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Next OTC statin doubted

Merck and Johnson and Johnson's bid to sell a cholesterol-lowering drug as OTC has been rejected by a US regulatory advisory panel.

Merck and Johnson and Johnson's bid to sell Mevacor, a cholesterol-lowering drug, as an over-the-counter, non-prescription medicine, was rejected by a US regulatory advisory panel by a mammoth vote of 20-3.

The Food and Drug Administration is likely to accept the panel's decision, which determined that the low dose version of Mevacor, part of the statin class of drugs used to lower cholesterol and heart disease risk, should not be sold without a prescription due to safety fears. The panel advised that patients should interact with a doctor to ensure they use the medication safely and effectively. In particular, the drug could cause birth defects and would be easily accessible to pregnant women, it was noted.

The approval of Mevacor for OTC status could have seen the opening of the floodgates for a whole wealth of medications for chronic, potentially life-threatening diseases to be sold in pharmacies. Indeed, the rejection is a setback to the pharma industry's efforts to target medications for chronic illnesses directly to the consumer. Last year, Merck gained approval to sell Zocor, another statin, to consumers in the UK who have to ask a pharmacist for it from 'behind the counter'. The news is also bleak for Bristol-Myers Squibb which had proposed to ask the FDA for approval to sell statin, Pravachol, as an OTC.

One argument for OTC statins was that evidence showed that more Americans needed to lower their cholesterol, and therefore statins could help improve national health, although critics have countered that potential patients should first consult a doctor.

30th September 2008

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