Regulatory agency comes under fire from Consumers' Association
The Consumers' Association has criticised the Medicines and Healthcare products Regulatory Agency saying it should be more vigilant in policing the pharmaceutical industry. The criticism comes after an advertisement for Cerazette (desogestrel), a new progestogen-only oral contraceptive pill, was withdrawn by its manufacturer Organon Laboratories.
The September issue of the Drug and Therapeutics Bulletin, which is published
by the Consumers’ Association, last week called for the withdrawal
of the Cerazette advertisement. The advertisement claimed the pill had
the “efficacy of a combined pill with the reassurance of an oestrogen
free pill”. The DTB said this claim had no rigorous scientific
basis. “Given the absence of published trials directly comparing
Cerazette with a combined oral contraceptive, we believe the company’s
claim ... is unsubstantiated and should be withdrawn.”
Dr Robert Kaper, medical director of Organon, told The Journal that the
advertisement had been withdrawn in mid-August at the request of the
MHRA and not in response to the DTB article. However, a spokesman for
the Consumers’ Association pointed out that draft copies of the
DTB article had been sent to the MHRA and Organon in July.
In a statement issued earlier this week, the Consumers’ Association
says that the advertisement is the third in a year to be withdrawn following
DTB investigations. Wendy Garlick, principal policy adviser at the Consumers’ Association,
said: “The CA has long warned of the dangers of allowing the pharmaceutical
industry to be a direct source of information to the public. The fact
that yet another advert has had to be withdrawn not only calls into question
the ability of the MHRA to do its job, but highlights the fact that drug
companies are incapable of communicating honestly with health care professionals,
let alone the public.
“It should not fall to the likes of the Consumers’ Association
to catch drug companies trying to circumvent the rules. The MHRA must
be
more robust and vigilant in taking charge of policing the industry.”
In response to the criticism, a spokesman for the MHRA said: “By
the time the article in the Drugs and Therapeutics Bulletin on Cerazette
was published, the MHRA had already taken action ... following a complaint
from a health care professional. As a result of the Agency’s action,
not only was the material withdrawn by the company, a corrective statement
is being issued to address the concerns raised.”
| MHRA remit on policing advertising The control of medicines
advertising in the United Kingdom is based on a system of self-regulation
underpinned by statutory powers administered by the MHRA. Given
the volume of medicines advertising material, the MHRA in part
relies on concerns being drawn to its attention in order that regulatory
action can be taken. In addition, the MHRA pre-vets advertising
in cases where a particular risk has been identified.
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