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Published on 17 June 2008

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Drugs approval process “too tight”

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A new survey has found that the development of new drugs is being threatened by investor wariness and competition from generic rivals.

The study by American law firm Marks & Clerk asked almost 500 biotechnology and pharmaceutical executives in the US and the UK for their views on the US Food and Drug Administration’s increasing reluctance to give marketing approval for new drugs.

Some 90% of respondents felt that funding for research into new drugs would become harder to secure as investors took the “safer” option of later-stage drug development. Almost eight in ten (78%) felt that the climate surrounding biotechnology innovation had declined in the past year.

And 72% of those surveyed said that future drug developments would become much harder to deliver unless the drug approval process was relaxed.

“Biotechnology represents the future of modern medicine, where yesterday’s innovators now struggle with dwindling pipelines, generic competition and a chequered research and development record,” said Dr Gareth Williams, partner at Marks & Clerk and co-author of the report.

“Whilst the long-term view has not changed, we are seeing a short to mid-term funding gap in the current climate, which poses a genuine risk to essential, early-stage research and development.”

Copyright © PA Business 2008

US Food and Drug Administration



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