Drug approvals down worldwide

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 is 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. [See the table]
http://bmj.com/cgi/content-nw/full/326/7381/119/Fu1

The report adds, "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."

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

For text http://bmj.com/cgi/content/full/326/7381/119?etoc
For more on FDA Drug Approval http://www.ncpa.org/iss/reg/

FMF Policy Bulletin\22 January 2003

Publish date: 29 January 2003
Views: 355

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The views expressed in the article are the author’s and are not necessarily shared by the members of the Foundation. This article may be republished without prior consent but with acknowledgement to the author.

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