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.