Open Medicine EU

Could it happen here?

There have been many serious cases of mis-selling and off-label promotion of medicines in the US. Could the same thing be happening here, or do pharmaceutical companies behave better on this side of the Atlantic?

For my BMJ blog I compiled a table of cases taken by the US Department of Justice since 2004 involving off-label promotion, where the company had to pay over $300 000 in fines, penalties and/or settlements – you can see the table here.

Of the seventeen companies listed, at least seven were among the top ten companies by sales in recent years – see below (1)

Of the medicines involved, at least twelve were among the top ten selling branded medicines for one year or more – the kind of medicines that would be followed closely by the CEO and other senior executives of the companies concerned -see below (2).

It seems clear therefore that off-label promotion was more than a temporary lapse or oversight by just a few companies.

In some cases the company pleaded guilty to one or more charge. In others, a settlement was agreed without any admission on the part of the company.

The forms of mis-selling were many and various – promoting for children medicines approved only for adults, selling on the basis of symptoms when the same symptoms (e.g. dementia) may have many different causes, withholding publication of inconvenient trial results, citing partial results of trials that were never subject to regulatory review, paying doctors to recommend off-label uses etc.

So, is this also happening in Europe? We don’t know. We have 28 member states, with nearly as many languages, with medicines agencies and enforcement authorities of varying size and sophistication. There is also a problem of transparency. Compared to the US, we know little about payments to doctors (or political parties) in Europe. Access to data in national medicines agencies is often very limited.The lack of public access to clinical trial data also facilitates mis-selling. Information on sales, marketing and the uses of medicines can be very patchy, or expensive to obtain.

Against that background it is difficult to believe that pharmaceutical companies behave very much better here than in the US.

Anyone care to comment?

(1) Abbott, Eli Lilly,GSK, J&J, Merck, Novartis, Pfizer
(2) Abilify, Aranesp, Epogen, Lexapro, Lyrica, Neurontin, Oxycontin,Paxil, Risperdal, Seroquel, Vioxx, Zyprexa,

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  1. Much as I admire Peter’s work and his commitment to good scence and good medicine, I would not myself use that term to describe the pharmaceutical industry, although they sometimes do very bad things, and often have an irreducible conflict of interest when it comes to transparency.

  2. Are there actual laws on the books in the EU about off-label promotion, as there are in the US? This is something I’ve not been able to determine…

  3. Sorry for delay in replying.
    Art. 87 of Directive 2001/83/EC is normally quoted as the basis for the prohibition of off-label promotion in the EU.
    In the directive, “advertising” is defined broadly to include promotion. Promotion off-label would be seen as advertising not complying with the “particulars listed in the summary of product characteristics”.
    Article 87(1) is also often quoted, by EFPIA and others, as the basis for the prohibition, an interpretation that is not obvious to me.
    Article 87(3) could also be interpreted as prohibiting off-label advertising/promotion.
    An explicit prohibition would be a lot better than the formulation here.
    best wishes,

    Article 87
    1. Member States shall prohibit any advertising of a medicinal product in respect of which a marketing authorization has not been granted in accordance with Community law.
    2. All parts of the advertising of a medicinal product must comply with the particulars listed in the summary of product characteristics.
    3.The advertising of a medicinal product:
    – shall encourage the rational use of the medicinal product, by presenting it objectively and without exaggerating its properties,
    – shall not be misleading

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