Archive for March 17th, 2008

Finally FDA Standards for Generics are Questioned

March 17, 2008

I don’t know about you, but with my health issues I’ve been a big time consumer of prescription drugs for years. And I’ve almost always noticed the difference between the effectiveness of generics vs name brand on my body.  When I’ve asked my doctors what they take, they take brand for the same reason. Now I read that the FDA rigidly applies a standard of “bioequivalence” when testing generics . That is, the generic must deliver the same active ingredient, in the same amount, at the same rate as the original brand drug. This does not take into account “therapeutic equivalence”, which is the abililty of the two drug formulations to ease symptoms or cure disease. The inactive ingredients can result in variations  in the various formulations and effects of various generics made by various manufacturers.  I don’t know about you, but as a patient and a consumer various variations don’t make me feel warm, fuzzy and safe. The kicker here is that generics are touted as copycat drugs, or replicas of the originals. They’re not.  Read the whole article in todays LA Times.