Following a review of pharmaceutical advertising, the UK’s Prescription Medicines Code of Practice Authority (“PMCPA”) cited several pharmaceutical manufacturers for bringing “discredit upon, and reduced confidence in, the pharmaceutical industry.” The involved manufacturers are Daiichi-Sankyo, GW Pharmaceuticals, Bayer plc, Proveca Ltd, Otsuka Europe and Otsuka UK. In addition, the PMCPA has required Daiichi-Sankyo to issue a corrective statement, and publicly reprimanded Otsuka Europe and Otsuka UK.
Specifically, the PMCPA identified the following instances of wrongdoing.
For Daiichi-Sankyo’s advertising of Lixiana, a drug used for stroke prevention, and to treat and prevent recurrent deep vein thrombosis and pulmonary embolism: Two Lixiana guides were misleading “in that they failed to highlight an important safety consideration and … did not encourage the rational use of the medicine.”
For GW Pharmaceuticals’ advertising of Epidiolex, a drug used to treat certain epilepsy syndromes: GW Pharmaceuticals promoted Epidiolex before receiving marketing authorization.
For Bayer’s advertising of Xarelto, a drug used to reduce the risk of blood clots: Bayer made misleading claims which potentially put patients with several renal impairment at risk.
For Proveca’s advertising of Sialanar, a glycopyrronium drug used to treat sialorrhoea: Proveca sent a letter “which could be seen as threatening in tone” to individual pharmacists about the supply of unlicensed and off-label glycopyrronium as opposed to the use of Sialanar.
For Otsuaka Europe’s and Otsuaka UK’s advertising of Jinarc, used to treat a type of polycystic kidney disease, Samsca, used to treat hyponatremia, and Abilify, used to treat depression:
These entities failed to communicate changes to the summaries of product characteristics, failed to update prescribing information, and failed to withdraw materials in a timely manner. The PMCPA also noted that Code of Practice Panel has “broader concerns about the governance within the two companies,” and that Otsuka Europe was “not transparent in its response.”
The PMCPA noted that these companies would be named in advertisements in the British Medical Journal, the Pharmaceutical Journal and the Nursing Standard at various times in the months of August and September. In addition, Daiichi-Sankyo was required to issue a corrective statement, in which they updated their prescribing information for Lixiana to include a section of “Renal function in [nonvalvular atrial fibrillation] NVAF.” The corrective statement also noted that Daiichi-Sankyo was required to recover the “misleading” information already distributed, and requested that it be returned to them.
Finally, PMCPA commented that they were particularly concerned about an “overall failure of governance processes” at Otsuka Europe and Otsuka UK, and required that these two companies be audited.