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Pharmaceutical regulatory regime should be overhauled, say MPs

Posted: 05 April 2005 | Subscribe Online


MPs have called for the “lax” pharmaceutical regulatory regime to be overhauled, saying it has let the interests of the industry override public safety, writes Mithran Samuel and Rich Heap.

In a report today, the health select committee says the adverse reactions caused by a number of drugs, such as the antidepressant Seroxat, have revealed fundamental flaws in the regulatory regime.

It says: “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.”

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

The report says the regulatory climate has allowed firms to suppress clinical trial results and aggressively promote drugs to prescribers, with GPs in particular overly influenced by the industry.

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It calls for all clinical trial results to be put on an independent register before companies are given a licence to market drugs and greater controls on promotional materials.

The report also recommends much tougher restrictions on what GPs can prescribe and says doctors should declare any significant gifts they receive from the industry, with a register kept by professional bodies.

The report is available from www.parliament.uk



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