OTC simvastatin response mix up
The Medicines and Healthcare products Regulatory Agency has this week admitted that only a third of the responses to the consultation on the change of simvastatin to an over-the-counter medicine were favourable.
The MHRA had originally said that “about two thirds of respondents
were in favour of the proposal”. In April, the Drug and Therapeutics
Bulletin claimed that the MHRA exaggerated the proportion of favourable
responses to the public consultation. The MHRA refuted the claim of misrepresentation
saying that the Committee on Safety of Medicines had full access to all
responses to the consultation.
However, in a correction to information on its website (PDF 25K), the
agency has said that, in fact, a third were in favour, a third against
and a
third
were not opposed, but raised issues to be considered. The incorrect information
was, the agency says, “due to an administrative error”.
In a statement issued this week, the MHRA said: “We apologise for
any confusion caused by this error.
“We in no way intended to misrepresent the results and can assure
the public and other interested parties that the correct findings were
given
to the Committee on Safety of Medicines who made their recommendations
with the full facts in front of them.”
The MHRA has published a listing of all consultation responses on its
website, together with the full text of all responses other than those
where the respondent has not given consent for public disclosure. “We
are now adopting this model for all future switch consultations, so as
to avoid any further confusion,” the MHRA added. |
The
Pharmaceutical Journal
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