By Roger Dobson Abergavenny

The number of new drugs approved in the United States last year fell to half the annual average over the past five years.

Only 15 new drugs were approved by the Food and Drug Administration in 2002, compared with a five year annual average of 31, says an editorial in Nature Reviews Drug Discovery (2003;2:3).

It warns that the fall in the number of new drugs is reaching crisis point and says that new drug applications are down worldwide.

It says that the European parliament's environment committee has asked Thomas Lonngren, executive director of the European Agency for the Evaluation of Medicinal Products, to explain the fall in the number of applications.

"The miserable tally of new drug approvals in 2002--at the time of writing, just 15 new molecular entities had passed FDA review--well down even on the depressingly low average for the last five years--31 a year, shows just how rare an event success can be in the drug discovery world. And with new drug application numbers down worldwide, concern is beginning to spread beyond the borders of the pharmaceutical industry," says the editorial.

"Faced with sparsely populated pipelines, companies are beginning to shift research budgets towards more aggressive marketing of existing products. These are worrying times."

It points out that the process of turning ideas into drugs is acknowledged as being the hardest skill to teach new recruits to the drug discovery business.

And a report in the same journal (2003;2:63-9) says that selecting research targets for new drugs takes place in an environment that is strongly influenced by financial considerations.

It warns that most so called blockbuster drugs were not forecast to be big sellers. The initial sales forecast for tamoxifen, it points out, was a modest £100 000 ($160 000; ¤150 000).

"To select a proposed research target, a range of issues needs to be evaluated. The first, and perhaps most important, is what constitutes an improved medicine. Many descriptors of varying utility are used to describe new medicines.

"The current favourite is 'blockbuster drug,' which is much used by stock analysts to indicate annual sales in excess of US $1 billion." The authors say that most marketing departments did not forecast the success of these drugs, at the time the decision was made to select the target.

The report adds, "Furthermore, if informal conversations are a reliable guide, several projects that resulted in multi-million pound sales were not strongly supported at the phase of target selection, even by the research manager. The point here is not to criticise those who prepare sales forecasts, but to emphasise the inherently unpredictable nature of sales forecasting, particularly for truly innovative medicines."

The journal is available at www.nature.com/nrd

Drugs with annual sales in excess of $1bn whose success was not anticipated at the time they were suggested as research targets

Drug Position in class (sales) Indications Initial forecast of annual sales