NCPA - National Center for Policy Analysis

Drug Approvals Down Worldwide

January 17, 2003

According to the British Medical Journal, an editorial in Nature Reviews Drug Discovery points to an alarming fall in new drug approvals in the United States and worldwide.

  • 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.

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...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.

The editorial says that the hardest skill to teach new recruits to the drug discovery business is the process of turning ideas into drugs.

A report in the same journal says that selecting research targets for new drugs is strongly influenced by financial considerations. However, it difficult to forecast potential sales of new drugs.

For example, most so-called blockbuster drugs -- those with worldwide sales of more than $1 billion -- were not forecast to be big sellers. The initial sales forecast for tamoxifen, for example, was only $160,000.

The report adds, "The point here is not to criticize those who prepare sales forecasts, but to emphasize the inherently unpredictable nature of sales forecasting, particularly for truly innovative medicines."

Source: Roger Dobson, "Lack of new drugs is reaching crisis, point, says review," British Medical Journal, January 18, 2002.


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