The crusade for lifting the ban on advertising prescription drugs to consumers has hardly been helped by the recent fluctuating fortunes of advertising for an apparently revolutionary new contraceptive pill.
Who: Schering Healthcare and the Medicines Control Agency ("MCA")
When: December 2002
Where: The UK
Bold claims in advertising aimed at Doctors for a new female contraceptive pill have been questioned by the UK's drug watchdog, the MCA, after initially clearing the advertising.
The story of the "Yasmin" contraceptive pill began with the 2002 launch of the pill by its manufacturer Schering on the back of ads to Doctors showing a smiling attractive woman and featuring the strap line "the pill for wellbeing". The advertising also claimed that the pill had a "demonstrably positive effect" on pre-menstrual symptoms and skin conditions. The advertising also claimed that unlike other female contraceptive pills, Yasmin would not make women put on weight.
The all clear for this advertising was given by the MCA in June 2002, but after questions were raised about the claims' veracity by commentators such as the Consumers Association "Drug and Therapeutic Bulletin" (over which Schering threatened to sue for libel in September 2002) the pharmaceutical industry's own watchdog committee, the Prescription Medicine's Code of Practice Authority, checked out the adverts' claims.
By this stage Yasmin had 1,000,000 users worldwide and thousands in the UK, but the PMCPA concluded that the advertising breached its own code of practice on 10 counts, finding for instance that the claim to have no associated weight gain was "a strong absolute claim which did not reflect all of the evidence and was misleading in that regard".
Schering indicated its desire to appeal that decision, but in the meantime Yasmin has been withdrawn from the market on a voluntary basis by Schering following a request by the MCA, apparently now taking a different view of the advertising to that which it took back in June 2002.
Why this matters:
Schering's appeal against the PMCPA finding is by all accounts still current, but whatever the outcome of that process, there has to be cause for concern as to how the MCA reached an original decision which could potentially have enormous implications for drug manufacturers and consumers alike. On the one hand Schering cannot be best pleased that having successfully gone through the process of substantiating its claims with the MCA in May 2002 and launched the product on that basis, the entire matter is now being reopened in circumstances where Schering has felt it best to withdraw the product from the market temporarily.
On the other side of the equation, consumers of the product will ask whether the MCA's processing of the original submissions was as rigorous as it should have been, bearing in mind the thousands of prescription decisions that have been made as a result, not to mention public expenditure by way of the high £59 per 12 treatment cycles cost of the drug.
On a wider front, although we have suggested on a number of occasions on marketinglaw that the drug advertising trend is inevitably in the direction of a US-style controlled environment for permitted prescription drug advertising to consumers (as opposed to the current ban), cases like this will hardly advance progress in that direction on this side of the Atlantic.