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  • Novartis accused of exploiting loophole in drug scheme


The Swiss drug firm Novartis has come under fire for accepting a benefit aimed at rewarding the creation of new drugs for developing countries — for a drug that was first registered a decade ago.

The award, issued by the US Food and Drug Administration (FDA), is worth US$100 million but it is not a cash prize. It entitles its recipient to fast-track registration of drugs with the FDA — six months instead of the standard ten months.

Novartis, which has received the first of these "priority review vouchers", has accepted it for the malaria drug Coartem — which was first registered in 1999. This was permitted because the scheme applies to drugs that have not previously been registered in the United States, not just to completely new drugs.

Critics have deemed this an abuse of the system which they say is flawed because it fails to prioritise new drugs.

One such critic, Bernard Pecoul — director of Drugs for Neglected Diseases, a not-for-profit partnership that develops drugs — fears other companies will follow Novartis' lead and register old drugs, "to benefit from a windfall". He also says that the current method will not reward or encourage innovation.

But others say that the large sum might encourage the company to put other drugs into late-stage clinical trials.

Novartis defended the decision, saying that it had planned to register the drug long before winning the award. It also believes that its track record in neglected-diseases research merits a voucher.

Link to full article in The Lancet*

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