Editorials

Newly licensed drugs

The Medicines Act 1968 set up a licensing authority that grants a marketing authorisation (product licence) for a medicinal product only if it is effective and safe and of good quality. Once licensed, a drug can usually be prescribed by any doctor under the NHS. But general use of a newly licensed drug may be undesirable.

Firstly, the licensing process cannot define uncommon adverse effects. It is easier to measure common therapeutic benefits than rare, but important, reactions. The numerical problem is daunting. If n patients have been treated, and none has suffered a particular adverse effect, then we can be 95% sure that the true incidence of that adverse effect is between 0/n and 3/n.¹ Licensing decisions are based on trials involving on average around 1500 patients,² so at the time of licensing, a serious reaction that affects as many . . . [Full text of this article]

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