How the FDA stifles new cures: the rising cost of clinical trials

Who are the regulators working for? #MSBlog #MSResearch

“With the FDA in the MS spotlight today you may find the following article of interest. It highlights the problems we (pharma and academia) are facing regarding drug development for MS. We need a new model. Which is why we have proposed the BPA (Big Pharma Alternative) to drug development. To get the BPA off the ground will require political will and stamina. May be then we will see real movement in the repurposing field and regulators that understand what academia is trying to do for people with MS and other diseases.”

Avik Roy. How the FDA Stifles New Cures, Part I: The Rising Cost of Clinical Trials. PHARMA & HEALTHCARE. Forbes 4/24/2012.


….. In 1975, the pharmaceuticals industry spent the equivalent of $100 million in today’s dollars for research and development of the average drug approved by the U.S. Food and Drug Administration, according to the Tufts Center for the Study of Drug Development. By 1987, that figure had tripled, to $300 million. By 2005, this figure had more than quadrupled, to $1.3 billion…..

….. The true amount that companies spend per drug approved is almost certainly even larger today. My Forbes colleague Matthew Herper recently totaled R&D spending from the 12 leading pharmaceutical companies from 1997 to 2011, and found that they had spent $802 billion to gain approval for just 139 drugs: a staggering $5.8 billion per drug…..

….. The biggest driver of this phenomenal increase has been the regulatory process governing Phase III clinical trials of new pharmaceuticals on human volunteers. One reason: Phase III clinical trials have become far larger and more complex than they were in the past. From 1999 to 2005, as the Tufts group has shown, the average length of a clinical trial increased by 70 percent; the average number of routine procedures per trial increased by 65 percent; and the average clinical trial staff work burden increased by 67 percent. On top of that, increasingly stringent enrollment criteria and trial protocols resulted in 21 percent fewer volunteers being admitted into trials and 30 percent more enrollees dropping out before completion of the tests…..

……. Overall, Phase III trials now represent about 40 percent of pharmaceutical companies’ R&D expenditures. But this often-cited statistic actually understates the gravity of the burden. This is because overall R&D expenditures include all pharmaceutical candidates that a company tests—including hundreds that never reach the Phase III trial stage. When we confined our analysis to those drugs that actually get approved, we found that Phase III clinical trials typically represent 90 percent or more of the cost of developing an individual drug all the way from laboratory to pharmacy……

Click here to read the full article

23 Dec 2012
“Why is a drug license necessary? I posted on this topic last week, under the title off-label prescribing. Each country or region has an agency that licenses drugs; in Europe it is the European Medicines Agency (EMA), in the US 
22 Dec 2012
BPA: drug repurposing. #MSBlog: to repurpose or not, that is the question? “The length of time it takes to develop new drugs is frustratingly long and expensive. A short-cut is to repurpose existing drugs; i.e. drugs that have 
21 Dec 2012
Preliminary poll results: big pharma alternative (BPA). “The response to this initiative has been very poor; only 57 votes in 2 weeks. Quite depressing really!!” “I am really not sure if the repurposing of off-patent drugs for MS is 

About the author

Prof G

Professor of Neurology, Barts & The London. MS & Preventive Neurology thinker, blogger, runner, vegetable gardener, husband, father, cook and wine & food lover.


  • All this does is make sure that only big pharma has any chance of performing trials and is therefore anti-competitive.

  • Isnt this because BP is targeting on drugs for harder to treat diseases? How many of these 139 drug actually cured any disease? In MS case any drug that was introduced o market is FAR away from cure.

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