Conversations between pharmaceutical sales reps and physicians are now tightly controlled experiences. Interactive visual aids and other tools are linear and highly structured trajectories, designed to ensure reps stay within the letter of the law, and in no way deviate into “off-label” territory. But the boundary between the sharing of FDA-approved clinical information about a drug and additional research can become ambiguous and confusing, especially when outside experts are used to consult, and physicians already routinely prescribe drugs outside their approved indications.
Further complicating matters, a recent decision by the Second Circuit Court of Appeals of New York could have profound implications on how pharmaceutical and medical device companies market their treatment options. By designating off-label marketing as “protected free speech,” the boundary between regulated and unregulated content has become ambiguous, opening the door to increased opportunity but also heightened risk. So let’s take a look at this landmark case, discuss implications, and speculate about its potential impact on digital health.
The Caronia Case
Back in 2005 a sales rep for Orphan Medical, Inc. filed a whistleblower lawsuit against her company, alleging off-label marketing practices. The government then conducted a sting operation, recording a rooky rep named Alfred Caronia discussing unapproved uses of the drug Xyrem. Indicated only for the treatment of certain cases of narcolepsy, Caronia instead promoted the drug for conditions including insomnia, fibromyalgia, and Parkinson’s. Icing on the off-label cake, Caronia also suggested its administration for an unapproved patient population below 16 years of age. Soon afterwards, the government filed charges against Caronia, a paid speaker bureau physician Dr. Peter Gleason, a sales manager David Tucker, and Orphan Medical itself, since acquired by Jazz Pharmaceuticals.
So far so typical a case, but at this point things got interesting: Within two years Gleason, Tucker, and Orphan Medical all pleaded guilty to felony charges, and Jazz Pharmaceuticals paid $20 million and entered a corporate integrity agreement. Caronia, however, who was represented by a smart attorney fresh out of law school, pleaded not guilty, his defense based on First Amendment grounds. Their argument was essentially this: The rep-to-physician communication was indeed “off-label” in terms of going outside approved indications for Xyrem, but as a citizen of the United States of America, Caronia had the right to share additional information about the drug and its use as he saw fit. Not a word Caronia said on tape was in any way false, deliberately misleading, or scientifically inaccurate. Besides, speaker bureau physicians such as Dr. Gleason routinely discussed additional uses for the drug, which were all substantiated by peer-reviewed studies. So why couldn’t a sales rep?
Caronia was nonetheless convicted, eventually leading to the next and most interesting part of this legal odyssey: The recent granting of his appeal by the Second Circuit Court of New York, one step short of the Supreme Court. The arguments used by the court are fascinating, citing how off-label information is permitted to physicians, clinicians, researchers, and others, while pharma companies and reps do not have these rights; how off-label conversations are technically legal when not false or misleading; and how the legality of physicians prescribing drugs off-label make prohibiting their promotion by pharma companies ineffective or only remotely supportive of the government’s purpose. Long story longer, the court finally and quite surprisingly concluded, “that the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA (Federal Food, Drug, and Cosmetic Act) for speech promoting the lawful, off-label use of an FDA-approved drug.”
Great summary of the Caronia Case on The American Law Journal, featuring host Christopher Naughton moderating a panel discussion.
Taken at face value, this ruling could bring down the traditional firewall between off-label and formally approved drug content. The mission of the FDA is to “protect the public health by assuring the safety, efficacy and security of drugs, biological products, medical devices, etc.” The agency does so by approving only those drugs that have gone through a systematic and robust series of clinical trials designed to help ensure their efficacy and safety for a particular disease state and patient population. Countless other peer-reviewed clinical trials are conducted in parallel and outside the auspices of the government, nonetheless considered truthful and scientifically accurate; according to the Caronia ruling, these adjunctive studies could also be discussed with physicians during sales calls by pharma reps exercising their First Amendment right to free speech.
Researchers and advocates have for decades discussed the many inherent problems with how drugs are created, approved, and marketed. Central to the challenge is the current system surrounding clinical trial methodology, recruitment, filtering, and relevance. Some allege that by enabling a more open, broader discussion of off-label uses many of these challenges can be addressed; at the very least, some assert that offering healthcare professionals and their patients additional treatment options is in the best interest of public health. Conversely, however, unabashedly opening the door for the manufacturers and distributors to participate in these “off-label” conversations exacerbates the potential for conflict of interest and even the manipulation of data. Clearly a line must be drawn, but where, to what extent, by and for whom?
Meanwhile, pharma and device marketers strictly uphold the letter of the law, at least as currently understood and interpreted. Any form of branded content, whether a sales rep script, point of care interactive visual aid, product website, CRM program, or the like is subject to vigorous scrutiny, each going through numerous rounds of legal and regulatory review before being approved and released to the audience. But the repercussions of the Caronia case could go well beyond what sales reps are or aren’t permitted to discuss at the point of care—if reps could conceivably be allowed to exercise their First Amendment rights and discuss off-label topics with physicians, then what, technically, could preclude pharmaceutical companies from doing the same, and through multiple if not all channels of communications available to them, including and especially digital?
Digital Health Post Caronia
The digital channel has proven to be both rife with opportunity and plagued by challenges for pharma marketers. Engagement is off the charts, especially in social media—but adverse event reporting and reputation management have so far precluded active participation. Mobile is sweeping the world off its desktops—but the smaller screens create unique problems for presenting fair balance information and introduce a slew of privacy concerns. Even such basics as pay-per-click advertising remain problematic, as the inherent space limitations preclude brand names to even appear with the indications they treat. And let’s not forget video and multimedia, so perfect for education and outreach yet equally problematic in terms of safety information, transparency, and content repurposing…
The more one thinks about the Caronia decision the more it could transform pharma and device marketing, especially within digital. If “free speech” becomes a right that supersedes the FDA prohibition of sharing off-label information, then the doors to two-way dialogue, user-generated content, and social networking could open to an industry so far five-to-ten years behind most other verticals. The current approach to fair balance could also conceivably change, as additional clinical trials outside the boundary of a drug’s label might be cited and considered equally relevant. In short, Caronia calls into question the very foundation of pharma and device digital marketing, introducing daunting possibilities that with them could bring astonishing patient benefit, but also the potential for rampant abuse and misinformation.
The key and immediate takeaway here is that nothing, at least initially, changes. The ruling is technically effective in only three states, and the FDA has dismissed the case, eliminating the possibility of it going to the Supreme Court. But that doesn’t preclude it being reintroduced, nor will the pharma and device industries, eager to expand their ability to communicate with their constituents, sit idle. From our vantage point as digital health communicators, the ruling has the potential for transforming how the industry connects with its targets, perhaps some day getting us all closer to using the incredible power of digital to deliver the most patient benefit. While everyone awaits the FDA response and pharma probes the boundary, we can only hope that an equitable balance can be found between open and unfettered access to clinical data, and the safety and protection of the ultimate end-user—the patient.
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