The USA’s Food and Drug Administration (FDA) recently introduced its “Tropical Disease Priority Review Voucher” law, which gives any company that develops a new drug for neglected diseases of the developing world a “priority review” voucher that can be used for any other drug brought before the agency. The intention is to stimulate the development of drugs for neglected diseases. (For details see our TropIKA.net news story here.)

However, the scheme is already under attack. One of its critics is blogger Merrill Goozner of the Center for Science in the Public Interest. He describes (here) the scheme as ‘ill-conceived’ and uses the example of a voucher that has been obtained by Novartis on the basis of its development of the antimalarial drug Coartem. Goozner points out that Coartem is already in widespread use in the countries which actually need it and obtaining approval for its use in the US serves no useful purpose. However, the company now holds a voucher that will allow it to obtain faster registration of a new ‘blockbuster’ drug for a first-world medical condition. (Alternatively it is allowed to sell the voucher to another company.) The FDA registration process is lengthy and, with a priority voucher, a company can get its products on to the lucrative US market some 6-18 months sooner.

There is no doubt that this scheme is well intentioned but are its critics right when they say that it will be misused? Let us know your views.