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HSC attacks pharma and MHRA

The long awaited HSC report accuses pharma of being over promotional and the MHRA of being too lax in their regulation.

Pharma firms are over-zealously promoting their medicines for wider use just for the sake of profits, and the Medicines and Healthcare products Regulatory Agency (MHRA) is operating a ìlaxî regime, according to a damning report by the House of Commons health select committee.

ìLike any industry, drug companies need effective discipline and regulation, and these have been lacking,î said committee chairman David Hinchliffe.

The report called for a ìfundamental reviewî of the UK drug regulator MHRA, which had ìfailed to adequately scrutinise licensing dataî and whose post-marketing surveillance was ìinadequateî.

ìThe organisation has been too close to the industry,î the report said. ìWe are concerned that a rather lax regime is exacerbated by the MHRA's need to compete with other European regulators for licence application business.î

The group of MPs warned that ìthe aggressive promotion of medicines shortly after launch, the sheer volume of information that is received by prescribers and the `promotional hospitality masquerading as education' all contribute to the inappropriate prescription of medicines.î

The committee also said that pharma companies exercised too much control over the clinical trial process, sometimes designing trials to show a drug in the best possible light while failing to indicate the medicine's true effects on health outcomes relevant to the patient.

Calling for more restrictions on promotional material sent to doctors as well as better reporting of side-effects by doctors and patients, the panel said better information on medicines had to be made available.

Association of the British Pharmaceutical Industry director general Dr Richard Barker said that while the HSC had put forward a number of constructive proposals, any moves to limit the promotion of drugs would be a step backwards.

ìIt is critically important to patients, the NHS and the pharmaceutical industry that the public have trust in, and benefit from, advances in medicines,î he said.

Health minister Lord Warner said the government would consider the proposals and respond ìin due courseî.

The HSC investigation into the pharma industry's influence on drug development, research and promotion began in June 2004. The panel has heard testimony from drug companies, regulators, journalists and university researchers.

The full 126 page report can be downloaded here

30th September 2008

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