Last December, the 2nd US Circuit Court of Appeals ruled that blocking drug companies from promoting truthful statements about off-label drug uses violates the First Amendment. The FDA decided to not pursue an appeal of this decision at this juncture, meaning that in New York, Connecticut, and Vermont, med-tech companies may give physicians information that they were previously prohibited from disseminating. In other states, this prohibition still applies.
Although the court did not clarify what promotion is allowed and what is prohibited under its decision (there was little transparency on what is still false and misleading), this ruling potentially opens the door to many marketing possibilities for the industry. As a result, this should allow the discussion of generally accepted off-label uses of devices. To be clear, this ruling certainly does not allow companies or their representatives to disseminate false or misleading information, especially when harm to patients is likely to result.
So why should the entire industry pay attention to this ruling? Does it have any practical effect on my company’s current situation? Is this a go-ahead to become more liberal when reviewing my marketing material? What are the potential consequences?
The industry wants answers to these questions and more, but reality is more qualitative than quantitative. Exact regulation and guidance for all situations that can arise in the industry is difficult for the FDA to generate.
Nevertheless, we believe that this decision should not be construed as allowing companies to create promotional materials for direct marketing of the off-label uses of their products. The ruling simply allows the open discussion of legitimate off-label uses between companies, their representatives, and physicians. This was previously only possible if the physician initially approached the company for information.
The reason for this is that by currently allowing off-label marketing on free speech grounds, the Appeals Court decision opens the door for companies to more broadly market their technologies based on un-vetted effectiveness claims, rather than stringently reviewed effectiveness evidence. On-label indications often have a body of clinical evidence in support, while off-label claims often do not have this same level of evidence review. As a result, the differentiation between what is a strong and valid claim and a misleading claim can be unclear.
There can be a number of unexpected consequences for companies which perform off-label marketing of their products, especially when they erroneously believe that these off-label uses are considered legitimate by the medical community. The FDA may still warn companies for the open marketing of off-label uses of products, and companies may still be held liable for invalid claims. In addition, it is possible for this appeals court decision to be reversed in the future.
How can you avoid off-label marketing risks in the medical device world?
Despite the seemingly looser requirements for marketing, the regulatory landscape still exists, and must be carefully followed. Though the door to off-label marketing has now been cracked open, there is still potential for it to be closed again in the future.
In order to avoid the potential costs associated with off-label promotion, medical device manufacturers should be sure to have their marketing materials reviewed by a regulatory expert to ensure that they are not promoting off-label claims. Alternatively, value may be created by dedicating resources to turn these off-label claims into on-label claims which pass regulatory muster.