The Pharmaceutical Journal
Vol 269 No 7228 p837
14 December 2002

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Medicines Control Agency (www.mca.gov.uk)

MCA refutes incompetence allegation over Yasmin advertisement withdrawal

The Medicines Control Agency maintains that it acted swiftly to secure voluntary withdrawal of an advertisement for the oral contraceptive Yasmin (ethinylestradiol with drospirenone) after a complaint, and has refuted a claim that it had been incompetent.

The allegation was levelled by Professor Joe Collier of the Drug and Therapeutics Bulletin who last week criticised the MCA for failing to recognise the misleading nature of the advertisement in its initial vetting in the spring, when the product was launched. In addition, he said the MCA had failed to keep in close contact with the Prescription Medicines Code of Practice Authority, which had itself first ruled against the Yasmin advertisement in September after investigating concerns outlined in a DTB article (PJ, 17 August, p204).

Professor Collier said: "This level of incompetence, which seems to favour the industry rather than public health, is totally unacceptable. The MCA's position is untenable and demands an inquiry. What is more, [the manufacturers] should be required to send letters to prescribers and print a corrective advertisement."

However, the MCA said the allegation of incompetence was unmerited, and that the withdrawal of the advertisement had been secured in October, earlier than was possible through the self-regulatory system operated by the PMCPA, and before that body's final ruling had occurred in November. A spokesman for the Medicines Control Agency added: "Any claims that we do not keep in close contact [with the PMCPA] are not merited. The MCA does not interfere in PMCPA adjudications, taking independent action where there is a potential breach of advertising legislation leading to public health concerns, as in this case."

A spokeswoman for Schering Health Care, manufacturer of Yasmin, told The Journal that the company believed the claims made in the advertisement accurately reflected data published in peer reviewed journals. "We will continue supporting the product and advertising will form part of the support for this brand," she added.

Yasmin, launched in the United Kingdom in April 2002, was described as "a pill for well-being" in an advertisement aimed at health care professionals. An initial MCA review, carried out as part of new product monitoring, concluded the advertisement was acceptable. As a result of a complaint, the MCA investigated claims made in the advertisement that Yasmin had no associated weight gain and showed demonstrable effects on premenstrual symptoms and skin condition. Following the results of that review in October the manufacturers agreed to withdraw the advertisement.