New drugs are twice as hard to get approved today as they were just a few years ago, according to a new study released Monday that outlines some of the challenges faced by pharmaceutical firms.
The study comes in the midst of a major downsizing in pharmaceutical research-and-development budgets, including the announcement that Pfizer Inc. will cut its local work force by 1,100 by next year.
A nearly one-in-five success rate of drugs moving through clinical trials to U.S. Food and Drug Administration approval in 2003 had declined to less than one in 10 by the end of last year, according to the study released by the Biotechnology Industry Organization.
"This groundbreaking study highlights the depth and breadth of risk inherent in the drug development process more comprehensively than any other previous study," said Alan Eisenberg, an executive vice president at BIO, in a statement.
Christopher Milne, associate director of the Tufts Center for the Study of Drug Development, said pharmaceutical firms are currently in a lull in developing new medicines. The lull comes partly because of more stringent FDA requirements imposed over the past few years, he said, and partly because so much time and money has gone into highly challenging research that doesn't pay quick dividends.
What's more, as an article by Megan McArdle last year in The Atlantic magazine stated, "New treatments need to prove that they have better efficacy, fewer side effects, or something like a longer-lasting dose that makes them superior to the pills already on the market."
This is an arduous and expensive process that can cost companies more than $1 billion in development costs, according to industry analysts.
But Milne said he expects the pace of drug discovery to pick up slightly in the near future as companies benefit from a decade of research in such areas as personalized medicine - medicines that target people with certain genetic makeups. This approach represents a significant breakthrough, he said, but is more complicated to study than the one-size-fits-all pharmaceuticals of the past.
"It may not go as far and as fast as developments in the '80s and '90s," Milne said. "Whether we're going to get to another golden age, I can't say."
Milne, who is no relation to former local Pfizer site leader George Milne, said drug breakthroughs inevitably will boost companies like Pfizer if they are able to increase productivity. And this, in turn, could mean an increase in local employment.
Pfizer's employee base will be reduced to 3,400 by next year at its Groton labs, from its previous level of about 4,500. Last year, Pfizer sold its former R&D headquarters in New London and, in 2009, slashed 500 local positions after purchasing Wyeth Pharmaceuticals.
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