Biotech Values

[bladerunner1717]

Hattie,

When it comes to scientific/medical issues, I'm the dumbest person on this forum, so take what I say with the proberbial grain of salt. There are some brilliant people on this forum--I'm not one of them-- including some who are accomplished attorneys and who have great knowledge of the FDA regulations and biotech in general. I'm sure they can offer more than I can. Dew and others can do a better job than I can in explaining the FDA's concept of "bioequivalency," both in reards to active ingredients as well as inactive ingredients. Here are some articles below that I found helpful in my research.

Here is an article describing how the "FDA Ensures the Equivalence of Generic Drugs." This article can fairly be described as part of the "FDA propaganda machine," as the source for the article is the FDA's Director of the Office of Generic Drugs. Notice that the article does not ever use the term "identical." Furthermore, the article makes absolutely no reference to "inactive ingredients."


http://www.co.monterey.ca.us/personnel/benefits/GenericDrugFacts.pdf

Here is the official FDA response to the Wellbutrin XL controversy. The response is defensive, to say the least. I think the FDA well understands the potential problems that the Wellbutrin lawsuit could cause it, although the FDA is not a defendant in the lawsuit. It strikes me as incredibly self-serving and disingenuous for the FDA to make the assertion that the problems with generic Wellbutrin are a manifestation of the disease itself!!! I think this is proof of the FDA's sensitivity on the subject. The response, though, will give you a good sense of how the FDA decides whether a generic is "bioequivalent" or not.

http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm153270.htm

Here is an interesting review of a very recent finding by U.S. District Judge Berle Schiller in the Wellbutrin XL case.

http://www.law.com/jsp/article.jsp?id=1202458908406&FDA_Certification_No_Shield_to_Suit_Against_Generic_Drug_Makers

Here is Tod Cooperman's response to and critique of the FDA defense of its approval of Wellbutrin XL. I think it's informative.

http://www.consumerlab.com/news/FDA_Review_Budeprion_XL_Wellbutrin/4_16_2008/

I hope this helps.


Bladerunner