Q. I would like to know what has happened with FDA’s investigation into generic Wellbutrin (bupropion). Has anyone heard about the results of the studies that were supposed to be completed by March 2013?
There is not a word on the FDA website. Even if the results were late, it’s now been several months.
I was on the brand for years since in the past the generic didn’t work for me. Now my insurance company will not pay for the brand name so I’m forced to switch back to the generic. I’m worried about getting depressed again.
A. Last fall the FDA admitted that one generic form of bupropion (Budeprion XL 300) was not bioequivalent to the brand name Wellbutrin XL 300. The formulation was removed from the market. Visitors to this website played a role in bringing this problem to the agency’s attention.
At that time the FDA asked other generic manufacturers to complete further tests by March 31, 2013. We have repeatedly asked the FDA for the results of these tests but we have not yet seen a report or any data.
We find it discouraging that the FDA has not released data about other generic bupropion formulations. The most recent response from the agency suggests that it won’t be releasing the kind of specific information we need to assess the bioequivalence of the other long-acting generic bupropion products that remain on the market. That does not seem patient friendly or transparent. The FDA has been bragging about its effort to be transparent, but when it comes to generic drugs, getting data is like pulling teeth. The agency seems to say, “trust us, we know what we are doing.” But we tend to follow Ronald Reagon’s famous admonition, “Trust, but verify.” We would like to see the data so we can verify for ourselves that what the FDA says is true.
Just recently we learned that a bupropion SR product made by Wockhardt of India might have caused problems. Although the FDA has banned importation of products from Wockhardt’s Wuloj plant (where bupropion SR was made), the agency has not called for removal from pharmacy shelves. To learn more about this odd affair, here is a link.
Your doctor may be able to appeal to the insurance company on your behalf if the generic does not work as well as the brand name did. Sadly, though, insurance companies fall back on the FDA’s assurance that generic drugs are identical to brand name medicines, even though we cannot see the data to back up this assertion.