FDA Admits Contradictions in Generic Drug Labeling (Part 2)

“bioequivalent and therapeutically equivalent (interchangeable) with Wellbutrin XL 300 mg. And though they admitted “small differences in the pharmacokinetic profiles” of the two formulations, they said they “are not outside the established boundaries for equivalence nor are they different from other bupropion products known to be effective.” According to the FDA statement, the recurrent nature of depression provides a “scientifically reasonable explanation for the reports of lack of efficacy following a switch to a generic product.”

On October 2nd, an FDA spokeswoman told Dow Jones that the FDA considers the product to be “labeled appropriately.” Apparently, the unsupported statements are copied from the package insert for the original Wellbutrin XL but, as explained by the spokeswoman, the labeling of a generic drug must match that of the drug it copies and this is “the standard” for all generics. After a review of the FDA’s test requirements, ConsumerLab.com found that generic products are allowed to vary from one another by a fairly wide range. For example, a twice-a-day (SR) version of bupropion is permitted to release anywhere from 60 to 85 percent of its ingredient after four hours into a dissolution test. At the completion of such a test (which only runs eight hours), a product could be as little as 80 percent dissolved or over 100 percent dissolved and still be considered bioequivalent. ConsumerLab also discovered that the acceptable limits for once-a-day (XL) versions have been blacked-out or deleted in documents on the FDA website. Dr. Cooperman says the FDA rules “clearly need to be changed to protect consumers.”

The Dow Jones also reported that the FDA is considering a highly unusual step—new tests of Budeprion XL 300 to help them understand complaints about the product.

ConsumerLab.com suggests that if you find a generic version of Wellbutrin is not working for you, either have your doctor prescribe the brand-name version and indicate “Dispense as Written” or “Do Not Substitute.” You might also try a different generic or consider a different version of the drug. For example, if a once-a-day generic is not working, consider a twice-a-day (SR) or three-times-a-day version that will yield the same total daily dose. However, you will have to remember to take the medication on schedule.