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Pharma Compliance Info Something Rotten in Denmark? The International Criminalization of Drug Advertising Digital

Something Rotten in Denmark? The International Criminalization of Drug Advertising

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. Pharma Compliance Info Something Rotten in Denmark? The International Criminalization of Drug Advertising Digital
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.

To read the article by Robert Radick , Contributor

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