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THE SUPERVISORY COMMISSION FOR THE MARKETING OF MEDICINAL PRODUCTS: SUMMATION OF DECISIONS CONCERNING MARKETING OF PRESCRIPTION-ONLY MEDICINES - YEAR 2005 Final decisions made by the Supervisory Commission (after appeal) 1/2005 Xyzal Oy Leiras Finland Ab made a complaint about Xyzal brochure sent to medical doctors by Oy UCB Pharma Finland Ab. The scientific reference in brochure did not support the argument about Xyzal’s efficacy in comparison to other antihistamines. The brochure included also another comparison that did not specify either the object or the subject of the comparison. Oy UCB Pharma Finland Ab was requested to abstain from incorrect marketing and imposed a sanction payment of 7 000 euros. 2/2005 Crestor Pfizer Oy made a complaint about AstraZeneca Oy’s advertisement on Crestor web pages and a Crestor dosage card printed for marketing purposes. In spite of changes in Crestor’s SPC it could be said that Crestor was as well tolerated as the other statins and the advertisement in Internet did not violate the Code for the Marketing of Medicinal Products. However, in the dosage card there should have been a warning concerning possible adverse events in situations when the Crestor dosage is raised, due to which AstraZeneca Oy was requested to abstain from incorrect marketing and imposed a sanction payment of 5 000 euros. 4/2005 Fucithalmic Santen Oy made a complaint about Fucithalmic advertising letter sent to medical doctors by LEO Pharma Oy. The idea given in advertisement, that it is more comfortable for children to use product which, according to the SPC, is dosed more seldom, was pertinent. The advertisement included also elements which violated the Code for the Marketing of Medicinal Products but as LEO Pharma Oy had already in the negotiations between parties made a commitment to abstain from using those elements, the complaint was without cause. 5/2005 Announcement in ”Allergia & Astma” magazine AstraZeneca Oy made a complaint about GlaxoSmithKline Oy’s announcement in a consumer magazine covering asthma and allergies. In the announcement the reader was encouraged to discuss with a doctor about the treatment of his asthma. As the announcement did not include any elements that would have been considered as marketing of prescription-only medicines to the public, the complaint was dismissed. 6/2005 Free emergency packages AstraZeneca Oy made a complaint about actions of Orion Oyj Orion Pharma in the exhibition area of the Annual Finnish Medical Convention. Open distribution of free emergency packages at the exhibition stand falls within the definition of marketing of medicinal products and use of free emergency packs for marketing purposes is prohibited. Orion Oyj Orion Pharma was requested to abstain from incorrect marketing and imposed a sanction payment of 5 000 euros. 7/2005 Metforem Oy Leiras Finland Ab made a complaint about Orion Oyj Orion Pharma’s advertisement which gave a false impression that all the other products containing metformin but Orion Oyj Orion Pharma’s own Metforem tasted bad. Orion Oyj Orion Pharma was requested to abstain from incorrect marketing and imposed a sanction payment of 10 000 euros. 9/2005 Flamenco performance at a training event GlaxoSmithKline Oy made a complaint about programme of a training event arranged by AstraZeneca Oy. Along with the scientific program and the following dinner the programme included music and a flamenco performance. Recorded music can be played as background music but the flamenco performance was beyond the hospitality allowed in the Code for the Marketing of Medicinal Products. AstraZeneca Oy was requested to abstain from incorrect marketing and imposed a sanction payment of 2 000 euros. 11/2005 Actos GlaxoSmithKline Oy made a complaint about Actos advertisement by Oy Eli Lilly Finland Ab. In the advertisement it could be said that Actos is effective also against lipids because the claim was supported by scientific evidence and the SPC, the actual indication of the product, type II diabetes, was clearly brought out and controlling of lipids is of relevance to these patients. The advertisement was not misleading in the sense that it would have suggested Actos’ indications to include lowering cholesterol and therefore the complaint was dismissed. 12/2005 Olmetec Novartis Finland Oy made a complaint about Olmetec brochure by Oy Leiras Finland Ab. Results of the clinical study cited in the brochure should have been reported from the whole period of observation (8 weeks). By citing the results only from week 2, the advertisement gave too favourable impression of Olmetec’s efficacy in comparison with other sartans. Also, in the comparative study Olmetec’s approved starting dose should have been used, as it was done with other products included in the study. Oy Leiras Finland Ab was requested to abstain from incorrect marketing and imposed a sanction payment of 8 000 euros. 13/2005 Symbicort advertisement in ”Arki ja allergia” book targeted at consumers AstraZeneca Oy informed the Supervisory Commission that an advertisement of company’s prescription-only medicine Symbicort had accidentally been published in a book about allergies that was targeted at consumers. AstraZeneca Oy could not be ordered to withdraw the whole book from the market, as it was published by an outside party and AstraZeneca had only bought one page for its advertisement. AstraZeneca was however in liability for the consumer marketing of its prescription-only medicine, even though it was caused by a fault of a subcontracting advertising agency. AstraZeneca Oy was requested to abstain from incorrect marketing and imposed a sanction payment of 15 000 euros. 14/2005 Micardis AstraZeneca Oy made a complaint about Micardis advertisement by Boehringer Ingelheim Finland Ky. The advertisement was lacking a reference to scientific proof that would have justified giving longer half-life than given in the Micardis’ approved SPC. Boehringer Ingelheim Finland Ky was requested to abstain from incorrect marketing and imposed a sanction payment of 5 000 euros. 16/2005 Symbicort GlaxoSmithKline Oy made a complaint about Symbicort advertisement in a magazine by AstraZeneca Oy. The advertisement gave an impression that Symbicort could be used as a treatment also for acute asthma attacks, which was not in line with indications included in Symbicort’s SPC. The advertisement was misleading also in a sense that it suggested Symbicort treatment to be effective in every case. AstraZeneca Oy was requested to abstain from incorrect marketing and imposed a sanction payment of 10 000 euros. 17/2005 Notice about insulin preparations Novo Nordisk Farma Oy made a complaint about a notice published by Aventis Pharma Oy, sanofiaventis Group. The notice gave a misleading impression of the availability of Novo Nordisk Farma Oy’s products and Aventis Pharma Oy, sanofi-aventis Group’s own products were marketed with insufficient product information. The notice was sent also to nurses specialised in treating diabetes, to whom it is not allowed to market prescription-only medicines. Aventis Pharma Oy, sanofiaventis Group was requested to abstain from incorrect marketing and imposed a sanction payment of 16 000 euros. 19/2005 Central nervous system symposium on a cruise to St. Petersburg Oy Eli Lilly Finland Ab made a complaint about central nervous system symposium which was going be organized by Oy H. Lundbeck Ab on a cruise to St. Petersburg. There were no scientific or educational grounds for organizing the symposium on a cruise which had its destination abroad. Invitations to the symposium gave an impression about hospitality that was more extensive than the Code for the Marketing of Medicinal Products allow. The invitations were also sent directly to the doctors employed by the public healthcare services, not to their employers as required by the Code. Oy H. Lundbeck Ab was requested to abstain from incorrect marketing and imposed a sanction payment of 10 000 euros. Final decisions made by the Inspection Board I controlling the marketing targeted at consumers Decision in May 11th 2005, “Häiritsevätkö intiimivaivat” –newspaper advertisement Inspection Board took up Novo Nordisk Farma Oy’s disease awareness orientated newspaper advertisement under examination on its own initiative. The advertisement called “Do trouble at the intimate areas bother you?” emphasized use of topical medication and did not include any information on other treatment options available. Thus it could be found as disguised advertising of Novo Nordisk Farma Oy’s own prescription drugs for local oestrogen therapy. Novo Nordisk Farma Oy was requested to abstain from incorrect marketing and imposed a sanction payment of 3 000 euros. Decision in July 26th 2005, advertisement in “Arki ja allergia” book GlaxoSmithKline Oy made a complaint about AstraZeneca Oy’s prescription drug Symbicort Turbuhaler’s advertisement in a book about allergies that was targeted to consumers. As Inspection Board had already earlier taken up the matter on its own initiative and as consequence AstraZeneca Oy had been requested to abstain from incorrect marketing and imposed a sanction payment of 15 000 euros (Decision 13/2005 by Supervisory Commission is about AstraZeneca Oy’s complaint in that matter), the complaint was dismissed. Decision in October 26th 2005, advertisement about psoriasis Inspection Board took up Serono Nordic’s disease awareness newspaper advertisement about psoriasis under examination on its own initiative. The advertisement told about a new treatment for psoriasis and the information about the treatment was expressed in a way that it led to Serono Nordic’s new prescroption drug. Inspection Board found the advertisement as disguised advertising of a prescription drug. Serono Nordic was requested to abstain from incorrect marketing and imposed a sanction payment of 10 000 euros. Decision in October 26th 2005, advertisement about psoriasis Inspection Board took up Wyeth’s disease awareness orientated newspaper advertisement under examination on its own initiative. The advertisement was targeted at consumers but it guided the recipient to ask doctor about Wyeth’s new product for the disease. Inspection Board found the advertisement as disguised advertising of a prescription drug. Wyeth was requested to abstain from incorrect marketing and imposed a sanction payment of 16 000 euros. Decision in December 14th 2005, Internet pages www.nordicdrugs.com Inspection Board took up Nordic Drugs Ab’s homepages on Internet under examination on its own initiative. Product information on the pages contained marketing of a prescription drug to consumers. Prescription-only and non-prescription medicines should have been presented separately. In addition the required minimum information in the advertisements was incomplete. Nordic Drugs Ab was requested to abstain from incorrect marketing and imposed a sanction payment of 4 000 euros. Decision in December 14th 2005, Internet pages www.novonordisk.fi Inspection Board took up Novo Nordisk Farma Oy’s homepages on Internet under examination on its own initiative. The pages told broadly only about oestrogen therapies in treatment of osteoporosis but left the first line of treatment without mentioning. On the homepages there was a direct link to other Internet pages which contained healthcare personnel’s recommendation to use an antidiabetic drug and glowing expressions about Novo Nordisk Farma Oy’s injection devices. This was found as disguised advertising of prescription drugs to consumers. Novo Nordisk Farma Oy was requested to abstain from incorrect marketing and imposed a sanction payment of 8 000 euros. Decision in December 21st 2005, Internet pages www.glaxosmithkline.fi Inspection Board took up GlaxoSmithKline Oy’s homepages on Internet under examination on its own initiative. The pages contained press releases which marketed prescription drug Havrix directly to consumers, as the information in them was not equally covering all treatment options as required by the Code when disease awareness campaigns are carried out. In addition there was another press release on the pages that was found as disguised advertising of a prescription drug to consumers. GlaxoSmithKline Oy was requested to abstain from incorrect marketing and imposed a sanction payment of 5 000 euros. Decision in December 21st 2005, Internet pages www.lilly.fi Inspection Board took up Oy Eli Lilly Finland Ab’s homepages on Internet under examination on its own initiative and found that some press releases published on the pages were marketing of prescription drugs to consumers. Trade names of company’s products had been used in the press releases even though in the study cited they had not been mentioned. From the press releases it was also possible for the recipient to get a misleading impression about the results of the study. In addition one of the press releases included glowing remarks about company’s product by medical director of the study. Oy Eli Lilly Finland Ab was requested to abstain from incorrect marketing and imposed a sanction payment of 5 500 euros. Decision in December 21st 2005, Internet pages www.astmaonline.com Inspection Board took up disease awareness orientated Internet pages maintained by AstraZeneca Oy under examination on its own initiative. The pages were not neutral but emphasized company’s own products. There was also a link only to AstraZeneca Oy’s own homepages but not to any other companies providing treatments to the disease in question and thus the pages were not neutral as required. In addition there was a link to other pages maintained by AstraZeneca Oy which contained articles with misleading recommendations for a prescription drug by a celebrity and healthcare personnel. AstraZeneca Oy was requested to abstain from incorrect marketing and imposed a sanction payment of 11 000 euros. Decision in December 21st 2005, Internet pages www.kivuton.info Inspection Board took up disease awareness orientated Internet pages maintained by Suomen MSD Oy under examination on its own initiative. On the pages was published an article which emphasized progressiveness of coxibs but made no mentioning about adverse effects while telling about their safety. The article mentioned also products which already had been recalled of the market. Suomen MSD Oy was requested to abstain from incorrect marketing and imposed a sanction payment of 5 000 euros. Decision in December 21st 2005, Internet pages www.verensokeri.fi Inspection Board took up disease awareness orientated Internet pages maintained by Aventis Pharma Oy, sanofi-aventis Group under examination on its own initiative. The pages mentioned only company’s own insulin injection pens. The information on the pages contained also advertising expressions and thus the pages were found as disguised marketing of prescription drugs to consumers. In addition there was a link only to Aventis Pharma Oy, sanofi-aventis Group’s own homepages. Aventis Pharma Oy, sanofi-aventis Group was requested to abstain from incorrect marketing and imposed a sanction payment of 8 000 euros. Final decisions made by the Inspection Board II controlling the marketing targeted at healthcare professionals Decision in January 4th 2005, Seretide AstraZeneca Oy made a complaint about GlaxoSmithKline Oy’s marketing which according to AstraZeneca Oy did not comply with an agreement between the parties to abstain from incorrect marketing activities. Inspection Board found that the parties had agreed not to refer to certain study results in marketing materials before these results were published. In this case the study in question had later been published as an article in a scientific journal and thus after publication it could be referred to in marketing materials. The complaint was dismissed. Decision in February 17th 2005, Femar AstraZeneca Oy made a complaint about Femar advertisement by Novartis Finland Oy. Inspection Board found that the advertisement did not try to market the product for any other indication than what was officially approved for it. The advertisement did neither use an unpublished study for marketing purposes. The complaint was dismissed. Decision in March 3rd 2005, Cialis Pfizer Oy made a complaint about Cialis brochure sent to medical doctors by Oy Eli Lilly Finland Ab. The brochure gave a misleading impression that Cialis would be more efficient than the other comparable products even though it actually was only a matter of the products’ duration of action. Oy Eli Lilly Finland Ab was requested to abstain from incorrect marketing and imposed a sanction payment of 10 000 euros. Decision in March 31st 2005, Exelon Pfizer Oy made a complaint about Exelon marketing by Novartis Finland Oy. Inspection Board found that the question was about demonstration of Novartis Finland Oy’s entrepreneurship, not about marketing of any medicinal products, and thus it could also not be found that Exelon was marketed for an unapproved indication. The complaint was dismissed. Decision in March 31st 2005, “Liikkeellä ajassa” publication Algol Pharma Oy made a complaint about publication called “Moving in time” by Aventis Pharma Oy sanofi-aventis group. The publication, which was considered as being part of company’s marketing materials, recommended Xatral CR for an unapproved indication. In addition the publication did not include the product’s minimum information required by the Code. Aventis Pharma Oy sanofi-aventis group was requested to abstain from incorrect marketing and imposed a sanction payment of 17 000 euros. Decision in April 22nd 2005, Seretide AstraZeneca Oy made a complaint about Seretide advertising by GlaxoSmithKline Oy. The complaint was made over 30 days after AstraZeneca Oy’s first verifiable contact to GlaxoSmithKline Oy. Because of the 30 days deadline set in the Code was exceeded, the Inspection Board did not handle the case. Decision in May 9th 2005, Artelac Novartis Finland Oy made a complaint about Artelac marketing by Santen Oy. Inspection Board found that distribution of table racks for free emergency packages constituted prohibited use of them in marketing of medicinal products because the racks tempted doctors to use the product placed in them. Santen Oy was requested to abstain from incorrect marketing and imposed a sanction payment of 4 000 euros. Decision in May 25th 2005, Teveten Novartis Finland Oy made a complaint about Algol Pharma Oy’s marketing that according to Novartis Finland Oy did not comply with an agreement between the parties about not using certain clinical study for marketing purposes before it was properly published. Because the marketing letter to doctors had been mailed after the research was published as an article, the agreement had not been violated even though the letter was dated before the article’s date of publication. Inspection Board dismissed the complaint but gave Algol Pharma Oy an admonition for future reference because the marketing letter lacked a clear reference to scientific proof. (Articles of the EFPIA Code suitable for the case: 3) Decision in May 25th 2005, Seretide AstraZeneca Oy made a complaint about Seretide newspaper advertisement by GlaxoSmithKline Oy. In the advertisement an expression from the cited clinical study was misleadingly translated from “totally controlled asthma” into “living without symptoms”. Absence of symptoms was also emphasized too categorically. GlaxoSmithKline Oy was requested to abstain from incorrect marketing and imposed a sanction payment of 8 000 euros. (Articles of the EFPIA Code suitable for the case: 4) Decision in August 3rd 2005, Kinzal AstraZeneca Oy made a complaint about Kinzal advertisements by Bayer Oy. Results of scientific studies made with AstraZeneca’s product could also be used in the marketing of Kinzal, because of Kinzal was actually produced under licence given by AstraZeneca and the two products are therefore practically the same. The fact that the advertisement told about general qualities of antihypertensive medicines could not be found as broadening of the product’s indication outside of those approved in the SPC. The complaint was dismissed. (Articles of the EFPIA Code suitable for the case: 3) Decision in August 3rd 2005, Enbrel Serono Nordic made a complaint about Enbrel advertisement by Wyeth. The expression “Go away psoriasis” was not found to misleadingly promise that the product would cure psoriasis completely. The complaint was dismissed. (Articles of the EFPIA Code suitable for the case: 3) Decision in September 1st 2005, Atacand Bayer Oy made a complaint about Atacand newspaper advertisement by AstraZeneca Oy. The message of advertisement was not found to be in conflict with the referred clinical studies. The advertisement did neither give a false impression about efficacy and positive effects of the product. The complaint was without cause and therefore ignored. (Articles of the EFPIA Code suitable for the case: 3) Decision in September 22nd 2005, Metforem Oy Leiras Finland Ab made a complaint about Orion Oyj Orion Pharma’s Metforem marketing that according to Oy Leiras Finalnd Ab did not comply with a request to abstain from incorrect marketing given earlier by Supervisory Commission. However, it was found that Orion Oyj Orion Pharma had changed the message of the advertisement so it did not violate the request to abstain from incorrect marketing given to the company. The complaint was dismissed. (Articles of the EFPIA Code suitable for the case: 3) Decision in November 18th 2005, Raptiva Schering-Plough Oy made a complaint about Serono Nordic’s Raptiva information in Pharmaca Fennica database (the pharmaceuticals compendium) and an advertisement in a magazine for doctors. Raptiva’s SPC published in Pharmaca Fennica database gave more positive impression about Raptiva’s efficacy than the approved SPC. The advertisement gave also too positive impression about Raptiva’s efficacy and was not in accordance with the results of clinical studies cited in the advertisement. Serono Nordic was requested to abstain from incorrect marketing and imposed a sanction payment of 15 000 euros. (Articles of the EFPIA Code suitable for the case: 1, 3) Decision in December 9th 2005, Zemplar Amgen Oy made a complaint about Zemplar advertisement by Abbott Oy. The complaint was made over 30 days after Amgen Oy’s first verifiable contact to Abbott Oy. Because of the 30 days deadline set in the Code was exceeded, the Inspection Board did not handle the case. Decision in December 19th 2005, Cymbalta Oy H. Lundbeck Ab made a complaint about two Cymbalta brochures for healthcare personnel and a Cymbalta patient’s brochure by Oy Eli Lilly Finland Ab. Inspection Board found that the marketing material was in accordance with Cymbalta’s SPC and the clinical studies cited. The material was also otherwise complying with the Code. The complaint was dismissed. (Articles of the EFPIA Code suitable for the case: 1, 3)