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Where you stand depends on where you sit

Thu, Dec 27, 2012 | Peter Pitts

From the pages of Medical Marketing & Media

The year ahead: A Capitol bit of crystal ball-gazing

Peter Pitts
president, Center for Medicine in the Public Interest,
and a former FDA associate commissioner


Will the federal appeals court's decision in US vs. Alfred Caronia result in thin-to-no regulation of off-label marketing?

PP: When it comes to Caronia, where you stand depends on where you sit.

For industry, the decision opens up tremendous potential for enhanced (but restrained and responsible) sharing of important scientific data. For the FDA (understandably) the decision was the Nightmare Before Christmas. The question is, do the opportunities outweigh the risks? There are a few ways to approach this.

There's the First Amendment question. While I can't predict which way a Federal Appeals court will rule, I will certainly predict that Caronia will impact the way FDA views off-label promotion within the context of the free-and-fair dissemination of scientific data. I believe a new (and hopefully more enlightened) FDA view based on intent will arise. Alas, that will not assuage any of the ambiguity that is currently driving FDA (OPDP) communications oversight. That being said, any revisitation and discussion is for the better.

Another way to look at it is that, if Caronia stands, pharmaceutical companies will no longer feel obligated to seek FDA approval for new indications, since they can openly "promote" them without fear of prosecution. This is a flawed argument. Indications of the on-label variety have many benefits—not the least of which is reimbursement. But such negative unintended consequences are important to discuss and consider. IMHO, any company that chose this route would be acting in a highly irresponsible manner, putting promotion before the public health.

The third, most important and most contentious angle is to consider whether or not such relaxed communications approaches would actually advance the public health. Would industry (on one side) and the FDA (on the other) answer this differently? I'm not so sure.

All that being said, whether or not the Appeals Court overrules Caronia, it is likely to offer a stern rebuke to the FDA for its unpredictable, ambiguous and sometimes capricious application of off-label speech constraints.

Considering the hazy regulations, what will it take for pharma to engage in more digital dialogue with patients?

PP: Social media for regulated industry is a wonderful green field of opportunity. But to maximize the opportunity, we must accommodate the reality of a messier world. Social media, almost by definition, is messy—and the regulatory framework (or lack thereof) is equally so. And it's not likely to get much better. Get used to it. Embracing social media means embracing regulatory ambiguity. And that's a paradigm shift for an industry that has (in a post-Vioxx world) been going in precisely the opposite direction. It's not going to be easy, or risk-free, or inexpensive. And whatever social media “marketing models” companies build will have to be elastic—just like the media environment in which they are designed to operate. Pharma, guide thyself!

Will we see big movement on online privacy regulations? Or elsewhere impacting advertising and promotion?

PP: Just because DDMAC got a “promotion” to OPDP doesn't mean that (1) they have any more resources (they do not) or authority. The FDA must still abide by the First Amendment, and they are acutely aware of the limitations that that places on their regulation of industry speech. That's one of the reasons they have been so prudent in their statements and guidances regarding social media. They will continue to address advertising and promotion with one major goal in mind—to make sure industry efforts are neither false or misleading. Alas—the truth is that the definition of those terms is often in the eyes of the beholder.

Will the year bring greater regulatory clarity? Or will FDA, CMS, et al. kick the can down the road again on Sunshine, etc.?

PP: The Sunshine Act is a mess. First, HHS will have to determine how various state laws will impact one federal statute. Will the administration invoke federal preemption? And, if so, what will they put in its place? Also, why aren't payments to physicians from insurance companions included in the Sunshine Act? This will be debated and will further delay (and appropriately so) swift implementation. When it comes to the Sunshine Act, it's best to measure it twice and cut it once.

Will FDA keep inching the drug approvals window open with the economy improving and executive leadership no longer in doubt?

PP: Will she stay or will she go?  I predict that Commissioner Hamburg will stay. That's a good thing because what moves drug approvals ahead is predictability and that starts at the top. The solution is to make the regulatory process more predictable.

For all that modern science has to offer, developing new treatments is still very much an art, in which hunches, intuition, and luck play a critical role. The odds are long. But for more medicine that is affordable and innovative, we need up-to-date regulations that complement the drug trial process in order to take these chances, which is precisely the mission of the FDA's Reagan-Udall Foundation.

What provisions of the Affordable Care Act will cause the most disruption—positive or negative?

PP: The ACA greases the skids toward government price controls through both the IPAB and the Patient-Centered Outcomes Research Institute (PCORI). Through these two new bodies, Uncle Sam is morphing into not only Uncle Sam MD, but also Uncle Sam as our nation's largest payer, as funder of comparative effectiveness research, as “academic” detailer of what's best for patients, and as determiner of Essential Health Benefits. What's also interesting is what President Obama wants to remove from the ACA—specifically, the 12 years of exclusivity for biologics. Will the President continue to push to roll that number back to seven years? Will he have the chutzpah to claim he is pro-innovation if he does?

The full article can be found here.