these Untitled Letters in whatever policy FDA eventually issues regarding social media promotion?

I’ll be live-tweeting tomorrow’s meeting using the hashtag #FDAletters. Please follow along and look for another update on this blog later this week. And if you have additional questions for the FDA, please leave them in the comments section. I’d love to see them.

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NextWorks’s Matt Snodgrass speaks with Chris Iafolla, Director at Twist Marketing, about the recent guidelines issued by the FTC regarding clear disclosures in advertising. This updates existing rules that have been in place for more than 10 years and now broadens the scope to cover social media and smartphones.

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For watchers of the U.S. Food and Drug Administration, the question of whether a new year will bring solid social media guidelines has become as much a part of December as peppermint bark and “Grandma Got Run Over by a Reindeer.” So will the FDA act in 2013?

In November, the answer was “yes”: “The Office of Prescription Drug Promotion (OPDP) has placed developing social media guidance at the top of its work plan for 2013, director Thomas Abrams says.” (Drug Industry Daily)

In August, the answer was also “yes”: “Social media ‘high priority’ for FDA 2012, despite lack of 2012 guidance.” (Scrip)

In June 2011, the agency said it was poised to act: “Tom Abrams, director of FDA’s Division (soon to be Office) of Drug Marketing, Advertising & Communications (DDMAC), said that publishing social media guidelines for industry is the division’s “highest priority.” (PharmaExecBlog)

The FDA said it was ready in March 2011, too: “Policy and guidance development for promotion of FDA-regulated medical products using the Internet and social media tools are among our highest priorities.” (FDA email)

And two years ago, in December 2010, guidance was imminent: “Our goal is to issue one draft guidance that addresses at least one of these topics during the first quarter of 2011.” (FDA email)

Of course, this was all kicked off in November 2009, when the agency held a two-day meeting on social media that was capped by a firm commitment to come up with rules: Social media guidelines are “important and we will do it.” Tom Abrams, Director, Division of Drug Marketing, Advertising, and Communications (FDA Public Meeting, page 450)

I don’t mention the historical record to suggest that 2013 won’t be the year where some pressing questions are answered (though the agency is working against a summer 2014 congressional deadline). Clearly, whatever the communications concerns that prompted the original FDA meeting in 2009 have only grown more clear, and some sort of action will come, either dramatically or more gradually. But, as the past few years shows, the tea leaves remain hard to read.

So what should companies be doing in the meantime? The advice remains almost unchanged from what we were suggesting two years ago: move quickly — and cautiously — to build up social media chops in corporate and unbranded spaces, improve online monitoring and work to understand and engage with the new leaders in social media. And if you need help with that? Well, we’re standing by. Drop us a line.

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Early this week, Scrip published an article that notes that the FDA still considers social media a “high priority,” even though the agency’s working list of topics in need of additional guidance hasn’t included social media in a couple of years.

It’s tempting to say that the FDA’s continued commitment to more explicit rules really doesn’t matter. At WCG, we’ve been consistent for years in our belief that no company need wait for the FDA before wading into social media. There are well-established, safe ways into interact online, and the simple act of setting up a blog or responding on Twitter is no longer causes eyebrows to arch or tongues to wag. (For an excellent example of how one large pharma company — that happens to be a client — is plunge ahead, check out Fast Company’s examination of Sanofi’s efforts.)

That doesn’t mean that there haven’t been consequences, and I outlined some of them last December. But most of my concerns from last year have been allayed, in part, by the rising number of successful case studies and trial-and-error advancement made by the pharma industry in moving forward (cautiously), even without rules.

But one of the consequences I didn’t talk about then was the impact of the FDA’s inaction on smaller companies: organizations that don’t have the legal support or regulatory know-how to test undefined waters. Though pharma is sprinting ahead in its exploration of this space, biotech companies remain laggards, and the smaller the company, the more resistance there is to implementing social media platforms without some sort of solid direction from the FDA.

Increasingly, these are the groups that need guidance the most: more and more of the important conversations — among patients, among investors, among doctors — is taking place online. And while my colleagues at WCG can certainly present options and show how others have done it safely, there is no stack of case studies high enough to outweigh the positive impact of FDA action.

So this week’s news that the FDA still “committed to this area in terms of both time and human resources”, could mean good things around the corner. Especially for those who need it the most.

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“The Secretary shall develop and implement strategies to solicit the views of patients during the medical product development process and consider the perspectives of patients during regulatory discussions.”

That’s one of the final lines of Senate bill 3187, which passed the Senate 96 to 1 yesterday, and is expected to easily pass in the House. The bill is also known as the “Food and Drug Administration Safety and Innovation Act” or — more importantly — PDUFA V, the fifth installment of the early-1990s regulatory change that forever altered the Food and Drug Administration. It’s an important line, and this is an important piece of legislation. Here’s why:

PDUFA, the Prescription Drug User Fee Act, was first passed in 1992 and it set up the drug regulatory system we have today: companies pay “user fees” to the government, and the FDA works to review drugs in a timely fashion. The initial law had a revolutionary effect, ramping up approval times and changing the FDA from a plodding bureaucracy, often behind the rest of the world in approving new products, into a far more efficient regulatory machine.

PDUFA must be renewed every 5 years, and each iteration has brought subtle changes. The last two iterations focused on making the agency more safety-conscious, boosting the agency’s funding to spot unexpected adverse events. But this go-round, the focus has been on making the agency more patient-centric.

It’s not just that the FDA will start implementing “strategies to solicit the views of patients.” They’re changing the rules to bring drugs to populations with serious and life-threatening diseases, bringing a regulatory pathway already in place for cancer and HIV drugs to a much broader group of diseases.

While the specifics of the bill will no doubt change the way that industry interacts with industry, the explicit inclusion of patients should be of more general interest to those of us in health communications. It is yet another acknowledgment of the welcome trend of ensuring that patient voices are a part of the dialogue around public health.

Just as medical meetings and others are beginning to recognize the importance of the patient perspective, the FDA will also be amping up the attention they pay to this hugely important group. That means that communications firms and companies that ignore what patients are saying will be depriving themselves of counsel that will be informing the direction of modern medicine. And while building relationships between patients and industry is not without issues (many of which were discussed at the “Friending Pharma” SXSW panel), such issues must be addressed head-on to ensure open communication between every part of the health care system.

Because we know the FDA will be listening. We cannot afford to do any less.

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Imagine, for a moment, that you are a cancer patient in an examination room. Your doctor enters and tells you that there are two treatment options. One assures you of 18 additional months of survival, but no more. The other will either extend your life by 3 years, or not at all. Which option do you choose?

In most areas of life, people opt for the sure bet. Approach someone on the street and tell them you’ll hand them $150 — or let them flip a coin, double-or-nothing — and they’ll take the $150. But when it comes to cancer care, a survey of cancer patients found that 77 percent would take the 50/50 gamble on getting three extra years of survival, according to research in the latest edition of the journal Health Affairs.

While the paper delves into detail on why, exactly, we seem more likely to take what the authors call a “hopeful gamble” (patients with short life expectancy may feel that they have less to lose), the results are important to health communicators for another reason: it gives insight into the way that patients themselves want to choose treatments, and how patients view statistical descriptions of a drug’s effectiveness.

In the hypothetical presented in the Health Affairs paper, both of the fictional drugs had exactly the same median overall survival: 18 months. From a strictly statistical point of view (and from the point of view of the U.S. Food and Drug Administration), the two medications are identical, despite the fact that deaths are clustered in two vastly different ways. But just because they are indistinguishable to the statistician does mean that a patient would see no difference. Indeed, patients in the study said that not only did they prefer taking the hopeful gamble, a quarter of the breast cancer patients surveyed said they’d be willing to pay an extra $90,000 for the opportunity to flip the coin. The value of the gamble far outstrips that of the safe bet, for the patient anyway.

It’s a reminder that though it’s important to talk about median survival, which remains the gold standard for regulators, we do patients a service when communication about a drug’s efficacy includes other metrics, such as the percentage of patients alive after a given number of years, that might help quantify how much hope is built into those survival statistics. With that need for additional information comes addition responsibilities — patients examining a hopeful gamble need to understand the consequences when the gamble doesn’t pay off — but it’s clear from the Health Affairs paper that patients value that information. Our job, as communicators, is to make sure they get it.

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Here at WCG, we’ve long been advocates for the idea that biopharma companies should not wait around for the Food and Drug Administration to codify super-precise social media rules before using new technologies. While there are some specific points of clarification that the agency would vastly simplify our lives, there is no question that a convention wisdom has emerged that points to a safe way to engage on social media.

But it’s one thing to talk about “a conventional wisdom,” and quite another to specifically detail an emerging set of best practices. We have created our own set of next practices (contact us to learn more), but — increasingly — the areas of consensus are becoming publicly outlined with more precision.

One of the notable attempts is coming out of the Digital Health Coalition, a non-profit that counts industry, patients, docs, tech companies and others among its membership. Earlier this month, they outlined seven “Guiding Principles” for how regulated health care companies should approach social media.

None of the seven principles are particularly edgy: They call for companies to be transparent and forthcoming with information and they note the importance of reporting adverse events and correcting misinformation. They make clear that companies shouldn’t be responsible for information they didn’t create or control, and they encourage a patient-centric approach to online. But the lack of an edge is exactly the point. This defines the common-sense approach to online social media use by biopharma.

The “Guiding Principles” are not a detailed road map. At fewer than 225 words, the document is a 30,000-foot view at best. But it gives everyone — including, I hope, the FDA — a starting point to build from. There’s no question that biopharma is behind when it comes to digital, but the industry pioneers have closed the gap quickly. And with more attention and more collaboration, the digital revolution will only pick up more steam, FDA or no FDA.

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This Groundhog’s Day, Punxsutawney Phil saw his shadow, suggesting the unseasonably warm season might be taking a turn for the frigid. Nowhere has it been hotter this year than in the life science industry, which saw blazing Food and Drug Administration approvals of a handful of new, game-changing drugs. But unlikely the weather on the Eastern seaboard, it’s unlikely that the groundhog will bring a big chill to biopharma.

What made January extraordinary for drugmakers was not merely the speed with which the FDA acted (at least two were approved well ahead of the agency’s deadlines), but the fact that the highestprofile of the major approvals came in so-called orphan diseases, which affect less than 200,000 patients and can afford developers additional market exclusivity.

The trend of serving smaller patient populations with more targeted drugs is almost certainly going to increase, thanks to better technology and an better-understood business model for serving smaller groups. The best evidence for this the number of drugs for which orphan designation was granted. For years, this number hovered in the double-digits. Then, in 2004, 133 drugs were given orphan status. Last year, 199 made the cut. If the trend holds, we’ll top 200 in 2012. (See chart.)

And this is a leading indicator: many of these drugs are years from getting an FDA nod. But the number of approvals is rising, too. A record number of orphan indications — 26 — got FDA approval last year, and it’s not a stretch to think that that number will rise, too.

The race to explore orphan indications marks a fundamental shift in the way breakthrough therapies are introduced. The number of drugs that are aimed at populations of millions and millions are shrinking. And while we won’t see the end of primary-care-driven blockbusters, they will certainly become more rare. That’s going to mean a move for those in communication to get closer to the smaller patient and provider populations: less flashy celebs, fewer DTC ads, more emphasis on trade publications and narrow online communities.

It’s always dangerous to make large conclusions out of a few data points. Regression to the mean means that it will get cold again. And the FDA isn’t likely to have many weeks where they sign off on three new drugs. But the surging number of orphan designations means that — over the long term — the orphan drug climate is likely to stay hot, no matter what the groundhog says.
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The Food and Drug Administration, last week, pushed out guidance on how companies may respond to inquiries about off-label use of marketing drugs and devices, reaffirming a policy that’s been in place for at least a quarter-century. The document includes a discussion of a number of different arenas in which information in shared, including online outlets. **

As a result — in a fitting reflection of how starved people are for rules governing the use of new media technology – the document has been widely referred to as the FDA’s “social media guidance.” AdAge’s headline called them “Social-Media ‘Guidelines” in a widely cited piece. Slate’s headline used “Draft Guidance on Social Media.” FiercePharma’s headline talked about “sharing in social media.”

Though the excitement is forgivable, the headlines are not quite right. None of the larger philosophical questions about social media were addressed. None of the impacts of FDA inaction I wrote about last month have been ameliorated. It’s hard to imagine any large-scale changes in approach based on this document. Indeed, to the extent that the new guidance is helpful, it is in codifying a set of policies that are already in place.

What the FDA published last week is not social media guidance. It is merely guidance that mentions social media, or — in FDA’s parlance — “emerging electronic media.” It uses the words “YouTube” (once) and “Twitter” (once) and “blog” (once). The lack of ambition was skewered by former Merck policy guru Ian Spatz, who called the document “a belated lump of coal” on Twitter.

But even if the guidance doesn’t change the rules on social media, there is reason for optimism. The FDA is clearly conversant in digital media strategies and the new rules suggest an understanding of the way that companies are operating in the online space. When it comes to the narrow topic of unsolicited off-label communication, the agency did a thoughtful job of including a broad range of potential communication scenarios, from YouTube contests to public medical meetings. If all future guidance is as inclusive, we’ll begin to see the outlines of a coherent communications framework. Eventually.

Of course, the alternative is that the FDA could pull back the curtain on that framework even faster. Now that would be headline-worthy.

** WCG clients: We’ve done a brief analysis of the implications of the new guidance for both real-world and on-line communications. Please talk to your client partner if you’d like to learn more.

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