Download summation of decisions concerning marketing of prescription

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)