'Overhaul drugs regulatory system'

April 11, 2005
by Angela Hussain

A group of MPs have called for the "lax" pharmaceutical regulatory regime to be overhauled, saying it has prioritised the interests of the industry over public safety.

Adverse reactions caused by a number of drugs, such as the antidepressant Seroxat, have revealed fundamental flaws in the regulatory system, a report published last week by the health select committee said.

The report read: "An effective regulatory regime to ensure the industry works in the public interest is essential. Unfortunately the present regulatory system is failing to provide this."

It called for a wholesale review of the Medicines and Healthcare products Regulatory Agency, saying it has grown too close to industry and inadequately scrutinised clinical trials for Seroxat and other drugs.

It also called for sponsorship of the industry to be transferred from the Department of Health (DoH) to the Department of Trade and Industry, saying the DoH had let companies' interests override its responsibilities towards patients.

It has also recommended that all clinical trial results to be put on an independent register before companies are given a licence to market drugs.

Sophie Corlett, mental health charity MIND's director of policy, said: "The government must now put in place a drug regulation system that prioritises consumer safety."

Read for yourself:
Health Select Committee's report on the influence of the pharmaceutical industry (pdf)

See also:
Feb 2, 2005: 'SSRI antidepressants are safe' drugs regulator repeats to doctors - publication of research linking suicidal behaviour to SSRIs prompts reaction by MHRA.
Dec 6, 2004: No evidence that SSRI antidepressants likely to increase suicidal behaviour, watchdog announces - NICE guidelines also issued for treatment of depression

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