MHRA gives evidence to pharmaceutical industry influence inquiry
The Medicines and Healthcare products Regulatory Agency will, from the middle of the year, issue a “United Kingdom product public assessment report” for each licence it issues, Sir Alasdair Breckenridge, chairman of the board of the MHRA, said last week.
Speaking at the Health Select Committee inquiry into the influence of
the
pharmaceutical industry, he said that these reports would include data
from all the clinical trials on which the licence decision was based.
Sir Alasdair countered criticisms of the MHRA’s reliance on company
summaries for its approvals.
He said that although it does not routinely look at the individual case
reports on each individual patient, the MHRA can, and sometimes does,
ask companies for this raw data.
He added that the company summary that the MHRA uses for each trial can
run to several hundred pages and there may be 10–15 trials for
each licence application, so the submission for any one agent may run
to hundreds of volumes.
The issue of direct-to-consumer promotion via “disease awareness” campaigns
was also discussed. MHRA board member June Raine said that if the MHRA
thought a disease awareness campaign was, in effect, promoting a specific
medicine, it would take careful advice. |
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Pharmaceutical Journal
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