Extra stage of clinical trials is under consideration
The Government is considering introducing a fourth stage in the vetting of medicines before granting marketing approval (our Lobby correspondent
writes).
As health minister responsible for medicines regulation and advocacy
of the pharmaceutical industry, Lord Warner wants to raise standards
of drug safety to avoid public scares about new medicines. A spokeswoman
for the minister said: “This is very much in the early stages and
it relies on a lot more work being done at a European level. We are thinking
about a half-way house between clearing certain drugs and rolling them
out to millions of people. It would be a fail-safe device.”
But any necessary legislation would have to wait until after the next
general election. The spokeswoman said: “This is not something
we are going to rush into.”
Under the proposals a fourth trial monitored by hospital consultants
would take account of a wider potential cross-section of patients than
currently applies.
Earlier this month Lord Warner told The Times: “With some new products
there is an anxiety about whether you shouldn’t have a more specialist
range of doctors controlling the prescribing before they go into widespread
distribution.” |
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