| Misleading claim |
8 (38%) |
15 (79%) |
Advertisement claimed: “There are no long-term cardio-vascular concerns regarding the use of Actos” (pioglitazone; Takeda). Failed to mention that drug might exacerbate and precipitate heart failure and was contraindicated in patients with, or with a history of, heart failure. (UK 2125/5/08
a
) |
| Breach of undertaking |
3 (14%) |
6 (32%) |
Bayer marketed Levitra (vardenafil) with claims of rapid onset inconsistent with the SPC despite three successive rulings on this matter. (SWE W950/07; W955/07) |
| Pre-licensing promotion |
6 (29%) |
1 (5.3%) |
Four §2 rulings regarding pre-licensing promotion of Victoza (liraglutide; Novo Nordisk): on website; via sponsored meetings disguised as scientific and medical meetings; via paid-for insert in medical journal disguised as independent supplement; at diabetes meeting by professor who failed to disclose financial relationship with company. (UK 2234/5/09) |
| Promotion to the public |
5 (24%) |
1 (5.3%) |
Novo Nordisk promoted Victoza in a newspaper supplement (The Times) on World Diabetes day and, further, did so prior to the granting of marketing authorization. (UK 2202/1/09) |
| Hospitality |
3 (14%) |
0 |
Bayer invited health professionals to a one and a quarter hours meeting on “The medical and surgical management of erectile dysfunction” followed by a champagne reception and gourmet dinner. Hospitality considered “excessive”. (UK 1741/7/05) |
| Disguised promotion |
3 (14%) |
0 |
Article in Future Prescriber constituted disguised and pre-licensing promotion of linagliptin by Boehringer-Ingelheim. The article incorrectly claimed that the drug had received marketing authorization, and that it was “safer to use” together with some medications than saxagliptin despite the lack of head-to-head trials. (UK 2424/8/11; 2425/8/11) |
| Conduct of representative |
2 (9.5%) |
0 |
Without apparent company approval, a representative implied that continued funding of an educational post within the local diabetes network could be in danger if the hospital did not increase its use of Lilly insulins. (UK 2044/9/07) |
| Off-label promotion |
1 (4.8%) |
1 (5.3%) |
Claim in mailing and advertisements, that Glucobay (acarbose, Bayer) had “cardioprotective effect” on patients with IGT and type 2 diabetes constituted off-label promotion since the drug was approved neither for patients with IGT nor for any cardioprotective use. (SWE W647/04; W648/04) |
| Rules on information |
0 |
1 (5.3%) |
Astellas sent letter entitled “Important information for people who work in health care” to doctors. The label “Important information” is only allowed for new information on ADRs, contraindications, restrictions, or withdrawals. The letter contained no such information, but instead promoted Vesicare (solifenacine). The MPA alleged disguised promotion, but the NBL rejected the allegation on this point. (SWE 913/11) |
