Posts Tagged ‘ Drug Approvals ’

80% of Approved US Drug Trials Done Outside US – What?!?

July 1st, 2010. By Hunter West

 

“As sponsors increase the number of foreign clinical trials in support of FDA marketing applications, the agency’s current method of using inspections to ensure human subject protections and data validity is becoming increasingly strained.”

– Daniel R. Levinson

A recent report by the inspector general of the Department of Health and Human Services reveals just how much pharmaceutical drug testing is going on in the shadow of foreign shores… 

Eighty percent, according to Daniel R. Levinson. That’s 80 percent for trials of all drugs approved for sale in the US by the Food and Drug Administration (FDA) in 2008. 

Wow. 

What’s more, 78 percent of all subjects who participated in clinical trials were enrolled in foreign sites for drugs given the nod that year. 

For some time now, there has been concern about the quality of drugs manufactured offshore. China comes to mind. Look at the heparin debacle of a few years ago. While there is massive incentive for drug companies to manufacture on foreign soil for the cost savings (and the better bottom line that goes along with it), the downside is that often you don’t know what you’re getting. 

And now, the revelation that most drug testing is going on somewhere else. 

That’s troubling, because in both cases—manufacturing and testing—the FDA lacks both the financial and staff resources to properly monitor things. 

Check out some of the numbers contained in Levinson’s report, released towards the end of June and summarized in The New York Times. The FDA inspected fewer foreign clinical trial sites, than Read the rest of this entry »

Tags: Clinical Trials, Drug Approvals, FDA
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