Sometimes, when it comes to drafting posts for The Insider, a little digging can turn up remarkable results. This week’s post demonstrates the point, as it originates from short news stories that appeared recently in two journals that may not be so well known: Medwatch, based in Copenhagen, and Stat, headquartered in Boston. Both sites cover the pharmaceutical and health care industries, and both deserve considerable appreciation, because what they have uncovered is alarming and even disturbing: in the pharmaceutical industry, despite a recent increase in legal protections, you can still go to prison for posting truthful statements on social media about government-approved prescription medications.
With that introduction, some context is certainly in order. As the Medwatch and Stat articles both indicate, Danish law enforcement officials are currently investigating a potential violation of Danish law regarding an anti-cancer drug that has been approved for sale in no fewer than twenty-five countries and economic regions, including the United States, the European Union, Australia, Canada, Mexico, South Korea, and Russia. The drug in question – Kyprolis, which is also known by the generic name Carfilzomib – is a prescription medication used to treat patients with multiple myeloma, a cancer that forms in a specific type of white blood cell and impedes the production of infection-fighting antibodies. On August 30, 2017, Amgen issued a press release indicating that, based on a study requested by the U.S. Food and Drug Administration, patients who were administered Kyprolis after a multiple myeloma relapse had a reduced risk of death as compared to those who used an alternative chemotherapy drug called Velcade. At some point thereafter, according to Stat, an Amgen employee in Denmark posted a link to the press release on his or her LinkedIn page, and then liked the post.
So far, so good, right? Where’s the crime? Well, the Amgen employee’s post actually is the crime, or at least it’s the alleged crime. As both Medwatch and Stat report, Danish law enforcement authorities are now considering whether to ask a Danish court to fine Amgen, and potentially charge the Amgen employee with a criminal offense, based on this seemingly innocuous reposting on social media of a press release whose accuracy has never been questioned. In fact, the Danish Medicines Agency – which is part of the Danish Ministry of Health and describes its mission as ensuring “effective, safe and accessible medicines and safe medical devices that benefit society” – is assessing whether, by transmitting on social media the results of the U.S.-based study, the Amgen employee in question violated the Danish Medicines Act. Pursuant to Section 66(1) of an official English translation of the Act, “advertising to the general public” of a medicine such as Kyprolis, which is “available only on a prescription,” is “not allowed.” Further, the Danish Medicines Act provides that a violation of Section 66(1) can be punished either by a fine, or by up to four months’ imprisonment. Thus, to restate: a pharmaceutical company employee can actually go to prison in Denmark for posting positive study results on his or her LinkedIn account.
Undoubtedly the Danish authorities have their reasons for restricting the advertising of prescription drugs, whether through social media or otherwise. A document issued by the World Health Organization discusses Danish concerns that prescription drug advertising may suggest that it is not necessary to visit a general practitioner, that side effects don’t exist, that one drug is better than another, or that scientists recommend a specific drug. Additionally, it is unclear whether, in the real world, a Danish court would actually sentence a pharmaceutical employee to prison for an alleged violation of the Danish Medicines Act, especially one that appears to involve a single LinkedIn post. And, the hospitable nature of Danish prisons may even provide a modest degree of reassurance. In February 2016, a research team from the Washington Post reported that most Danish prisons are “open” facilities without walls or secure perimeters, and that prisoners wear their own clothes, cook their own meals, and have private family visits at least once a week. Still, it is hardly likely that any of these factors will produce a sigh of relief for the unfortunate Amgen employee who is the subject of the ongoing criminal investigation. To the contrary, for a pharma employee who is now facing a daunting criminal investigation for reposting a truthful press release about a successful drug trial for cancer patients, the likely reaction is presumably one of shock, as well as a healthy skepticism regarding the enforcement priorities of Danish authorities.
The news that Danish investigators are assessing whether to charge Amgen and its employee in this case also raises no less than three additional points, each of which is worthy of further consideration. First, the fact that it is the Danish authorities who are considering criminal charges against Amgen and one of its employees serves to underscore what has been a growing trend in the criminal law generally, and in the health care arena in particular – namely, the internationalization of law enforcement activities. Several years ago, this blog discussed the surprisingly aggressive role that another then-obscure regulator, the Chinese Ministry of Public Security, had taken in pursuing allegations of bribery by foreign executives with Glaxo Smith Kline. More recently, Stat has posted several notable stories involving Novartis and investigations that were or are reportedly being conducted by law enforcement authorities in South Korea, Turkey, and Greece. At least in the pharmaceutical industry, then, the message appears to be clear – the United States is far from the only major player on the health-care enforcement beat, and the already daunting level of scrutiny from a growing range of international law enforcement agencies can only be expected to intensify.
A second takeaway from the ongoing Danish investigation into Amgen and its employee’s use of social media relates to what, until recently, has been a growing sense of comfort arising from the decline of off-label prosecutions in the United States. In December 2012, the United States Court of Appeals for the Second Circuit held, in United States v. Caronia, that the Federal Food, Drug, and Cosmetic Act does not criminalize the truthful promotion of drugs and devices for uses that have not been approved by the FDA, because to hold otherwise would unconstitutionally restrict the First Amendment right to freedom of speech. Prior to Caronia, the Department of Justice had frequently used a misdemeanor provision of the Food, Drug, and Cosmetic Act to obtain massive criminal and civil settlements from pharmaceutical and device manufacturers who engaged in the promotion of drugs and devices for unapproved uses, even when such promotion was entirely truthful. Subsequent to Caronia, commentators and observers have noted a decline in prosecutions arising out of promotional activities for drugs and medical devices, especially when the promotion in question has been neither false nor misleading – and this, in turn, has given a greater sense of comfort to companies in the pharma and medical device industries. Yet obviously the First Amendment protections afforded by Caronia and similar cases that have followed its lead do not protect companies and their employees from foreign regulators, or from the international criminalization of commercial speech. Indeed, according to a commentator who is cited in the recent Stat article regarding the Amgen matter, the United States and New Zealand are the only countries that do not prohibit direct-to-consumer advertising for prescription medications. As a result – and, as the Danish investigation now makes painfully clear – whatever comfort the pharma and medical device industries may have taken from the Caronia decision must be tempered by concerns about the potential for foreign sanctions, including fines and imprisonment.
A third (and, for this post, last) point to take away from the investigation that the Danish authorities are currently pursuing relates to the dangers inherent in working in a heavily regulated industry such as health care. It is hardly a novel concept that employees in tightly-monitored industries must be concerned about running afoul of regulatory or even criminal sanctions. Bank officials whose role includes anti-money laundering efforts and compliance with know-your-customer regulations face nearly daily fear that their actions will be second-guessed in ways that are both career- and life-altering. The same is true for many top-level compliance officers and in-house counsel in a range of industries, including the medical and financial fields. In the Danish matter, Amgen at least appears to have provided its affected employee with a meaningful level of reassurance, as the company has vigorously argued that the employee’s posting of a press release on LinkedIn was a matter of corporate pride, rather than an effort to affirmatively and illegally promote the ordering, use, or sale of a prescription drug in Denmark. Nonetheless, an employee in the health care arena is yet again in the cross-hairs for conduct that, at the time, almost certainly seemed harmless, inconsequential, and hardly likely to result in possible criminal sanction. And, since it is doubtful that the hardships faced by this one employee will scare away qualified candidates from pursuing employment in the pharma and medical device fields, it remains incumbent upon employees and their compliance departments to take seriously the risks that can arise from even the most unlikely of sources – Denmark included.
From The Insider Blog: White Collar Defense & Securities Enforcement.