In The Twilight Zone 2013
The Caronia decision was excitedly hailed as a breakthrough for pharmaceutical marketing, but industry observers say as FDA continues business as usual, pharma companies are not changing their tactics – though the ruling could open the way for the industry to engage in online conversations.
When the U.S. Court of Appeals for the Second Circuit ruled that the off –label statements made by pharmaceutical marketing representative Alfred Caronia about the drug Xyrem were protected free speech, there was an excited flurry of commentary, for and against the pharma industry, and experts predicted that the decision was a game changer for pharma companies’ promotional efforts. Almost three months after the decision was handed down, however, healthcare ad agency leaders say they and their clients are still trying to figure out what the ruling means – and no one is doing anything differently in their marketing campaigns. With FDA officials publicly stating that the agency will continue to go after companies for what it believes is misbranding, it looks like things won’t be changing for quite some time.
Meanwhile, with healthcare organizations generating their own data about the effectiveness of drugs on the market, often establishing standards of care based on off -label use, the pharma industry has to remain silent even as debate about off -label uses expands online – another tricky area of involvement for pharma companies, with its corresponding lack of FDA guidelines.
Cautious And Quiet
Nick Colucci, president and CEO of Publicis Healthcare Communications Group and head of the board for the industry group the Coalition for Healthcare Communication, says the atmosphere in the wake of the Caronia decision is “complicated.”
“There are some that I actually don’t think know how to take it right now, and there are some that believe that very little will change in terms of how they act and in enforcement, and I guess that there are combinations of both, in that they are a little confused by it,” Colucci told Med Ad News.
Matt Giegerich, chairman and CEO of Ogilvy CommonHealth Worldwide, says the decision is massively important, and was surprising when it came out. However, “then you start to ponder what does it mean and what happens next, and it becomes a hell of a lot less clear than the decision itself,” he says. “The decision sounded emphatically clear, but it’s only a district that only affects legally those states in the district, and what will happen next is an open debate.
“The question of whether or not there will be an appeal, will it go to the Supreme Court, with the FDA eventually modifying their guidelines, and would their power be disintermediated because of the decision, all of those things are left completely unanswered, although as we understand it the FDA is letting it sit and not responding and letting it fade into the background while they keep doing what they’re doing. It is a very strange, uncertain moment considering how momentous it was when it was first announced and decided.”
Colucci believes that the decision will have an impact – eventually. “I think like always, when these things happen, there’s a heightened reaction that there’s a whole lot of ‘this can change and is unprecedented,’ and then people start to think about it and pull it apart piece by piece, and not, in the way that they act, see a huge impact on their day-to-day life until something profound in the marketplace beyond this happens, or whether someone will take the initiative at OPDP and places like that, where they’ll need to interact,” he says.
“From the 30,000 foot vantage, this decision creates potential risk for our industry,” says Jay Carter, VP of strategy, AbelsonTaylor. “The key to the credibility of our industry’s claims to both healthcare provider and consumer stems from the legitimacy offered by the FDA’s imprimatur. Reducing that credibility in any way opens up the potential for our credibility to be undermined. The reason for this is that claims not supported by a label can be perceived as misleading, something that is both illegal and bad for patient outcomes. I’ll refer you to PhRMA’s statement on Caronia: ‘truthful and nonmisleading’ – my emphasis – ‘communication between biopharmaceutical companies and health care professionals is good for patients, because it facilitates the exchange of up-to-date and scientifically accurate information about new treatments.’”
However, these three leaders are not seeing their clients doing anything differently.
“On a day-to-day practical level, I believe it is business as usual,” Carter says. “Communications to physicians and to patients rely heavily upon making relevant and believable claims about our brands, and the package insert is, and will remain, the core source for those claims. I believe that my clients will continue to base formal promotion to healthcare professionals and consumers on the package insert. I don’t believe that there is an appetite for very much risk in pharma today.”
“It will be interesting to see how it plays out, but for the moment, we don’t have a single client who has changed their belief set or approach or direction as a result of this ruling, not a single change,” Giegerich told Med Ad News. “And if you think about big pharma in total, many of them are operating under corporate integrity agreements in the U.S. as it is, so no one is gong to step out of line, they’re just going to have to wait until it plays out and try to keep themselves clear and clean in the process.”
Colucci agreed that companies will not want to stick their necks out, and agencies will not be leading the way. “Agencies have to follow along how their clients are going to approach,” he says. “Some clients who are already under these corporate integrity agreements, they’re going to be very cautious, no matter what.”
Carter theorizes that a certain kind of company may test the waters. “I think if anyone does stick their neck out, it will be a new company, with a single brand, who decides to try it because they have a lot less to lose,” he says. “You’re not going to see a major pharma do it.
A quick poll of the agency’s account directors showed that none of AbelsonTaylor’s clients are moving to take advantage of the implications off ered by the ruling, Carter says. “None of our clients are even remotely considering anything other than sticking to the label, sticking to the package insert, because that’s where there’s great confidence that you’re not going to misbrand,” he told Med Ad News. “I felt that way anyway. This is a very conservative business, it’s become even more conservative, and in some ways I think this is a little uncomfortable.”
Still, Colucci believes something will happen. “There will be something, there always is, with a ruling like this, once there’s a wedge, there’s going to be a couple of little taps on that wedge over time and the log will split,” he says. “I’m not so sure what that means, whether it will split for the positive or the negative, and I’m not so sure what the positive or the negative is, based on what your perspective is. But I do think the feeling many of the thought leaders in this industry have is something different has happened with this ruling, we’re just not sure what it is.”
Fda Still Holds The Hammer
The problem right now for any company wanting to test the strength of the ruling is that FDA, for all intents and purposes, is steadfastly ignoring the decision. At a conference last month, Tom Abrams, director of FDA’s Office of Prescription Drug Promotion, told the audience that the ruling does not challenge the agency’s enforcement ability. FDA has declined to appeal the case, and the ruling technically applies to just the states that the Second Circuit covers.
John Kamp, executive director of the Coalition for Healthcare Communication, fervently believes that something will happen to shake FDA into action to put together new standards on what can be discussed off label, but still be considered truthful and not misbranding or misleading. “It’s going to be multiple petitions to FDA to do something, they’re going to stay in the denial stage, and then it will probably have to take some court action to get them to do something. To them, the label is the label is the label, and anything that’s off the label is, in their perspective, false and misleading. But virtually no one else in the industry believes that, because many times off label use is the standard of care in a lot of areas.”
In a Webinar held by the CHC in January, Bert Rein, managing partner of the law firm Wiley Rein; Alan Bennett, managing partner of the law firm Ropes and Gray; and Mit Spears, general counsel of PhRMA, stated their belief that FDA will have to move to a system that will have to acknowledge that many unapproved uses have become the standard of care, and any companies truthfully talking about those uses should not be penalized for doing so.
Spears is “very anxious” to reach out and work directly with FDA on creating new standards for the industry, Kamp says.
Colucci and Giegerich believe that FDA will have to consider new standards because so many discussions about off -label use are happening online and so much data that will drive treatment decisions is being amassed.
“There’s so much data out there now, people pull it together, they are in many respects contextually ignorant about what the different pieces can mean,” Colucci says. “If they engage a company in a conversation about trying to better understand it, it’s almost irresponsible for a company to not respond or to say, I can’t respond.”
According to Colucci, it’s better for the consumer to have someone – either the company, or a physician going on the most recent information supplied by a knowledgable rep – to help them understand the data that they find.
As accountable care organizations and insurers start to compile usage and effectiveness data for marketed drugs, and the data direct more prescribing decisions and formulary coverage, pharma should not be barred from the discussions, so long as the data being discussed was generated in scientific, rigorous ways.
“You’ve got integrated health systems and large group practices coming together, and more and more powered by their own data,” Giegerich says. “Their future is not dependent on the clinical trial data, like the pharma companies. Their future is going to be dependent on their experiential data and their own outcomes data. They, for example, could amass their own formularies and protocols that say product X is good for this condition even though it’s not approved for that condition, because of their experience with thousands of patients, it is the appropriate first-line choice for the treatment of this disorder. And that is data invalidating some clinical pathway, but it has almost nothing to do with what the pharmaceutical companies are doing. T is again begs the question of who regulates what? Are you allowed to do anything you want if you’re not a pharmaceutical company? That’s a very strange position to take.”
Meanwhile, “The only one with a gag order is the one with the actual information” – the pharma companies that conducted the approval studies, Giegerich says.
Carter says discussing off -label use, even if the company is conducting its own studies and has good data and the best intentions, can be a pitfall. “For instance – say you have a great drug, with killer Phase II studies – how confident are you to have a rep have a conversation with a physician about that?” he says. “You don’t know if the dose is exactly right, and you don’t have Phase III powered support to know if it’s going to work or not. So what truth are you going to make that’s not misleading?”
Until everything is figured out, agencies will continue to do what they have been doing for years – getting the best messages possible out of the label data for promotion, he says.
“It’s gotten tighter, year after year, with CIA after CIA, but it’s still about looking at the label and figuring out what to say that is responsible to patients,” Carter says. “The good news for me is that 15 years ago I figured out that I felt a lot better when it was about patients. The people who are happiest in our industry focus on what’s good for patients. If you use that as your metric, you’re a lot better off.”