FDA says generics study is wrong

The FDA is questioning a study that found generics produced abroad included a notable degree of contamination. Bloomberg reports that the regulator is taking on a study presented at a February congressional hearing in which a Brigham & Women's Hospital researcher said he found contaminants among generics made abroad.

The FDA says it will be publishing its own study about generic heart medications, one that used a different testing approach. This approach, reports Bloomberg, did not find contaminants, and the regulator alleges that the Brigham & Women's Hospital researchers contaminated their own samples.

Concern about generics quality has not been hard to find over the last few weeks, particularly when it comes to disputes over drugs manufactured in India.

An FDA spokesperson tells Bloomberg that the regulator expects to publish its findings soon.

You must be a registered member of MMM to post a comment.
close

Next Article in Channel

 

Did you miss January's Top 40 Healthcare Transformers issue? Read how these inventors, strategists, entrepreneurs and wonks are challenging, disrupting and otherwise transforming the healthcare business. And join us April 30 to honor them at the Transforming Healthcare Dinner. Click here.